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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - MP-ORIF (Innovative biocompatible game changing material for medical implants in trauma)

Teaser

Summary

MP-ORIF is a game changing open reduction internal fixation implant, made of MP-1 polyimide. It is aimed to replace currently orthopedic implants for trauma surgery. The problem: Orthopedic fractures are a common daily acute health issue, where distal radius is the most frequent case. Bone fracture will increase in the coming years due to aging population, more active lifestyle, falling, and road and sport injuries. Fractured bone injuries are treated with various fixation implants (nails and plates) made of metal or composite materials containing C fibers. Wear debris of metal and of C fibers cause allergy, inflammation and subsequent implant failure. Other problems: bone breakage (cut out), CT and MRI dispersion, limited location due to pre-drilled holes and extended surgery time. The common surgeries involve long cuts, which leave ugly scars on the healed limb. MP-ORIF solution solves all these issues and enables the surgeon to execute a minimal invasive surgery. Impact on society: Shorter surgery time, less risk, 50 % lower overall cost for the hospital and healthcare providers, Better reputation for the hospitals and the doctors. Shorter recovery time and patient quality of life significantly improved â€“ due to eliminating pain and negligible scarring. Lower public healthcare costs. The trauma surgery is simpler, so developing economies may gain access to high quality trauma care otherwise impossible, serving wider congestions and in rural areas. The overall objectives: TECHNICAL: The MP-ORIF device was proved to be durable and biocompatible thus causing no inflammation. FINANCIAL: to reduce the overall price of the ORIF procedure. OPERATIONAL: to prepare a device which gives more freedom to the operating surgeon. COMMERCIAL: To gain CE mark PRODUCTION: To set up the industrial level process of near-net shape compression molding. PUBLICATION: To protect the intellectual property rights and prepare for commercial launch.

Work performed

\"he work included: Wear Debris compatibility in animals: done in UNSW Australia. Wear debris were supplied by MMATECH. 75 rats participated in this study, tested after 1, 3 and 6 weeks of surgery. 3 group were involved: saline (control), and fractured bone with 2 MP-1 debris concentrations. Results: Healing was progressing in a normal manner. The MP-1â„¢ polyimide debris were within the fracture callus. Cartilage and new bone formation demonstrates closing of the fracture gap. Conclusion: At 6 weeks, the healing is advanced with new bone growth. No effect of MP-1â„¢ particles on the healing procedure or healing time. Mechanical Testing â€“ Plates: Four point bending static test and Dynamic fatigue test (ASTM F 382) of MP-1 bone plates. Results: The static and the dynamic results of the MP-1 bone plates were within the requirement of the medical device. All samples endured over 1 million cycles of fatigue - a very good resistance to fatigue. Pull-out test (ASTM F543-17) of 8 screws from MP-1 block. Results: All screws either deformed or broke when pulled out of the MP-1â„¢ block material. This proves that pullout strength is lower than MP-1â„¢ bulk strength. The MP-1â„¢ material tends to track weld the screw when inserted in it. Blood biocompatibility test â€“ coagulation test: performed in Eurofins Italy. The MP-1 samples were put in direct physical contact with the blood / plasma of humans. Thrombogenicity time of plasma with or without MP-1â„¢ samples was measured. Results showed that the MP-1 does not cause coagulation or alteration of the plasma compared to control, proving that MP-1â„¢ delays coagulation. Nail and screw production: from compression molded near-net shape bulks by CNC machining. All products were measured, and QA tested. Building Press and Mold: both were designed and built by \"\"Proment\"\". The press includes 2 static plates and 3 moving plates for holding the mold, enabling the mold to press the powder from both sides. Heating bodies were installed in the mold. An electrical control panel controls the process. The mold was built to manufacture a near-net-shape product that includes both a nail and a screw in a rectangular shape. The molded parts were perfect. QA of the near-net shape parts included: Color, hardness, density, machining and X ray. During the project, we finalized the regulation of IQ / OQ and PQ. PQ was based on 3 sets of moldings, which were tested for bending and flexure. The results of the molded nails were compared to machined nails from blocks and were identical. We now have a working process for hot compression molding of MP-1 powder. This achievement will lower significantly the price of production. Additional trauma implants were planned and produced (plate and distal radius). Animal Trial 3 sheep â€“ 2 sheep had nail implanted in their bone and screws drilled in the nail. After 6 weeks, they were sacrificed and histology was performed on the implanted nail. Results showed excellent healing and growth of new tissue. Another sheep was implanted with a plate. Helsinki for 2 humans in Israel â€“ 2 cases will be tested in Israel after Helsinki approval. Follow-up of 6 weeks. CRA was located for clinical trial follow-up in EU. 2 centers in EU each of them for 10 cases were found. The cases will be compared to Ti nail existing operations. Follow up: 6 weeks. CE mark: Preparation to obtain CE mark. Several regulation files are being written: Intended use document. Failure Mode and Effects Analysis (FMEA), Risk analysis, all are added to the QA folder. Many files were altered to fit the ISO 2016. An updated Project plan was summarized in MS Project file. Patent: covering trauma nails, plates and screws was written and registered in USA and applied in EU. . Exploitation and dissemination: Website domain: www.mma-tech.com . New LOGO and new brochure were created. Conferences: MMATECH attended 5 conferences presenting posters and lectures, a workshop and 2 exhibitions for which we prepared t\"

Final results

1-Progress : The 2nd period should have ended the project we needed to update the plan because of animal trials and therefor, delay the human surgeries. We filed an amendment and extended the project by 12 months. A new Gantt and extended MS project was prepared. We also needed to nominate a CRO, in order to carry out the clinical trials abroad (WP 4). We got a few quotations and Biomapas (www.biomapas.eu) provided the most convincing one. This extension implies the shifting of the end date of the work packages 4, 5, 6, 7 and 8.
2-Socio-economic impact: 50 % lower overall cost for the hospital and healthcare providers. Trauma surgeries can be also offered by small and medium hospitals and private clinics that cannot serve congestions in large hospitals. Shorter post-operation recovery time, patient quality of life will be significantly improved. Lower the public healthcare costs. wider societal implications: developing economies and rural locations may gain access to high quality trauma care (for the most frequent injury), otherwise impossible.