EU Grants CE Mark to Aperion for ACL Repair Technology

Aperion Biologics Inc. was granted Europe’s CE mark for its lead product, the Z-Lig ACLR device.

The Z-Lig is an engineered biologic device—the company claims it’s the first— for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be approved anywhere worldwide.

Aperion conducted a prospective, randomized, controlled clinical trial in Europe and South Africa that company officials say demonstrated biological acceptance of its bioengineered porcine tendons, re-establishment of knee stability, and remodeling over time into the patient’s own human ligament. U.S. clinical evaluation is pending final discussions with the U.S. Food and Drug Administration on its approved pivotal clinical study of the Z-Lig.

According to figures cited by the company, 600,000 ACL reconstruction surgeries are performed around the globe annually, using either a patient’s own tissue (autografts) or cadaver tissue (allografts).Prior attempts at use of animal tissue or synthetic grafts to meet the high demands of the knee have proven unsuccessful.

Aperion’s device is designed to provide immediate stability and function to the knee while promoting gradual remodeling into human tissue over time.

“The international trial and CE mark approval independently confirm the successful results we saw in our U.S. pilot study, which now has patients with Z-Lig devices 10 years after implantation,” said Kevin R. Stone, M.D., the founder of Aperion Biologics. “The advantage of an off-the-shelf, biologic device is it avoids the weakening of the patient by taking their own tissue.”

Stone was not a participant in the CE mark trial.

Aperion Biologics, based in San Antonio, Texas, is a privately owned medical device company addressing the need for alternatives to human-based grafts with animal-based tissue technology.

Aperion developed and patented a technique to make animal tissues compatible for challenging human applications. The core platform technology uses the company’s proprietary Z-Process, which removes the key antigens from animal tissues, followed by a conversion process that both stabilizes and sterilizes the tissue without affecting its biomechanical or biological properties.This creates functioning scaffolds capable of remodeling into healthy tissue. The company says the Z-Process is applicable to a variety of tissues used in orthopedic, cardiovascular, plastic,general and other surgical specialties.