Harvard Apparatus Regenerative Technology Collaborates with University of Southern California to Test Treatment for Esophageal Disease
MWN-AI** Summary
Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN), a biotechnology company focused on regenerative medicine, has announced a collaborative effort with the University of Southern California (USC) to study its innovative Cellspan™ Esophageal Implant (CEI). This partnership aims to advance clinical research around the CEI, particularly targeting benign esophageal diseases. The first-of-its-kind feasibility study is set to recruit up to ten patients across five clinical sites, with surgeries conducted to replace diseased sections of the esophagus using the CEI, which is personalized by seeding it with the patient’s own cells.
Dr. John Lipham, the principal investigator for the study at USC’s Keck Medical Center, emphasized the potential of this research to pave the way for new therapies that may help restore organ function through tissue regeneration. Harvard’s CEO, Jerry He, remarked that the study represents significant progress toward providing regenerative solutions for patients with critical unmet health needs.
Harvard Apparatus is committed to using its proprietary cell therapy platform to regenerate tissues and restore functions of damaged organs, thereby eliminating the need for organ transplants or artificial implants. The company successfully performed the world’s first esophagus regeneration in a patient with esophageal cancer in 2017, showcasing the potential effectiveness of their technology.
With 13 U.S. patents and additional designations that could result in market exclusivity upon FDA and EMA approvals, Harvard Apparatus is positioning itself as a leader in the regenerative medicine space. As the clinical study unfolds, the company anticipates gathering important data that could further validate the applicability of its innovative treatments for serious gastrointestinal disorders.
MWN-AI** Analysis
Harvard Apparatus Regenerative Technology, Inc. (HRGN) has recently made headlines with its collaboration with the University of Southern California (USC) to launch a first-in-human feasibility study for its Cellspan™ Esophageal Implant (CEI). This clinical study, targeting benign esophageal diseases, stands as a potential milestone for the company as it works on cutting-edge regenerative therapies.
As HRGN advances its research, investors should take a keen interest in several key factors influencing the company’s market outlook. First, the firm’s innovative approach to treating esophageal diseases, which utilizes a patient's own cells for tissue regeneration, differentiates it from traditional treatments and showcases its potential for high clinical impact. This regenerative solution could significantly reduce the dependence on donor organs and artificial implants, thus appealing to a broader patient demographic.
Moreover, the recent acquisition of orphan-drug designations in the U.S. and EU suggests that HRGN is focused on rare diseases with significant unmet medical needs. This often translates into financial incentives like market exclusivity post-approval, representing a potential revenue boost.
However, it is vital to consider the inherent risks associated with clinical-stage biotechnology investments. Investor sentiment can be volatile due to factors such as regulatory hurdles, the unpredictability of trial outcomes, and the need for substantial capital. The reliance on external partnerships, such as with USC, means HRGN’s success is partly contingent on the capabilities of its collaborators.
In summary, while HRGN presents a compelling investment opportunity due to its innovative technology and strategic partnerships, potential investors must remain vigilant about the risks and uncertainties in the biotechnology landscape. Diversifying investments and staying informed about trial outcomes will be crucial for stakeholders engaging with HRGN’s evolving narrative.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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
FAQ**
How does Harvard Apparatus Regenerative Technology Inc. (HRGN) plan to address potential regulatory hurdles as it advances the CEI product candidate through clinical trials?
What specific metrics will Harvard Apparatus Regenerative Technology Inc. (HRGN) use to assess the success of the feasibility study for the CEI?
Given the prior successful regeneration of the esophagus by HRGN, what unique advantages does the Cellspan™ Esophageal Implant offer compared to traditional treatment methods?
How does the collaboration between Harvard Apparatus Regenerative Technology Inc. (HRGN) and USC enhance patient access to the CEI and potentially expedite the study's timelines?
**MWN-AI FAQ is based on asking OpenAI questions about Harvard Apparatus Regenerative Technology Inc. (OTC: HRGN).
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