ZipLine® Medical Receives CE Mark and Regulatory Approvals in Japan and South Korea for Zip® Surgical Skin Closure, Begins International Distribution
CAMPBELL, Calif., April 17, 2014 — ZipLine Medical announced today that it has received CE-Mark for Europe, Todokede premarketing notification for Japan, and Korean Ministry of Food and Drug Safety (MFDS) approval to sell its patented Zip® non-invasive surgical skin closure device. Zip® is already FDA-cleared and classified by the U.S. FDA as ‘Class I, Exempt.’
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.
“This partnership between ZipLine Medical and Cosmotec is an important event for surgeons and their patients in Japan,” said Akio Yoshida, President of Cosmotec. ”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,” said Mr. Yoshida.
“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 excellent cosmetic outcome and rapid wound closure.”
ZipLine Medical (www.ziplinemedical.com), headquartered in Campbell, Calif., is an emerging medical device company developing cost-effective, non-invasive surgical skin closure devices for suture-like outcomes at the speed of staples. 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’s addressable market opportunity is estimated at $4 billion worldwide.
ZipLine and Zip are registered trademarks of ZipLine Medical, Inc.
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