In addition to clinical trial cooperation with one of the largest U.S. hospital groups, investment will support clinical development in orthopedics and wound healing
Houston, Texas, and Sioux Falls, South Dakota, March 6, 2017 – InGeneron, Inc., a regenerative medicine and cell therapy company, announces that Sanford Health, one of the largest integrated healthcare providers in the U.S., has invested $20 million in the company in the form of a Series D financing. The funding is in addition to an active cooperation between InGeneron and Sanford Health for the execution of InGeneron’s clinical programs to improve outcomes in rotator cuff and venous ulcer treatment with its proprietary cell-based therapeutic approach.
“This significant investment demonstrates Sanford’s commitment to be an active participant in InGeneron as well as being our clinical trial site of choice,” said Ron Stubbers, MBA, President of InGeneron. “Our joint efforts will enable the company to make regenerative cell therapies available to clinical practice and to establish a leading position in the application of adipose-derived regenerative cells.”
Earlier this year, Sanford began enrolling participants in the FDA-approved Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections into Partial Thickness Rotator Cuff Tears clinical trial. The trial uses stromal vascular fraction, a mixture of cells and nutrients isolated from a patient’s own body that contain adipose-derived stem cells, as a potential therapy for partial-thickness rotator cuff tears. Sanford scientists and clinicians are exploring the application of this type of stem cells for other conditions.
Kelby Krabbenhoft, President and CEO of Sanford Health, notes that InGeneron’s approach can help meet a medical need in key orthopedics and wound healing. “Our active collaboration enabled us to be among the first U.S. health care providers to study adipose stem cell therapy in clinical trial,” Krabbenhoft said.
“The investment and expertise Sanford Health brings will accelerate the clinical developments and be a significant facilitator en route to bringing new regenerative cell therapies to patients,” commented Fabian Alt, CFO of InGeneron.
InGeneron is developing regenerative cell therapy applications for orthopedic and wound-healing indications based on its proprietary technology, which enables physicians to use adipose-derived regenerative cells from the patient’s own body for immediate therapeutic application at point of care. InGeneron has an active collaboration with Sanford Health to conduct its clinical trials in rotator cuff tears and venous ulcers at different sites in the Sanford Health network. These studies aim to investigate the safety and efficacy of using autologous adipose-derived regenerative cells in patients compared to current standard of care treatments. With the aim of regulatory approval in the U.S., the first patients were enrolled in InGeneron’s clinical program in January 2017.
About the Transpose® RT System and FDA approved clinical trials
InGeneron’s Transpose® RT cell therapy platform consists of a processing unit, a set of disposables and Matrase®, a proprietary enzyme mixture. The platform allows the isolation of regenerative cells from the patients’ own adipose tissue at point-of-care in less than 90 minutes for same-day treatment. The cells are re-administered into the patient’s damaged tissue by injection under ultrasound or fluoroscopic guidance.
The Transpose® RT System is being investigated in several FDA-approved clinical trials and is currently available in the U.S. for research use only. More information on InGeneron’s actively enrolling clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.
InGeneron is a clinical-stage biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to validate our technology as a disease-modifying treatment. Based on more than 20 years of research, InGeneron is dedicated to developing therapies supported by clinical evidence and approved by the FDA.
Eckhard Alt, MD, PhD
Executive Chairman of InGeneron
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