Surgical technology company set for further success in China

A Yorkshire surgical technology company has gained regulatory approval for its main product in China.

Leeds-based Tissuemed’s whose product TissuePatch, the world’s only synthetic, self-adhesive patch for preventing leaks during and after surgery, has been approved by China’s Federal Drug Administration (CFDA).

Now the business is now working with Chamber International’s China specialist, Matthew Grandage, as the company increases its communication with the medical devices market in China which totalled more than £30bn in 2015.

Soon after CFDA approval, a leading hospital in Sichuan province became the first user of Tissuepatch in China, when surgeons used it during a thoracic procedure.

Tissuemed chief executive, David Mandley, says: “TissuePatch is unique in China as the first synthetic sealant in the medical market with a broad range of surgical uses, from neurosurgery to thoracic and general surgery. China holds great potential for us – for example, the country has 12,000 practicing neurosurgeons alone.

“The TissuePatch product range, which was CE Mark approved in 2007, is now exported to 25 countries and China has huge potential. We have many users from different surgical specialisms in large hospitals and the breadth of our regulatory approval has created positive signs that we can expand our market share.”
Scientists at Tissuemed took five years to develop TissuePatch, which is designed to complement conventional wound closure techniques, such as stitching or stapling, reducing post-operative complications, and the need for extended hospital stays.
Tissuemed was founded in 1985 by two cardiothoracic surgeons at the Cardiac Research Centre at Killingbeck Hospital, who developed and introduced the first CE marked tissue heart value. The heart valve business was divested in 2000 to enable Tissuemed to focus on developing surgical sealants. The company now has 15 staff, and exports more than half of its £1.1m turnover.

Grandage says ”It’s no surprise that there is a ready market for Tissuemed in China as western medical devices, drugs, and expertise are highly sought after, not least because of repeated breaches of trust in the domestic regulatory environment. For example, last year China’s own Xinhua news agency reported that around 80% of approval applications for domestically- produced medicines at that time contained fraudulent clinical trial data.

“However, such weaknesses do not automatically guarantee export success. Good market entry always requires careful research and planning. Tissuemed has gone about this prudently, securing their own intellectual property first, strategizing well, and identifying trustworthy distribution partners for the future – all tasks that Chamber International is glad to assist with.”