Hemostemix announces major milestone achieved with first 3 u.s. trial sites for phase ii clinical trial open for patient enrollment tsx venture exchange hem database query example

CALGARY, Alberta, May 30, 2018 (GLOBE NEWSWIRE) — Hemostemix Inc. (“ Hemostemix” or the “ Company”) (TSX VENTURE:HEM) is pleased to announce that it has entered into agreements and has received all approvals from three additional facilities that have agreed to be clinical trial sites for the Company’s Phase II clinical trial for critical limb ischemia (“CLI”).

University of Florida Health (“UFH”), located in Gainesville, Florida, includes 9 major research institutes. UFH investigators have launched more than 4,200 clinical research studies including clinical trials over the last four years. UFH includes UF Health Shands, which has made the list of the 100 Great Hospitals in America.

Clinical Research of Central Florida, located in Winter Haven in central Florida near Orlando, is a multi-specialty clinic, with a network of over 50 medical doctors, with a large patient database.


Working closely with acute care emergency departments, inpatient resources and physician referrals, CRCH continuously adds subjects to their vast proprietary HIPAA-compliant database to quickly meet enrollment goals.

Clinovation Research (“Clinovation”), located in Weston, Florida near Ft. Lauderdale, is a Site Management Organization (“SMO”) and is made up of a consortium of physicians representing their therapeutic specialties and passionate about the advancement of medicine and quality of care.

Florida is an important state for the clinical trial as it has the 3 rd highest population in the United States with approximately 21 million people and the highest percentage of senior citizens of all states in the US. In addition, Florida’s population has a median age of approximately 40, with 25% of its population over the age of 60 and 5% over the age of 80. As CLI is more prevalent in older persons, management believes having 3 sites throughout the state of Florida will be beneficial for patient enrollment in the trial.

Currently, the Company has identified 21 potential clinical trial sites in the United States and Canada that are in various stages of the on-boarding process. Of these 21 sites, 4 sites are open to patient enrollment, 12 are in the final stages of the on-boarding process and 5 have been newly identified. As previously announced, the first patient has been enrolled in the clinical trial to date.

“Our growing trial site numbers are a strong indicator of the positive momentum that Hemostemix as a company, and its Phase II trial, are starting to gain. Obtaining not just one, but three clinical trial sites in the US is another major milestone that Hemostemix management has recently achieved. This is the first time in the history of Hemostemix and the Phase II trial that US sites have agreed to be part of the clinical trial and been successfully on-boarded. We have made significant progress with adding new trial sites this past month and look forward to additional sites being fully on-boarded which will contribute to meeting our patient enrollment goals,” states Kyle Makofka, CEO and President of Hemostemix.

Hemostemix is a publicly traded 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 II 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 II trial targets a participant’s diseased tissue with proprietary cells grown from his or her blood that can support the formation of new blood vessels. The Company’s intellectual property portfolio includes over 50 patents issued or pending throughout the world. Hemostemix has a manufacturing contract with Aspire Health Science, LLP (“Aspire”), for the production of ACP-01 and for research and development purposes at Aspire’s Orlando, Florida, facility. Building towards commercialization, Hemostemix has also licensed the use, sale and import of ACP-01 for certain indications to Aspire in certain jurisdictions. The Company is continuing research and development of its lead product, ACP-01 with other applications, including cardiovascular, neurological and vascular indications.

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. By their nature forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the Company’s stage of development, future clinical trial results, long-term capital requirements and future ability to fund operations, future developments in the Company’s markets and the markets in which it expects to compete, risks associated with its strategic alliances and the impact of entering new markets on the Company’s operations. Each factor should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. 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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