Holliston, MA, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced that it officially executed a sponsored research agreement (SRA) with Drs. Stephen Badylak, George Hussey and Vincent Anto at the McGowan Institute for Regenerative Medicine, a center of the University of Pittsburgh and UPMC focused on developing regenerative therapies to address organ and tissue failure. The program will focus on the use of Harvard Apparatus Regenerative Technology’s cell-based scaffold platform to repair the colon following colon resection in a rodent model of colectomy.
Colectomy is a surgical procedure that involves the complete removal of the colon or partial removal of sections that are obstructed or diseased due to conditions such as cancer, diverticulitis, Crohn’s disease and inflammatory bowel disease. About 300,000 colectomies are performed annually in the US. Complications associated with the procedure include leaks where the colon has been reconnected, narrowing of the intestine, holes called fistulas that leak into the abdomen, infection, blood clots and dead tissue, or necrosis, that results from poor circulation. Post-operative complications are well documented and cost an average of $15,000 to $20,000 per patient with an annual overall cost to the health care system of $1B.
“We are building on our platform technology by applying it to other gastrointestinal organs. Developing a product to repair and/or regenerate the colon following colectomy will expand our pipeline and further our product portfolio for repairing and regenerating tubular organs within the gastrointestinal tract”, commented Jerry He, Harvard Apparatus Regenerative Technology 's Chief Executive Officer.
“The program is designed to test several versions of our cell-based scaffold technology to repair tubular organs in the digestive system. Establishing a use for the technology to minimize or eliminate many of the complications associated with colectomy has the potential to significantly reduce the costs to the health care system”, commented Dr. William Fodor, Harvard Apparatus Regenerative Technology’s Chief Scientific Officer.
“This new technology aimed to restore colonic tissue and reduce the risk of anastomotic leak in patients requiring colorectal resections may potentially decrease post-operative morbidity and obviate the need for patients to undergo additional surgeries,” stated Dr. Anto.
About Harvard Apparatus Regenerative Technology, Inc.
We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.
We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.
HRGN has 13 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, 2 U.S. orphan-drug designations which can provide seven years of market exclusivity in the US market after market approval from the FDA and 1 EMA orphan drug designation, which can provide ten years of market exclusivity in the European market after market approval from the EMA.
For more information, please visit www.hregen.com and connect with the Company on LinkedIn.
About the University of Pittsburgh School of Medicine
As one of the nation’s leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top recipients of funding from the National Institutes of Health since 1998. In rankings released by the National Science Foundation, Pitt is in the upper echelon of all American universities in total federal science and engineering research and development support.
Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the region’s economy. For more information about the School of Medicine, see www.medschool.pitt.edu.
Forward-Looking Statements
Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company’s products, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the Company's ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 or described in the Company’s other public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
Investor Relations Contact
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com
