Press Releases

Harvard Apparatus Regenerative Technology Files Pre-IND Meeting Documents and Orphan Biologics Application with U.S. Food and Drug Administration
First Step in Regulatory Approval for InBreath Airway Transplant System

HOLLISTON, Mass.--(BUSINESS WIRE)--Harvard Apparatus Regenerative Technology, Inc. (NASDAQ:HART), a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, has filed its pre-Investigational New Drug (IND) meeting documents with the U.S. Food and Drug Administration (FDA). The company expects the pre-IND meeting to take place by the end of January 2014.

Additionally, the company has filed an orphan biologics application with the FDA and expects to obtain feedback before the end of first quarter 2014.

David Green, Chief Executive Officer of Harvard Apparatus Regenerative Technology, said, “During our pre-IND meeting with the FDA in January, we expect to review our proposals for pre-clinical work that will need to be completed in order to begin a clinical trial within the USA. We also expect to get early feedback on the clinical trial requirements for approval in the USA.”

About Harvard Apparatus Regenerative Technology

Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the InBreathTM Airway Transplant System, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. None of our products are yet approved by a government regulatory authority for marketing. On November 1, 2013, HART was spun-off from Harvard Bioscience. The trademark “Harvard Apparatus” is used under a sublicense agreement with Harvard Bioscience, who has licensed the right to use such trademark from Harvard University.

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. For example, the company is using forward-looking statements when it discusses clinical trials, any future meetings with the FDA and its anticipated IND submissions. These forward-looking statements and their implications are based on the current expectations of the management of Harvard Apparatus Regenerative Technology, Inc. only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to

the amount and timing of costs associated with our development of products; the success of our clinical trials and product development programs and the number of patients who can be treated with our products; and our ability to obtain and maintain regulatory approval for the products we pursue. The forward-looking statements in this press release speak only as of the date of this press release. Harvard Apparatus Regenerative Technology 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.

Contact:

Harvard Apparatus Regenerative Technology
David Green
President and CEO
dgreen@HARTregen.com
or
Tom McNaughton
CFO
tmcnaughton@HARTregen.com
or
Investor Relations:
Dian Griesel Int’l.
Cheryl Schneider, 212-825-3210
or
Public Relations:
Dian Griesel Int’l.
Susan Forman or Laura Radocaj
212-825-3210