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Harvard Apparatus Regenerative Technology Obtains Orphan Drug Designation From U.S. Food And Drug Administration For HART-Trachea

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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.

Posted-In: News FDA Press Releases

 

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