Arcuro Medical Announces FDA 510(k) Clearance for the SuperBall RC for Rotator Cuff Indications

Rhea-AI Summary

Arcuro Medical has received FDA 510(k) clearance for its new SuperBall-RC™ system designed for rotator cuff repair procedures. The technology addresses the significant challenge of rotator cuff re-tear rates, which affect 20%-40% of patients over 50 years old. The system builds upon Arcuro's established SuperBall platform, which has been successfully used in over 5,000 meniscus repairs.

The device aims to simplify the fixation of rotator cuff augmentation grafts, offering surgeons an improved solution for enhanced healing outcomes. Following this regulatory milestone, Arcuro plans a user release in Q2 2025, with a full market launch scheduled for the second half of 2025 - ahead of their original timeline due to expedited FDA clearance.

Positive

• FDA 510(k) clearance received ahead of schedule
• Technology builds on proven platform with 5,000+ successful procedures
• Addresses large market need (20-40% re-tear rate in patients over 50)
• Accelerated commercial launch timeline

Negative

• None.

MINNEAPOLIS and MISGAV, Israel, Feb. 27, 2025 /PRNewswire/ -- Arcuro Medical Ltd., ("Arcuro") today announced that it received FDA 510(k) clearance for its new SuperBall-RC™ system for use in rotator cuff repair procedures.

Current rotator cuff re-tear rates following surgery can range from 20%-40% in patients over 50.^[1] Rotator cuff augmentation with biologic or biosynthetic grafts can mitigate this risk but can be technically demanding with current surgical techniques. The new SuperBall-RC product, based on Arcuro's SuperBall technology platform successfully used in over 5,000 meniscus repairs, addresses this unmet need. 

Philip Davidson, MD, Arcuro's Medical Director, commented, "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."

Jamal Rushdy, Arcuro's CEO, added, "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."

The SuperBall-RC will enter a limited user release in the second quarter of 2025 in anticipation of a full launch in the second half of 2025, ahead of schedule due to the timely FDA clearance.

Arcuro will provide company updates at the upcoming Canaccord Genuity Musculoskeletal Conference on March 10 in San Diego, CA and the LSI Emerging MedTech Summit 2025 on March 18 in Dana Point, CA.

About Arcuro Medical Ltd.

Arcuro Medical Ltd., a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), headquartered in Israel with U.S. operations in Minneapolis, Minnesota and Naples, Florida, was founded by executives with over 40 years' combined experience developing and manufacturing minimally invasive orthopedic products, bringing medical devices from concept to market. Arcuro is expanding its established worldwide distribution network to introduce the SuperBall™ technology to healthcare professionals in every market. The company continues the development of game-changing technologies for sports medicine to improve patients' lives.

For more information on Arcuro and its products, visit arcuromedical.com and follow the company on LinkedIn.

Contact information:
Jamal Rushdy
Chief Executive Officer
jamal.rushdy@arcuromedical.com

^[1] Routledge et al. Re-Tear Rates Following Rotator Cuff Repair Surgery. Cureus. 2023 Jan 31;15(1)

 

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SOURCE Arcuro Medical

FAQ

What is the re-tear rate for rotator cuff repairs that SuperBall-RC aims to address?

Current rotator cuff re-tear rates following surgery range from 20%-40% in patients over 50 years old.

When will Arcuro Medical launch the SuperBall-RC system commercially?

A release is planned for Q2 2025, followed by a full launch in the second half of 2025.

How many procedures has Arcuro's SuperBall technology platform been used in?

The SuperBall technology platform has been successfully used in over 5,000 meniscus repairs.

What regulatory approval did Arcuro Medical receive for SuperBall-RC?

Arcuro Medical received FDA 510(k) clearance for the SuperBall-RC system for rotator cuff repair procedures.