US-based tissue repair device company ZipLine Medical has obtained European CE Mark approval, Todokede premarketing notification for Japan, and Korean Ministry of Food and Drug Safety (MFDS) approval for its Zip non-invasive surgical skin closure device.
ZipLine Medical has also announced Japan-based Cosmotec as its distributor of Zip surgical skin-closure devices in the Japanese healthcare market.
Cosmotec president Akio Yoshida noted that this partnership between ZipLine Medical and Cosmotec is an important event for surgeons and their patients in Japan.
"Clinical experiences using the Zip device have demonstrated that it is an easy-to-use and fast skin-closure modality, offering excellent comfort and cosmesis for the benefit of patients and the opportunity for improving healthcare economics," Yoshida added.
ZipLine Medical Finance vice president Lori Munoz, who also manages ZipLine OUS commercial business, noted that these regulatory approvals represent a major milestone for the company’s international business.
"We are very excited about the business partnerships we are developing in Japan, Korea, and other international markets. Patients, hospitals, and physicians in these markets clearly see the benefits ZipLine provides, and these include improved cosmetic outcome, speed of application, and reduced risk of infection," Munoz added.
ZipLine and Zip are registered trademarks of ZipLine Medical. The patented Zip non-invasive surgical skin closure device has already obtained the US Food and Drug Administration (FDA) approval and the device is classified as ‘Class I, Exempt’ by the FDA.
Image: ZipLine Medical’s noninvasive surgical skin closure. Photo: Courtesy of Business Wire, ZipLine Medical, Inc.