Cesca Therapeutics, Inc. (NASDAQ: KOOL) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. SNNLive caught up with Kenneth Harris, President of Cesca Therapeutics, Inc. at the Growth Capital Expo 2015 in Las Vegas, NV.
“Cesca Therapeutics is a small-cap company focused in the vascular and orthopedic regenerative medicine space, meaning we take cells from patients own body, re-implant them in the operating room in the same procedure, and they end up having a cell therapy in about 90 minutes,” Mr. Harris begins. The company is currently working in, “critical limb ischemia, which is a peripheral vascular disease that affects the legs, and in heart attacks, or, acute myocardial infarction, as well as in bone marrow transplant for pediatric patients that have a mismatch donor, and they need to have a bone marrow transplant to survive, and we work to make that possible.”
We spoke with Cesca during the “Biotech Week” in January (See here: Cesca Therapeutics, Inc. – Develops Stem Cell Therapies in the Orthopedic, Oncological and Vascular Indications), and in this interview he provides an update, “So, in January, we received our notice from the FDA that our pivotal, Phase III trial for CLI, had some deficiencies that we needed to address. We’ve been working on that. We announced last Friday (See release here: Cesca Therapeutics Management Provides Update on Clinical Trials for Critical Limb Ischemia (“CLI”) and Acute Myocardial Infarction (“AMI”) that we had completed that work and we’re in the process of compiling the data to submit to the FDA, which we will submit in the next few weeks.”
He continues, “Additionally, we have, for heart attack, or AMI Phase 2 trial, we’ve submitted that to the institutional review board and expect to have a response from them in the next couple of weeks, and when that happens, we will also be applying for a Phase 2 approval. And so, we expect by the end of this fiscal year to be in clinical trials with our Phase 3 CLI and our Phase 2 AMI trial(s).”
For more information about Cesca Therapeutics, Inc., go to: www.CescaTherapeutics.com
Since speaking with Mr. Harris, the company has made the following announcements:
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