Surgical sealant film maker, UK-based Tissuemed Ltd tells us its TissuePatch™ Surgical Sealant Film product platform has gained approval in China.
TissuePatch surgical sealants are very thin, self-adhesive “films” which are CE marked in Europe for use in the avoidance of leakage of blood, air or liquid from tissues, an occupational hazard for surgeons of numerous specialties. Tissuemed’s marquee product, TissuePatchDural has been in commercial use since 2007 by Neurosurgeons for prevention of post-operative Cerebrospinal Fluid (CSF) leakage following surgery that has involved breaching the Dura Mater. However the material was originally conceived to seal and protect against air leakage during and after thoracic surgery. It has since also been used in a variety of indications, from maxillofacial and thyroid through to liver and other general surgical use.
Tissuemed says Chinese approval has been gained as a result of close collaboration with a local partner who will now be involved in the commercialization of the technology across the country. Significantly the approval permits use of the product in all appropriate disciplines which, says Tissuemed, makes the market opportunity even more attractive.
Tissuemed is seeing the approval as validation of its technology, given what was a rigorous approval process. The TissuePatch device platform has to face a high regulatory barriers by virtue of the fact that it is used in higher risk applications and is ultimately absorbable. The question remains as to whether the company is now sufficiently buoyed by its Far Eastern win to consider hitting the trail with the U.S. FDA where the more mature market for sealants of all types might make it an easier commercial prospect.
Tissuemed CEO David Mandley stated; ‘We have a 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.’
Source: Tissuemed Ltd.