Arcuro Medical Significantly Expands SuperBall® Market Opportunity with New Rotator Cuff Repair System; Launches Newly-Enhanced Meniscus Repair System

Arcuro Medical, Ltd. (“Arcuro” ) announced its first cases of the new SuperBall^®-RC (Rotator Cuff Repair System), an enhanced iteration of the SuperBall^®-MR (Meniscal Repair System), and newly published white papers summarizing data supporting both technologies.

Rotator Cuff Indication Significantly Expands Addressable Market

The SuperBall-RC offers an all-suture, knotless solution for arthroscopic medial rotator cuff augmentation, with a mesh construct to minimize potential damage to tissue and avoid potential complications of alternative hard polymer staple technologies. Following U.S. regulatory clearance in early 2025, Arcuro initiated a limited user release of the SuperBall-RC primarily addressing patch-augmented rotator cuff repair and other challenging rotator cuff procedures. Early cases have been successfully completed using a range of commercially available biologic and synthetic patches. The Company estimates SuperBall-RC procedures will have a global addressable market opportunity of $389 million by 2028, growing in low double-digits through the end of the decade.

Surgeon-led design improvements reinforce optimal strength, reproducibility, and all-inside efficiency in meniscal preservation

The SuperBall-MR was engineered to deliver reliable, consistent meniscal repair constructs through a streamlined all-inside, all-suture technique. The latest enhancements introduced in mid-2025 based on surgeon feedback build upon its proprietary platform to further optimize deployment performance, construct strength, and procedural reproducibility. The Company estimates approximately 7,000 SuperBall procedures have now been performed across meniscus repair applications, with an estimated 700 procedures successfully completed using the upgraded system. The Company estimates the global addressable market opportunity for SuperBall-MR is $705 million by 2028, also growing in low double-digits through the end of the decade.

New Clinical and Biomechanical Publications

Arcuro released new white papers summarizing SuperBall-MR post-market clinical experience and preclinical SuperBall-RC data. A multi-center post-market SuperBall-MR evaluation of 140 patients reported a 98.6% deployment success rate, no device-related complications, and no revision surgeries in early follow-up. An interim SuperBall-MR post-market surveillance report similarly reported no adverse events and demonstrated continued functional improvement in evaluated patients. Finally, biomechanical testing of SuperBall-RC demonstrated fixation strength comparable to or greater than traditional hard polymer staples, with substantially higher individual implant pullout strength.