HOLLISTON, Mass.--(BUSINESS WIRE)--Harvard Apparatus Regenerative Technology, Inc. (NASDAQ:HART), or HART, a clinical stage biotechnology company developing regenerated organs for transplant, initially focused on the trachea, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the HART-Trachea, which is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma.
David Green, President and CEO of HART, said, “We greatly appreciate the FDA’s support of our efforts to develop our first product, the HART-Trachea, to help patients who require a replacement trachea. Orphan designation is the first step toward clinical trials whose successful completion will be necessary to obtain FDA approval for use of the HART-Trachea in the U.S.”
Mr. Green continued, “We informed the public at the time of our first quarter earnings release that although the FDA was satisfied with the market size, they requested additional information about the clinical results for the five humans treated as of the time of the request of the indication included in our application. It was based on their review of these human clinical data that FDA rendered their favorable judgment and approved the orphan drug designation for the HART-Trachea. This designation provides us added confidence for our clinical development pathway.”
In order to receive orphan drug designation, a company must first demonstrate that the disease or condition that will be addressed by the drug or biologic affects less than 200,000 persons in the U.S. Second, the company must provide the FDA with sufficient information about the drug or biologic, or the disease or condition for which it is intended, to establish a medically plausible basis for expecting that their product will be effective for the treatment of that disease or condition.
Orphan drug designation entitles HART to a seven-year period of marketing exclusivity in the United States, if the HART-Trachea is approved by the FDA, and enables the Company to apply for research funding, tax credits for certain research expenses and a waiver from the FDA’s application user fee.
The FDA’s orphan designation for the HART-Trachea was published at the following link on the FDA website:http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=419813.
About Harvard Apparatus Regenerative Technology
Harvard Apparatus Regenerative Technology makes regenerated organs for transplant. Our first product, the HART-Trachea, is intended to replace or repair a trachea that has been severely damaged by either trachea cancer or physical trauma. Our technology has been used in eight human trachea transplants to date approved under compassionate use exemptions, but 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.
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. These "forward-looking" statements include statements relating to, among other things, the planned commercialization efforts and marketing approvals of HART’s products as well as the success thereof and the availability of a market for the HART securities. These statements involve risks and uncertainties, including among other things, market conditions that may cause results to differ materially from the statements set forth in this press release. 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.