PHOENIX: Creative Medical Technology Holdings (OTCQB - CELZ) announced today completion of the safety data analysis on 20 patients with pharmacologically-resistant erectile dysfunction treated with the Company's patented CaverStem procedure.
The trial, sponsored by Creative Medical Technology Holdings, was conducted at the University of California Los Angeles Harbor Hospital/LA Biomed under Institutional Review Board (IRB) approval. An independent medical safety monitor was also appointed to review the patient data for safety and feasibility of administering bone marrow derived stem cells into patients with erectile dysfunction. The goal of this procedure is to regenerate blood vessels and smooth muscle, parts of the penis that are not functioning properly in this patient population.
"Based on establishment of safety of the CaverStem procedure in a formal university-based clinical trial, and independent confirmation of efficacy in an European clinical trial1, we have launched commercialization for the CaverStem procedure," said Timothy Warbington, President and Chief Executive Officer of Creative Medical Technology Holdings. "Amongst other top urologists, we have recruited a world-renowned urologist as a lead physician to roll-out the procedure. We anticipate that the procedure will be available to patients that meet the eligibility criteria within the next 60 days."
According to the National Institutes of Health, approximately 30 million men in the United States suffer from Erectile Dysfunction2, of which 9 million do not respond to pharmacological treatments such as Viagra, Levitra and Cialis.
"The CaverStem procedure involves obtaining a small amount of bone marrow from the patient, purifying the stem cells using a closed system device that is FDA cleared, and then administering these cells in the same procedure into the patient's penis," said Thomas Ichim, Ph.D, Chief Scientific Officer and Co-Founder of the Company. "Having published the first peer-reviewed paper on this procedure back in 2013 together with internationally renowned urologists and stem cell experts3, it is very exciting for me to watch this translate from bench to bedside."
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