The company raises up to an additional $23 million from strategic partner Sanford Health to advance a pivotal program in rotator cuff tendinopathy
Houston, TX, USA, June 11, 2019 – InGeneron, Inc., a clinical-stage regenerative medicine and cell therapy company, announced today the extension of its Series D financing by up to $23 million, totalling up to $43 million to be invested in the organization. The additional funds will come from InGeneron’s clinical partner Sanford Health, one of the largest integrated health systems in the United States. The investment is structured in various tranches linked to progress in the company’s development. It will support the advancement of InGeneron’s pivotal study in rotator cuff tendinopathy, a degenerative and often chronic condition found in a person’s shoulder, as well as other clinical programs in its autologous point-of-care cell therapy portfolio. Last month, the company announced the enrollment of the first patients in its rotator cuff tendinopathy pivotal trial.
“We are impressed by the progress InGeneron has made toward the use of adult stem cells to treat a number of injuries and conditions,” said Kelby Krabbenhoft, President and CEO of Sanford Health, who is also a board director of InGeneron. “Through our collaboration with the company, Sanford Health is among the first health systems in the U.S. in a clinical-stage of researching this novel treatment approach for the benefit of patients in compliance with the FDA’s regulatory pathway.”
InGeneron’s therapeutic approach involves isolating and preparing adipose-derived regenerative cells (ADRCs) from a patient’s own fat tissue and administering the cells locally at the site of injury. The therapy is enabled by a proprietary cell processing system, designed for a one-time, minimally-invasive, outpatient procedure performed at the bedside. The company’s primary focus is on developing an autologous cell therapy to treat pain and functional impairments associated with musculoskeletal conditions.
“Sanford Health’s continued support helps advance InGeneron’s regenerative cell therapy into the expansive pivotal trial phase, a significant step toward bringing our therapy into the clinic,” said Angelo Moesslang, PhD, Chief Executive Officer of InGeneron. “This is an exciting time for the company, as one of the largest health systems in the United States further affirms the potential of adipose-derived regenerative cell therapy, while we diligently work to make it available to patients.”
InGeneron has launched three clinical programs centred around key musculoskeletal conditions. Its lead program in partial-thickness rotator cuff tears is presently enrolling patients in a double-blinded, multi-centre pivotal study. The company is also conducting feasibility trials in chronic back pain and wrist osteoarthritis. It reported top-line data of its partial-thickness rotator cuff tear feasibility study in December 2018, which found the therapy to be safe and well-tolerated. The data can be found on the company’s website, and the results of that trial are being prepared for peer-reviewed publication.
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.
About Sanford Health
Sanford Health, one of the largest health systems in the United States, is dedicated to the integrated delivery of health care, genomic medicine, senior care and services, global clinics, research and affordable insurance. Headquartered in Sioux Falls, South Dakota, the organization includes 44 hospitals, 1,400 physicians and more than 200 Good Samaritan Society senior care locations in 26 states and nine countries. Nearly $1 billion in gifts from philanthropist Denny Sanford have transformed how Sanford Health improves the human condition. www.sanfordhealth.org
Eckhard Alt, MD, PhD
Executive Chairman of InGeneron
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