ZipLine Medical announced today that it has received a triple whammy of marketing clearances for its patented Zip® non-invasive surgical skin closure device. Already FDA cleared, the device can now also claim European CE Marking, Todokede premarketing notification for Japan, and Korean Ministry of Food and Drug Safety (MFDS) approval.
Background
Californian company ZipLine Medical is developing cost-effective, non-invasive surgical skin closure devices that deliver suture-like outcomes at the speed of staples, with a reduced risk of surgical site infection. Because skin-closure is the common denominator of nearly all surgical procedures, the Zip® Surgical Skin Closure devices have extensive applicability across multiple medical specialties. The Company says its addressable market opportunity is estimated at $4 billion worldwide.
The company also announced a partnership with Cosmotec Co. Ltd of Japan, which will distribute ZipLine Medical’s Zip® surgical skin-closure devices for the Japanese healthcare market.
Company comments
“These regulatory approvals represent a major milestone for our international business,” said Lori Munoz, Vice President of Finance and CFO of ZipLine, who also manages ZipLine’s OUS commercial 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.”
Source: ZipLine Medical, Inc., Business Wire
published: April 17, 2014 in: Approval/Clearance, General Surgery, Wound Care