Harvard Apparatus Regenerative Technology
HOLLISTON, Mass., Aug. 26, 2024 (GLOBE NEWSWIRE) — Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing technology to regenerate organs in the body to treat serious diseases, today announced that it has raised approximately $5 million in a private offering of equity from new investors. More details available below.
The funds will be used to accelerate the clinical development of HRGN's lead product candidate, the HRGN Esophageal Implant (BEI). The FDA has approved a 10-patient Phase 1 and 2 clinical trial studying the repair of esophageal damage in adults caused by cancer or injury. The FDA has indicated it intends to consider expanding this clinical trial to pediatric subjects with esophageal birth defects once the implant's safety in adults has been proven. HRGN therefore anticipates that repair of esophageal birth defects will be an additional indication for which it will seek FDA approval.
Jerry Her, Chief Executive Officer, Director and Chairman of the Board of HRGN, said, “We are excited to welcome our new strategic investors. This private placement will accelerate our clinical trials and pipeline development. We look forward to making HRGN a success for both patients and shareholders.”
Private Placement Details
On August 19, 2024, Harvard Apparatus Regenerative Technology, Inc. (the “Company”) entered into a securities purchase agreement (the “Purchase Agreement”) with an investor (the “Investor”), pursuant to which the Investor has agreed to purchase an aggregate of 1,388,888 shares of Common Stock in a private placement for aggregate purchase price of $5,000,000, or $3.60 per share (the “Private Placement”).
About Harvard Apparatus Regenerative Technology, Inc.
We are a clinical-stage biotechnology company developing regenerative medicine treatments for disorders of the digestive system and other organs resulting from cancer, trauma and birth defects. Our technology is based on a proprietary cell therapy platform that uses a patient's own stem cells to regenerate damaged organs and restore their function. We believe our technology represents the next generation solution for organ function restoration because it enables patients to regenerate their own organs, eliminating the need for transplants from human donors or animals, the sacrifice of the patient's own separate organ, or permanent artificial implants.
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In August 2017, we performed the world's first successful esophageal regeneration in a patient with esophageal cancer. The surgery was performed by Dr. Dennis Wigle, Chief of Thoracic Surgery at Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. This surgery demonstrated that our technique can successfully regenerate esophageal tissue, including the mucosal lining, restoring the integrity, continuity and functionality of the esophageal tract.
HRGN has 15 U.S. patents, two in China, one in Japan and two in Europe, two U.S. Orphan Drug Designations which provide for seven years of market exclusivity in the U.S. market upon market approval by the FDA, and one EMA Orphan Drug Designation which provides for ten years of market exclusivity in the European market upon market approval by the EMA.
For more information, visit www.hregen.com or connect with us on LinkedIn.
Forward-Looking Statements
Certain statements in this press release are “forward-looking” and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements regarding the functionality and performance of our products and product candidates, development expectations and regulatory approvals, including from the U.S. Food and Drug Administration, the European Medicines Agency and others, for any of our products (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 for our products (which successes may not be achieved or obtained on a timely basis or at all). These statements involve risks and uncertainties that could cause results to differ materially from the statements made in this press release, including our inability to raise necessary capital in the near future and our ability to obtain and maintain regulatory approvals for our products. In addition, other factors described under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or in our other public filings. Our performance may also be affected by factors that we are not currently aware of. The forward-looking statements in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to publicly update or revise such statements to reflect any change in our expectations with respect thereto, or any change in events, conditions or circumstances on which any such statement is based.
Investor Relations Contact
Joseph Damasio
CFO
774-233-7330
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