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Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.
On Oct. 19, 2020, Orgenesis, a biotechnology company specializing in cell and gene therapies, announced that it has completed its previously announced acquisition of Koligo Therapeutics, a regenerative medicine company, while also acquiring substantially all of the assets of Tissue Genesis, also a regenerative medicine company, and gaining Tissue Genesis’ Icellator technology for cell isolation.
Under the agreement, Orgenesis acquired all of the outstanding Koligo stock from Koligo shareholders for approximately $14.5 million in shares of Orgenesis common stock, which is valued at $7.00 per share, and an assumption of $1.9 million in liabilities (estimated to be substantially all of Koligo’s liabilities). Orgenesis acquired the assets of Tissue Genesis for an additional consideration of $500,000 in closing cash and future royalties.
With the Tissue Genesis acquisition, Orgenesis will now own the entire inventory of 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. The Icellator device is a point-of-care (POC) cell isolation technology. It rapidly recovers high yields of stromal and vascular cells (SVF) from adipose tissue, which has been recognized as a superior source of adult stem cells, to be used therapeutically.
The Icellator device is commercially available in Korea and the Bahamas where Orgenesis plans to continue commercial distribution. Clearance is expected in Japan for Icellator X in the first quarter of 2021, pending completion of manufacturing tests requested by the Japanese Pharmaceutics and Medical Devices Agency. In addition, Tissue Genesis has initiated several Phase I pilot trials of the Icellator system in the United States under FDA investigational device exemptions for use in erectile dysfunction, critical limb ischemia, tissue repair, and other therapeutic indications.
Orgenesis intends to potentially develop a broad range of POC autologous cell therapies with significantly reduced costs using the Icellator technology. The company plans to deploy these therapies 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, in a company press release. “Specifically, we plan to leverage the therapies and technologies from Koligo and Tissue Genesis across our POCare Platform. One of our first goals is to accelerate the commercial scaleup of KYSLECEL throughout the United States and, subject to regulatory and logistical considerations, in international markets as well. Subject to FDA review and clearance of our IND [investigational new drug] application, we also look forward to commencing patient recruitment for a [Phase II] 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.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.”
“The Icellator system is highly complementary to our POCare technology systems, as well as Koligo’s 3D-V bioprinting technology. Technologies such as these support our mission of improving the efficacy and lowering the costs of cell and gene therapies by delivering autologous cell therapies at the point of care through our global network of hospitals and healthcare institutions,” Caplan added in the press release.