Orgenesis announces use of the Tissue Genesis Icellator® in a Hospital for Special Surgery clinical study for rotator cuff repair

Orgenesis announces use of the Tissue Genesis Icellator® in a Hospital for Special Surgery clinical study for rotator cuff repair

Investigator-initiated, randomized, placebo-controlled, phase 2 trial to evaluate autologous stromal and vascular fraction cell (“SVF”) injections after rotator cuff surgery

Germantown, MD, US, June 10, 2021 -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, announces that enrollment has commenced for a clinical trial using the Tissue Genesis Icellator(R) at the Hospital for Special Surgery (“HSS”) in New York, NY. 

The phase 2, randomized, placebo-controlled trial, which is supported by the National Stem Cell Foundation and an OREF Clinical Research Grant in Cellular Therapy in Honor of James Urbaniak, MD, will evaluate safety and efficacy of autologous stromal and vascular fraction cells (“SVF”) that are injected after surgical rotator cuff repair. The Tissue Genesis Icellator will be utilized for the cell recovery process. Fifty-six (56) patients are to be enrolled in total; as of today, nine (9) patients have been enrolled.  Scott Rodeo, MD, Professor of Orthopedic Surgery at Weill Cornell Medical College and Co-Chief Emeritus of the Sports Medicine Institute at HSS, is the principal investigator. Further details of the trial are available at ClinicalTrials.gov, identifier NCT03332238.

Orgenesis acquired the Tissue Genesis Icellator technology in October 2020 to supplement its offering of POCare technology systems. The Icellator is an automated, functionally closed system for recovery of SVF from autologous adipose (fat) tissue. It is designed for use at the point of care. 

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. The ability to successfully rehabilitate these injuries postoperatively is limited by the poor quality of the muscle and tendon after rotator cuff repair. Published nonclinical and clinical evidence demonstrate that SVF from the Icellator may enhance tissue regeneration directly by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate healthy tissue regeneration pathways. SVF has also been shown to modulate inflammation and reduce scarring.

Scott Rodeo, MD, principal investigator: “I am pleased to lead this trial investigating the efficacy of Icellator-generated SVF in patients after rotator cuff repair.  There is a significant clinical need to improve outcomes for these patients and SVF injection has shown promise in early research.”

Matthew Lehman, Orgenesis U.S. POCare General Manager: “We are excited to support this investigator-initiated trial and thank the HSS, the Orthopaedic Research and Education Foundation, and the National Stem Cell Foundation for their involvement. Designed to be used point-of-care, the Tissue Genesis Icellator is a practical and cost-effective solution for clinical applications of SVF. Data from this study may support expanded development of the Icellator in other orthopedic applications.”

The Tissue Genesis Icellator is an Investigational Device in the United States and in other countries. Use of the Icellator in the United States is currently limited to Investigational Use within approved clinical trials.

About Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 11th consecutive year), No. 4 in rheumatology by U.S. News & World Report (2020-2021). HSS is ranked world #1 in orthopedics by Newsweek (2020-2021). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 130 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

About Orgenesis
Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. Learn more about the work Orgenesis is doing at www.orgenesis.com.

About the Orthopaedic Research and Education Foundation (OREF)
OREF is a charitable 501(c)(3) organization committed to improving lives by supporting excellence in orthopaedic research. OREF is dedicated to being the leader in supporting research that improves function, eliminates pain, and restores mobility, and is the premier orthopaedic organization funding research across all specialities. A list of research and funding priorities is available at oref.org/grants or follow @oreftoday on Twitter.

About the National Stem Cell Foundation (NSCF)
The National Stem Cell Foundation is a 501(c)3 non-profit organization that funds adult stem cell and regenerative medicine research, connects children with limited resources to clinical trials for rare diseases, and underwrites the National STEM Scholar Program for middle school science teachers inspiring the next generation of STEM pioneers nationwide. For more information, visit http://www.nationalstemcellfoundation.org.

Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the coronavirus outbreak, the sufficiency of working capital to realize our business plans, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.