Hemostemix Announces Successful Re-Certification of its Israeli Manufacturing FacilitySeptember 21, 2016
Hemostemix Inc. (“Hemostemix” or the “Company) (TSX VENTURE: HEM) (OTCQX: HMTXF), a clinical-stage autologous cell-therapy company, announces today that it has successfully completed the annual re-certification of its Israeli manufacturing site and lab facility. The re-certification complies with the cGMP standards for manufacturing of biological products for use in humans and fulfills the requirements of the US-FDA and other international health authorities. The re-certification was conducted by QCC Calibration Technologies, one of Israel’s largest specialized laboratories.
“This recertification is proof that Hemostemix maintains the highest manufacturing standards and professionalism in the preparation of cell therapy products. In particular, Hemostemix is ready to produce and deliver our lead cell product, ACP-01, to support our ongoing phase 2 clinical trial”, said Eilat Bain, Director of Operations at Hemostemix.
“I am more confident than ever that our Israeli manufacturing team is now in a position to meet the anticipated increased demand from the international expansion of our ongoing phase 2 clinical trial”, said Dr. Elmar Burchardt, President and CEO of Hemostemix.
ABOUT HEMOSTEMIX INC.
Hemostemix is a public clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is the first clinical-stage biotech company to test a stem-cell therapy in an international, multicenter, phase 2 clinical trial for patients with critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. The phase 2 trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that are capable of supporting the formation of new blood vessels. The Company recently received FDA clearance to commence clinical trials in the United States.
Hemostemix Inc. is traded on the TSX Venture Exchange under the trading symbol HEM and on the OTCQX® Best Market under the trading symbol HMTXF. For more information, visit hemostemix.com or email firstname.lastname@example.org.
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Neither the TSX Venture Exchange Inc. nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward-looking statements. Forward-looking statements are based on the beliefs, estimates, and opinions of Hemostemix management on the date such statements were made. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.
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