PITTSBURGH, April 7, 2016 /PRNewswire/ -- Carmell Therapeutics announced today the appointment of Dr. James Hart as its new Chief Medical Officer (“CMO”).
Link to Dr. Hart’s bio - http://www.carmellrx.com/management_advisors.php
“I am excited about the opportunity to join Carmell Therapeutics as its new Chief Medical Officer and am looking forward to bringing forth the company’s first BLA (biologic license application),” said Dr. Hart.
Before joining Carmell as its new CMO, Dr. James Hart, MD, FACS, FACC, FACCP has worked with small medical device companies to provide medical and clinical expertise, since his retirement from JNJ (Johnson & Johnson) in February, 2014. Dr. Hart was with J&J for over twelve years with multiple roles of increasing responsibility, being named VP Medical Operations in 2006, Worldwide VP, Evidence Based Medicine and Chief Medical Officer for ETHICON in 2011 and, finally, Chief Medical Officer and VP Medical Affairs for JNJ’s Global Surgery Group in 2012. Since 2006 to his departure, he was very active with the regulatory, clinical and evidence based medicine strategy and execution for Ethicon Biosurgery. The Biosurgery operating company had multiple successful regulatory submissions around the world, including new and novel BLA (Biologic License Application) technologies approved by CBER (Center for Biologics Evaluation & Research).
Prior to joining JNJ, Dr. Hart practiced Cardiovascular and Thoracic surgery for 20 years, during which time he was a pioneer in the early evolution of minimally invasive cardiac surgery.
“Dr. Hart brings significant senior executive experience and knowledge of the biologic-surgical device industry to the management team. This experience will be particularly important as we take the next steps with the FDA and executing the pivotal study for US approval,” said Randy Hubbell President & Chief Executive Officer of Carmell Therapeutics.
About Carmell Therapeutics Corporation
Plasma-Based Materials Using the Body to Heal Itself
Founded in 2007 as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics has created a unique, highly innovative, patented technology based on biologically-active adaptive materials manufactured from human blood plasma. These plasma-based materials contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings. Unlike previous approaches to delivering growth factors to injuries/surgeries, Carmell’s plasma-based devices can be designed to vary the release time of active biologics to accommodate the needs of the body. The company has successfully developed multiple forms, such as pastes, putties, scaffolds, plugs and screws, using pooled plasma from healthy donors with its proprietary cross-linking process. Carmell’s first product, REPAIR putty, is designed to treat bone fractures through accelerated bone healing of the fracture and surrounding soft tissues while reducing complications, infections and duration of care. Early human clinical evidence suggests that REPAIR putty is efficacious, safe, consistent and affordable.
For more information on Carmell Therapeutics, please visit the Company’s website at http://www.carmellrx.com/
CONTACT: Carmell: Randy Hubbell, +1-412-208-8033
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SOURCE Carmell Therapeutics Corporation