Stemedica will work with Dr. Applegate as she advances her proprietary cell treatment for pediatric burns and wound care into a Phase III trial in Switzerland. In turn, Dr. Applegate will assist Stemedica in securing FDA clearance for an IND ("Investigative New Drug") and Phase I clinical trial in the United States for the same applications. Noting why she chose Stemedica, Dr. Applegate said, "Stemedica's commitment to innovative cell product development and its reputation for high quality cell processing is exactly what I was looking for in a partner. I have conducted due diligence on all the best players in this space and find that Stemedica shares my vision to deliver the highest quality care to those who need it the most."
Nikolai Tankovich MD, PhD, Stemedica's President and Chief Medical Officer, stated, "We believe our collaborative work with Dr. Applegate's Phase III clinical trial in Switzerland will be an excellent first step in demonstrating our innovative cell development capabilities along with our manufacturing strengths in the marketplace. Further, we believe the compelling results from Dr. Applegate's Phase I and Phase II clinical trials in Switzerland will be very helpful to Stemedica as we advance our burn and wound care efforts with the FDA here in the United States. Finally, the working agreement with Dr. Applegate comes at an opportune time for Stemedica as we recently announced the opening of our international operations, Stemedica International, in Lausanne, Switzerland which is also where Dr. Applegate is headquartered."
Stemedica anticipates approaching the FDA for an IND to conduct a Phase I clinical trial in the next few months. Dr. Applegate's Phase III clinical trial in Switzerland is scheduled to begin this fall.
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