cartilage News
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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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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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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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Gelmetix signs collaboration for development of Knee Osteoarthritis product
Stemmatters and Gelmetix have established an agreement to develop an innovative hydrogel based device for the treatment of cartilage lesions. The partnership established focuses on the pre-clinical development of the new device towards clinical studies in human patients and subsequent market authorization. The new medical device aims to ensure a significant advance in the treatment of ...
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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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Cytex Awarded CRP Award for First-In-Human Pilot Trial
Cytex is thrilled to announce the receipt of a Commercialization Readiness Pilot Program Award from the National Institute of Health entitled “Cartilage Regeneration with Tunable Inflammation Resistance.” The goal of this project is to prepare for and then conduct a First-In-Human pilot clinical trial that will test the safety of Cytex’s innovative hip implant. Cytex is ...
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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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Cytex Awarded CRP Award for First-In-Human Pilot Trial
Cytex is thrilled to announce the receipt of a Commercialization Readiness Pilot Program Award from the National Institute of Health entitled “Cartilage Regeneration with Tunable Inflammation Resistance.” The goal of this project is to prepare for and then conduct a First-In-Human pilot clinical trial that will test the safety of Cytex’s innovative hip implant. Cytex is ...
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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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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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GRAFTYS announces the extension of its CE mark for its calcium phosphate cements to now include GRAFTYS® HBS and GRAFTYS® Quickset for the indication of subchondral bone marrow lesions around the knee joint (BML)
Aix-en-Provence, September 14th, 2015 – GRAFTYS SA, a company focused on development and commercialization of orthopedic biomaterials, is pleased to announce that it has obtained authorization from its notified body, NSAI (National Standards Authority of Ireland) for European commercialization for two of its cements (GRAFTYS® HBS and GRAFTYS® Quickset) for treatment of bone marrow ...
By Graftys
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Vericel to Present at the Ladenburg Thalmann Healthcare Conference on Tuesday, July 13, 2021
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present the latest company overview at the Ladenburg Thalmann Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Tuesday, July 13, 2021, at 9:00 a.m. ...
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Vericel to Present at the Canaccord Genuity Musculoskeletal Conference on March 22, 2022
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present at the Canaccord Genuity Musculoskeletal Conference in Chicago, IL on Tuesday, March 22nd at 11:00 a.m. Central Time. A webcast of the presentation will be available on the Investor Relations section of the ...
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Vericel to Present at the Cowen 42nd Annual Health Care Conference on March 9, 2022
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on Wednesday, March 9th at 1:30 p.m. Eastern Time. A webcast of the presentation will be available on the Investor Relations section of ...
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Vericel to Participate in the Morgan Stanley 19th Annual Global Healthcare Conference on September 13th, 2021
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, September 13, 2021, at 4:15p.m. Eastern Time. A webcast of the presentation will be available on the ...
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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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Vericel to Present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 7:30 a.m. Eastern Time. A webcast of the presentation will be available on the Investor Relations section of the Vericel ...
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What Are D-Glucosamines?
Glucosamine is a natural component of cartilage and is widely used as an over-the-counter nutritional supplement to reduce the pain and cartilage loss of osteoarthritis. Glucosamine is usually taken in combination with chondroitin, which is a glycosaminoglycan that also exists in cartilage.Glucosamine is an amino sugar and an important molecule in the biochemical pathway of glycosylated protein ...
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Vericel to Present at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health and Services Forum on November 18th, 2021
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, President and CEO, will present at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health and Services Forum on Thursday November 18th, at 10:00a.m. Eastern Time. A webcast of the presentation will be available on the Investor ...
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BioPoly Oversubscribes $2M Private Equity Offering
FORT WAYNE, IN – BioPoly, LLC announced today that it has fully subscribed its latest round of private equity financing of $2M. The financing round also includes oversubscription funding of $890k. BioPoly has now raised over $20M through its initial grants ($3.27M) and private equity offerings. The funds received from the most recent private offering will be used to bring products to the ...
By BioPoly, LLC
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