[November 26, 2014] |
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Harvard Apparatus Regenerative Technology No Longer Supporting Studies in Russia; Will Continue Focus on Preclinical Processes in the U.S. and EU
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 it will no
longer be providing its HART-Trachea product for future transplant
procedures performed at Krasnodar, Russia as part of the ongoing airway
transplant studies there. HART will continue to focus primarily on
completing preclinical work necessary to initiate clinical trials for
its HART-Trachea product in the EU and U.S. It has made recent progress
in the U.S. and EU, including the granting of orphan designation by the
U.S. Food and Drug Administration (FDA) and a productive meeting with
the Medicines and Healthcare Products Regulatory Agency of the U.K.
(MHRA, the equivalent of the FDA in the U.K.). HART anticipates that
during 2015 it will file its Investigational New Drug application to
initiate a U.S. clinical trial and a Clinical Trial Authorization
application to initiate an EU clinical trial.
About Harvard Apparatus Regenerative Technology
Harvard Apparatus Regenerative Technology makes regenerated organs for
transpant. Our first product, the HART-Trachea, is intended to replace
or repair a trachea that has been severely damaged by either physical
trauma or trachea cancer. Our trachea scaffold technology has been used
in six 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.
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. These "forward-looking" statements in
this press release include, but are not limited to, statements relating
to the regulatory filings and approval pertaining to the HART-Trachea or
any other HART products, by the FDA, MHRA, European Medicines Agency, or
otherwise, which such filings or approvals may not be made or obtained
on a timely basis or at all, and success with respect to any clinical
trials and other regulatory approval efforts, commercialization efforts
and marketing approvals of HART's products as well as the success
thereof, including our HART-Trachea product. These statements involve
risks and uncertainties that may cause results to differ materially from
the statements set forth in this press release, including, among other
things, factors described under the heading "Item 1A. Risk Factors" in
our Annual Report on Form 10-K for the fiscal year ended December 31,
2013 or described in our other public filings. Our results may also be
affected by factors of which we are not currently aware. 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.
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