Harvard Apparatus Secures $5 Million for Clinical Advancements
Harvard Apparatus Regenerative Technology Secures $5 Million
Holliston, MA — Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN), a clinical-stage biotechnology firm specializing in regenerative medicine, has secured approximately $5 million in a private placement through a new investor. This funding aims to support the ongoing clinical development of the HRGN Esophageal Implant, a leading product candidate designed to repair esophageal damage caused by cancer and injuries.
Funding Utilization for Clinical Development
The newly raised funds will facilitate the advancement of the HRGN Esophageal Implant, which has received FDA approval for a ten-patient phase one and phase two clinical trial. This clinical trial aims to evaluate the efficacy of the implant in repairing esophageal damage in adults.
Expanding Potential for Pediatric Use
Significantly, the FDA has expressed a willingness to consider expanding the clinical trial to include pediatric patients with esophageal birth defects, contingent on successful safety demonstrations in adult subjects. The Company anticipates seeking FDA approval for this indication, highlighting its commitment to addressing critical health needs.
CEO Statement on Strategic Investment
Jerry He, Chief Executive Officer, Director, and Chairman of Harvard Apparatus Regenerative Technology, expressed optimism regarding the investment. He stated, “I am very pleased to welcome our new strategic investor. This private placement will accelerate our clinical trial and pipeline development. We look forward to making HRGN a success both for its patients and shareholders.”
Details of the Private Placement
On August 19, 2024, Harvard Apparatus Regenerative Technology entered into a Securities Purchase Agreement for the sale of 1,388,888 shares of common stock at a purchase price of $3.60 per share. This strategic move is intended to bolster the Company’s efforts in clinical advancement and expansion.
About Harvard Apparatus Regenerative Technology
Harvard Apparatus Regenerative Technology is pioneering regenerative treatments aimed at restoring the functionality of the gastrointestinal system and other vital organs affected by cancer, trauma, or congenital defects. The Company leverages a proprietary cell-therapy platform that utilizes a patient’s own stem cells to regenerate damaged organs.
Groundbreaking Achievements in Organ Regeneration
The Company made history with the first successful regeneration of the esophagus in a patient with esophageal cancer, a surgical achievement performed by a leading thoracic surgeon. The procedure effectively demonstrated the capability of their technology to regenerate tissues and restore the functionality of the esophageal structure.
Patents and Market Exclusivity
Harvard Apparatus Regenerative Technology holds 15 issued U.S. patents, along with corresponding patents in China, Japan, and Europe. The Company has also secured orphan drug designations, providing significant market exclusivity in different regions upon FDA and EMA approvals.
Contact Information
For further inquiries, you can reach out to:
Investor Relations Contact
Joseph Damasio
Chief Financial Officer
774-233-7330
jdamasio@hregen.com
Frequently Asked Questions
What is the purpose of the $5 million financing?
The financing will be used to accelerate the clinical trial and development of the HRGN Esophageal Implant, which aims to repair esophageal damage.
Who is the new investor involved in the financing?
The identity of the new investor has not been disclosed, but they are part of the private placement agreement.
What FDA approvals has the HRGN Esophageal Implant secured?
The implant has been approved for a ten-patient phase one and phase two clinical trial focusing on adult patients.
Does the company have plans for pediatric applications?
Yes, the FDA has indicated a willingness to consider including pediatric patients with birth defects if safety is demonstrated in adults.
How does Harvard Apparatus Regenerative Technology innovate in medicine?
The company utilizes a proprietary cell-therapy platform, using patients' own stem cells for organ regeneration, aiming to eliminate the need for donor organs or artificial implants.
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