Harvard Apparatus Regenerative Technology Collaborates with University of Southern California to Test Treatment for Esophageal Disease
HOLLISTON, Mass., Jan. 21, 2026 (GLOBE NEWSWIRE) -- Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company advancing a platform designed to regenerate tissue inside the body to restore organ function in severe disease, is proud to announce a new collaboration with University of Southern California (USC) to conduct a study of its Cellspan™ Esophageal Implant (CEI) product candidate. The collaboration will focus on clinical research and trial execution, including efficient patient identification and recruitment, with the goal of expanding access to potentially life-changing regenerative treatments.
The first-in-human feasibility study of CEI is actively recruiting participants with benign esophageal diseases. Each participant will undergo surgery to remove a diseased section of esophagus, and implant a CEI matrix seeded with their own cells. The study will involve up to 10 patients at a maximum of five clinical sites, including Keck Hospital of USC.
Dr. John Lipham, M.D., gastrointestinal surgeon with Keck Medicine of USC, professor of surgery and chief of upper GI surgery and the study’s principal investigator at the Keck School of Medicine of USC, said, “This study may be an important step toward developing therapies that may help patients regain essential organ function through tissue regeneration.”
Jerry He, Chief Executive Officer of Harvard Apparatus Regenerative Technology (HRGN), added, “This study works toward bringing a regenerative solution to patients with serious unmet needs.
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 issued 13 patents in the U.S., 2 in China, 1 in Japan, and 2 in Europe. HRGN has also obtained 2 orphan-drug designations, which can provide seven years of market exclusivity in the U.S. market after market approval from the FDA, and 1 EMA orphan drug designation, which can provide 10 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.
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, 2024 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 Contacts
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com
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