Proje Geliştirme ve
Koordinasyon Birimi

2017-08-27 Russia: Development of the Innovative Osteoarthritis Treatment Method


 

Development of the Innovative Osteoarthritis Treatment Method

Description of the project offered: 
The proposal is to carry out clinical trials and conformity assessment of a new medical device for osteoarthritis treatment

Osteoarthritis is a widespread problem in modern orthopedics. The lack of effective treatments in the early stages of disease has led to resorting to joint replacement as the mainstay of the treatment strategies.
To date, there is not a single treatment method that offers:
• cessation of joint degeneration and sparing the patient from the traumatic, high-risk and costly joint replacement
• reduced patient suffering, especially in cases where preexisting health conditions and weight or age make joint replacement impractical
LLC Medel has developed a revolutionary treatment method (IMPLESO®) that effectively alleviates these problems. The treatment method IMPLESO® is based on restoration of bone and cartilage tissue via electric field emitted from the new medical device: Electret Stimulator for Osteoreparation (ESО). 
ESO is an implant in the form of a small rod made of tantalum with a quasi-constant electric field on its surface. The ESO is implanted into the affected joint to locally treat the necrotic area. The implantation takes up to 15 to 40 minutes. The electrostatic interaction between the negatively charged surface of the implant and cell membranes results in polarization, increasing cell proliferation and apoptosis in mutated cells, enhancing differentiation of bone marrow cells into osteocytes and chondrocytes while retaining the synthesis of specific proteins.
Intellectual property rights on the treatment method and medical device are protected by the Russian patent and national patent applications in US, EU, China, India, and other regions.
Clinical trials results in Russia: Reduction in the pain index of stiffness and overall joint function on the WOMAC scale: 2 times reduction within one month post-procedure and up to 7-8 times decrease over a 6 month period. The range of motion of the joint increases. In 60% cases, full range of motion of the joint was restored to normal. At 6 months post procedure, there is no increase of degenerative changes visible via CT and MRI.
Previous observations: In the event of recurring pain 6-7 years post-procedure due to depletion of the implant’s electric charge; the stimulator is replaced with a new implant and the therapeutic effect is extended. Observations of sustained therapeutic effect reaches 20 years.
By this time, LLC Medel has developed mass production technology and got an official approval on medical device from Russian Health-care authority.
Project proposer:   Olga Kuzmenko (Russia)
Partner role:  Project coordinator 
Partner organisation:  Consultancy
Call for proposal title:  N/A 


Description of the collaboration sought: 
LLC Medel is looking for organizations that can facilitate access to the EU market for Medel’s medical device. We are looking partners that can devise the optimal conformity assessment path, design clinical trails, conduct clinical trails, do other conformity assessment actions.