is a platform technology company for biomaterial applications for medical implants and devices in the fields of cardiology (Pacemakers, Valves), Dental, Orthopedic (Hip, Knee, Finger, Shoulder etc. Founded in 2001, MMATECH company, has developed a novel advanced, tough, low-friction, biocompatible, wear and cold flow resistant polyimide MP-1™, for medical implants and devices that can revolutioniz
e the multi-billion dollar orthopedic and dental markets. The company received CE Mark in October 2011 and ISO 13485 approval in July 2011. The company intends to penetrate initially into the European market and later into the US and ROW markets. The company holds USP 6,686,437 covering the medical MP-1™ application and an exclusive license for the raw material production. In addition, the technological proof-of-concept and efficacy of the MMATECH implant have been established in a successful pilot clinical study. The study was conducted in New-Zealand, and showed remarkably successful results. The study showed that the implant is safe and the patients returned to full activity with no adverse events. Two clinical studies of total 100 patients are planned to initiate with two strategic partners in 2012. Joint replacement
Total joint replacement has become a widely accepted treatment for many injuries and destructive joint diseases including osteoarthritis, rheumatoid arthritis, osteonecrosis and very severe pathologic fractures of total joint replacements. The two most commonly and most successfully replaced joints are the knee and the hip. MMATECH first indication is the hip replacement market. Hip replacement is a surgical procedure in which the hip joint is replaced by a prosthetic implant. Hip replacement surgery can be performed as a total or a hemi (half) replacement. Such joint replacement orthopedic surgery generally is conducted to relieve arthritis pain or fix severe physical joint damage as part of hip fracture treatment. A total hip replacement (total hip arthroplasty) consists of replacing both the acetabulum and the femoral head with an implant consisting of three major parts: Acetabular shell, liner and femoral head coupled to the hip implant (Fig 1). Hemiarthroplasty is a partial replacement of the femoral head. Hip replacement is currently the most successful and reliable orthopedic operation with 97% of patients reporting improved outcome. The clinical need
The main disadvantage of currently available artificial joints is their limited life span, particularly in applications for the young patient (under 65 years old). Some recalls were announced by the FDA of major orthpeadic companies of hip implants due to limited life span. Total joint replacements experience wear debris problems when produced from polymers (UHMWPE - Ultra High Molecular Weight Polyethylene), ceramic or metal. Microssize debris accumulating in the space around the implant or may cause inflammation. This reaction may cause pain and/or losening of the implant. Metal toxicity - Metal ions from the implant may enter into the bloodstream, which may cause severe medical problems. Some patients with metal-on-metal hip implants developed a reaction to these ions, which could affect the nervous system, heart and thyroid gland. Metal debris in the bloodstream can lead to cobalt poisoning. Limited life span of orthopedic implants is due to:
Polymers wear debris, degradation and delamination (following Gamma radiation and wear)
Crosslinked UHMWPE demonstrates high water absorption low fatigue resistance and high stiffness (deleterious for wear). Ceramics are brittle and prone to fracture and stress-corrode in humid environment. Metals produce potentially toxic, carcinogenic and allergenic wear debris. Coatings of orthopedic implants are wear resistant but tend to peel off with time (aging). According to AAOS and NIH approximately 10-15% of the hip and knee operations necessitate costly and complicated. MP-1™ - Advanced Revolutionary Biomaterial for Next Generation Implants
MP-1™ polyimide from MMATECH is a high performance biomaterial providing advanced solutions for implant manufacturers. MP-1™ is safe, biocompatible and durable polymer. Polyimide MP-1™ polymer, was originaly developed for Jet engine bearings. It exhibits a superior combination of strength, toughness, wear resistance, creep and fatigue stability, together with extensive biocompatibility which makes it suitable for medical device applications. MP-1™ can be processed by a conventional technique of compression molding allowing a broad design and manufacturing flexibility. INTRODUCTION
MP-1 ™ polymer is an advanced biomaterial for long-term use in the human body (fig 2). Radioopaqueness, radiation inertness, wear resistance, excellent Mechanical properties, relative ease of fabrication by compression molding and demonstrated biocompatibility have helped make this material become an important alternative to other polymer, ceramic or metal implants. IDEAL PROPERTIES
Available as a natural bulk polymer or as a reinforced compound, the mechanical and physical properties are wide ranging (Table 1). The mechanical modulus matches well that of a cortical bone. Table 1 – Mechanical properties of pure MP-1™
MEDICAL IMPLANT SOLUTIONS
Uses of MP-1™ include: Orthopedic implants for hip, knee and shoulder joints, spinal cages and spacers, replacement for heart valves, stents and pacemakers, hardware for fracture repair, dental splines and healing caps, and other pins, screws and bone plate devices, middle ear implants and urological implants. BIOCOMPATIBILITY
Biocompatibility and biostability studies including: cytotoxicity, sensitization, genotoxicity as well as long term implantation in rabbits, according to ISO 10993 & USP class V, demonstrated excellent results for the polymer MP-1™ showing that there is no evidence for the release of any harmful ingredients are during lifetime exposure. The fibrotic tissue grown around the implant is minimal (Fig 3). All tests were produced in an FDA approved lab, and have demonstrated perfect biocompatibility of the MP-1™ material. STERILIZATION
MP-1™ polymer parts offer maximum in-use flexibility using steam, ETO, Gamma Irradiation and heat sterilization. The high thermal stability of MP-1™ (up to 400 °C) enables the use of a common sterilization technique of autoclave heating to 250 °C for 2 hrs, which is easy to use, available in any location and offers a pyrogen-free product. IMAGING
MP-1™ polymer offers exceptional imaging versatility being easily radioopaque (Fig4) . Imaging artifacts are eliminated which enables perfect inspection using conventional techniques such as X-Rays, tomography and MRI. MRI technologies can be employed to scan patients with MP-1™ implants, since the polymer is non-magnetic.
