Business Wire06.21.17
The board of regenerative medicine company Avita Medical Limited has appointed Dr. Michael Perry as its new CEO.
Perry has been an Avita non-executive director since February 2013. His former executive role was senior vice president and chief scientific officer of global business development and licensing for Novartis AG. From 2014 to 2016 he was chief scientific officer of Novartis’ Cell and Gene Therapy Unit. Prior to that Perry served as vice president of the inegtrated hospital care franchise and global head of stem cell therapy for Novartis Pharmaceuticals Corp., a U.S. affiliate of Switzerland-based Novartis AG.
Perry, based in the United States, has previously served as the global head of R&D for the Bioscience Division of Baxter Healthcare, president and CEO of cell and gene therapy for Novartis subsidiaries Systemix Inc. and Genetic Therapy Inc., vice president of regulatory affairs for Sandoz Pharma and Syntex Corp., director of regulatory affairs for Schering-Plough Corp., and chairman, CEO or chief medical officer for several early-stage biotech companies. He also previously served as a venture partner with Bay City Capital LLC in San Francisco, Calif. He presently serves as a director of listed companies Arrowhead Pharmaceuticals and AmpliPhi Biosciences Corp., and holds academic affiliations with the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine and with the Houston Methodist Research Institute. Perry also serves as a director and operating partner of Bioscience Managers Pty. Ltd.
The board determined that Avita’s achievement of U.S.-focused milestones will largely drive company value and as such, a decision was made to retain a U.S.-based chief executive to optimize shareholder value. London-based CEO Adam Kelliher has elected not to relocate to the United States and has resigned from his position, but will remain a consultant to the board of directors. Board Chairman Lou Panaccio stated, “We are most grateful to Mr. Kelliher for his significant contributions to Avita during his tenure. He oversaw a diversity of critical company achievements; most notably progress of our clinical programs, strategic capital raises and continued progress on our BARDA contract. We are also appreciative of the keen focus and energy he brings to his work, qualities we are sure he will apply in his future endeavours.”
Major company regulatory and commercial milestones are increasingly U.S.-oriented including the $62 million contract with the U.S. defense preparedness group BARDA for burns applications using ReCell. The BARDA contract includes $27.9 million to support U.S. Food and Drug Administration (FDA) premarket approval requirements. Further, the company has recently completed treatment of patients in its U.S. pivotal trial, which compares ReCell in combination with meshed autograft against conventional skin grafts. Positive results from the U.S. pivotal burns trial were released last month. In the near term, Avita intends to submit a premarket approval application to the FDA for its blessing of ReCell for use in patients with severe burns.
Panaccio said he welcomes Perry to the senior executive role. “Mike’s expertise across the value chain in cell therapy along with his experience in business development, regulatory affairs and general management will be crucial to Avita’s future success. These fundamental attributes complemented by his U.S. presence, will maximize Avita’s prospects as the company progresses through PMA submission, FDA review and preparation for large-scale product commercialization.”
The appointment is effective immediately.
Avita’s patented and proprietary collection and application technology provides treatment solutions derived from the regenerative properties of a patient’s own skin. Its medical devices work by preparing a Regenerative Epithelial Suspension (RES), an autologous suspension comprised of the patients’ own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
In all countries outside of Europe, Avita's portfolio is marketed under the ReCell brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. ReCell is TGA‐registered in Australia, and China Food and Drug Administration‐cleared in China. In the United States, ReCell is an investigational device limited by federal law to investigational and compassionate use.
In Europe, Avita's portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. ReCell is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell is tailored for aesthetic applications including the restoration of pigmentation.
Perry has been an Avita non-executive director since February 2013. His former executive role was senior vice president and chief scientific officer of global business development and licensing for Novartis AG. From 2014 to 2016 he was chief scientific officer of Novartis’ Cell and Gene Therapy Unit. Prior to that Perry served as vice president of the inegtrated hospital care franchise and global head of stem cell therapy for Novartis Pharmaceuticals Corp., a U.S. affiliate of Switzerland-based Novartis AG.
Perry, based in the United States, has previously served as the global head of R&D for the Bioscience Division of Baxter Healthcare, president and CEO of cell and gene therapy for Novartis subsidiaries Systemix Inc. and Genetic Therapy Inc., vice president of regulatory affairs for Sandoz Pharma and Syntex Corp., director of regulatory affairs for Schering-Plough Corp., and chairman, CEO or chief medical officer for several early-stage biotech companies. He also previously served as a venture partner with Bay City Capital LLC in San Francisco, Calif. He presently serves as a director of listed companies Arrowhead Pharmaceuticals and AmpliPhi Biosciences Corp., and holds academic affiliations with the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine and with the Houston Methodist Research Institute. Perry also serves as a director and operating partner of Bioscience Managers Pty. Ltd.
The board determined that Avita’s achievement of U.S.-focused milestones will largely drive company value and as such, a decision was made to retain a U.S.-based chief executive to optimize shareholder value. London-based CEO Adam Kelliher has elected not to relocate to the United States and has resigned from his position, but will remain a consultant to the board of directors. Board Chairman Lou Panaccio stated, “We are most grateful to Mr. Kelliher for his significant contributions to Avita during his tenure. He oversaw a diversity of critical company achievements; most notably progress of our clinical programs, strategic capital raises and continued progress on our BARDA contract. We are also appreciative of the keen focus and energy he brings to his work, qualities we are sure he will apply in his future endeavours.”
Major company regulatory and commercial milestones are increasingly U.S.-oriented including the $62 million contract with the U.S. defense preparedness group BARDA for burns applications using ReCell. The BARDA contract includes $27.9 million to support U.S. Food and Drug Administration (FDA) premarket approval requirements. Further, the company has recently completed treatment of patients in its U.S. pivotal trial, which compares ReCell in combination with meshed autograft against conventional skin grafts. Positive results from the U.S. pivotal burns trial were released last month. In the near term, Avita intends to submit a premarket approval application to the FDA for its blessing of ReCell for use in patients with severe burns.
Panaccio said he welcomes Perry to the senior executive role. “Mike’s expertise across the value chain in cell therapy along with his experience in business development, regulatory affairs and general management will be crucial to Avita’s future success. These fundamental attributes complemented by his U.S. presence, will maximize Avita’s prospects as the company progresses through PMA submission, FDA review and preparation for large-scale product commercialization.”
The appointment is effective immediately.
Avita’s patented and proprietary collection and application technology provides treatment solutions derived from the regenerative properties of a patient’s own skin. Its medical devices work by preparing a Regenerative Epithelial Suspension (RES), an autologous suspension comprised of the patients’ own skin cells and wound healing factors that are necessary to regenerate natural healthy skin. This is then applied to the area to be treated.
In all countries outside of Europe, Avita's portfolio is marketed under the ReCell brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. ReCell is TGA‐registered in Australia, and China Food and Drug Administration‐cleared in China. In the United States, ReCell is an investigational device limited by federal law to investigational and compassionate use.
In Europe, Avita's portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. ReCell is designed for the treatment of burns and plastic reconstructive procedures; ReGenerCell has been formulated for chronic wounds including leg and foot ulcers; and ReNovaCell is tailored for aesthetic applications including the restoration of pigmentation.