Descripción del proyecto
M.M.A.TECH has developed a novel advanced, tough, low-friction, biocompatible, wear, cold flow and fatigue resistant, polyimide MP-1™, with modulus close to bone, approved for medical device articulating implants that can revolutionize the multi-billion dollar orthopedic market. The MP-ORIF project aims at bringing to the market an Open Reduction Internal Fixation (ORIF) implant made of MP-1™ able to overcome the challenges often encountered by surgeons treating trauma with metal implants. Metal implants need holes to be pre-drilled before implantation and, once in the body, X-ray imaging is essential to position the screws through the holes, a challenging and time consuming task. However, MP-1™ implant is a solid rod with no pre-drilled holes. Once implanted, the screws are directly drilled into the rod, with minimal use of X-ray imaging. Screws can be inserted in several angles allowing for anatomic fracture fixation and hardware placement optimization. This procedure reduces the surgery and the healing times. Moreover, better surgical results with lessened failure rates are expected and additional surgery to remove the implant after healing is not necessary. Therefore, MP-ORIF will contribute to change the paradigm of trauma care injuries by improving the patient quality of life while reducing health costs, offering emerging countries real possibilities to provide quality trauma injury treatments, at a lower cost and shortened use of burdened surgical facilities. Our company has developed an Acetabular liner for Hip Replacement Arthroplasty made of MP1™ with outstanding performance. It received CE mark, and has been proved in 3 successful pilot clinical studies, some exceeding 9 years period, and some implanted for the first time in young people. The MP1 material received FDA clearance (MAF 2543) in 2014. MMA.TECH is ISO 13485 certified and holds USP 6,686,437 patent covering the medical application of MP-1™ and exclusive license for the raw material production.