Aperion Biologics‘ lead product, Z-Lig ACLR, can now be used by surgeons in the European Union and other international territories, as the San Antonio-based company was granted the CE Mark approval for this product.
According to a press release from the company, the Z-Lig is the first engineered biologic device for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be granted a CE Mark or to be approved anywhere worldwide.
Before this approval, Aperion, a privately owned, medical device company addressing the need for alternatives to human-based grafts with animal-based tissue technology, conducted a prospective, randomized and controlled clinical trial in Europe and South Africa. The trial demonstrated biological acceptance of its bioengineered porcine tendons, re-establishment of knee stability, and remodeling over time into the patient’s own human ligament. Currently, the device is not commercially approved for sale in the United States, as U.S. clinical evaluation is pending final discussions with the FDA on its approved pivotal clinical study of the Z-Lig.
Over 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. The Z-Lig provides a revolutionary new option for patients around the world, as it is designed to provide immediate stability and function to the knee while promoting gradual remodeling into human tissue over time.
Kevin R. Stone, M.D., the founder of Aperion Biologics, says the trial the company conducted, as well as CE Mark approval, independently confirm the successful results the company say in its US pilot study, which now has patients with Z-Lig devices 10 years after implantation. “The advantage of an off-the-shelf, biologic device is it avoids the weakening of the patient by taking their own tissue.”
Aperion was in the Texas biotech news more than a year ago, when BioNews Texas writer Connie Anna reported that the company was named as one of the ten most promising life sciences companies by the Texas Life Sciences Venture Forum.