NAPLES, Fla.--(BUSINESS WIRE)--Oct 15, 2024--
Catalyst OrthoScience Inc. ("Catalyst"), a private medical technology leader focused on shoulder arthroplasty, the fastest growing segment in the orthopedics market, announces it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the first surgeries have been successfully performed for the Catalyst Fracture Shoulder System, a reverse for fracture arthroplasty system to treat proximal humeral fractures (PHFs).
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Catalyst OrthoScience Announces FDA 510(k) Clearance for Shoulder Fracture System (Photo: Business Wire)
"The use of reverse shoulder arthroplasty (RSA) for the treatment of PHFs is steadily increasing," said Dr. Steven Goldberg, chief medical officer of Catalyst. "One of the most critical challenges in treating PHFs is ensuring tuberosity fixation and healing. Traditional reverse implants are designed to treat shoulder arthritis, but fractures are a completely different problem with different objectives for the surgeon. Catalyst has engineered a solution that specifically addresses the complexities of PHFs in an efficient and novel way."
Dr. John A. Brown from The CORE Institute AZ, a co-designer of the system, commented, "This fracture system represents a significant step forward in shoulder arthroplasty, providing surgeons operating in hospitals and ambulatory surgery centers (ASCs) with a solution specifically designed to enhance tuberosity fixation and healing, which is consistently shown to produce better outcomes."
One of the first cases using the new fracture system was successfully performed by Dr. Matthew D. Budge from Salem, OR, who commented on the experience: "The unique design of the proximal body greatly simplified the usual difficulties encountered with tuberosity management. In addition, the ability to get excellent diaphyseal fixation of the implant without cement or screws greatly improved the efficiency of the case. Overall, I was very impressed."
"With the addition of the Catalyst Fracture System, we now have a comprehensive portfolio that allows surgeons to help a broader range of patients," said Carl O'Connell, CEO of Catalyst. "This product is key to our strategy and builds our leadership in the orthopedics market."
Key elements of the Catalyst Fracture System for RSA include:
Tuberosity-specific fossa designed to maximize tuberosity contact and healing to a porous surface.Patented tuberosity retention rails designed to further restrict tuberosity motion post-operatively.Uncemented, secure press-fit diaphyseal fixation and strong rotational stability, with cemented options as well.Compatibility with glenospheres and baseplates in standard, augmented, and lateralized configurations to suit nearly every type of glenoid anatomy.
Catalyst will complete a limited user release to gather further data on the system's performance ahead of a broader commercial release in 2025.
About Catalyst OrthoScience Inc.
Naples, Florida-based Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, MD, who saw the need to make shoulder replacements less invasive, with fewer complications and a more natural-feeling shoulder after surgery. Catalyst is disrupting the traditional approach to shoulder replacement surgery. Our total shoulder systems are designed by combining fundamental principles with forward-thinking technology to offer precision and accuracy in shoulder restoration while preserving the patient's bone and soft tissue. Catalyst has a growing portfolio of patents and pending patents on its distinctive offerings, which are available across the U.S. For more information, visit www.catalystortho.com.
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CONTACT: Mark Quick
Investor Relations
(239) 325-9976Nicole Nelson
Media Relations
(239) 325-9976
KEYWORD: FLORIDA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: MEDICAL DEVICES FDA HEALTH SURGERY HEALTH TECHNOLOGY GENERAL HEALTH
SOURCE: Catalyst OrthoScience Inc.
Copyright Business Wire 2024.
PUB: 10/15/2024 10:00 AM/DISC: 10/15/2024 09:59 AM
http://www.businesswire.com/news/home/20241015208361/en