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Lee-Collier-Charlotte
Business Observer Friday, Mar. 19, 2021 6 months ago

Medical device firm gains regulatory approval for new product

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Catalyst OrthoScience aims to address multiple needs in the shoulder arthroplasty market.

NAPLES — Catalyst OrthoScience, a Naples-based medical device company focused on the upper extremity orthopedics market recently received approval from the FDA to market its reverse shoulder system.

Catalyst expects to begin a limited user release in the United States in the second quarter of 2021, followed by a commercial launch later in 2021, according to a statement. The addition of the reverse shoulder system, the release adds, allows Catalyst to offer a broader shoulder portfolio and multiple arthroplasty options to shoulder surgeons across the U.S. Reverse shoulder arthroplasty is estimated to encompass more than 60% of the shoulder arthroplasty market.

“With the addition of our reverse shoulder system, Catalyst is now addressing the two fastest growing segments of the shoulder arthroplasty market – stemless anatomic and reverse TSA,” Catalyst Chairman and CEO Brian Hutchison says in the statement. “This is beneficial for our distributors as well, who can now help surgeons more easily meet the needs of patients.”

Catalyst’s reverse shoulder system is a single-tray arthroplasty system that was engineered to combine the most beneficial and evidence-based attributes of reverse shoulder arthroplasty design. The system offers surgeon-targeted implant positioning, a streamlined and versatile system and bone sparing implants, the release states.

Catalyst was founded in 2014 by orthopedic surgeon Dr. Steven Goldberg, who saw the need to make shoulder replacement surgery less invasive and give patients a more natural-feeling shoulder after surgery. The Catalyst CSR system can be used in both inpatient and outpatient settings and was cleared for use by the FDA in 2016. The firm has a growing portfolio of U.S. patents with several more pending nationally and internationally.

 

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