HAPPE Spine announces that the first clinical case with the INTEGRATE®-C Interbody Fusion System was completed by co-inventor and neurosurgeon Dr. Stephen Smith, MD, at the Beacon Health System – Memorial Hospital in South Bend, Indiana.
Dr. Smith said, “The Integrate-C handled extremely well and went right to work. The porosity immediately draws blood and any autologous factors into the implant to promote healing. Radiographic visibility was excellent, and once implanted the Integrate-C even looks like bone.”
Powered by the HAPPE® platform, INTEGRATE®-C is the first interbody fusion cage that is fully integrated with porosity and hydroxyapatite to provide a superior healing environment. Interconnected, cancellous porosity promotes bone ingrowth from endplate-to-endplate. Hydroxyapatite is exposed on all surfaces to promote cell signaling and bone on-growth. The INTEGRATE®-C is both radiovisible and radiolucent for superior intra-operative imaging and post-operative assessment of fusion.
Dr. Ryan K. Roeder, PhD, founder of HAPPE Spine and co-inventor of the HAPPE® material platform and INTEGRATE®-C said, “This is a momentous milestone in a journey that began with an idea to integrate porosity and hydroxyapatite into polyetheretherketone at a time when PEEK interbody fusion cages were still new. Many team members have worked diligently to develop a product that has the potential to improve patient outcomes.”
Andrew Iott, CEO of HAPPE Spine added, “We are now excited to kick-off a strategic limited user release aimed at establishing clinical data supporting the efficacy of the innovative HAPPE® biomaterial platform and the INTEGRATE® product line. A national launch will commence later this year.”
About HAPPE Spine:
HAPPE Spine LLC is a medical device development company that designs and commercializes innovative orthopedic and spinal implants utilizing the patented Hydroxyapatite Porous Polyetheretherketone (HAPPE®) material platform. HAPPE transforms polyetheretherketone from a hydrophobic, inert, and non-integrating material into a hydrophilic, surface active, and osteointegrating material, confirmed by robust bone in-growth and on-growth in preclinical testing. In vitro performance or animal studies may not be representative of clinical performance. The HAPPE INTEGRATE®-C interbody fusion system is the first to offer interconnected cancellous porosity with exposed hydroxyapatite on the pore surfaces, as well as porosity extending across the entire implant height to promote endplate-to-endplate osteointegration. INTEGRATE®-C is designed to promote both load bearing and healing, as well as superior post-operative imaging. The HAPPE INTEGRATE®-C interbody fusion system thus offers allograft-like qualities in a synthetic implant that may improve clinical outcomes in interbody spinal fusion by overcoming the problems of pseudoarthrosis, subsidence and imaging artifacts that limit current PEEK and titanium implants.
Learn more about HAPPE Spine, the HAPPE® material platform at happeortho.com.
SOURCE HAPPE Spine
