Within 2017, Ziptek received notice of allowance for four patents related to its ZipE® resorbable knotless tissue repair system, including the method for use. The company has over nine U.S. and three international issued patents, with many pending approval.
Ziptek was incorporated in 2012 with three patents, at the time. Angel investor support occurred in March 2014, and was followed by receipt of numerous domestic patents:
- August 2014 – Ziptek receives first new patent related to the evolving ZipE® knotless tissue repair device, a locking mechanism within an implant for securing the suture. This mechanism will be added to Ziptek’s second-generation screw.
- September 2014 – Ziptek receives an additional patent related to the original ZipE® surgical button/capture design; this design has been shelved for indications different from the original 21 IFUs allowed by FDA.
- April 2016 – New patent received for ZipE® surgical button/capture design with continuation
- March 2017 – New patent received for ZipE® method of using a surgical button/capture with a suture that has protuberances with driver
- August 2017 – Three new patents awarded: ZipE® screw utility, allowing shuttling of suture through the screw after placement in bone; also ZipRE® screw design awarded, and Zipe® driver driver design to move the surgical button/capture over the protuberances
International patents have been issued in Columbia, Mexico and Singapore; EU patent is allowed. All issued U.S. patents from 2017 are filed for in 35 other countries.
In 1Q17, Ziptek received FDA 510(k) clearance to market the ZipE® knotless tissue repair and attachment device. The absorbable button functions like a zip-tie, obviating the need to make knots in small spaces, and is designed to disperse pressure across a large surface area and prevent the suture from tearing through tissue and it resorbs.
At the start of 3Q17, the company received regulatory approval in the United Arab Emirates (UAE). Agreements in Israel and the UAE are to be inked within August. Furthermore, Ziptek has signed agreements to be on the prime vendor list for the Department of Defense, NATO and U.S. Special Operations.
Sources: Ziptek LLC; ORTHOWORLD Inc.