Major Milestone Achieved With First 3 U.S. Trial SitesMay 30, 2018
CALGARY, Alberta, May 30, 2018 — 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”).
The three new sites that are now fully open to patient enrollment are all located in the state of Florida in the United States. 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 3rd 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.
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