MedShape Solutions, Inc. announced today the first FDA cleared shape memory PEEK (polyaryletheretherketone) device for orthopedics using proprietary shape memory PEEK Altera™ material. The Morphix™ Suture Anchor was recently granted FDA clearance and will be released to select U.S. markets in the coming months. Over $2.5B of PEEK-based implants are sold every year in the field of orthopedics. These devices range from spinal cages to suture anchors and across all sectors of orthopedics. As a material, PEEK provides excellent benefits such as strength, radiolucency and reliability.
“PEEK Altera™ is a proprietary shape memory material that will allow us to develop devices that will be ‘dynamic’ in nature versus the current PEEK technology which is ‘static’,” stated Chris Fair, MedShape Solutions’ COO. The Morphix™ Suture Anchor system design takes advantage of the shape memory material and provides the clinician with superior fixation strength both in pull out as well as improved performance under cyclic loading. “Shape memory allows us to design and develop implants that can enter a cavity or bony tunnel in one diameter and deploy them to a much larger size. This shape change can drastically improve the strength profile of the device as well as improve the delivery environment. As an example, our 3.5mm Morphix™ device has a greater strength profile than most 5.5mm devices currently in the market,” stated Ken Gall, PhD, founder and CTO of MedShape Solutions.
“What is unique about the Morphix™ device is the simplicity of its design coupled with outstanding performance when compared to competitive devices,” stated orthopedic surgeon Bill Bryan, MD, Houston, TX. “I love the fact that the dynamic nature of the implant allows it to adjust to the surrounding changes in the bone that occur after cyclic loading. The Morphix™ is the only implant I am aware of that can do this.”
MedShape Solutions also announced that it has recently closed approximately $10M of equity funding from various qualified private investors. “This recent round of financing will allow MedShape to bring forward several unique shape memory orthopedic devices that will improve patient outcomes and improve surgical procedures,” stated Kurt Jacobus, PhD, President & CEO.
“We continue to make progress in building a company of significant value centered around our shape memory technology platform.”