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UK-based Metaphysis, known for its Intelligent Orthopaedics brand, is looking at the Indian market for its next phase of growth by offering advanced mechanics in bone healing and problems associated with long bone fractures.
The move, according to Indian hospitals is expected to see a major transformation in the country’s orthopaedic treatment offerings.
Intelligent Orthopaedics’ products were developed by professor Peter Thomas, an experienced orthopaedic trauma surgeon from the University Hospital of North Midlands and founder of Metaphysis. The globally certified range has been used to treat thousands of patients in the US, EU, Middle East and Australasia
Its first product STORM (The Staffordshire Orthopaedic Reduction Machine) was initially developed as a research tool to help the surgeons ensure that every fractured shin-bone was anatomically reduced so that accurate comparisons of the various methods of fixation could be achieved. During its maiden hospital trial, the device worked so well that surgeons asked the researchers not to remove the machine, Susan Hartman, partner and general manager, Metaphysis, told Pharmabiz in email.
STORM helps surgeons achieve anatomical reductions of unstable tibial fractures prior to fixation. Surgery time is shortened by 25 per cent and the average reduction takes just 11 minutes. Using STORM decreases x-ray exposure by 50 per cent and enables faster healing and reduced complications.
The second product IOS Fixator is used to treat unstable tibial shaft fractures. It is lightweight and easy for the patients to wear normal clothing. IOS also permits full weight bearing. The shortest healing time from surgery to fixator removal is 8 weeks and 3 days. Fixator can be removed in a clinic and has in-built fracture stiffness measurement allowing surgeons to know when it is safe to remove the IOS, she added.
The company has a full pipeline of new products based on the results of over 20 years of basic research. All the products are certified by CE Mark, ISO 13485 and FDA clearance to market. In addition, it also holds local market registrations from Turkey and Australia. All initial trials were completed in the UK. The CE Mark and FDA evaluations have been completed in several markets including Germany, US and India.
The India entry would be through Dr Suresh Krishnamurthy, leading orthopaedic consultant surgeon who has used the STORM while working in the UK.
With the new medical device legislation on the anvil in India, Hartman said that its products belong to a minimally invasive Class I device with CE and FDA certification and would not face compliance issues. However, the biggest challenge would be to scout for a manufacturing partner that fulfills global production criteria. In this regard, Metaphysis considers a licensed manufacturing option with a company having an established orthopaedic trauma presence as an ideal fit.
Currently, majority of the IO products are manufactured in the UK with a few components made in the EU. For its India and South East Asia entry, the ultimate plan for Metaphysis would be to manufacture it locally to achieve economies-of-scale and drive affordability.
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