M.M.A. Tech Ltd. has developed an Acetabular liner for hip replacement arthroplasty procedures made of Polyimide MP1™ to overcome the life span problems often encountered by total arthroplasty hip surgery patients. Common complications are bone resorption and a shifting of the implant from its original position due to wear and debris from the polyethylene in use today.
The MP1™ Acetabular liner has received CE approval and M.M.A. Tech Ltd is ISO 13485 certified since October 2011.
M.M.A. Tech Ltd. is conducting a 3rd clinical study of 100 patients in New Zealand. M.M.A. Tech Ltd established a contract with a leading orthopedic company in Europe.
M.M.A. Tech Ltd. is initiating a new clinical study of 15 patients in Israel, which is already registered in ClinicalTrials.gov (NIH no. NCT02503891). The results of the clinical study will serve as a pilot for the FDA approval.
M.M.A. Tech Ltd. submitted a Master File of MP1™ for the FDA which was accepted under the No. MAF 2543 on October 2014.
Worldwide, the total joint replacement, implant and regenerative product markets generated approximately $23.8 billion in 2010
- Joint replacement implant market exceeded $26.8B By 2015
- 285,000 Total Hip Replacements (THR) performed in the United States in 2012 and 570,000 THR in Europe in 2008 with CAGR of 6%
- Unit price to the consumer is approximately US $7,000 – 13,000 per knee implant and $10,000-12,000 per hip implant.
(Source: Global Market Information Database)
- Ø Market growth is offset by decreasing of unit price. In this market, better implant material produces competitive advantage.
Use of the innovative, high performance polymer MP1™
Use of the innovative MP1™ will allow:
-Much longer life spans for articulating implant.
-Better quality of life for patients with fewer post-surgical complications
-Greater flexibility in implant design
MP1™ is preferable to existing materials used in articulating artificial joints; however, its cost is no greater than many existing products. MP1™ is tougher than metal, wears less than UHMWPE, and has higher fracture toughness than ceramics. Other attributes include it’s close to bone density, resistance to cold flow and fatigue, low friction and chemical inertness, surpassing cross-linked UHMWPE.
Fluid analysis of particles after Hip Simulator test shows that the MP1™ is not releasing fine, submicron particles which are the main reason for failure of orthopedic joint implants due to the inflammatory process evoked by these particles resulting in bone absorption.
Full scale a clinical study of 100 new cases with strategic partner was initiated in January 2013. During the last year 43 Total Hip Replacement surgeries using MP-1 liners were conducted in University of Otago-Hospital (Christchurch), New Zealand. Recruitment is estimated to finalize by H4, 2015.
The full-scale clinical study was based on two preliminary pilot cases:
In November 2006 The first patient was implanted with MP-1 liner and discharged from the hospital three days after surgery walking on her operated leg.
Follow-up of 9 years showed excellent results.
A second surgery was conducted in September 2007 Patient returned to normal activities. Follow-up of 6 years showed excellent results.
||Fig. 1 – Insert of MP1™
in the Hip Implant (X Ray image) –
4 years post operative
The 2nd patient died a year ago from a disease not connected to the implant. He agreed to have histology. The results showed: no osteolysis,
no osteoclasts, no measurable wear. The soft tissues around the hip were very bland without fibrosis or reactive macrophages.
The CT scan of the specimen showed: no osteolysis even through the cup screw holes.
To date, all patients are healthy and gain good quality of life.
Future M.M.A. Tech products will address the need of knee and other joint replacement parts such as ankle, shoulder, trauma and spinal.
Other applications fit in the cardiovascular area: such as for pacemakers, heart valves, coronary stents, in dentistry, etc.
M.M.A TECH also has the capabilities to adjust its polymer formulation as per the requirements of the application.
Material composition of the MP1™ is a trade secret which has been developed by an outsourcing manufacturer in the US for non-medical applications. M.M.A.TECH received exclusive rights from the manufacturer for its medical applications.
M.M.A.TECH IP (USP 6686437) was approved in 2004 and covers all medical applications of the MP-1 material.
Founding the company
The clinical experience in Israel spans over 30 years and we have learned that every solution and upgrading in the orthopedic field encounters problems and pitfalls that get uncovered the longer and more experience we gain.
therefore, research in bio-materials and body tissues reaction to deterioration of materials is an intimate part of researchers studies to address the challenge of a better biomaterial at MMA Tech Ltd.
Was founded by five scientists: Alisa Buchman (M.Sc), Simha Sibony (M. Sc), Prof David G. Mendes, Dr. Rob Bryant and Dr. Ray Payne and developed a new bio-material called MP1™.
M.M.A. Tech was founded within the framework of Yozmot Ha’emek Technological Incubator in Migdal Haemek, Israel. Since then MMA-Tech is an independent company situated in Naharya, Israel.
Number of employees: 8
Types of customers: OEM of orthopedic implants
Desired cooperation: strategic partnerships.
Main export markets: US, Europe and APAC
Standards and regulations: CE Class IIb Blue Book approved, G95-1 and ISO 10993-1 (biocompatibility requirements) , approved, FDA- 510K.
Founders short background:
CEO: Simha Sibony, M.Sc. – Biomedical Engineer in the field of biomaterials, expert in biocompatibility testing of medical devices and GMP/QSR/FDA / CE regulations.
CTO: Alisa Buchman, M.Sc. - Materials Engineer and chemist in the field of polymers, expert in adhesion science, durability, failure analysis and Non Destructive and polymer Testing.
Scientific Advisor: Robert G. Bryant, Ph.D. – Senior Polymer Scientist, expert in polymer synthesis and applications.
Medical Advisor: G. Raymond Payne III, M.D., F.A.A.O.S., and F.A.A.H.C.S. - Director Clinical Professor of Orthopedics, Eastern Virginia Medical School
Medical Advisor: David G. Mendes, M.D.- Director, Former Director Center of Implant Surgery and Department of Orthopedic Surgery, Bnai Zion Medical Center – Haifa, Israel.
Address: P.O. Box 12082
Zip code: 22358
Tel: +972 526- 546 - 625
Fax: +972 4 814-6056
Contact person: Simha Sibony, CEO firstname.lastname@example.org