ZuriMED Secures FDA Clearance for the FiberLocker(R) System

BOSTON, MA / ZURICH, SWITZERLAND / ACCESSWIRE / December 20, 2024 / The Swiss MedTech startup ZuriMED Technologies AG is pleased to announce FDA clearance of its FiberLocker® System, a cutting-edge solution for rotator cuff repair reinforcement. This milestone marks the upcoming U.S. launch in early 2025 and enables surgeons to leverage this novel technology for rotator cuff repair procedures.

Just in time for the holiday season, ZuriMED Technologies AG celebrated a significant achievement: FDA clearance of their 510(k) submission for the FiberLocker® System. This represents the first clinical indication of the pioneering Surgical-Fiberlock® technology.

Rotator cuff tears are among the most prevalent shoulder-related ailments, affecting a vast segment of the population.¹ Traditional repair techniques often fail at the suture-tendon interface², leading to retears that necessitate further surgeries and extend recovery times. Committed to resolving this critical issue, ZuriMED has introduced the FiberLocker® System. This novel technology reinforces soft tissue repairs at the time of surgery in an effort to improve traditional repair techniques.³

The FiberLocker® System: Felting is the Solution

The FDA-cleared medical device comprises two components: A patch (SpeedPatch® PET), which is implanted onto the repaired tendon, and a single-use instrument (FiberLocker® Instrument SN), designed to facilitate its fixation. Hereby, the startup has been translating an established technology from the textile industry into medicine - felting.

Made of non-woven polyethylene terephthalate (PET) fibers, the patch acts as medical felt. During surgery, the FiberLocker® Instrument SN employs a reciprocating needle that pushes the fibers into the underlying tendon tissue, creating an interwoven construct that securely integrates the implant to the tendon.

Unlike other augmentation methods, the FiberLocker® System simplifies the fixation process and establishes a new method for soft tissue repair by offering immediate, enhanced biomechanical support.² "I truly believe that ZuriMED's unique technology has the potential to become a game changer in shoulder surgery by helping us to improve patient's outcomes. The application of the device is simple and fast and has shown to reinforce traditional repair techniques," said Prof. Dr. Karl Wieser, Head of Shoulder and Elbow Surgery at Balgrist University Hospital.

Pre-Clinical Data: A Robust Foundation for FDA Clearance

Comprehensive ex vivo biomechanical testing has supported the enhanced suture retention and even load distribution across the implant achieved with the FiberLocker® System.³ The technology facilitates an arthroscopic procedure, streamlining the surgical process with a rapid, 90-second patch-to-tendon fixation.³

Further supporting its clinical utility, in vivo animal studies have confirmed the excellent biocompatibility of the SpeedPatch® PET, with no adverse effects noted up to 13 weeks post-implantation. The implant was well-tolerated and integrated with the tendon, evidenced by a smooth transition between the patch and tendon tissues and cellular ingrowth into the porous scaffold.^3,4

Mission Statement: Innovation Rooted in Zurich‘s Health Cluster

The FiberLocker® System is the fruit of five years of dedicated effort by the team at ZuriMED Technologies AG, situated within Zurich's premier health care cluster and supported by the Balgrist Beteiligungs AG. Originating from the Laboratory of Orthopedic Biomechanics at ETH Zurich and the University of Zurich, the startup has capitalized on direct access to leading-edge research labs at Balgrist Campus and top-tier orthopedic clinics like Balgrist University Hospital. These collaborations have accelerated the system's journey from concept to clinical application, showcasing a swift bench-to-bedside transition.

Professor Jess Snedeker, a professor of orthopedic biomechanics and co-founder of ZuriMED Technologies along with Dr. Xiang Li and Elias Bachmann, had this to say: "The challenges of traditional rotator cuff repair, long a source of frustration for both patients and surgeons, are intended to be addressed with our FiberLocker® System. This FDA clearance isn't just a milestone for ZuriMED - it represents a significant leap forward in surgical technology. Our system, born from pioneering research and clinical collaborations, has the potential to enhance patient outcomes. With the U.S. launch on the near horizon, we are poised to set new benchmarks in soft tissue repair."

With the recent clearance of the FiberLocker® System, ZuriMED is driven by the ambition to leave a long-lasting impact on the medical technology landscape. The company anticipates a limited U.S. market release of the SpeedPatch® PET and FiberLocker® Instrument SN in early 2025, allowing patients to soon benefit from this new technology.

¹ Zumstein MA, Künzler M, Hatta T, Galatz LM, Itoi E. Rotator cuff pathology: state of the art. Journal of ISAKOS. 2017 July, 213-221

² Cummins CA, Murrell GA. Mode of failure for rotator cuff repair with suture anchors identified at revision surgery. J Shoulder Elbow Surg. 2003 Mar-Apr, 128-33

³ Meyer DC, Bachmann E, Darwiche S, Moehl A, von Rechenberg B, Gerber C, Snedeker JG. Rotator Cuff Repair and Overlay Augmentation by Direct Interlocking of a Nonwoven Polyethylene Terephthalate Patch Into the Tendon: Evaluation in an Ovine Model. Am J Sports Med. 2023 Oct, 3235-3242.

⁴ Data on File

Contact information:

Name: Alicia Wirz
Email: alicia.wirz@zurimed.com
Phone Number: +41 44 552 12 28

SOURCE: ZuriMED Technologies AG