PITTSBURGH, Oct. 5, 2016 /PRNewswire/ — Carmell Therapeutics, a biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials, continues to grow and add the necessary management capabilities to advance its products towards US FDA regulatory approval. Carmell’s first product, REPAIR™ Putty, is designed to accelerate bone healing with the first application in long bone fractures. Future clinical studies are planned to expand the label to include other orthopedic bone applications. The Carmell near-term pipeline also includes REPAIR™ Paste for accelerated soft tissue healing, such as surgical site and chronic wound management.
To successfully advance these programs through the development and commercialization process, Carmell is significantly expanding their senior management capabilities. Joining Randy Hubbell, CEO, and Dr. James Hart, Chief Medical Officer, are:
- Donna Godward, Chief Quality Officer – Ms. Godward spent most of her career at J&J before retiring as a Chief Quality Officer for J&J’s Medical Device and Diagnostic Business.
- Stephanie Kladakis, PhD, VP of R&D – Dr. Kladakis brings with her over 14 years of experience in product development, from concept through CE Mark and PMA approvals, and was most recently the VP of R&D for Cohera Medical.
- Janet Vargo, PhD, VP of Clinical Sciences – Dr. Vargo has extensive experience in designing and executing clinical trials and most recently worked at Mentor, LLC (J&J) as Head of Clinical Development and Regulatory Affairs.
- Carmell is also expanding the expertise and capabilities of their Board of Directors with the addition of:
- David Anderson, President and CEO, Orteq Sports Medicine as an independent board member. Mr. Anderson has over 20 years experience as a senior executive in the orthobiologics space. His insights and knowledge will be extremely useful to the Carmell management team as they expand their development pipeline and prepare for commercialization.
“I am very excited to be able to assemble an extremely experienced team of experts that will ensure success for Carmell,” commented Randy Hubbell.
About Carmell Therapeutics
Founded in 2007 as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics Corporation is a privately-owned biosurgical technology company focused on the development and commercialization of innovative plasma-based bioactive materials (PBMs). These PBMs contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings. Utilizing its proprietary cross-linking process, the company has successfully developed multiple PBM formulations such as pastes, putties, scaffolds, plugs and screws, using pooled plasma from healthy donors. 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. Carmell’s first product, REPAIR™ Putty, has been 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. Carmell’s proprietary blood plasma-based technology will serve as the foundation for groundbreaking products designed to improve the lives of patients and to reduce the costs of healthcare across variety of surgical procedures.
For more information on Carmell Therapeutics, please visit the Company’s website at http://www.carmellrx.com/
CERTAIN STATEMENTS IN THIS RELEASE ARE FORWARD LOOKING STATEMENTS ABOUT CARMELL’S FUTURE PLANS, OBJECTIVES AND PROJECTED PERFORMANCE. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON CERTAIN ASSUMPTIONS THAT THE COMPANY BELIEVES ARE REASONABLE, BUT ARE SUBJECT TO KNOWN AND UNKNOWN RISKS AND UNCERTAINTIES. CARMELL MAKES NO REPRESENTATION, WARRANTY OR CLAIM REGARDING THE INFORMATION IN THIS RELEASE OR ANY OF ITS PRODUCTS. ACTUAL RESULTS MAY VARY SIGNIFICANTLY FROM OUR PREDICTIONS AND DEPEND ON KNOWN AND UNKNOWN RISKS. CARMELL’S PRODUCTS ARE NOT CURRENTLY AVAILABLE FOR SALE OR USE AND HAVE NOT BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION OR ANY COUNTRY’S REGULATORY AUTHORITY.
SOURCE Carmell Therapeutics Corporation