Making Implants Integrate
Promimic has developed a state-of-the-art nanotechnology that mimics nature, making it possible to create a unique bioactive surface on any implant. HAnano Surface is a 20 nanometer (.02 micrometer) thin implant surface modification composed of crystalline hydroxyapatite (HA) particles, which have the same shape, composition, and structure as HA found in human bone.
HAnano Surface has proven to accelerate bone growth in over 30 in vivo and in vitro studies. Faster and stronger osseointegration has been demonstrated through biomechanical, histomorphological, and biological evaluations, in combination with over 500,000 clinical applications to date.
Promimic operates primarily in the United States, Europe, and South America, with current product applications in the dental, spine, total joint, extremities, and sports medicine implant markets.
Product Development and Commercialization Partner
Promimic partners with medical device companies through all phases of product development and commercialization, including: initial feasibility and optimization, testing and regulatory submission, production setup and implementation, as well as launch and marketing support. The business model is flexible, based on the desires and capabilities of the customer.
Established Contract Manufacturing Organization
Promimic’s strategic partner Danco Anodizing offers OEMs without in-house manufacturing capabilities, an opportunity to treat their implants with HAnano Surface. Danco Anodizing is a leading supplier of surface treatments to the medical device industry and has a fully implemented HAnano Surface production line in their facility in Warsaw, Indiana (US).
Clear Regulatory Pathway
HAnano Surface® is currently used clinically in tens of thousands of patients. Promimic fulfills the requirements of SS-EN ISO 13485:2012 and the process meets both FDA and CE specifications. Promimic’s scientific documentation combined with the regulatory approvals in the U.S. (510(k)), EU and South America provides a clear regulatory pathway for products using HAnano Surface.