Proactiveinvestors USA & Canada VentriPoint Diagnostics Ltd. https://ca.proactiveinvestors.com Proactiveinvestors USA & Canada VentriPoint Diagnostics Ltd. RSS feed en Mon, 25 Mar 2019 03:52:04 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Ventripoint showcases its latest VMS+3.0 cardio-monitoring system at American College of Cardiology's 68th Annual conference ]]> https://ca.proactiveinvestors.com/companies/news/216763/ventripoint-showcases-its-latest-vms30-cardio-monitoring-system-at-american-college-of-cardiology-s-68th-annual-conference-216763.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCQB:VPTDF) said Tuesday that it staged a successful hands-on demonstration of its next-generation VMS+3.0 system at the American College of Cardiology’s 68th Annual Scientific Session & Expo in New Orleans over the weekend (March 16-March 18).

Not yet available for sale, the VMS+3.0 system is Ventripoint’s latest version of its machine, which revolutionizes the way doctors treat heart patients as it can give accurate and rapid volumetric information about all four chambers of the heart.

READ: VentriPoint Diagnostics' heart monitoring tech further boosted by agreement with Canadian government

It is the only technology in the world that can perform such an analysis of all four chambers using data from a conventional 2D (two dimensional) eco-cardiogram (in other words an ultrasound test).

Ventripoint's most up-to-date 3.0 system uses sensor technology, which allows for patients to move during the imaging portion of the examination, and it is compact and portable enough that it can be set up within minutes.

The Toronto company seized the opportunity to showcase the latest advances in its technology at the ACC’s Annual Scientific Session & Expo, which was attended by nearly 20,000 cardiologists.

The VMS+3.0 system is for investigational use only.

READ: Ventripoint Diagnostics reports progress for latest VMS +3.0 heart monitoring system

Ventripoint has developed a suite of applications to monitor heart disease. Its VMS+ system is the first AI tool for measuring the function of the entire heart using ultrasound.

Ventripoint shares closed at C$0.175 in Canadian trade on Monday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Tue, 19 Mar 2019 08:48:00 -0400 https://ca.proactiveinvestors.com/companies/news/216763/ventripoint-showcases-its-latest-vms30-cardio-monitoring-system-at-american-college-of-cardiology-s-68th-annual-conference-216763.html
<![CDATA[News - Ventripoint Diagnostics' stock rockets after VMS System approved for sale, clinical use in China ]]> https://ca.proactiveinvestors.com/companies/news/215822/ventripoint-diagnostics--stock-rockets-after-vms-system-approved-for-sale-clinical-use-in-china-215822.html VentriPoint Diagnostics Ltd’s (CVE:VPT) (OTCQB:VPTDF) heart analysis technology was boosted Tuesday after its partner Ma’anshan YuTian Medical Technology Company Ltd was granted approval by Chinese regulatory authorities to sell Ventripoint's VMS (QAS-R) system in China.

The Canadian heart-focused medtech group’s Chinese partner received China Food and Drug Administration (CFDA) approval and a certificate of production for the company’s VMS QAS-R system, which is used for clinical analysis of the right ventricle of the heart.

Shares in VentriPoint soared nearly 65% to $0.18 in the OTC Markets, while it was up nearly 13% to $0.23 in the Canadian Venture Exchange.

Dr George Adams, the chief executive at VentriPoint said China represents a huge opportunity.

READ: VentriPoint Diagnostics eyeing big opportunity after winning first US customer for VMS plus

“We commend our Chinese partners for their diligence in achieving approval for the VMS,” said Dr Adams in a statement. “Now all 32,000 hospitals in China and its territories have access to a 2D ultrasound analytical system to accurately assess right-heart function.”

The company had earlier received Good Manufacturing Practice (GMP) certification for a manufacturing facility in Ma’anshan, Anhui Province. The factory is fully functioning and scaled to produce the VMS at a significant rate to address the Chinese market. Yutian Technology has also received the Chinese equivalent of an ISO60601 for the VMS, which allows it to be used in hospitals in China.

The company said marketing efforts in China have been cranked up and are “well underway” with the creation of a multi-channel distribution network. The medical-device market in China was pegged at over US$58 billion in 2017 and experienced 20% growth from 2015 to 2016. There are over 2,500 Tier 1 hospitals and a total of 32,000 hospitals, with over 1,000 new hospitals currently under construction.

“We are looking forward to the rapid rollout of the VMS as we have a number of key leading hospitals which have been preparing to acquire the system,” said Yutian Technology CEO Kevin Li.

Heart disease is a top healthcare issue in China, with 23% of hospital admissions related to cardiovascular conditions. This is almost twice the 13% rate in North America. In addition, it is common to have an echocardiogram prior to any surgery and so the rate of exams is much higher than the rate in the United States. As a result, China represents a large and rapidly growing market for the VMS.

It was in May 2017, that YuTian Technology made a submission to the CFDA for approval to sell the VMS in China and to certify the factory to build the VMS system.

VentriPoint's technology is aimed at identifying heart problems early on and provides medics with a more efficient and cost-effective method for evaluating cardiac volumes and ejection fractions.

-- (Updates with massive spike in share price) -- 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 05 Mar 2019 08:14:00 -0500 https://ca.proactiveinvestors.com/companies/news/215822/ventripoint-diagnostics--stock-rockets-after-vms-system-approved-for-sale-clinical-use-in-china-215822.html
<![CDATA[News - Ventripoint Diagnostics reports progress for latest VMS +3.0 heart monitoring system ]]> https://ca.proactiveinvestors.com/companies/news/214015/ventripoint-diagnostics-reports-progress-for-latest-vms-30-heart-monitoring-system-214015.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCQB:VPTDF) announced Tuesday that the development stage for its next-generation VMS +3.0 heart-monitoring system is nearing completion.

Usability studies are now underway at a pair of leading Canadian hospitals to establish the effectiveness and ease of use of VMS +3.0 and the Toronto-based company will seek regulatory approval in North America and Europe as soon as these studies are finished.

READ: VentriPoint Diagnostics eyeing big opportunity after winning first US customer for VMS plus

VMS is a machine, which revolutionizes the way doctors treat heart patients as it can give accurate and rapid volumetric information about all four chambers of the heart.

It is the only technology in the world that can perform such an analysis of all four chambers using data from a conventional 2D (two dimensional) eco-cardiogram (in other words an ultrasound test).

Ventripoint's latest system uses sensor technology, which allows for patients to move during the imaging portion of the exam, and it is compact and portable enough that it can be set up within minutes.

READ: VentriPoint Diagnostics shares nudge higher as it updates on sales efforts

“Replacing the old magnetic tracking system with our new tracking sensor technology enables patient repositioning during the examination,” said George Adams, CEO of Ventripoint. “This feature eliminates the usual restrictions on the person being scanned and will be instrumental in the ease of use by clinicians for both children and adults.”

Ventripoint is also developing a workstation version of the VMS + 3.0 software, which allows for the analysis of echocardiograms in a reading room elsewhere in the hospital. This will permit sonographers to continue to scan new patients, while studies are analyzed by cardiologists.

Ventripoint shares held steady at C$0.16 in morning trade on Tuesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Tue, 05 Feb 2019 09:36:00 -0500 https://ca.proactiveinvestors.com/companies/news/214015/ventripoint-diagnostics-reports-progress-for-latest-vms-30-heart-monitoring-system-214015.html
<![CDATA[News - Ventripoint Diagnostics awarded medical device single audit program certification ]]> https://ca.proactiveinvestors.com/companies/news/213079/ventripoint-diagnostics-awarded-medical-device-single-audit-program-certification-213079.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCMKTS:VPTDF), the heart monitoring tech group, has been awarded medical device single audit program (MDSAP) certification.

The Toronto-based company is behind the VMS Plus, which is an accurate AI (artificial intelligence) tool for measuring whole heart function using conventional ultrasound.

READ: Ventripoint Diagnostics increases placing to $1.5M due to demand

"We are very proud of this latest achievement, which solidifies Ventripoint's abilities to continue to produce and sell its VMS+ System globally and positions us at the forefront of quality assurance," said Dr. Alvira Macanovic, Ventripoint's director of regulatory affairs and quality assurance.

The MDSAP became a mandatory requirement by Health Canada on January 1 this year.

It allows a single regulatory audit of a medical device manufacturer's quality management system to satisfy multiple regulatory jurisdictions, including Canada, United States, Japan, Brazil, and Australia, reducing the need for duplicate audits.

Yesterday, Ventripoint announced it had increased its previously announced non-brokered private placement to $1.5 million from $1 million due to investor demand.

The proceeds will be used for sales and marketing, development and general working capital.

The company has closed the order book on the offering and intends to complete the offering of debenture units at $1,000 per unit by January 25 this year.

Contact Giles at giles@proactiveinvestors.com

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Tue, 22 Jan 2019 08:47:00 -0500 https://ca.proactiveinvestors.com/companies/news/213079/ventripoint-diagnostics-awarded-medical-device-single-audit-program-certification-213079.html
<![CDATA[News - Ventripoint Diagnostics increases placing to $1.5M due to demand ]]> https://ca.proactiveinvestors.com/companies/news/212998/ventripoint-diagnostics-increases-placing-to-15m-due-to-demand-212998.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCMKTS:VPTDF) has increased its previously announced non-brokered private placement to $1.5 million from $1 million due to investor demand.

The proceeds will be used for sales and marketing, development and general working capital, the Toronto-based, heart-focused medtech company said in a statement.

READ: Ventripoint Diagnostics arranges C$1M private placement of debenture units

The company has closed the order book on the offering and intends to complete the offering of debenture units at $1,000 per unit by January 25 this year.

Each unit of the offering will include a principal amount of C$1,000 in convertible, unsecured debentures maturing in three years, as well as 6,000 common share purchase warrants, with each warrant exercisable for one common share at C$0.175 per share for 18 months.

The debentures will have an annual interest rate of 6.5%, and the company may pay a finder's fee of up to 7% of the gross proceeds.

Ventripoint uses an artificial intelligence (AI) method known as knowledge-based reconstruction to create applications monitoring heart disease.

Contact Giles at giles@proactiveinvestors.com

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Mon, 21 Jan 2019 13:14:00 -0500 https://ca.proactiveinvestors.com/companies/news/212998/ventripoint-diagnostics-increases-placing-to-15m-due-to-demand-212998.html
<![CDATA[Media files - VentriPoint's VMS System used to test 500 Sarcoidosis patients in Netherlands ]]> https://ca.proactiveinvestors.com/companies/stocktube/11765/ventripoint-s-vms-system-used-to-test-500-sarcoidosis-patients-in-netherlands-11765.html Wed, 09 Jan 2019 17:28:00 -0500 https://ca.proactiveinvestors.com/companies/stocktube/11765/ventripoint-s-vms-system-used-to-test-500-sarcoidosis-patients-in-netherlands-11765.html <![CDATA[News - Ventripoint Diagnostics arranges C$1M private placement of debenture units ]]> https://ca.proactiveinvestors.com/companies/news/212243/ventripoint-diagnostics-arranges-c1m-private-placement-of-debenture-units-212243.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCMKTS:VPTDF) said Wednesday that it plans to complete a non-brokered private placement of as much as C$1 million debenture units.

The proceeds will be used for sales and marketing, development and general working capital, the Toronto-based, heart-focused medical device company said in a press release.

READ: Ventripoint Diagnostics shares pump after positive findings from sarcoidosis study in Netherlands using VMS

Each unit of the offering will include a principal amount of C$1,000 in convertible, unsecured debentures maturing in three years, as well as 6,000 common share purchase warrants, with each warrant exercisable for one common share at C$0.175 per share for 18 months.

The debentures may be converted at any time following the date of issuance at C$0.155 per common share.

Shares of Ventripoint slipped C$0.01 to C$0.18 in Tuesday’s Canadian trading. They were down US$0.01 to US$0.13 on the OTC Markets.

Depending on market conditions, Ventripoint said it has the right to increase the maximum gross proceeds under the offering, subject to the approval of the TSX Venture Exchange.

The debentures will have an annual interest rate of 6.5%, and the company may pay a finder's fee of up to 7% of the gross proceeds.

Ventripoint uses an artificial intelligence (AI) method known as knowledge-based reconstruction to create applications monitoring heart disease.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Wed, 09 Jan 2019 08:29:00 -0500 https://ca.proactiveinvestors.com/companies/news/212243/ventripoint-diagnostics-arranges-c1m-private-placement-of-debenture-units-212243.html
<![CDATA[News - Ventripoint Diagnostics shares pump after positive findings from sarcoidosis study in Netherlands using VMS ]]> https://ca.proactiveinvestors.com/companies/news/212069/ventripoint-diagnostics-shares-pump-after-positive-findings-from-sarcoidosis-study-in-netherlands-using-vms-212069.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCMKTS:VPTDF) revealed its VMS heart monitoring system was again proving its worth - after positive results from the St Antonius Hospital in the Netherlands, sending shares in the company higher.

Cardiac specialists there are using the med-tech group's VMS system to study patients with sarcoidosis, an inflammatory disease, which affects multiple organs in the body, including the heart.

READ: Ventripoint says Johns Hopkins doctor cited VMS+ heart analysis system’s clinical feasibility at Milan conference

The cause of Sarcoidosis is unknown and affects about 50,000 people a year in the US. Between 150,000 and 200,000 people have chronic sarcoidosis.

Pulmonary hypertension occurs in 6% to 74% of patients with sarcoidosis. This is a serious complication leading to early death.

Around 500 sarcoidosis patients have been studied at the Dutch hospital so far. The focus is on the early detection of pulmonary hypertension.

The study has found almost 20 patients with confirmed pulmonary hypertension and the cardiac team will continue to monitor the right-ventricular function of these patients, using the Ventripoint solution, to better understand the progress of the disease.

"The right heart is difficult to assess, and in patients with pulmonary disease, this challenge is even more difficult," said Dr Marloes Huitema, MD Cardiology at St. Antonius Hospital.

"Ventripoint provides a solution that allows us to overcome these barriers and might be an alternative to MRI, which is costly, time consuming and not possible for all patients.

"Furthermore, in those patients with pulmonary hypertension, the Ventripoint technology gives us an ability to repeatedly evaluate the right-ventricular dimensions with a rapid, inexpensive, non-invasive procedure to determine therapeutic efficacy."

Ventripoint noted that there were many potential applications for its VMS technology; providing confidence in the volumetric measurements of patients with accuracy comparable to cardiac MRI (magnetic resource imaging) is its strength.

The group's VMS Plus heart monitoring technology measures whole heart function using conventional ultrasound.

The company has developed a suite of applications for all major heart diseases and wants to commercialize the technology to improve heart care.

Shares in Toronto added almost 12% to $0.19.

Contact Giles at giles@proactiveinvestors.com

Follow him on Twitter @ Gile74

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Mon, 07 Jan 2019 08:43:00 -0500 https://ca.proactiveinvestors.com/companies/news/212069/ventripoint-diagnostics-shares-pump-after-positive-findings-from-sarcoidosis-study-in-netherlands-using-vms-212069.html
<![CDATA[News - Ventripoint says Johns Hopkins doctor cited VMS+ heart analysis system’s clinical feasibility at Milan conference ]]> https://ca.proactiveinvestors.com/companies/news/211245/ventripoint-says-johns-hopkins-doctor-cited-vms-heart-analysis-systems-clinical-feasibility-at-milan-conference-211245.html Ventripoint Diagnostics Ltd (CVE:VPT) (OTCMKTS:VPTDF) said Friday that a Johns Hopkins doctor cited the clinical feasibility of the company’s VMS+ 3.0 heart analysis system at a cardiovascular imaging conference in Milan.

The Toronto-based medical care device company said in a press release that Dr Shelby Kutty recently gave a presentation on a study of the system at EuroEcho 2018. The study was conducted at the University of Nebraska Medical Center Children's Hospital, according to Ventripoint.

READ: VentriPoint Diagnostics reveals that University of Chicago will assess its heart analysis system

"This study presented at EuroEcho 2018 demonstrates the clinical feasibility of quantifying right and left ventricular volumes and function using VMS+ on two- and three-dimensional images acquired from multiple cardiac ultrasound systems,” Shutty said in a statement.

More than 4,200 people attended the conference, according to Ventripoint.

The response to the system at EuroEcho 2018 indicates a significant need for a cost-effective and accurate approach to volumetric measurements of all four chambers of the heart, according to Mehran Mehrtash, vice president for worldwide distributor sales at Ventripoint.

“The VMS+ technology sets us apart and can make a valuable difference in patient outcomes," Mehrtash said.

The system is not yet available for commercial sale and is for investigational use only, according to Ventripoint.

Shares climbed C$0.01 to C$0.17 in Thursday’s Canadian trading.

Last month, the company told investors that the University of Chicago's medical center was preparing to study the VMS+ system.


Contact Dennis Fitzgerald at dennis@proactiveinvestors.com
 

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Fri, 14 Dec 2018 08:30:00 -0500 https://ca.proactiveinvestors.com/companies/news/211245/ventripoint-says-johns-hopkins-doctor-cited-vms-heart-analysis-systems-clinical-feasibility-at-milan-conference-211245.html
<![CDATA[News - VentriPoint Diagnostics to showcase its VMS Plus heart system at Milan conference ]]> https://ca.proactiveinvestors.com/companies/news/210235/ventripoint-diagnostics-to-showcase-its-vms-plus-heart-system-at-milan-conference-210235.html Medtech group VentriPoint Diagnostics Ltd (CVE:VPT) will showcase its next-generation VMS Plus heart imaging system at EuroEcho 2018 in Milan.

With nearly 4,000 healthcare professionals from over 90 countries around the world, EuroEcho is one of the world's largest cardiovascular imaging congress.

READ: VentriPoint Diagnostics reports that its new approved heart technology being used by internationally renowned pediatric cardiologist

"We are excited to showcase our next-generation VMS+ System to the European market. We will have live scanning in the booth to provide the opportunity for hands-on use by the cardiology community," said Mehran Mehrtash, the vice-president, the worldwide distributor of sales at VentriPoint.

The next-generation system is designed to use Artificial Intelligence (AI) to assess the performance of all four chambers of the heart from standard 2D echo images.

Artificial Intelligence (AI) is the future of cardiac imaging and is transforming clinical outcomes, says the company.

The conference is in Milan, Italy and runs from December 5 to 7, providing hands-on demonstrations of the next-generation VMS+ System.

Contact Giles Gwinnett at giles@proactiveinvestors.com

Follow Giles on Twitter @Gile74

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Thu, 29 Nov 2018 09:14:00 -0500 https://ca.proactiveinvestors.com/companies/news/210235/ventripoint-diagnostics-to-showcase-its-vms-plus-heart-system-at-milan-conference-210235.html
<![CDATA[News - VentriPoint Diagnostics reports that its new approved heart technology being used by internationally renowned pediatric cardiologist ]]> https://ca.proactiveinvestors.com/companies/news/209595/ventripoint-diagnostics-reports-that-its-new-approved-heart-technology-being-used-by-internationally-renowned-pediatric-cardiologist-209595.html Medtech group VentriPoint Diagnostics Ltd (CVE:VPT) gave another operational update on Tuesday, saying its VMS+ technology for the heart was now being used for analysis of the left ventricle as well as the right by an internationally renowned pediatric cardiologist in Germany.

As reported earlier this week, Ventripoint extended its reach into the heart imaging market as it revealed its VMS+ software had been approved for analyzing 3D echo images generated by any commercially available 3D echocardiography system.

READ: VentriPoint Diagnostics' heart monitoring tech further boosted by agreement with Canadian government

Renowned Dr Kai Thorsten Laser has now begun using the VMS+ software for 3-D echo analysis of the left ventricle at the HDZ NRW Heart and Diabetes Center in Germany, the firm said in a regulatory release Tuesday.

"We have experienced very positive results and accuracy using Ventripoint's VMS+ system on the right ventricle," said Dr Thorsten Laser.

"We now look forward to performing 3D analysis to validate accuracy of volumes of the left ventricle and in turn, improve cardiac patient care," he added.

Now that the company's software has been approved for all four chambers of the heart, the hospital will be using the Ventripoint VMS+ system for left ventricular volume analysis, particularly for pediatric patients.

There are many potential applications for this innovative technology, the firm says, which provides confidence in the volumetric measurements of patients with accuracy comparable to cardiac MRI.

Shares in Toronto were unchanged at $0.185.

Contact Giles Gwinnett at giles@proactiveinvestors.com

Follow Giles on Twitter @Gile74

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Tue, 20 Nov 2018 08:54:00 -0500 https://ca.proactiveinvestors.com/companies/news/209595/ventripoint-diagnostics-reports-that-its-new-approved-heart-technology-being-used-by-internationally-renowned-pediatric-cardiologist-209595.html
<![CDATA[News - VentriPoint Diagnostics says its innovative heart machine can also analyse 3D echo images ]]> https://ca.proactiveinvestors.com/companies/news/209480/ventripoint-diagnostics-says-its-innovative-heart-machine-can-also-analyse-3d-echo-images-209480.html VentriPoint Diagnostics Ltd (CVE:VPT) says it has extended its reach into the potential heart imaging market.

The Toronto-based medtech group said that its VMS+ software approved for analysis of all four chambers of the heart can be used for the analysis of 3D echo images generated by any commercially available 3D echocardiography system.

READ: VentriPoint Diagnostics receives order for its VMS Plus - from leading cardiac hospital in Toronto

"This extends our product line to a software solution that increases our footprint in the cardiac medical imaging market," added the firm in a brief regulatory statement.

Ventripoint's heart analysis machine provides medics with a more efficient and cost-effective method for evaluating cardiac volumes and ejection fractions.

Its accuracy already matches that of the MRI (Magnetic resonance imaging (MRI) scan), the gold standard, so there is a significant opportunity for this unique piece of equipment in the market.

"We are looking forward to offering cardiac centres the opportunity to purchase the VMS+ Software to complement their existing 3D echo equipment," said Desmond Hirson, president of Ventripoint Diagnostics.

Ventripoint's strategy is to build value for customers by providing tools to improve clinical outcomes and standard of care for pediatric and adult cardiac patients.

Last week, the group unveiled another boost for its technology  - an agreement with the Government of Canada to develop further its heart monitoring system.

The National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory support and conditional funding to share costs of a project designed to accelerate the company's VMS+ system's next-generation product.

Shares are at $0.185 in Toronto at the time of writing.

Contact Giles Gwinnett at giles@proactiveinvestors.com

Follow Giles on Twitter @Gile74

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Mon, 19 Nov 2018 09:06:00 -0500 https://ca.proactiveinvestors.com/companies/news/209480/ventripoint-diagnostics-says-its-innovative-heart-machine-can-also-analyse-3d-echo-images-209480.html
<![CDATA[News - VentriPoint Diagnostics' heart monitoring tech further boosted by agreement with Canadian government ]]> https://ca.proactiveinvestors.com/companies/news/209195/ventripoint-diagnostics-heart-monitoring-tech-further-boosted-by-agreement-with-canadian-government-209195.html VentriPoint Diagnostics Ltd (CVE:VPT) unveiled another boost for its technology  - an agreement with the Government of Canada to develop further its heart monitoring system.

The National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) will provide advisory support and conditional funding to share costs of a project designed to accelerate the company's VMS+ system's next-generation product.

READ: VentriPoint Diagnostics receives order for its VMS Plus - from leading cardiac hospital in Toronto

The goal is to extend the visualization extracted from 2D ultrasound images of the heart to construct and visualize 4D images.

"Currently, 4D products are available in the marketplace and while they have improved significantly, they still are only able to get useable images in 60% of people for the basic heart analysis and, therefore, are only used for research purposes," said Ventripoint in a statement.

Ventripoint's heart analysis machine provides medics with a more efficient and cost-effective method for evaluating cardiac volumes and ejection fractions.

Its accuracy already matches that of the MRI (Magnetic resonance imaging (MRI) scan), the gold standard, so there is a significant opportunity for the unique 4D VMS+ system in the market, the firm reckons.

Also in today' statement, Ventripoint revealed it had entered into a business development contract for a term of six months.

Under the deal, which is subject to the approval of the TSX venture exchange, Ventripoint will pay the consulting fee of US$150,000  via shares at the end of the term, with the number of shares being determined by the market price at the time of issue.

On Monday, the company said that St. Michael's Hospital in Toronto had ordered its VMS Plus system to use it to assess cardiac patients

Dr Howard Leong-Poi and Dr Chi-Ming Chow are spearheading the VMS+ acquisition.

Leong-Poi is the head of the cardiology division at St. Michael's Hospital and a clinician-scientist in the Keenan Research Centre for biomedical science.

"We are very pleased to have the interest and commitment from such a high profile cardiac institution in our own backyard," said Desmond Hirson, the president of VentriPoint.

"We believe that our AI technology and product in the hands of Drs. Leong-Poi and Chow will make a valuable difference to patient outcomes."

 

Contact Giles Gwinnett at giles@proactiveinvestors.com

Follow Giles on Twitter @Gile74

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Wed, 14 Nov 2018 09:02:00 -0500 https://ca.proactiveinvestors.com/companies/news/209195/ventripoint-diagnostics-heart-monitoring-tech-further-boosted-by-agreement-with-canadian-government-209195.html
<![CDATA[News - VentriPoint Diagnostics receives order for its VMS Plus - from leading cardiac hospital in Toronto ]]> https://ca.proactiveinvestors.com/companies/news/209027/ventripoint-diagnostics-receives-order-for-its-vms-plus-from-leading-cardiac-hospital-in-toronto-209027.html VentriPoint Diagnostics Ltd (CVE:VPT) and its heart analysis technology was boosted again today - as St. Michael's Hospital in Toronto, Canada ordered its VMS Plus system to use it to assess cardiac patients.

The VMS+ system uses standard 2D echocardiogram images and Artificial Intelligence (AI) to show 3D volumes for, significantly, all four chambers of the heart.

READ: VentriPoint Diagnostics reveals that University of Chicago will assess its heart analysis system

This provides medics with a more efficient and cost-effective method for evaluating cardiac volumes and ejection fractions.

The heart is a pump, so when there is a problem, it is not always easy to know where exactly the fault lies, so analysis of each of the four chambers is essential.

Dr Howard Leong-Poi and Dr Chi-Ming Chow are spearheading the VMS+ acquisition.

Leong-Poi is the head of the cardiology division at St. Michael's Hospital and a clinician-scientist in the Keenan Research Centre for biomedical science.

Chow, meanwhile, is the director of the echocardiography lab and has expertise in the development of innovative technologies in the practice of echocardiography.

"We are very pleased to have the interest and commitment from such a high profile cardiac institution in our own backyard," said Desmond Hirson, the president of VentriPoint.

"We believe that our AI technology and product in the hands of Drs. Leong-Poi and Chow will make a valuable difference to patient outcomes."

READ: VentriPoint Diagnostics shares tick higher as it hires new marketing manager

Dr Leong-Poi added: "Artificial intelligence holds a great deal of promise for many clinical imaging applications and we are very excited to participate with this leading-edge technology to more accurately assess cardiac chamber volumes and function by echocardiography."

VentriPoint noted that there were many potential applications for this innovative technology - including assessing ventricular volumes and function after percutaneous valve interventions, and after cancer chemotherapies.

The firm's VMS system is getting some traction at the moment. Last week, it told investors that the University of Chicago's medical centre was to assess the system.

With the recent market clearance from the key FDA, Chicago will be one of the first sites to evaluate and publish on the performance of the VMS+ system compared to MRI for all four cardiac chambers, spearheaded by Dr Roberto Lang, said the company.

Shares in the company pumped up over 21% to $0.20 in Toronto.

Reporting by Giles Gwinnett

giles@proactiveinvestors.com

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Mon, 12 Nov 2018 09:00:00 -0500 https://ca.proactiveinvestors.com/companies/news/209027/ventripoint-diagnostics-receives-order-for-its-vms-plus-from-leading-cardiac-hospital-in-toronto-209027.html
<![CDATA[News - VentriPoint Diagnostics reveals that University of Chicago will assess its heart analysis system ]]> https://ca.proactiveinvestors.com/companies/news/208552/ventripoint-diagnostics-reveals-that-university-of-chicago-will-assess-its-heart-analysis-system-208552.html VentriPoint Diagnostics Ltd (CVE:VPT) told investors that the University of Chicago's medical centre is to assess the its innovative VMS plus  heart analysis system.

With the recent market clearance from the key FDA, Chicago will be one of the first sites to evaluate and publish on the performance of the VMS+ system compared to MRI for all four cardiac chambers, spearheaded by Dr Roberto Lang, said the company.

"We are very pleased to have the VMS+ system installed in a very busy clinical environment such as the Department of Medicine at the University of Chicago," said Desmond Hirson, president of Ventripoint.

"We believe that our product in the hands of the non-invasive cardiac imaging laboratory under the direction of Dr. Lang , will make a valuable difference to patient outcomes."

The VMS+ system uses standard 2D echocardiogram images and Artificial Intelligence (AI) to render 3D volumes for all four chambers of the heart providing clinicians with a more efficient and cost-effective method for evaluating cardiac volumes and ejection fractions.

Dr Lang is an internationally renowned cardiologist and specialist in echocardiography, the study of heart function using sound waves.

He uses vast knowledge of cardiac imaging techniques to evaluate patients with a wide variety of heart conditions, including heart failure and valve disease, noted Ventripoint.

Dr George Adams, chief executive of Ventripoint, noted that Dr Lang had been "one of the leading doctors" who encouraged the firm to expand the VMS to include all four chambers of the heart and not just the RV to address the unmet need in many heart conditions.

"We have proven to the FDA that the VMS+ is accurate and reliable, but we did this ourselves, and it needs independent verification, which the University of Chicago will provide," he added.

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Mon, 05 Nov 2018 12:31:00 -0500 https://ca.proactiveinvestors.com/companies/news/208552/ventripoint-diagnostics-reveals-that-university-of-chicago-will-assess-its-heart-analysis-system-208552.html
<![CDATA[News - VentriPoint Diagnostics shares tick higher as it hires new marketing manager ]]> https://ca.proactiveinvestors.com/companies/news/207408/ventripoint-diagnostics-shares-tick-higher-as-it-hires-new-marketing-manager-207408.html Shares in heart-imaging specialist VentriPoint Diagnostics Ltd (CVE:VPT) ticked higher on Thursday as it revealed it had a new marketing manager and gave an update on sales.

Jessica Naman will be responsible for marketing strategies that drive revenue, the med-tech group said. The firm's VMS Plus device is an accurate AI (artificial intelligence) tool for measuring whole-heart function using conventional ultrasound.

Naman will be leading the team in the pre-launch plan as the company showcases the next-generation system at EuroEcho 2018 in Milan, Italy, this December and will explore further opportunities in the future of 3-D heart analysis using conventional 2-D ultrasound technologies, said Ventripoint.

Proven track record

"With 15 years of experience in marketing for technology-based companies, most recently in the medical device industry, she brings a proven track record in the development and management of comprehensive marketing campaigns, which integrate a strategic approach to public relations, social media, conferences and events," said Desmond Hirson, president of Ventripoint.

Notably, Ventripoint said it had secured two new orders for its VMS Plus heart analysis products at leading hospitals in Germany and the USA.

A further cardiac centre in Canada is in the final stages of institutional sign-offs prior to issuing a purchase order, it added.

"The sales funnel has also expanded with 12 clinical studies being planned to show the merits of the VMS Plus approach to cardiac analysis in specific heart conditions, including pregnancy, stress tests, right heart failure, left heart failure, along with congenital heart disease in children and adults, and pulmonary hypertension," the company said in a regulatory statement.  

"In addition, the company's sales team will be delivering several presentations to pediatric cardiologists across North America and Europe on the VMS Plus products."

Shares added 3.13% to stand at $0.155 each.

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Thu, 18 Oct 2018 10:52:00 -0400 https://ca.proactiveinvestors.com/companies/news/207408/ventripoint-diagnostics-shares-tick-higher-as-it-hires-new-marketing-manager-207408.html
<![CDATA[News - VentriPoint Diagnostics brings in over C$1mln from placing; closes second tranche ]]> https://ca.proactiveinvestors.com/companies/news/204951/ventripoint-diagnostics-brings-in-over-c1mln-from-placing-closes-second-tranche-204951.html Heart-imaging specialist VentriPoint Diagnostics Ltd (CVE:VPT) has closed the second and final tranche of its previously announced placing, raising more than C$511,000.

The group issued around 2.43mln units at C$0.21 each for gross proceeds of $511,499.94. In total, the firm raised gross proceeds of C$1,011,499.94 under the placing.

Proceeds will be used for sales and marketing, development and general working capital, Ventripoint said. Each unit consists of one Ventripoint share, and one-half of a share warrant. Each whole warrant will entitle the bearer to buy one further share at US$0.34 each for two years after the issue.

Chief executive Dr George Adams subscribed for 1.5mln units, the company said in the regulatory filing.

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Fri, 14 Sep 2018 10:16:00 -0400 https://ca.proactiveinvestors.com/companies/news/204951/ventripoint-diagnostics-brings-in-over-c1mln-from-placing-closes-second-tranche-204951.html
<![CDATA[News - VentriPoint Diagnostics closes C$500,000 first tranche of financing ]]> https://ca.proactiveinvestors.com/companies/news/204272/ventripoint-diagnostics-closes-c500000-first-tranche-of-financing-204272.html Heart-imaging specialist VentriPoint Diagnostics Ltd (CVE:VPT) has closed the first tranche of its non-brokered private placing, raising C$500,000.

On August 15, the group said it was set for a C$1mln  placing to be used for sales and marketing, development and general working capital. The firm has now issued to one investor, over 2.38mln units at C$0.21 each. Each unit consists of one Ventripoint share, and one-half of a share warrant. Each whole warrant will entitle the bearer to buy one further share at US$0.34 each for two years after the issue.

Ventripoint said that the total size of the placing was up to C$1mln. The company intends to close the second tranche of the private placement in the near future.

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Wed, 05 Sep 2018 14:07:00 -0400 https://ca.proactiveinvestors.com/companies/news/204272/ventripoint-diagnostics-closes-c500000-first-tranche-of-financing-204272.html
<![CDATA[News - VentriPoint Diagnostics set for C$1mln raise ]]> https://ca.proactiveinvestors.com/companies/news/202975/ventripoint-diagnostics-set-for-c1mln-raise-202975.html Heart imaging specialist VentriPoint Diagnostics Ltd (CVE:VPT) is set for a C$1mln private placing to be used for sales and marketing, development and general working capital.

The firm will issue up to 4.7mln units at C$0.21 a throw for gross proceeds of up to C$1mln.

READ: VentriPoint Diagnostics updates on AI collaboration

Each unit consists of one Ventripoint share and one-half of a warrant, which allows the bearer to buy one further share at C$0.34 each for two years after issue.

Earlier this week, the company updated on its project to advance the artificial intelligence (AI) capabilities already embedded in its heart monitoring VMS+ products.

In March, it reported on its collaboration with Ryerson University after Ventripoint revealed it was taking part in a Natural Sciences and Engineering Research Council (NSERC) Engage grant

The university researchers have now completed an initial prototype of the AI engine aimed at analyzing all four heart chambers, Ventripoint said Monday.

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Wed, 15 Aug 2018 10:26:00 -0400 https://ca.proactiveinvestors.com/companies/news/202975/ventripoint-diagnostics-set-for-c1mln-raise-202975.html
<![CDATA[News - VentriPoint Diagnostics updates on AI collaboration ]]> https://ca.proactiveinvestors.com/companies/news/202779/ventripoint-diagnostics-updates-on-ai-collaboration-202779.html Medtech group VentriPoint Diagnostics Ltd (CVE:VPT) updated on the project to advance the artificial intelligence (AI) capabilities already embedded in its heart monitoring VMS+ products.

In March this year, the firm reported on its collaboration with Ryerson University after Ventripoint revealed it was taking part in a Natural Sciences and Engineering Research Council (NSERC) Engage grant.

The university researchers have now completed an initial prototype of the AI engine aimed at analysing all four heart chambers, Ventripoint said Monday.

"This software can be used to detect the end systolic and end diastolic frames in cardiac video clips in a number of different views.

"In initial testing with images provided by the company, results were impressive with an up to 90% accuracy rate in identifying cardiac ultrasound views," the firm said.

Now more images are being provided to the Ryerson team to further the development of their deep-learning algorithm to enable automatic, real-time cardiac-feature detection using AI on ultrasound imaging.

Ventripointb shares shed around 4% to C$0.235.

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Mon, 13 Aug 2018 11:17:00 -0400 https://ca.proactiveinvestors.com/companies/news/202779/ventripoint-diagnostics-updates-on-ai-collaboration-202779.html
<![CDATA[News - VentriPoint rises as it announces prototype of VMS-plus 3.0 ]]> https://ca.proactiveinvestors.com/companies/news/202522/ventripoint-rises-as-it-announces-prototype-of-vms-plus-30-202522.html VentriPoint Diagnostics Ltd (CVE:VPT) has built a prototype of an improved version of its VMS-plus heart analysis system.

This new device, designated VMS-plus 3.0, is undergoing final testing and development to verify its performance.

READ: VentriPoint Diagnostics shares up as it files patent for new invention

The new design eliminates the need for patients to remain motionless during image acquisition and improves the work-flow of the VMS-plus through a more intuitive user interface, Ventripoint said.

The new device will reduce the cost of its equipment significantly and allow a “per-use” sales model that is expected to prove especially appealing to small and medium-sized medical centres.

The company intends to offer both a capital purchase as well as the subscription option to customers starting in 2019.

Shares in VentriPoint were up 4.4% at C$0.24.

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Wed, 08 Aug 2018 13:46:00 -0400 https://ca.proactiveinvestors.com/companies/news/202522/ventripoint-rises-as-it-announces-prototype-of-vms-plus-30-202522.html
<![CDATA[News - VentriPoint Diagnostics shares nudge higher as it updates on sales efforts ]]> https://ca.proactiveinvestors.com/companies/news/202028/ventripoint-diagnostics-shares-nudge-higher-as-it-updates-on-sales-efforts-202028.html VentriPoint Diagnostics Ltd (CVE:VPT) updated on  progress for its VMS+ heart analysis system, revealing it has five  pending sales, nudging shares higher.

Last month, the medtech group said the renowned MD Anderson Cancer Center in Texas had ordered the VMS+ system to evaluate cancer patients.

Today, it said a second machine will be installed at the hospital in a few weeks and will be used for routine clinical assessment of oncology patients to determine cardiac changes during and after treatment.

Ventripoint has also installed the first VMS+ in Edmonton at the University of Alberta Mazankowski Alberta Heart Institute , where it is being used with oncology patients, who require contrast-enhanced ultrasound imaging. It is also being employed on women with normal and high-risk pregnancies.

Pending sales

"The company has 5 pending sales where the cardiology department has an approved budget to purchase the VMS+ and the company is awaiting a purchase order," Ventripoint said in a regulatory release today.

"Each of these new users are recognized leaders in cardiac care and will be using the VMS+ for routine applications as well as research into expanding the application of the VMS+ to inform the best treatment path to be taken for each patient."

The firm has also recently exhibited at conferences in Toronto and in Nashville, Tennessee, where there were a combined 3,000 attendees, and identified a number of potential customers.

"The sales team is following up with these contacts and reaching out to 300 clinical centers, which have a profile of patients where the VMS+ would provide significant benefits to their cardiac service.

A long process for approval

"Capital purchases require a long process for budget approval, as well as signoff by a number of hospital departments, such as bioengineering and IT, before a purchase order is generated," it noted.

Shares in VentriPoint added 4.35% in Toronto to C$0.24.

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Wed, 01 Aug 2018 10:19:00 -0400 https://ca.proactiveinvestors.com/companies/news/202028/ventripoint-diagnostics-shares-nudge-higher-as-it-updates-on-sales-efforts-202028.html
<![CDATA[News - VentriPoint Diagnostics' innovative tech under the spotlight as word leading cardiac centre kicks off study ]]> https://ca.proactiveinvestors.com/companies/news/200971/ventripoint-diagnostics-innovative-tech-under-the-spotlight-as-word-leading-cardiac-centre-kicks-off-study-200971.html VentriPoint Diagnostics Ltd (CVE:VPT) said a clinical study has started at a world leading cardiac centre in Alberta  evaluating the firm's Ventripoint VMS+ heart analysis system.

The study is expected to take around three months and include 40-50 patients.

READ THE BIG PIC: VentriPoint Diagnostics eyeing big opportunity after winning first US customer for VMS plus

Clinicians at the Mazankowski Alberta Heart Institute in Edmonton will be using the firm's tech to  analyze poor quality ultrasound images from heart patients.

Normally, contrast enhanced 2D echocardiography would be used to try and get better images but the study will assess the capabilities of the VMS+ .

"In 10-20% of patients the images collected by standard 2D ultrasound are not clear enough to allow for interpretation using conventional methods. Using the artificial intelligence (AI) approach embedded in the VMS+ heart analysis system, the standard images can be analyzed," said Ventripoint.

The reduction in the number of contrast-enhanced 2D echo studies would lead to significant savings in time and costs, it added.

It would also reduce the need to inject patients with contrast media.

It is worth noting that the use of contrast-enhanced ultrasound is increasing in the western world with the burgeoning population of heavier people making it more difficult to obtain clear images using ultrasound.

The Mazankowski insititure is home to a team of skilled cardiologists, cardiovascular surgeons, cardiac care professionals and researchers and educators.

VentriPoint shares in Toronto are up 1.82% to C$0.28 at the time of writing.

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Tue, 17 Jul 2018 10:01:00 -0400 https://ca.proactiveinvestors.com/companies/news/200971/ventripoint-diagnostics-innovative-tech-under-the-spotlight-as-word-leading-cardiac-centre-kicks-off-study-200971.html
<![CDATA[News - VentriPoint Diagnostics eyeing big opportunity after winning first US customer for VMS plus ]]> https://ca.proactiveinvestors.com/companies/news/198393/ventripoint-diagnostics-eyeing-big-opportunity-after-winning-first-us-customer-for-vms-plus-198393.html Heart-focused medtech group VentriPoint Diagnostics Ltd (CVE:VPT) has been on a news tear recently and the latest shot in the arm was its first US customer for the ground-breaking VMS Plus machine.

And that buyer is no less than the MD Anderson Cancer Center in Texas -  the number-one ranked cancer centre in the US.

It comprises a network of hospitals who see an eye-watering 1.5mln patients per year and perform almost 600,000 imaging studies.

News of this first sale comes after last month, the emerging medtech firm received the all-important FDA approval to sell the device with the four-chamber heart analysis system in the USA.

Doctors at MD Anderson will be using the VMS+ to monitor cardiac function in cancer patients since it is well known that chemotherapy agents are cardiotoxic and lead to  significant patients acquiring heart dysfunction. They are to start using it immediately clinically.

So what is the VMS Plus?

This is a machine, which will potentially revolutionise the way doctors treat heart patients as it can give accurate and rapid volumetric information about all four chambers of the heart.

It is the only technology in the world that can perform such an analysis of all four chambers using data from a conventional 2D (two dimensional) eco-cardiogram (in other words an ultrasound test).

The heart is a pump so when there is a problem it is not always easy to know where exactly the fault lies, so analysis of each chamber is essential.

So, rather than the doctor trying to decipher the 2D ultrasound image, the VMS Plus gives hard data about the pump's function and deterioration rates, or improvements, which means the treatment can be much more accurate and appropriate.

A huge potential opportunity..

Dr  George Adams, the chief executive at VentriPoint, says the MD Anderson Cancer Center order represents a huge opportunity.

 "Since all chemotherapy agents hurt the heart, the American Heart Association (AHA) has put out a statement saying cancer patients should ask to have their heart examined before, during and after therapy as they are more likely to die from heart problems than cancer after they have the therapy," he noted.

He reckons the hospital's network would need 750 VMS+ devices to treat their patients according to the AHA (American Heart Association) guidelines (3 three scans per patient) at "full utilisation".

There are 1,500 cancer centers in the USA, which deal with 23mln patients, who come back twice a year to check to see if the cancer has regrown and the AHA is saying they really should be more worried about heart conditions then cancer, suggests Adams. 

He says that to follow AHA guidelines in the USA with the normal use rates would require 20,000 VMS+ machines.  

At US$75,000 each this would be  US$1.5bn of sales, he says, and that is just for the USA. The European market is 1.5 times' the USA.

In March this year, the firm said it would advance the AI (artificial intelligence) capabilities of the system, via a government grant.

VentriPoint will partner with Ryerson University on a project to further advance the Al  already imbedded in  the VMS+ products as it is taking part in a Natural Sciences and Engineering Research Council (NSERC) Engage grant.

The same month, it established an business advisory committee (BAC) and named Samuel Schwartz as its inaugural chairman.

Significantly, in January, its VMSplus device received a European CE mark less than a month after the firm made the application.

It means it can now be sold to aid in heart treatment throughout the European Union and the medtech group said it aims to meet with distributors with a focus on Germany, the  UK and France.

According to the European Heart Network, cardiovascular disease (CVD) causes 3.9mln deaths in Europe annually and accounts for 45% of all deaths in Europe, so the opportunity is vast here.

Expansion plans

Last November, the group revealed it was putting expansion plans in the Middle East in  place.

It struck a partnership with the  SEED Group, which is a group of firms owned The Private Office of Sheikh Saeed Bin Ahmed Al Maktoum of Dubai, United Arab Emirates.

"The SEED Group has already introduced us to leading cardiologists and hospitals in the region, who have expressed their interest in acquiring the VMS-PLUS and demonstrating its application within the healthcare environment," Adams had said.

"We see Dubai as an excellent starting place for our expansion plans into the Middle East."

In September, the firm said that interest in VentriPoint products is strong from Iran, Singapore, Thailand, UAE and Saudi Arabia, and that regional distributors were verifying the local pathway to regulatory approval.

"2017 was a historical year for Ventripoint, our employees and shareholders, who have seen the company increase in market capitalisation by 384% and experience share price appreciation of 258%, while trading 206 million shares on the TSX Venture Exchange and 250mln shares on all share exchanges," Dr Adams has said.

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Wed, 06 Jun 2018 12:11:00 -0400 https://ca.proactiveinvestors.com/companies/news/198393/ventripoint-diagnostics-eyeing-big-opportunity-after-winning-first-us-customer-for-vms-plus-198393.html
<![CDATA[News - VentriPoint Diagnostics says leading cancer centre in Texas is first US customer for VMS plus ]]> https://ca.proactiveinvestors.com/companies/news/198288/ventripoint-diagnostics-says-leading-cancer-centre-in-texas-is-first-us-customer-for-vms-plus-198288.html The first customer for VentriPoint Diagnostics Ltd's (CVE:VPT) VMS Plus heart analysis system is the MD Anderson Cancer Center in Texas -  the number-one ranked cancer centre in the US.

It comes after the medtech group revealed last month FDA approval to sell the device with the four-chamber heart analysis system in the USA.

READ: VentriPoint Diagnostics hires Graba as chief trainer

The centre in Houston has ordered the VMS+ system to evaluate cancer patients. It is well known that chemotherapy agents are cardiotoxic and lead to  significant patients acquiring heart dysfunction, the firm said.

"We are very pleased to have the number-one ranked cancer centre in the United States as the first customer," said Desmond Hirson, president of Ventripoint.

"With our recent market clearance from the FDA, the doctors at MD Anderson will be using the VMS+ to monitor cardiac function in cancer patients."

According to the centers for disease control and prevention, there are 23mln people in the USA diagnosed with cancer and these patients visited their physicians 25mln times in 2015.

There are over 1,500 cancer centers in the USA, which monitor existing patients and treat over 1.7mln new patients annually.

The MD Anderson hospital sees around 1.5mln patients a year and performed 575,000 imaging exams in 2017

READ: VentriPoint Diagnostics soars as it's set to offer VMS Plus to medics in the US after FDA approval

Meanwhile, The American Heart Association recently put out a scientific statement acknowledging that some breast cancer therapies can damage the heart and healthcare providers should carefully monitor breast cancer treatment effects on the heart.

Breast cancer survivors, especially older women, are more likely to die from cardiovascular diseases such as heart failure rather than breast cancer.

The VMS+ is the first cost-effective and accurate artificial intelligence tool for measuring whole heart function using conventional ultrasound.

The  USA is the largest medical device market in the world with over 40mln cardiac ultrasound exams per year.

Two-dimensional ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.

VentriPoint Diagnostics shares in Toronto advanced over 6% to C$0.33.

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Tue, 05 Jun 2018 09:02:00 -0400 https://ca.proactiveinvestors.com/companies/news/198288/ventripoint-diagnostics-says-leading-cancer-centre-in-texas-is-first-us-customer-for-vms-plus-198288.html
<![CDATA[News - VentriPoint Diagnostics hires Graba as chief trainer ]]> https://ca.proactiveinvestors.com/companies/news/197568/ventripoint-diagnostics-hires-graba-as-chief-trainer-197568.html Wed, 23 May 2018 10:04:00 -0400 https://ca.proactiveinvestors.com/companies/news/197568/ventripoint-diagnostics-hires-graba-as-chief-trainer-197568.html <![CDATA[News - VentriPoint Diagnostics soars as it's set to offer VMS Plus to medics in the US after FDA approval ]]> https://ca.proactiveinvestors.com/companies/news/197115/ventripoint-diagnostics-soars-as-it-s-set-to-offer-vms-plus-to-medics-in-the-us-after-fda-approval-197115.html Medtech group VentriPoint Diagnostics Ltd (CVE:VPT) reported further progress on its flagship product, namely FDA approval to sell its VMS Plus machine with the four-chamber heart analysis system in the USA.

"The VMS Plus is the first simple echocardiography system to be approved by the FDA for the 3-D volumetric analysis of all four chambers of the heart using 2-D ultrasound," said Dr George Adams, chief executive officer of VentriPoint.

READ: VentriPoint Diagnostics to advance AI capabilities in its heart device with new gov't funding

"Now we can offer the VMS Plus to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment."

The VMS+ is the first cost-effective and accurate artificial intelligence tool for measuring whole heart function using conventional ultrasound.

The  USA is the largest medical device market in the world with over 40mln cardiac ultrasound exams per year.

Two-dimensional ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.

Dr Adams added: "There is more and more evidence that volumes and function can predict which patients require more or less drugs and more careful monitoring and this what the VMS+ does easily and cost-effectively.  

"Our mission to make it easier for every doctor worldwide to know what is actually happening with a heart without having to send everyone to an MRI has been advanced greatly with this approval.  The rest of the world looks to the USA as a leader in cardiac care and so this will help us elsewhere as well."

Looking ahead,  the company boss said: "We have sales and marketing plan for the USA and are now free to implement it.  

"You are not allowed to even market a device in the USA without approval, but we have a number of leading centres who are aware of the VMS and have been asking when the VMS+ would be available.  We can now actively contact them and solicit orders.  We will be announcing these orders as they come in."

Shares surged almost 29% in Toronto to stand at C$0.38 each.

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Wed, 16 May 2018 08:39:00 -0400 https://ca.proactiveinvestors.com/companies/news/197115/ventripoint-diagnostics-soars-as-it-s-set-to-offer-vms-plus-to-medics-in-the-us-after-fda-approval-197115.html
<![CDATA[News - VentriPoint Diagnostics exhibits at Canadian Society of Echocardiography conference ]]> https://ca.proactiveinvestors.com/companies/news/195599/ventripoint-diagnostics-exhibits-at-canadian-society-of-echocardiography-conference-195599.html VentriPoint Diagnostics Ltd (CVE:VPT) said its latest VMS+  heart monitoring system was well received when the group exhibited at the 20th annual Canadian Society of Echocardiography conference recently held in Toronto.

"This was an opportunity to showcase our latest VMS+ system that demonstrated volumetric measures for all 4 chambers of the heart," the firm said in a regulatory filing.

"This new system was well received by clinicians who appreciated the value of ultrasound 3D visualization with fast and accurate measurements, equivalent to the gold standard MRI for all heart chambers."

The medical imaging firm added: "This gave us the opportunity to engage with potential customers and to collect prospects and leads to contribute to our expanding sales effort."

The Toronto conference is attended by cardiologists and sono graphers, and is the largest single gathering in Canada with over 600 attendees.

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Mon, 23 Apr 2018 16:16:00 -0400 https://ca.proactiveinvestors.com/companies/news/195599/ventripoint-diagnostics-exhibits-at-canadian-society-of-echocardiography-conference-195599.html
<![CDATA[Media files - 'We have a shot at being a multi-billion dollar company', says VentriPoint Diagnostic's George Adams ]]> https://ca.proactiveinvestors.com/companies/stocktube/7132/-we-have-a-shot-at-being-a-multi-billion-dollar-company-says-ventripoint-diagnostic-s-george-adams-7132.html Mon, 20 Mar 2017 11:26:00 -0400 https://ca.proactiveinvestors.com/companies/stocktube/7132/-we-have-a-shot-at-being-a-multi-billion-dollar-company-says-ventripoint-diagnostic-s-george-adams-7132.html <![CDATA[News - Ventripoint says German study shows accuracy of heart imaging system across "wide spectrum" of cardiac conditions ]]> https://ca.proactiveinvestors.com/companies/news/102157/ventripoint-says-german-study-shows-accuracy-of-heart-imaging-system-across-wide-spectrum-of-cardiac-conditions-55234.html VentriPoint Diagnostics (CVE:VPT) said Monday that a German cardiac study has verified the accuracy of its VMS heart imaging system for cardiac MRI and 3D ultrasounds.

The results of the clinical study were published by a group led by Dr. Kai Laser at the Center for Congentinal Heart Defects, Bad Oeynhausen, Germany. 

"The Ventripoint approach to analyzing the right ventricle of the heart works for all types of scanning and gives rapid, accurate and important results for the diagnoses and management of patients with a wide spectrum of complex cardiac conditions," said Dr. Laser.

The company said that for the first time, the study showed that the bias often reported between MRI and echocardiography results are due to analysis technique, and not imaging modality. Indeed, in the study, all three types of imaging including 2D-echo, 3D echo and cardiac MRI gave the same results when analyzed using the VMS technique, and were equivalent to the "gold-standard MRI" analysis. 

In the past, the comparison of echocardiography and cardiac MRI analysis has been discouraged due to unexplained discrepancies, said Ventripoint, despite its importance in determining a patient's progress over time where multiple imaging modalities may have been used. The standardization across all images using the VMS would give comparable results, and allow for better patient monitoring and treatment decisions, according to the company's statement.

The medical device company says its heart imaging system is a more convenient and faster alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease.

In March, the company was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

The German study also showed that the time to complete the analysis using VMS was reduced to just five minutes, compared to between 10 to 30 minutes using conventional techniques. 

"This study, by an independent group, shows how the VMS technology can be applied across multiple imaging modalities and provides accurate and equivalent results for Right Ventricular function," said Ventripoint CEO, Dr. George Adams.

"This ability of the VMS greatly increases our market potential, as it allows us to seek partners who would integrate the VMS approach into MRI and 3D-echocardiography analysis packages, while continuing to market VMS for routine 2D-echocardiography."          

Ventripoint recently developed a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

The report announced Monday has been accepted for publication in the Journal of the American Society of Echocardiography, said the company. 

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Mon, 07 Jul 2014 13:08:00 -0400 https://ca.proactiveinvestors.com/companies/news/102157/ventripoint-says-german-study-shows-accuracy-of-heart-imaging-system-across-wide-spectrum-of-cardiac-conditions-55234.html
<![CDATA[News - Ventripoint closes first tranche of $2 mln private placement, wraps up shares-for-debt deal ]]> https://ca.proactiveinvestors.com/companies/news/101940/ventripoint-closes-first-tranche-of-2-mln-private-placement-wraps-up-shares-for-debt-deal-54932.html VentriPoint Diagnostics (CVE:VPT) has completed the first tranche of its $2 million private placement financing announced last month, the company said Monday.

The company said it issued 24.95 million units, with each unit made up of one common share and one half of a share purchase warrant. Every full warrant is exercisable for one additional common share at a price of 12 cents until June 20, 2016.

Ventripoint will use the new funds for sales and marketing needs, according to the company's statement, as well as general working capital purposes.

Three of the subscribers in the latest offering have accepted the units as payment in full of outstanding secured debentures, said Ventripoint, completing a shares-for-debt transaction. As a result, its net debt has been reduced by $773,626.

The medical device company has a heart imaging system that it says is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease. With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, the company has said. 

In March, the company was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

It has also developed a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

 

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Mon, 23 Jun 2014 09:30:00 -0400 https://ca.proactiveinvestors.com/companies/news/101940/ventripoint-closes-first-tranche-of-2-mln-private-placement-wraps-up-shares-for-debt-deal-54932.html
<![CDATA[News - Ventripoint Diagnostics looks forward to positive outcomes from American Society of Echocardiography event ]]> https://ca.proactiveinvestors.com/companies/news/101924/ventripoint-diagnostics-looks-forward-to-positive-outcomes-from-american-society-of-echocardiography-event-54913.html VentriPoint Diagnostics (CVE:VPT) says it is looking forward to showing off its heart imaging system to potential end users at the American Society of Echocardiography's annual conference in Portland over the next few days. 

The event, which will be held through June 20 to 24, will see Ventripoint at booth 608 in the main exhibition hall, where it will be distributing demonstration cases to highlight the features of its VMS device to individual cardiologists and research scientists.

The company has a heart imaging system that it says is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease. 

With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, the company said. In May, the company announced it is raising up to $2 million through a private placement financing, with the new funds to be used for sales and marketing purposes.

"Being part of the annual ASE Scientific Sessions is the greatest single event we can attend as it gives us direct access to thousands of potential customers, allowing us to demonstrate our product's capabilities to practitioners as well as to the ultrasound manufacturers," said the company's VP of clinical affairs and development, Jim Bodtke. 

"We look forward to engaging potential end users of the VMS and to further developing potential partnerships with world-leading companies to expand our product offerings."

At the event, the company said it will be emphasizing the recent FDA clearance of the system as "substantially equivalent" to MRI in patients with pulmonary arterial hypertension. 

Bodtke added that every year at the ASE, the company is seeing more time dedicated to presentations concerning right ventricle imaging and analysis, with the trend set to continue this week throughout the sessions, from the very first presentation on Saturday titled "Echo in Pulmonary Hypertension" to the last on Tuesday.

In March, the company was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

It has also developed a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

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Fri, 20 Jun 2014 10:38:00 -0400 https://ca.proactiveinvestors.com/companies/news/101924/ventripoint-diagnostics-looks-forward-to-positive-outcomes-from-american-society-of-echocardiography-event-54913.html
<![CDATA[News - Ventripoint extends maturity for secured debt, inks shares-for-debt exchange deal ]]> https://ca.proactiveinvestors.com/companies/news/101576/ventripoint-extends-maturity-for-secured-debt-inks-shares-for-debt-exchange-deal-54460.html VentriPoint Diagnostics (CVE:VPT) has agreed with a major debt holder to amend the terms of its US$748,000 debenture so that it is convertible into common shares of the company at a price of 7.48 US cents per share. 

The maker of the VMS diagnostic heart analysis system also told investors that the maturity date of the debenture has changed from July 18 of this year to February 27, 2015, with all material terms remaining unchanged.

The company said the secured debenture holder plans to convert the debt into shares, with Ventripoint to pay a one time fee of US$25,000 to the party in exchange for the amendments. 

In addition, the medical device company will issue 760,000 shares to pay the accrued interest under the debenture of about US$44,300 at a rate of 6.5 cents per share, which was the 10-day volume weighted average price of Ventripoint at the time the agreement was reached, according to a statement.

The TSX Venture Exchange has conditionally approved the shares-for-debt agreement, the company said.

Shares jumped 6.7% on Friday, to 8 cents in Toronto.

Earlier this month, VentriPoint said it is raising up to $2 million through a private placement financing. said Thursday. The new funds will be used for sales and marketing purposes, as well as for general working capital.

The company has a heart imaging system that it says is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease. 

With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, the company has said. 

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Fri, 30 May 2014 11:07:00 -0400 https://ca.proactiveinvestors.com/companies/news/101576/ventripoint-extends-maturity-for-secured-debt-inks-shares-for-debt-exchange-deal-54460.html
<![CDATA[News - Ventripoint to raise up to $2 mln via private placement ]]> https://ca.proactiveinvestors.com/companies/news/101440/ventripoint-to-raise-up-to-2-mln-via-private-placement-54270.html VentriPoint Diagnostics (CVE:VPT) is raising up to $2 million through a private placement financing, the maker of the VMS diagnostic heart analysis system said Thursday.

The new funds will be used for sales and marketing purposes, as well as for general working capital, the company told investors in a statement.

It has signed an engagement letter with D&D Securities to sell up to $2 million worth of units at a price of 8 cents apiece. Each unit will be made up of one common share and half of a share purchase warrant, with every warrant entitling the holder to buy an additional share at a price of 12 cents for a period of two years from closing.

Ventripoint said Thursday that the offering is expected to close around June 9, subject to regulatory approvals.

The medical device company has a heart imaging system that it says is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease. With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, the company has said. 

In March, the company was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

It has also developed a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

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Thu, 22 May 2014 09:17:00 -0400 https://ca.proactiveinvestors.com/companies/news/101440/ventripoint-to-raise-up-to-2-mln-via-private-placement-54270.html
<![CDATA[News - Ventripoint's VMS system to be used in re-admission study at Montefiore in New York ]]> https://ca.proactiveinvestors.com/companies/news/100833/ventripoints-vms-system-to-be-used-in-re-admission-study-at-montefiore-in-new-york-53438.html VentriPoint Diagnostics (CVE:VPT) said Tuesday that the Montefiore-Einstein Center for Heart and Vascular Care in New York City has received approval to conduct a re-admission study with its VMS diagnostic heart analysis system in patients with heart failure.

The study will determine if the quantitative assessment of right heart function using Ventripoint's sytems would enable cardiologists to identify those patients most likely to return to hostpital and be re-admitted within 30 days. 

The medical device company says its heart imaging system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

According to Ventripoint, right heart function remains one of the most significant prognostic parameters for all heart disease. With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, the company has said. 

"We are pleased to initiate this study to look for better ways to assess right heart function," said Dr. Mario Garcia, chief of cardiology at Montefiore and one of the leaders of the study.

"The VMS is a simple rapid technique, which uses conventional 2D echocardiographic data to obtain accurate functional information and should be prognostic in this patient population."

Last month, Ventrpoint was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). The system is also approved in Canada and Europe, with the company now working to further expand the system's applications.

Ventripoint has also developed a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

"We will immediately install two VMS heart analysis systems at Montefiore Hospital and begin recruitment," said Ventripoint's CEO, Dr. George Adams, in a release this morning announcing the New York hospital study. 

"We would expect to have interim data mid-summer and will initiate additional clinical sites based upon this information." 

The average cardiac re-admission rate within 30 days in the U.S. is 26%, according to Ventripoint's statement, and it is estimated that 48% of people with heart failure have "significant right heart involvement". 

"We are facing a new paradigm in healthcare today," said Dr. Ileana Pina, the other lead doctor of the study. "We see an explosion of risk factors for heart disease, coupled with a demand to practice evidence-based medicine and to lower costs.  

Indeed, the re-admission rate adds extra weight on the healthcare system, with the Affordable Care Act using this figure to penalize hospitals by clawing back 1% to 3% of total billings for those facilities with higher than acceptable re-admission rates. 

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Tue, 15 Apr 2014 10:55:00 -0400 https://ca.proactiveinvestors.com/companies/news/100833/ventripoints-vms-system-to-be-used-in-re-admission-study-at-montefiore-in-new-york-53438.html
<![CDATA[News - Ventripoint Diagnostics seeing accelerated sales as FDA approval sparks buzz ]]> https://ca.proactiveinvestors.com/companies/news/100718/ventripoint-diagnostics-seeing-accelerated-sales-as-fda-approval-sparks-buzz-53275.html VentriPoint Diagnostics' (CVE:VPT) recent FDA approval for its VMS heart analysis system has created a buzz in the cardiology community, with the company preparing to see more sales on the back of a revamped marketing strategy, according to a statement released Tuesday. 

"Clearance from the FDA has sparked renewed interest in the VMS in the cardiology community worldwide. We are seeing accelerated purchase decisions in Europe and Canada," said president and CEO of Ventripoint, Dr. George Adams, in the release. 

"Now functional evaluation of the right ventricle is available without an expensive MRI. We are initiating energetic marketing strategies to communicate news of the accessibility of VMS. With this in mind, we are making arrangements to make ourselves very visible at the upcoming meeting of the American Society of Echocardiography in June."

Indeed, the company said it has a focused marketing strategy that will include securing distribution partners for the VMS product in the U.S., signing up additional marketing partners in Europe and the Middle East, and furthering discussions with ultrasound manufacturers for collaborations on technology integration. 

Ventripoint is also planning to license the knowledge-based reconstruction of its VMS system to other providers of analysis software, and contact cardiology centres that previously indicated a desire to purchase the VMS following clearance for clinical use by the FDA, which was achieved in March. 

In addition, the company said Tuesday it would advance hospital-sponsored studies into new applications for the heart analysis system, and re-evaluate marketplace acceptance of a pay-per-use structure in patients with left heart failure while maintaining the current capital purchase approach in pulmonary hypertension and congenital heart disease applications.

Last month, Ventrpoint was granted FDA approval for its heart diagnostic system for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH). 

The medical device company says its heart imaging system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

According to the company, right heart function remains one of the most significant prognostic parameters for not just PAH, but all heart disease. With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, said Ventripoint. 

The company has a regulatory strategy in the works for further expanding the VMS's applications, with additional uses expected to be approved by the third quarter of this year. Multiple clinical uses for the system are already approved in Canada and Europe.

Separately, Ventripoint said that its board has decided not to initiate a share consolidation at this time, citing market conditions. 

"We have always said we would do the consolidation if it made sense within the context of the market.  Now is not the right time," Dr. Adams said in an email accompanying the release.  

Ventripoint, which is also negotiating to restructure some of its secured debt to extend the term, also announced that Don Black has resigned from the board of directors for health reasons, and that it is currently undertaking reviews to find the best replacement. 

Shares of Ventripoint closed Monday at 9 cents. The company has a 52-week trading range of 3 to 17 cents. Its stock has climbed almost 40% since the beginning of this year. 

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Tue, 08 Apr 2014 09:59:00 -0400 https://ca.proactiveinvestors.com/companies/news/100718/ventripoint-diagnostics-seeing-accelerated-sales-as-fda-approval-sparks-buzz-53275.html
<![CDATA[News - Ventripoint points to studies showing further applications for VMS heart analysis system ]]> https://ca.proactiveinvestors.com/companies/news/100646/ventripoint-points-to-studies-showing-further-applications-for-vms-heart-analysis-system-53186.html After securing approval from the FDA for its VMS heart analysis system last month, VentriPoint Diagnostics (CVE:VPT) is now focused on marketing the device and broadening its  applications, the company said Wednesday. 

The company, whose diagnostic system was cleared by the FDA in March for right ventricle assessment in adult patients with pulmonary arterial hypertension (PAH), reported that it has completed two studies to help expand the device's applications, one in PAH and one in congential heart disease. 

The company said both studies verify the benefit of VMS in monitoring patients after treatment to determine if the therapy has been effective.

"The VMS is the first ultrasound system to be cleared as equivalent to MRI for right ventricle analysis," said president and CEO of Ventripoint, Dr. George Adams, in a release late Wednesday.

"Now there is no need to wait to have an expensive MRI to functionally evaluate the right ventricle. We continue to build value for the company by looking at all possible ways to market and advance the VMS; with a focus on the upcoming cardiology meetings in the United States."

Ventripoint says its heart imaging system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

According to the company, right heart function remains one of the most significant prognostic parameters for not just PAH, but all heart disease. With its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart, said Ventripoint. 

The company said Wednesday that the recent FDA approval has paved the way for further expanding the VMS's application to all major heart conditions, with a regulatory strategy currently in the works. Indeed, it plans to use the Special 510(k) process using the VMS as the predicate device, with additional uses expected to be approved by the third quarter of this year. 

Ventripoint cautioned, however, that timelines are difficult to gauge for FDA processes, with the company hitting a snag for its FDA approval last year, as the VMS was initially rejected. 

But this did not phase the medical device company, with Ventripoint working with the regulatory body since last November to resubmit an application early this year, only to have it approved in March.

The device is now approved for clinical use in PAH patients in Canada, Europe and the U.S. 

Ventripoint said that Dr. Johannes Schwaiger of the Department of Cardiology at Royal Free Hospital in London, who completed the first study reported on today, will be lecturing on his experiences using the VMS at the 13th annual International Pulmonary Hypertension Forum in Lisbon this week.

Dr. Schwaiger has been using the device to verify a significant change in right ventricle ejection fraction after novel targeted treatments, which resulted in significant improvements in patients with PAH, Ventripoint said. This is potentially a great leap forward as an objective measure like right ventricle ejection fraction will allow doctors to more quickly change medication in patients who are not responding, whereas before, the only way to know was to ask the patients themselves. 

In addition, the Rikshospitalet University Hospital in Oslo, Norway, led by Dr. Henrik Brun, has published a paper in the Congenital Heart Disease Journal detailing the "excellent feasibility" of the VMS in patients who had undergone pulmonary valve replacement. The paper even goes so far as to conclude that "knowledge-based reconstruction [VMS] may replace MRI measurements for serial follow-up", according to Ventripoint's statement.

Shares of Ventripoint have risen more than 46% since the beginning of this year, closing Wednesday at 9.5 cents. 

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Thu, 03 Apr 2014 09:56:00 -0400 https://ca.proactiveinvestors.com/companies/news/100646/ventripoint-points-to-studies-showing-further-applications-for-vms-heart-analysis-system-53186.html
<![CDATA[News - UPDATE: VentriPoint Diagnostics hits new high as VMS heart imaging system gets FDA clearance ]]> https://ca.proactiveinvestors.com/companies/news/100260/update-ventripoint-diagnostics-hits-new-high-as-vms-heart-imaging-system-gets-fda-clearance-52654.html ***Updated with the latest share price data***

VentriPoint Diagnostics (CVE:VPT) reached a new 52-week high on Monday on news that the U.S. FDA approved its VMS heart analysis system, clearing the device to be an adjunct to all existing 2D ultrasound imaging systems. 

The news follows the FDA's rejection of the company's previous submission in November, with the two parties working together ever since on identifying the best and quickest way to obtain clearance for the VMS for use in pulmonary arterial hypertension (PAH) --- a major heart disease. 

Ventripoint said Monday that the FDA's approval of its system as an adjunct to all existing 2D ultrasound imaging devices will allow for "the computation of the 3D volume and ejection fraction of the right heart" in patients with PAH. 

"We are pleased to affirm the FDA's marketing clearance today for the VMS - the first ultrasound method to give accurate right ventricle functional measurements using conventional 2D ultrasound," said president and CEO of Ventripoint, Dr. George Adams, in a release Monday. 

"People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function."

Indeed, Ventripoint says its heart imaging system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. According to the company, right heart function remains one of the most significant prognostic parameters in PAH, and with its device, physicians can "quickly and non-invasively" determine the size and function of this side of the heart.       

Prior to submitting the new application at the end of January, the medical device company added significant additional information to address the FDA's concerns, related to accuracy, reproducibility and clinical use of various imaging approaches in patients with PAH. 

In November, the FDA said that despite an "average agreement" between the results for the Ventripoint Medical System (VMS) and the alternative magnetic resonance imaging (MRI) within the allowable 10% mean difference, it found that the substantial equivalency was not sufficiently proven to warrant approval, offering concerns about the routine use of the VMS in the PAH population.

"We thank the cardiology teams at The Hospital for Sick Children and Brigham and Women's Hospital for being the Core Labs on the clinical trial and the Allegheny Hospital, Mayo Clinic, Brigham and Women's Hospital, Baylor College of Medicine, University of Chicago, and the University Hospital Network (Toronto General Hospital), where the clinical testing was performed for this application," said VP of clinical affairs for Ventripoint, Jim Bodtke. 

Pulmonary arterial hypertension can occur for no known reason, but will typically be diagnosed in association with common conditions such as chronic liver disease and liver cirrhosis, connective tissue disorders, congenital heart disease and HIV. The average patient has a lifespan of less than three years once diagnosed with the devastating disease if untreated, with the condition affecting individuals from infancy to old age. 

The VMS device is already approved for clinical use in PAH patients in both Canada and Europe, with the U.S. approval set to go a long way in terms of opening up a new market for the company. It also has plans for further expansion internationally. 

One of the headline benefits to Ventripoint's VMS over the current standard is a significant cut-back on the time required for the procedure, from 1 to 1-1/2 hours for an MRI to as much as 5 minutes using the VMS. 

Shares of Ventripoint were halted late Friday pending the news this morning, at 10 cents. Its stock surged as much as 70% today shortly after the resumption of trading, reaching a new 52-week high of 17 cents. The stock was lately up at 13 cents in early afternoon trading, doubling in price since the beginning of the year. 

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Mon, 10 Mar 2014 13:34:00 -0400 https://ca.proactiveinvestors.com/companies/news/100260/update-ventripoint-diagnostics-hits-new-high-as-vms-heart-imaging-system-gets-fda-clearance-52654.html
<![CDATA[News - Ventripoint Diagnostics submits new FDA application for heart imaging system ]]> https://ca.proactiveinvestors.com/companies/news/99541/ventripoint-diagnostics-submits-new-fda-application-for-heart-imaging-system-51495.html VentriPoint Diagnostics (CVE:VPT) has submitted to the U.S. FDA a new 510(k) application for its VMS diagnostic heart imaging system for use in pulmonary arterial hypertension (PAH), the company said Thursday, after its previous submission was rejected in November.

"We have included in the submission significant additional information concerning the accuracy, reproducibility and clinical use of various imaging approaches in patients with PAH," said VP of clinical affairs, Jim Bodtke, in the release Thursday. 

"We feel we have appropriately addressed the Agency's concerns as expressed in their letter of November 8, 2013." 

In November, the FDA said it found that despite an "average agreement" between the results for the Ventripoint Medical System (VMS) and the alternative magnetic resonance imaging (MRI) within the allowable 10% mean difference, the substantial equivalency was not sufficiently proven to warrant approval.                

The company, after receiving the rejection letter in mid-November, responded within the specified 30-day timeframe, following several discussions with the FDA to identify the "best and quickest" pathway to obtain clearance for the VMS for use in pulmonary arterial hypertension -- a major heart disease.

Ventripoint said it maintained this open dialog with the U.S. regulatory body in preparing the submission, and as a result, changed the submission from a "software-only" application, as previously recommended by the FDA, to a submission with software and hardware descriptions. 

The company expects the review process to be completed by the end of the first quarter. 

"The team did an excellent job re-writing the submission so quickly, which allowed us to re-submit the 510(k) in record time," said CEO of Ventripoint, Dr. George Adams. 

"I would like to thank our consultants as well the agency for all their assistance."              

Separately, Ventripoint said that it plans to issue 2.19 million common shares at a price of 5 cents apiece to repay C$109,395.67 in accrued interest owing to debtholders of the company.

Shares of Ventripoint were trading unchanged at 8.5 cents on Thursday morning.

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Thu, 23 Jan 2014 10:59:00 -0500 https://ca.proactiveinvestors.com/companies/news/99541/ventripoint-diagnostics-submits-new-fda-application-for-heart-imaging-system-51495.html
<![CDATA[News - Ventripoint devises cost-cutting plan for new FDA submission ]]> https://ca.proactiveinvestors.com/companies/news/99038/ventripoint-devises-cost-cutting-plan-for-new-fda-submission-50715.html VentriPoint Diagnostics (CVE:VPT) is embarking on a restructuring plan that it says will ensure it has enough cash to complete its revised FDA process for its diagnostic imaging system, after the U.S. regulatory body rejected previous approval attempts last month. 

The company, after receiving a rejection letter in mid-November for its 510(k) application for approval of the device, said it has responded within the specified 30-day timeframe, following several discussions with the FDA to identify the "best and quickest" pathway to obtain clearance for the Ventripoint Medical System (VMS), for use in pulmonary arterial hypertension -- a major heart disease.

In a statement released Monday, Ventripoint said that together with the FDA, the parties agreed that the best approach is to submit a new 510(k) as a software-only Class II device, and address the issues identified in the agency letter. Rather than having to prove "substantial equivalency" to the alternative MRI procedure, it just has to prove the system is useful in clinical diagnosis of heart function.

The company is aiming to file this new application early in the New Year, it said, and expects to have a response from the FDA in the first quarter of 2014. 

“The FDA has been encouraging and specific in their advice to streamline the process to seek approval,” said VP of clinical affairs for the company, Jim Bodtke.

To ensure it has sufficient funding to complete the new FDA process, the company is planning to reduce development staff, reassign installation staff, accrue salaries for executive staff, cut direct sales staff in Europe and complete existing sales where the VMS evaluation periods are finished. 

Indeed, the device is already for sale in Canada, Europe. According to Ventripoint, the system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

“I think our greatest opportunity for success is to reach the U.S. market and so we have identified ways to economize to ensure that we have the resources to complete the new 510(k) process,” said CEO Dr. George Adams in the release.

“We owe it to ourselves, as well as to our shareholders, to reach this endpoint without further dilution.”

In November, the FDA said it found that despite an "average agreement" between the results for the Ventripoint Medical System (VMS) and the alternative magnetic resonance imaging (MRI) within the allowable 10% mean difference, the substantial equivalency was not sufficiently proven to warrant approval. 

As a first step in securing funds to achieve its FDA goals, Ventripoint has already cancelled its previously announced plans for participating at trade show EuroEcho. 

"Given that our primary focus is on the FDA at present, we felt it prudent to place all attention and resources on this subject in order to reach our goal as fast as possible," said Bodtke. 

"We will maintain our current strategies for Western and Eastern Europe, as well as other areas, as we continue developing partnerships for distribution, all of which were planned to take place outside of EuroEcho.”

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Mon, 16 Dec 2013 08:43:00 -0500 https://ca.proactiveinvestors.com/companies/news/99038/ventripoint-devises-cost-cutting-plan-for-new-fda-submission-50715.html
<![CDATA[News - Ventripoint Diagnostics develops strategy to respond to FDA as it plans sales tactics globally ]]> https://ca.proactiveinvestors.com/companies/news/98694/ventripoint-diagnostics-develops-strategy-to-respond-to-fda-as-it-plans-sales-tactics-globally-50168.html VentriPoint Diagnostics (CVE:VPT) says that it has developed a strategy to address the concerns of the U.S. FDA regarding the market clearance of its diagnostic imaging system, for which it already has plans to expand sales abroad.

The company has even been invited by the U.S. regulatory body to meet the review team that chose to reject the tool for pulmanory arterial hypertension, as a means to gain a better understanding into the reasoning behind the decision. Ventripoint said late Monday that this is an important first step in the appeals process and will form the basis of further discussions. 

The FDA, according to Ventripoint's statement released last week, found that despite an "average agreement" between the results for the Ventripoint Medical System (VMS) and the magnetic resonance imaging (MRI) alternative within the allowable 10% mean difference, the substantial equivalency was not sufficiently proven to warrant approval. 

"It is important for us to fully engage the FDA through the available engagement and appeal processes," said VP of clinical affairs, Jim Bodtke.  "We currently have other submissions for requesting regulatory approval of various applications for the VMS and we need to better understand the current criteria for acceptance before initiating these submissions."

The company said despite the results of the VMS falling within the pre-specified 10% range, the FDA had some concerns about the "routine use of the VMS" in this patient population.

Ventripoint's CEO Dr. George Adams acknowledged his disappointment earlier this month, but highlighted that the U.S. regulatory agency has said the company had met the criteria for all the mean differences for all the measured heart parameters, and has allowed the medical device company to re-submit an application, offering up suggestions to improve the trial design and analysis process. 

The medical diagnostic imaging tool is already for sale in Canada, Europe, with the CEO emphasizing that the U.S. agency's decision has no impact on its marketing and selling abilities elsewhere in the world. 

In fact, Ventripoint said Monday that it has reached distribution agreements for France, Germany, Austria and Switzerland for the VMS, with further expansion planned. "We look forward to the upcoming EuroEcho meeting December 11-14, 2013 in Istanbul to meet with the cardiology community and distributors for Western and Eastern Europe as well as the Middle East," said VP of sales and marketing for the company, Jerry Gatewood. 

The system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

Indeed, Gatewood said "many areas in the world" have expressed an interest in offering VMS in their respective regions for a more comprehensive evaluation of the right ventricle. 

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Tue, 26 Nov 2013 09:33:00 -0500 https://ca.proactiveinvestors.com/companies/news/98694/ventripoint-diagnostics-develops-strategy-to-respond-to-fda-as-it-plans-sales-tactics-globally-50168.html
<![CDATA[News - Ventripoint Diagnostics CEO says there are many ways to get through FDA approval process ]]> https://ca.proactiveinvestors.com/companies/news/98513/ventripoint-diagnostics-ceo-says-there-are-many-ways-to-get-through-fda-approval-process--49913.html VentriPoint Diagnostics (CVE:VPT) shares were falling sharply on Friday after the FDA rejected its revised 510(k) application for approval of the company's diagnostic imaging system for use in pulmonary arterial hypertension -- a major heart disease -- but its chief executive was optimistic. 

"We are actively seeking the best avenue of approach to get the VMS to market.  As a company, we remain dedicated in our belief of the benefit our product has to offer the medical community as a whole, most importantly the patients," said CEO Dr. George Adams.

The FDA, according to Ventripoint's statement, found that despite an "average agreement" between the results for the Ventripoint Medical System (VMS) and the alternative magnetic resonance imaging (MRI) within the allowable 10% mean difference, the substantial equivalency was not sufficiently proven to warrant approval. 

Dr. Adams acknowledged his disappointment, but highlighted that the U.S. regulatory agency has said the company had met the criteria for all the mean differences for all the measured heart parameters, and has allowed the medical device company to re-submit an application, offering up suggestions to improve the trial design and analysis process. 

Last month, the company submitted the revised version of its 510(k) application, which included extra information the FDA had requested. It had prepared a detailed statistical plan to obtain the additional information required, collecting another 21 clinical cases, which along with the 54 studies used in the first analysis, yielded 75 cases in total. 

Dr. Adams told Proactiveinvestors that the company will be consulting with clinical advisors and regulatory consultants to determine its options, which include an appeal of the FDA decision. The medical diagnostic imaging tool is already for sale in Canada, Europe, with the CEO emphasizing that the U.S. agency's decision has no impact on its marketing and selling abilities elsewhere in the world. 

The system is a faster and more convenient alternative to an MRI procedure, and is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. 

The FDA has also suggested that Ventripoint go through the pre-market approval (PMA) process as a class III device, and not have to prove "substantial equivalency" to MRI, but rather prove the system is useful in clinical diagnosis of heart function. The company is already set-up to do PMA-type studies, the CEO said, and in the meantime, it will continue to sell its VMS tool outside the U.S.

Ventripoint is also planning studies in the U.S. and Europe to show that VMS can improve cardiac diagnosis in all types of heart disease, and not just pulmonary arterial hypertension.

One of the headline benefits to Ventripoint's VMS over the current standard is a significant cut-back on the time required for the procedure, from 1 to 1-1/2 hours for an MRI to as much as 5 minutes using the VMS. 

Shares fell over 73% in morning deals Friday, to 4 cents on the TSX Venture Exchange. 

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Fri, 15 Nov 2013 11:24:00 -0500 https://ca.proactiveinvestors.com/companies/news/98513/ventripoint-diagnostics-ceo-says-there-are-many-ways-to-get-through-fda-approval-process--49913.html
<![CDATA[News - Ventripoint Diagnostics boosts financing for commercialization of diagnostic imaging system ]]> https://ca.proactiveinvestors.com/companies/news/98050/ventripoint-diagnostics-boosts-financing-for-commercialization-of-diagnostic-imaging-system-49164.html VentriPoint Diagnostics (CVE:VPT) has boosted its debenture unit financing from $0.3 million to $0.5 million, with the new funds to be used for the commercialization of its medical diagnostic imaging system as well as to clinically validate the product for additional applications and to potentially repay debt. 

The company issued $0.5 million in $1,000 prinicipal amounts of convertible, non-secured debentures, which will mature in three years. It also issued 2.5 million common share purchase warrants, with an exercise price of 15 cents for a period of three years. 

The debentures, which can be converted at any time at a price of 10 cents per share, will bear a 12% annual interest rate, according to a company statement released late Tuesday. They can be repaid partially, or in full, by Ventripoint at any time without penalty. 

Earlier this month, Ventripoint moved another step in the right direction after finishing the complete dataset for the clinical trial of its medical diagnostic imaging system, which includes the extra information the FDA had requested prior to approving the product in the U.S. 

This complete dataset was the final hurdle before submitting its revised 510k submission for its Ventripoint Medical System (VMS) to the U.S. regulatory agency. The system is a faster and more convenient alternative to a magnetic resonance imaging (MRI) procedure, and the company is seeking its approval for pulmonary arterial hypertension-- a major heart disease. 

Through a dialogue with the FDA, the company prepared a detailed statistical plan to obtain the additional information required, collecting another 21 clinical cases, which along with the 54 studies used in the first analysis, yielded 75 cases in total for the new dataset. With the positive results now in hand, the company has filed its revised submission, with a final decision expected shortly.

The company said the clinical trial achieved all its primary endpoints of accurately measuring the volume and ejection fraction of the right heart, as compared to the traditional MRI analysis. Right heart function remains one of the most significant prognostic parameters in pulmonart arterial hypertension. 

Ventripoint's diagnostic system is able to capture usable images of the right side of the heart, which has always been a challenge in the industry due to its proximity to the ribs, posing a particularly poor vantage for image capture. The company's VMS creates a 3D-rendering visualization of the right ventricle, where congenital heart problems typically cluster, by gathering standard 2D ultrasound data and using it to create a 3D model with “knowledge-based techniques”. 

One of the headline benefits to Ventripoint's VMS over the current standard of medical imaging -- the MRI – is a significant cut-back on the time required for the procedure, from 1 to 1-1/2 hours for an MRI to as much as 5 minutes using the VMS. This would in turn reduce long wait times at hospitals, allowing them to run more efficiently. 

Approval in the U.S. would mean expansion for the company into a major market, with Canada and Europe already granting approval for the sale of the diagnostic tool. 

Ventripoint said Tuesday that it will use the funds for product and service commericialization, as well as to validate the functionality for additional diagnoses and heart diseases, and for general working capital needs. 

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Wed, 23 Oct 2013 09:21:00 -0400 https://ca.proactiveinvestors.com/companies/news/98050/ventripoint-diagnostics-boosts-financing-for-commercialization-of-diagnostic-imaging-system-49164.html
<![CDATA[News - Ventripoint’s diagnostic imaging system: opening up a billion dollar market and lowering healthcare costs ]]> https://ca.proactiveinvestors.com/companies/news/96564/ventripoints-diagnostic-imaging-system-opening-up-a-billion-dollar-market-and-lowering-healthcare-costs-46608.html Capturing usable images of the right side of the heart has always been a challenge. By its very nature, the heart is an organ in constant motion, one that is encased in “a bone cage”, as Dr. George Adams, CEO of VentriPoint Diagnostics Ltd. (CVE:VPT), puts it, and the right side is close to the ribs and poses a particularly poor vantage for image capture. All the more challenging are congenital heart problems, which cluster on the right ventricle (a problem on the left side almost always would not result in a live birth) and are misshapen.

With cardiologists tending not to use ultrasound for the right side of the heart due to the blurry nature of the resultant image, they are forced to employ MRI to gather critical information about the right side of the heart - a solution that involves costs and inconvenience for all parties.

Under the current system, one to two hours of the patient’s time must be spent inside the MRI, while analysis clocks in at between 15 and 45 minutes of the radiologist’s time. MRIs also involve a second visit to the MRI centre for the patient and a third appointment back to the cardiologist in order to establish treatment.

For some patients, an MRI might be a necessity, but might not be practical. Take the case of a child – by the nature of the ailment, some sufferers of congenital heart defects will be very young – being asked to lie motionless inside the massive metal chamber for hours. In cases like these, the infant and toddlers must be put under a general anaesthetic -- which always carries a risk of death – thus necessitating the presence of “four very expensive people to conduct the procedure,” says Dr. Adams, including an anaesthesiologist, cardiologist, radiologists and MRI technician.

The time-intensive nature of a cardiac MRI is also a concern to staff negotiating long lines of patients waiting for access. 

It is this cluster of needs that the Ventripoint Medical System, variously known as VMS and Angelo, seeks to address. The VMS creates a 3D-rendering visualization of the right ventricle that puts existing technology in the shade.

The technology itself is a patented and proprietary system that Dr. Adams says works by “connecting the dots” -- the VMS gathers standard 2D ultrasound data and uses it to create a 3D model, via the method of placing dots on the image coincident with anatomical landmarks, such as heart valves, and from these dots builds an accurate 3D model, using as a reference the Ventripoint’s ‘knowledge-based reconstruction library.’

This library, a sizable database that contains reconstructions of hearts both of normal dimensions and those with a variety of abnormalities corresponding to different kinds of heart disease, provides a catalog of potential shapes and sizes. A 25-point constellation of dots is used to build the heart shape that matches (with, Adams says, 99% accuracy) and the resultant image is used to calculate such aspects as heart volumes. The image can be rotated to complete the visualization and allows the cardiologist to visually verify the model’s accuracy.

It is the “connecting-the-dots” aspect that has given rise to the other name by which the VMS is known: Angelo, short for Michelangelo, the great master who taught his students to put dots on a page to gauge proportionality before drawing an image.

The company reports that independent research by leading cardiologists around the world has shown the numbers arrived at as a result of these calculations are just as accurate as MRI and better than 3D echo, or any other means of measuring the heart. 

The benefit, however, of such new scrutiny of the right side of the heart is only one aspect of this new technology. While the technology returns a highly accurate picture of the heart, it does so in a much shorter time than other methods: the 2D ultrasound examination takes around 5 minutes and the analysis takes another 10 minutes. This compares with upwards of two hours for MRI. This fact alone is attention-grabbing for hospitals, as once cardiac patients are removed from the line-up for the MRI, the volume of the queue is cut by a fifth. Perhaps even more important to a money-minded hospital is the fact that cardiac screening is among the least profitable uses to which an MRI can be put.

An economic analysis for a U.S. pediatric hospital put the rate of net income that can be generated by the VMS as coming in at $1,000 per hour, well above the $350 brought in by an MRI for the same amount of time for doing cardiac procedures.

Once the time “liberated” for the MRI is factored in, another $250,000 per year -- generated from using the MRI more efficiently for other procedures -- thus flows, albeit indirectly, from the VMS. And it seems that the sky is the limit.

While the first application for VentriPoint’s technology relates specifically to congenital heart disease, the company has a suite of applications planned for all major heart diseases, including pulmonary hypertension, cardiovascular disease and heart failure -- multi-billion dollar market potential. 

Already, VentriPoint is working on an additional possible application – Dr. Adams says he was “amazed” at the discovery that 26 per cent of heart patients return to hospital within a month of initial discharge, which seems to indicate that while current therapies work well on the majority of people, a sizable proportion of patients need more aggressive monitoring and therapy. Under the current American system, whereby patients are re-admitted for reassessment, the cost of the subsequent hospital stay – which is not counted as a new admission – has doubled in the last decade to hit $33,079 in 2010, according to the University of Washington.

As Dr. Adams points out, judging from available figures, it would take as little as a month and as few as three eliminated returns to cover the cost of the VMS system. A study with a large American hospital to prove this assertion is underway.  If proven, right heart analysis will likely become mandatory and revolutionize cardiac care worldwide.

And the list price of $100,000 for the actual machine is backed up by recurring income in the form of $10,000 per year for access to the database, software support, training and hardware maintenance and various value-adds that can drive annual per-unit revenue up by up to $40,000 per year.

At present, Canada and Europe have granted approval for the sale of the diagnostic tool with Ventripoint now pursuing approval from the U.S. FDA with one last hurdle to clear, Dr. Adams says. The FDA is seeking “one final piece of information”, which Adams is due to submit by the end of the summer, with approval anticipated to come early in the fall.

Already, 12 are installed in the U.S. for the purposes of clinical trials, with 10 spread over Europe and four in Canada.

Ventripoint’s quest to connect the dots is proceeding apace.

Shares in Ventripoint are currently trading at about 9 cents on the TSX Venture Exchange, giving it a market cap of just under $13 million. 

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Tue, 30 Jul 2013 09:00:00 -0400 https://ca.proactiveinvestors.com/companies/news/96564/ventripoints-diagnostic-imaging-system-opening-up-a-billion-dollar-market-and-lowering-healthcare-costs-46608.html