Harvard Apparatus Regenerative Technology Secures $5 Million
Holliston, MA — Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN), a biotechnology company in the clinical stage that focuses on regenerative medicine, has successfully raised around $5 million through a private placement with a new investor. This funding is intended to advance the clinical development of the HRGN Esophageal Implant, which is designed to repair damage to the esophagus caused by cancer and injuries.
Funding Utilization for Clinical Development
The funds raised will be used to further develop the HRGN Esophageal Implant, which has already received FDA approval for a clinical trial involving ten patients in both phase one and phase two. This trial aims to assess how effective the implant is in repairing esophageal damage in adults.
Expanding Potential for Pediatric Use
Importantly, the FDA has shown openness to the possibility of expanding the clinical trial to include pediatric patients suffering from esophageal birth defects, provided that safety is demonstrated in adult trials. The Company plans to seek FDA approval for this application, emphasizing its dedication to addressing significant health challenges.
CEO Statement on Strategic Investment
Jerry He, the Chief Executive Officer, Director, and Chairman of Harvard Apparatus Regenerative Technology, expressed his enthusiasm regarding the new investment. He remarked, “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 to sell 1,388,888 shares of common stock at a price of $3.60 per share. This strategic decision aims to enhance the Company’s clinical development and expansion efforts.
About Harvard Apparatus Regenerative Technology
Harvard Apparatus Regenerative Technology is at the forefront of developing regenerative treatments that seek to restore the functionality of the gastrointestinal system and other essential organs affected by cancer, trauma, or congenital defects. The Company employs a proprietary cell-therapy platform that utilizes a patient’s own stem cells to regenerate damaged organs.
Groundbreaking Achievements in Organ Regeneration
The Company has made a landmark achievement by successfully regenerating the esophagus in a patient with esophageal cancer, a surgical milestone carried out by a leading thoracic surgeon. This procedure effectively showcased the potential of their technology to regenerate tissues and restore the functionality of the esophagus.
Patents and Market Exclusivity
Harvard Apparatus Regenerative Technology holds 15 issued U.S. patents, along with corresponding patents in China, Japan, and Europe. Additionally, the Company has obtained orphan drug designations, which provide substantial market exclusivity in various regions pending FDA and EMA approvals.
Contact Information
For further inquiries, please 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.
