MiMedx Group, Inc. (OTC Bulletin Board: MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that it has received notification of the Class III certification for a European product using the Company's proprietary HydroFix™ technology.
This certification for "post surgical adhesion inhibiting barriers" is in addition to the Company's previous certification for HydroFix™ Spine Shield designated as a Class IIb device for use in certain locations along the anterior spine as a plane of dissection during revision surgery. The new Class III certification is for use during posterior and anterior vertebral surgeries as a cover for the spine, including contact with the Central Nervous System ("CNS") and Central Circulatory System ("CCS"), to provide a plane of dissection during revision surgery.
"As with anterior spine surgeries, where patients are exposed to significant risks when revision surgeries are necessary, posterior revision surgeries pose similar significant risks to the patient. Adhesions from previous surgery can significantly interfere with surgical technique, increase operating time and cause subsequent complications as well," said Parker H. "Pete" Petit, MiMedx Chairman and Chief Executive Officer. "Posterior vertebral surgeries are more prevalent than anterior vertebral surgeries. With this latest certification, we can begin to market HydroFix™ Spine Shield for use in posterior surgeries. This will allow us to serve the demand for post-surgical adhesion inhibiting barriers in the much broader posterior surgical market."
Bill Taylor, MiMedx President and Chief Operating Officer, added, "In addition to revision surgery, the applications now available to surgeons with this latest certification include fusion surgery, trauma, laminectomy and implantation or removal of hardware. Since we began the commercialization of HydroFix™ Spine Shield with the original certification, physicians have expressed continual interest in the timing of the certification for an expanded product offering that is appropriate for contact with the CNS and CCS. We are pleased that we are now at that point."
Due to the contact with the CNS and CCS, the Medical Devices Directives of the European Economic Community mandate this as a Class III device requiring a design dossier to be reviewed/certified by a notified body prior to commercialization.
The HydroFix™ Spine Shield is a permanent and biocompatible implant which is suitable as an adhesion inhibiting barrier or plane of dissection between anatomical structures. The proprietary and patented manufacturing process produces a product that is pliable, constructed in a single-layer and hydrophilic. The product may be trimmed and fitted easily at the time of use and may be sutured into place.