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ProChon Biotech Appoints Brian Callahan as Executive Vice President, Regulatory & Quality Affairs

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WOBURN, Mass. - (BUSINESS WIRE) - ProChon Biotech, Ltd., an innovator of tissue regenerative technologies that are being developed to relieve pain and restore the mobility and quality-of-life for sufferers of articular cartilage injuries, today announced that Brian Callahan has joined the Company in the role of Executive Vice President, Regulatory and Quality Affairs.

Mr. Callahan brings eighteen years of regulatory affairs and quality assurance experience in the medical device, pharmaceutical, and biologics industries to ProChon. Mr. Callahan's primary role is to serve as the Company's liaison to all regulatory agencies - including the U.S. Food and Drug Administration, European Medical Authorities, and Israeli Ministry of Health - as well as oversee regulatory and quality strategy, implementation, and compliance. Previously, Mr. Callahan was Founder and Principle of EEC & Associates, a global compliance consulting firm for the medical device, pharmaceutical, and biologics industries. Prior to that, Mr. Callahan served on senior management teams for Quintiles Transnational and Organogenesis. Mr. Callahan spent ten years in the vascular, spine, orthopedics, and general surgery divisions of Johnson & Johnson, Covidien, and Becton Dickenson.

"Brian Callahan is an essential and timely addition to ProChon's executive management team as we navigate through the completion of the BioCart Autologous Cartilage System Phase II clinical study and collaborate with the FDA and EMA in regards to the upcoming Phase III pivotal trial," said Patrick O'Donnell, Chief Executive Officer of ProChon.

"Additionally, Brian will be responsible for defining the global regulatory path for our CartiMate Matrix-Assisted Microfracture (MAMF) technology, currently under development, and ensuring quality compliance for our internal and outsourced operations," added O'Donnell.

ProChon is currently embarking upon a Series B round capital fundraising initiative. The Company will be presenting at the In3 East Investors Conference in Boston on June 10 and the Musculoskeletal Joint Ventures Conference in Chicago on June 14.

About The BioCart Cartilage Regeneration System

The BioCart Cartilage Regeneration System is an autologous chondrocyte implant system that is a safe, minimally invasive, high-quality implant for long-term articular cartilage regeneration stemming from joint cartilage defects and injuries. The BioCart System is commercially available in Greece and Israel and ProChon has established a cell processing facility in Italy. The System is undergoing an FDA Phase II multicenter clinical study in the United States. To date, over 70 patients have received the BioCart implant with some patients over five years post-implantation.

About ProChon Biotech, Ltd.

Founded by world leaders in the field of regenerative medicine, ProChon is a privately held biotechnology company focused on modulating the fibroblast growth factor system to enable it to create more effective solutions for tissue regeneration. ProChon's products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues to normal. ProChon has filed patent applications, licensed patents for core technologies and products, and has been granted patents in the United States, Europe, Israel and Australia. ProChon's R&D facility resides in Ness Ziona, Israel and the executive management team is based in Woburn, Massachusetts.

Schwartz Communications
Jon Siegal or Rachel Gross, 781-684-0770
prochon@schwartz-pr.com
or
ProChon Biotech, Ltd.
Thomas C. May, 508-735-5524
tmay@prochon.co.il



 
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