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Carmell Therapeutics

Carmell Therapeutics is addressing the burden of healing with its proprietary Plasma-based Bioactive Materials (PBM) technology

  • Stage Full Product Ready
  • Industry Biotechnology
  • Location Pittsburgh, PA, US
  • Currency USD
  • Founded January 2007
  • Employees 19
  • Incorporation Type C-corp
  • Website carmellrx.com

Company Summary

Carmell is a clinical development stage company that is on path to gain US FDA & EU regulatory approval for its first Plasma-based Bioactive Material product, Bone Healing Accelerant, in the expanding market of orthopedic trauma. Spine fusion and shoulder rotator cuff repair will be added with label expansion. The second product, Tissue Healing Accelerant will be labeled for soft tissue accelerated healing such as knee & surgical site infection.

Team

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    President & CEO

    Randy took over the leadership role at Carmell in February of 2016, where he quickly updated and enhanced the company vision and strategy, hired a world class team, completed (to date 80%) of the open Series B preferred round and had a extremely successful pre-IND meeting with the FDA, which has agreed the company is ready to move to Ph III clinical development. Prior to Carmell, Randy was CCO at Cardiva and prior to that spend 13 years at J&J.

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    Chief Medical Officer

    An experienced cardiovascular and thoracic surgeon for 20 years, Dr. Hart recently retired after serving 12 years at Johnson & Johnson 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.

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    Vice President, R&D

    Dr. Stephanie Kladakis has over 14 years of experience in medical device and materials product development across three different organizations, J&J (Depuy Biologics), NMT Medical and Cohera Medical.

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    Chief Quality Officer

    Donna Godward retired from Johnson & Johnson in 2016 where she served as Chief Quality Officer, Medical Devices & Diagnostics (MD&D) from 2010-2016. As Chief Quality Officer, Ms. Godward provided strategic direction and oversight for all areas of quality and regulatory compliance across the global MD&D business sector.

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    Janet Vargo
    Vice President of Clinical Sciences

    Throughout her 17-year career in the medical products industry, Dr. Vargo has advised companies and negotiated with regulatory bodies on clinical trial designs and regulatory strategies for innovative, state-of-the-art devices, diagnostics, biomarkers, biologics, and combination products. She has managed global clinical and regulatory operations both through internal teams and outsourced models

Advisors

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    Thomas Einhorn, MD
    Unconfirmed
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    Toby Silverman, MD
    Unconfirmed

Previous Investors

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    Bill Newlin
    Unconfirmed