Chondrology News
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Hyalex Welcomes Chris Cain as VP of Clinical and Regulatory Affairs
Hyalex welcomes executive team member, Chris Cain, serving as Vice President of Clinical and Regulatory Affairs. Chris joins the Hyalex team with an impressive background in leading numerous clinical trials of implanted medical devices and taking innovative technologies through US PMA and international regulatory approvals. Chris provides the experience necessary to bring the HYALEX® ...
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Hyalex Orthopaedics appoints Carl Vause, orthopaedic industry veteran, as Chief Executive Officer and President; Names Mike Hawkins, PhD, Chief Technical Officer
Hyalex Orthopaedics, a privately-held medical device company developing transformational cartilage biomimetic products, today announced the appointment of Carl Vause as its new chief executive officer and president. Mr. Vause, who succeeds Hyalex’s interim president, Michael Hawkins, Ph.D., has also been appointed to the company’s board of directors. Additionally, Dr. Hawkins has ...
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Hyalex Receives ISO 13485 Certification
We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. It brings Hyalex one step closer to the clinic and patients who may benefit from the HYALEX Cartilage System. ...
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Mike Hawkins stepping in as interim President; Hyalex CEO & President, Mira Sahney, stepping down
Today we reflect on the growth of Hyalex Orthopaedics over the past 5 years under the leadership of our CEO Mira Sahney. We wish her all the best in her new role. She leaves behind a bright future for Hyalex and our HYALEX Cartilage System. Good luck, Mira! In the interim, long-time board member and company advisor, Michael Hawkins, PhD, will serve as our President. Meanwhile, our search for a ...
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Locate Bio Closes £10 million Funding Round
Funding to further advance Locate Bio’s regenerative medicine pipeline of orthobiologics Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that it has raised an oversubscribed £10 million of equity investment in a funding round co-led by existing shareholder Mercia Asset Management and new investor BGF. The funding will be used to further ...
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Hyalex receives FDA Breakthrough Device Designation for novel HYALEX Cartilage System
Hyalex Orthopaedics, Inc., announced that the HYALEX Cartilage System has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The HYALEX Cartilage System is intended to repair cartilage defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery. Hyalex is currently in the pre-clinical stage of development ...
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Locate Bio’s Chondro3 Granted FDA Breakthrough Device Designation
The Company’s second FDA Breakthrough Device designation granted in 2021 Locate Bio, an orthobiologics focused regenerative medicine company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Chondro3, currently in development as a biomimetic graft for osteochondral lesions. The FDA Breakthrough Device Program is designed ...
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BioPoly® Announces FDA Clearance of its Great Toe Implant
FORT WAYNE, IN – BioPoly LLC has announced that the U.S. Food and Drug Administration has granted clearance for its BioPoly® Great Toe Implant. With this FDA clearance, the BioPoly technology is available for the first time in the U.S. BioPoly first received regulatory approval in 2012 for its knee implants in Europe. “Although we have been in patients in Europe with our knee ...
By BioPoly, LLC
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BioPoly Orthopedic Resurfacing Products Enter North America
FORT WAYNE, IN – BioPoly, LLC has entered into an exclusive distribution agreement with Canada-based distributor, Verve Medical Products, Inc., to distribute the BioPoly® partial resurfacing family of products throughout Canada, with distribution initially taking place through the Canadian SAP. Verve Medical Products specializes in bringing medical-surgical products to Canada through ...
By BioPoly, LLC
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