ZipLine Medical said yesterday that it won Chinese FDA approval for its Zip surgical skin closure device and commercially launched the device in the region.
The Campbell, Calif.-based company’s Zip is a low-cost, non-invasive skin closure device designed to be alternative to suturing and stapling and to cut down on surgical site-related infections. The device has 510(k) clearance from the FDA.
“The non-invasive Zip closure is ideally suited for the healthcare market in China, in light of its large and growing procedure volume, need for cost-effective and efficient solutions, and appreciation of aesthetics. We look forward to working with our team of distribution partners across China to bring the speed, safety, comfort and convenience of Zip to Chinese patients,” prez & CEO John Tighe said in a press release.
In January, Zipline reported a more than $16 million funding round in a regulatory filing alongside an additional $19 million for its Zip surgical wound closure technology, led by new backer MVM Life Science Partners and including existing investor China Materialia.
“This financing allows us to further expand our global sales and marketing activities leveraging the favorable clinical study results and strong support from key opinion leaders among clinicians,” president & CEO John Tighe said in prepared remarks.
ZipLine said it’s adding MVM partner Dr. Bali Muralidhar and MVM managing partner Dr. Stephen Reeders to its board as part of the financing.