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SEE BREAKING NEWS !!!

SAOA 2016

 

MP1™ 

 Restoring the motion to life

 Advanced Polymer for Wear-Resistant Load-Bearing Implants

 About us:

MMA-TECH LTD.  

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 revolutionize the multi-billion dollar orthopedic and dental markets. The company received CE Mark in October 2011 and ISO 13485 approval in July 2011. Master –File was approved by FDA in October 2014. 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.

A clinical study of total 100 patients was initiated with a strategic partner in 2013. 53 cases were already implanted with 100% success. Some patients were as young as 43 years old.

 

 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.

                                                                                                                     Fig 1: The basic components of a total hip replacement

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 orthopedic 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. Sub- micron size debris accumulating in the space around the implant and may cause inflammation and bone regression. This reaction may cause pain and/or loosening 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. Many recalls concerning these implants reduces the use of MOM implants WW.

 

 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 revision surgeries.

 

 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 originally developed for Jet engine bearing-balls due to its self-lubricating property. 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). Radio-opaqueness, 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 articulating implants.

 

Figure 2 - MP-1™ Acetabular Cup

  IDEAL PROPERTIES

Available as a natural bulk polymer , 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™

Property

ASTM Test

Units

Value

Tensile Modulus

D 638

MPa

3175

Compr. Modulus

D 695

MPa

3578

Flexural Modulus

D 790

MPa

4273

Impact strength

D 256

KJ/m2

1.647

Glass Trans. Temp. Tg

TMA

0C

315

Water absorption

C 20

%

0.014

 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, trauma, 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.

 

 

 

 Figure 3: MP-1 implant in rabbit after 3 months implantation

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.

  

 Figure 4 – Inherent radio-opaque of MP-1™

 Outstanding Fatigue performance, Excellent Wear and Impact resistance
and excellent creep and cold flow Resistance

 

Figure 5 - Creep of MP-1™ (3 bottom graphs) vs. UHMWPE (2 top graphs) at various temperatures (RT, 45 C and 70 C)

Figure 5 shows NO creep of MP-1™ at RT, 45 and 70 C compared to UHWMPE with high creep already at RT and 45 C under a load of 100 Kg/cm2.

 

 

Figure 6 - S-N Fatigue of MP-1™ vs. UHMWPE @ 0.5 HZ., area 1 cm2, Max Strength S0 = 80 MPa

Figure 6 shows a fatigue endurance limit at 450 kg with high fatigue resistance of MP-1™. UHMWPE shows low fatigue resistance with no endurance limit.

Impact resistance was tested on an MP-1™ liner 2.5 mm thick. 100 impacts of 700 kg resulted in no crack or damage to the liner.

 The MP-1™ Acetabular liner (Fig. 2).

The MP-1 ™ acetabular liner is designed to optimize implant safety, advance patient care and improve hip replacement procedure outcomes.

The MP-1 ™ acetabular liner is a strong, tough, wear, creep and fatigue resistant polyimide which enhances joint stability and restore closer to normal joint function. The acetabular liner allows greater flexibility in implant design resulting in improved range of motion.

  • Polyimide MP-1™ polymer originated from Jet engine bearings balls
  • Exhibits a superior combination of strength, toughness, wear, creep and fatigue resistance
  • MP-1™ is a high performance biomaterial
  • MP-1™ is safe, biocompatible and durable polymer with modulus close to bone
  • MP-1™ can be processed by conventional techniques

 The MP-1™ acetabular liner main advantages:

MMATECH is offering a win-win proposition for everyone in the value chain:

Clinical benefits

For clinicians & patients the MP-1 implants brings real clinical value that can potentially improve patient outcome, safety and reduce the cost of care:

  • Superior implant properties – Instead of working with current materials the MP-1 has superior properties which enable improved implants quality for safer and longer treatment periods.
  • Reduced risk of debris and inflammation – getting into the safe zone where the implant biomaterials has negligible wear and no sub-micron particles which leads to reduced risk of inflammation and osteolysis and implant loosening.
  • Enables better patient care. Clinicians will be better able to reduce the number of revision procedures.
  • Become a standard of patient care – since there are serious risks associated with current materials, the MP-1 has every possibility of becoming a mandatory material to proper patient care and risk management.
  • No special training requirements – The implant is processed and used according to the original measurements and dimensions as for existing implants. There is no need for costly training and education programs.
  • Can be implanted in younger patients. First implant is already surviving more than 10 years (as of 2016).

 

Business benefit

For healthcare providers and orthopaedic implant companies, the MP-1™ is an affordable purchase with an attractive recurring revenue model:

  • Compatible with any implant. Implant companies will not need to replace the whole implant, just its metal, polymeric or ceramic liner component.
  • OEM product. MMATECH customers are implant companies; thus, relatively low S&M is required and large quantities are sold per order.

Product benefit

For healthcare workers, the MP-1 will not change or burden the workload:

  • Unobtrusive. The MP-1 component is an integrative part of any implant.
  • Once implanted, the component follow-up and treatment is similar to existing components.

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 




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