Harvard Apparatus Regenerative Technology Stock Price, News & Analysis

Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) is described as 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. The company reports that its technology is based on a proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs.

According to company disclosures, this approach is intended to allow patients to regenerate their own organs, eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs, or permanent artificial implants. Harvard Apparatus Regenerative Technology has highlighted its focus on severe diseases affecting tubular organs, including the esophagus and other parts of the digestive system.

Core technology and organ regeneration focus

The company states that its platform is a cell-based scaffold technology that supports the regeneration of organ tissue. This platform is being applied to the gastro-intestinal system and, in some disclosures, to the airway and other organs. A central element of the company’s work is the development of the Cellspan Esophageal Implant (often referred to as CEI or HRGN Esophageal Implant), a product candidate designed to repair damage to the esophagus.

Harvard Apparatus Regenerative Technology reports that it conducted what it describes as the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. The surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The company states that the results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021 and that the procedure demonstrated regeneration of esophageal tissue, including the mucosal lining, restoring the integrity, continuity and functionality of the esophageal tube.

Clinical-stage development and trials

The company characterizes itself as being in the clinical stage. It reports that the U.S. Food and Drug Administration (FDA) has approved a ten-patient phase one and phase two clinical trial to study the repair of damage to the esophagus in adults caused by cancer or injury, using its esophageal implant product candidate. Company disclosures indicate that the FDA has indicated a willingness to consider expanding this clinical trial to include pediatric subjects with birth defects in the esophagus once safety is shown in adults.

Harvard Apparatus Regenerative Technology has announced that Mayo Clinic was activated as the first site for its clinical trial in severe esophageal disease and that the University of Michigan was activated as a second clinical trial site. The company has also reported that it has contracted with IQVIA as the contract research organization to manage its first clinical trial and that it is recruiting patients at these sites.

Pipeline expansion and research collaborations

Beyond the esophagus, the company has described efforts to extend its platform technology to other organs. It has announced a research collaboration with the McGowan Institute for Regenerative Medicine at the University of Pittsburgh to study repair and regeneration of the colon following colectomy in a rodent model. The program is described as focusing on the use of the company’s cell-based scaffold platform to repair the colon after colon resection.

Harvard Apparatus Regenerative Technology has also disclosed a Sponsored Research Agreement with a physician at Yale School of Medicine to explore the use of its cell-based scaffold platform to repair uterine tissue and restore fertility in a mouse model of uterine damage. The company has characterized this as an application of its technology to a hollow organ outside the gastrointestinal tract, in the area of women’s health.

In another collaboration, the company has announced a partnership with the Children’s Hospital Capital Institute of Pediatrics in Beijing, China to develop treatments for Esophageal Atresia using its Cellspan Esophageal Implant product candidate. The partnership is described as focusing on clinical research, product development and patient access for this condition.

Intellectual property and regulatory designations

Harvard Apparatus Regenerative Technology reports that it holds multiple issued patents and orphan-drug designations related to its technology. In various disclosures, the company has stated that it has a portfolio of issued patents in the United States, China, Japan and Europe. It has also reported that it has U.S. orphan-drug designations that can provide seven years of market exclusivity in the U.S. market after market approval from the FDA, and an EMA orphan drug designation that can provide ten years of market exclusivity in the European market after market approval from the European Medicines Agency (EMA).

The company has further disclosed that it received approval of an Orphan Disease Application for its lead product, the Cellspan Esophageal Implant, by the EMA for Esophageal Atresia. The EMA is described in the company’s materials as the centralized regulatory agency for the review and approval of new medicines in the European Union.

Additional business activities

In addition to its regenerative-medicine programs, Harvard Apparatus Regenerative Technology has reported that a subsidiary in Hong Kong launched a longevity product business in Asia. Company disclosures state that this longevity product business includes dietary supplements focused on longevity and that these products are marketed to the general public, initially targeting consumers in the Greater China region through e-commerce channels.

The company has described this longevity product business as complementary to its regenerative medicine activities and as a way to generate revenue and operating cash flow from China while continuing its research and clinical-trial efforts in the United States.

Financing and capital markets

Harvard Apparatus Regenerative Technology’s common stock trades on the OTCQB market under the symbol HRGN. The company has reported multiple private placements and financing transactions, including private investments in public equity (PIPE) financings and other private placements of common stock. For example, it has disclosed private placements in which investors agreed to purchase shares of common stock for aggregate purchase prices in the millions of dollars, and an 8-K filing describes a Securities Purchase Agreement effective as of December 30, 2025 for a private placement of common stock.

Company press releases and filings indicate that proceeds from these financings are intended to support clinical development of the esophageal implant and expansion of the company’s product pipeline, as well as general corporate purposes.

Geographic and sector context

Harvard Apparatus Regenerative Technology identifies itself in public communications as being based in Holliston, Massachusetts. While the industry classification provided lists "Small Arms, Ordnance, and Ordnance Accessories Manufacturing" within the Manufacturing sector, the company’s own descriptions in press releases and SEC filings consistently characterize it as a clinical-stage biotechnology company focused on regenerative medicine for organ and tissue repair.

Frequently asked questions (FAQ)

• What does Harvard Apparatus Regenerative Technology, Inc. do?
  According to the company, it is 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, using a proprietary cell-therapy platform based on a patient’s own stem cells.
• What is the Cellspan Esophageal Implant (CEI) or HRGN Esophageal Implant?
  Company disclosures describe the Cellspan Esophageal Implant as a lead product candidate designed to repair damage to the esophagus. It is part of the company’s platform for regenerating esophageal tissue and has been associated with clinical trial activity and orphan-disease regulatory interactions.
• What clinical trials has the company reported?
  Harvard Apparatus Regenerative Technology states that the FDA has approved a ten-patient phase one and phase two clinical trial to study repair of esophageal damage in adults. It has reported that Mayo Clinic was activated as the first clinical trial site and the University of Michigan as a second site, with IQVIA engaged as contract research organization.
• What was the reported "world’s first" esophagus regeneration?
  The company reports that in August 2017 it conducted what it describes as the world’s first successful regeneration of the esophagus in a patient with esophageal cancer, with surgery performed by a Mayo Clinic surgeon. The results were later published in the Journal of Thoracic Oncology Clinical and Research Reports, and the company states that the procedure regenerated esophageal tissue and restored the integrity and functionality of the esophageal tube.
• Which organs beyond the esophagus is the company exploring?
  In its announcements, the company has described research collaborations to apply its cell-based scaffold platform to the colon following colectomy and to uterine tissue in models of uterine damage, as well as a focus on disorders of the gastro-intestinal system and other organs.
• What regulatory designations has Harvard Apparatus Regenerative Technology reported?
  The company has disclosed U.S. orphan-drug designations that can provide seven years of market exclusivity after FDA approval and an EMA orphan drug designation that can provide ten years of market exclusivity after EMA approval. It has also reported EMA approval of an Orphan Disease Application for the Cellspan Esophageal Implant in Esophageal Atresia.
• Does the company have any international collaborations?
  Yes. Public announcements describe a partnership with the Children’s Hospital Capital Institute of Pediatrics in Beijing, China to develop treatments for Esophageal Atresia using the Cellspan Esophageal Implant, and a Hong Kong subsidiary that launched a longevity product business in Asia.
• How does Harvard Apparatus Regenerative Technology describe its intellectual property?
  The company has reported that it holds multiple issued patents in the United States and other jurisdictions, as well as orphan-drug designations in the U.S. and Europe, which it associates with potential periods of market exclusivity following regulatory approvals.
• How does the company generate or plan to generate revenue?
  Company disclosures indicate that it is a clinical-stage biotechnology company focused on developing regenerative-medicine treatments. It has also reported revenue from a longevity product business operated by a Hong Kong subsidiary, involving longevity dietary supplements marketed to consumers in the Greater China region through e-commerce.
• On which market does HRGN stock trade?
  Harvard Apparatus Regenerative Technology states in its press releases that its common stock trades on the OTCQB market under the ticker symbol HRGN.