In addition, OrGenesis said in a statement that it has acquired all of the assets of Tissue Genesis LLC, adding to a growing list of POCare technology resources.
The acquisition of Tissue Genesis was initially undertaken via Koligo and became part of the Koligo acquisition transaction. As a result, Orgenesis said it will now own the entire inventory of Tissue Genesis Icellator\devices, related kits and reagents, a broad patent portfolio to protect the technology, registered trademarks, clinical data, and existing business relationships for commercial and development stage use of the Icellator technology.
READ: Orgenesis touts 2Q revenue jump from its POCare network, advances coronavirus vaccine platform
Under the terms of the Koligo merger agreement, Orgenesis said it acquired all of the outstanding stock of Koligo from its shareholders for approximately $14.5 million in shares of Orgenesis common stock at $7 per share (with certain non-accredited investors paid approximately $20,000 solely in cash) and an assumption of $1.9 million in liabilities, estimated to be substantially all of Koligo’s liabilities. Orgenesis acquired all the assets of Tissue Genesis for additional consideration of $500,000 in closing cash and future royalties.
The Icellator device is a point-of-care cell isolation technology that rapidly recovers high yields of stromal and vascular cells (SVF) from adipose tissue (fat) to be used therapeutically. Adipose tissue is recognized as a superior source for adult stem cells found abundantly in the micro-vasculature and stroma of human fat.
The device is commercially available in Korea and the Bahamas where Orgenesis plans to continue commercial distribution. Icellator X clearance is expected in Japan in the first quarter of 2021 subject to completion of manufacturing tests requested by the Japanese Pharmaceutics and Medical Devices Agency.
Orgenesis said Tissue Genesis has initiated several Phase 1 pilot trials of the Icellator system in the US under an investigational device exemption (IDE) by the US Food and Drug Administration for use in erectile dysfunction, critical limb ischemia, tissue repair, and other therapeutic indications.
Deploying the Icellator technology
Orgenesis said it intends to deploy the Icellator technology to potentially develop a broad range of point of care autologous cell therapies with significantly reduced costs across a growing POCare Network that includes leading hospitals and healthcare institutions.
“With the Koligo acquisition closed, we believe that we are making rapid progress on a number of fronts,” said Vered Caplan, CEO of Orgenesis. “Specifically, we plan to leverage the therapies and technologies from Koligo and Tissue Genesis across our POCare Platform."
Caplan said one of the company’s first goals is to accelerate the commercial scaleup of KYSLECEL throughout the US and in international markets.
“Subject to FDA review and clearance of our IND application, we also look forward to commencing patient recruitment for a phase 2 randomized clinical trial of KT-PC-301, an autologous clinical development stage cell therapy candidate for COVID-19-related Acute Respiratory Distress Syndrome, or ARDS,” he explained.
“We plan to use the Icellator device to support scalable, cost-effective production of KT-PC-301. Additionally, Koligo’s development stage 3D-V bioprinting technology for the vascularization of autologous cells to create biodegradable and shelf-stable three-dimensional cell and tissue implants will be explored for diabetes and pancreatitis applications, with longer term applications for neural, liver, and other cell/tissue transplants also potentially explored.”
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