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FDA Clears Arcuro Medical's SuperBall RC System for Rotator Cuff Repair Enhancement

• Arcuro Medical has received FDA 510(k) clearance for SuperBall-RC™, a novel system designed to improve rotator cuff repair procedures and reduce re-tear rates in patients over 50.

• The technology, based on Arcuro's established SuperBall platform used in over 5,000 meniscus repairs, aims to simplify the technically demanding process of rotator cuff augmentation with biologic or biosynthetic grafts.

• Commercial rollout will begin with a limited release in Q2 2025, followed by full market launch in the second half of 2025, addressing a significant clinical need where current re-tear rates range from 20-40%.

Arcuro Medical has secured FDA 510(k) clearance for its innovative SuperBall-RC™ system, designed to enhance rotator cuff repair procedures. The approval marks a significant advancement in addressing the persistent challenge of rotator cuff repair failures, particularly in patients over 50 years old who face re-tear rates of 20-40%.
The newly approved system builds upon Arcuro's proven SuperBall technology platform, which has demonstrated success in over 5,000 meniscus repair procedures. SuperBall-RC specifically targets the technical complexities associated with rotator cuff augmentation using biologic or biosynthetic grafts, offering surgeons a more streamlined approach to graft fixation.

Clinical Significance and Expert Perspective

Dr. Philip Davidson, Medical Director at Arcuro, emphasized the system's innovative approach: "The SuperBall-RC has been designed to facilitate safe and easy fixation of rotator cuff augmentation grafts. The device has exceeded my expectations and offers a very attractive alternative to fixate augmentation patches and enhance healing."

Commercial Strategy and Market Introduction

The company has outlined a strategic launch plan beginning with a limited user release in the second quarter of 2025. Following this initial phase, Arcuro plans to proceed with a full market launch in the second half of 2025, an accelerated timeline made possible by the timely FDA clearance.
Jamal Rushdy, CEO of Arcuro Medical, expressed enthusiasm about the milestone: "We are thrilled to have received this regulatory clearance, and I congratulate our product development and regulatory teams for their excellent work on this important milestone for the company which will help surgeons facilitate improved rotator cuff repair outcomes for their patients."

Technology Platform and Company Overview

Headquartered in Israel with U.S. operations in Minneapolis, Minnesota and Naples, Florida, Arcuro Medical leverages over 40 years of combined executive experience in developing minimally invasive orthopedic products. The company, a portfolio entity of The Trendlines Group, is actively expanding its global distribution network to bring the SuperBall™ technology to healthcare professionals worldwide.
The company will present detailed updates on the SuperBall-RC system at two upcoming industry events: the Canaccord Genuity Musculoskeletal Conference in San Diego on March 10 and the LSI Emerging MedTech Summit 2025 in Dana Point on March 18.
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