Houston, Texas-based InGeneron has secured up to $20 million in equity financing from one of the nation’s largest healthcare systems, Sanford Health.
In a phone interview, InGeneron President Ron Stubbers said the investment includes a $10 million upfront payment and up to $10 million more in milestone payments, based on the success of its regenerative medicine program.
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The investment builds on an established partnership to optimize the use of adipose-derived stem cells.
In a separate call, Rich Adcock, chief innovation officer for Sanford Health, said his organization was immediately attracted to the biotech’s devices and processes. With a progressive research agenda and some 45 hospitals and nearly 300 clinics in nine states and four countries, it also has the ability to make major commitments.
“We looked at each other and recognized, there’s a big future here,” Adcock said of the stem cell approach. “We’re not exactly sure if it’s going to be in one day or 10 years, but we knew that we wanted to be part of it and help mature and guide them through the regulatory processes and clinical trials to help make that a reality.”
Neither Adcock nor Stubbers view the partnership as a conflict of interest, despite Sanford’s role in executing the clinical trials. Adcock said the program is more about alignment, given the shared goals and complementary expertise.
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Stubbers also noted that the Phase 2 efficacy study will be run at third-party trial sites.
As a medical device, the path-to-market typically involves a Phase 1 feasibility study followed by a pivotal Phase 2 trial. The feasibility study for partial-thicknesses rotator cuff tears began in January and the company expects to start a second Phase 1 trial in wound care in the second quarter, Stubbers said.
Stubbers said the devices allow physicians to use a patient’s adipose tissue to treat a number of illnesses at the point of care.
“We’ve spent a lot of time optimizing a workflow for the device so that it integrates with the clinic,” Stubbers explained. “A physician can use it, collect the fat, do the processing and use the cells within a single surgical procedure — so 60-90 minutes.”
For most indications, the procedure follows a similar set of steps. Up to 100 grams of tissue is extracted via syringe lipoplasty (not enough to alter one’s silhouette). The collected tissue is then transferred into a processing tube, along with a proprietary enzyme. Once loaded into the device, the tubes are subjected to heating and agitation. After a couple of wash cycles, the mesenchymal cells are isolated and the therapy is ready-to-go.
Stubbers said the processed stem cells are injected into the trauma site, as is done with the standard-of-care corticosteroid shots. No culturing or cell selection is needed, which can simplify the process down to a single outpatient procedure.
The deal is part of a coming of age for regenerative medicine, following decades without a market approval. While the adipose-derived stem cell approach seems straightforward, Stubbers said InGeneron spent many years optimizing the technology and the process. As with other stem cell companies, they are now focused on healing tissues, not regrowing permanently damaged tissues.
Photo: sgame, Big Stock
