Holliston, MA, Oct. 28, 2024 (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, is proud to announce a new partnership with the renowned Capital Institute of Pediatrics in China to develop innovative treatments for Esophageal Atresia (EA) using our flagship Cellspan Esophageal Implant (CEI) product candidate. By combining HRGN’s pioneering platform technology with the Capital Institute of Pediatrics’ world-class expertise in pediatric care, this partnership will focus on clinical research, product development, and patient access to life-saving treatments.
Dr. Lishuang Ma, a chief surgeon at the Children’s hospital Capital Institute of Pediatrics, expressed great enthusiasm about the collaboration: “Partnering with HRGN offers an exciting opportunity to leverage cutting-edge regenerative medicine technology in addressing Esophageal Atresia, a condition that requires innovative solutions. Together, we aim to improve patient outcomes and bring hope to families affected by this challenging condition.”
Jerry He, HRGN’s Chief Executive Officer, Director and Chairman, shared: “Our CEI product holds tremendous potential to improve the quality of life for children with Esophageal Atresia, and this partnership accelerates our ability to bring this innovation to those who need it most.”
The partnership will focus on conducting Investigator initiated trials (IITs) to evaluate the safety and efficacy of the CEI product in treating Esophageal Atresia, with the aim of accelerating regulatory approval and expanding access to this novel treatment. Through joint efforts, Harvard Apparatus Regenerative Technology and the Children’s hospital Capital institute of Pediatrics in Beijing, China are committed to setting new standards of care in pediatric medicine.
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 and 2 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 Capital Institute of Pediatrics
The Children’s hospital Capital Institute of Pediatricians is a globally recognized leader in pediatric care, specializing in cutting-edge treatments and research for childhood diseases. The institute is dedicated to improving health outcomes for children through advanced medical solutions and compassionate care.
For more information, please visit https://www.shouer.com.cn/index.html
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, 2023 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
[email protected]
