Leeds-based Medilink member Tissuemed Ltd has been granted regulatory approval of its TissuePatch™ range of ultra-thin surgical sealant films by the Chinese FDA (‘CFDA’).
TissuePatch™ is the first and only synthetic sealant to be approved by the CFDA, giving Tissuemed sole access to a significant medical device market that is being driven by both an increase in income and a population greater than 1 billion, aging faster than any other country. Sales of medical devices in China have increased rapidly over the last decade, exceeding £30 billion in 2015.
The approval comes at the end of an exhaustive two and a half year programme and importantly covers all surgical applications for TissuePatch sealant film technology, allowing Tissuemed to extend its product reach beyond the traditional Neuro and Thoracic spaces.
Speaking about CFDA approval, Tissuemed’s CEO David Mandley said, ‘Approval of TissuePatch™ in China marks a major achievement for the company. This success opens the door to a significant market and is an exciting phase in the commercialisation of our innovative product range. With regulatory requirements in China becoming ever more challenging this approval is testament to Tissuemed’s proven technology and robust Quality System.’
‘We have a commercial partner in China with a proven track record of successfully introducing innovative products to address the demands of a rapidly growing healthcare system. Chinese surgeons will now be able to use our unique self-adhesive sealant film to prevent leaks after surgery, reducing post-operative complications and the need for extended hospital stay.’
For further information visit www.tissuemed.com