Zygofix

ZygoFix is an Israeli spine technology company that develops the zLOCK system, a fixation solution for lumbar spinal fusion intended as an alternative to pedicle screw constructs. The core product is a miniature, 3D-printed bendable titanium implant that is inserted into the facet joint and conforms to the joint anatomy during insertion, locking motion from inside the joint. The company describes the FDA-cleared system as consisting of the zLOCK spacer and the zLOCK trans-facet screw, with current clearance in conjunction with an interbody fusion device.

The system is positioned for use in posterior stabilization in ALIF and LLIF procedures, ipsilateral stabilization in TLIF, and stand-alone stabilization with or without decompression. The company states the procedure requires fewer tools, shorter procedure time and minimal surgical trauma, and can be performed as an outpatient procedure; it targets the Ambulatory Surgery Center market. ZygoFix cites biomechanical bench testing on six specimens loaded at 7.5 Nm in flexion-extension, lateral bend and axial rotation, reporting average motion reduction comparable to or better than a bilateral pedicle screw construct, and clinical testing in the EU since 2018 showing pain reduction and radiographic signs of bone growth.

Leadership includes CEO Ofer Levy, co-founder and CTO Uri Arnin, co-founder Prof. Yizhar Floman, VP R&D Maor Rozenberg, US General Manager Allen Rasoul and QA/RA Manager Ofir Kahlon. The board is chaired by Nicholas Pachuda and includes Barak Singer and Todd Dollinger, both associated with The Trendlines Group.

Founding story

ZygoFix was founded in 2017 by Prof. Yizhar Floman and Uri Arnin, serial entrepreneurs in the spine implant field who had previously co-founded ApiFix, acquired by OrthoPediatrics Corp in April 2020. The company was established within The Trendlines Group incubator and received initial investment from Trendlines together with funding from the Israel Innovation Authority. Co-founder Uri Arnin is also the inventor of the TOPS facet replacement system (Premia Spine) and served as CTO of Spine 21.

Business model

ZygoFix develops and commercializes implantable spinal fixation hardware, selling the zLOCK implant system and its associated instrumentation and navigation tooling for use in surgical fusion procedures.

Traction

Clinical use under study began in Hungary in 2018, with the company reporting sustained pain reduction and improved quality of life among study patients and radiographic signs of bone growth. An Israeli study site opened in 2021 with the first case at Rambam Health Care Campus, where placement of two zLOCK implants took under 30 minutes. A 2021 listing description noted clinical use in lumbar fusion for over two years. The company reports FDA clearance for the zLOCK spacer and trans-facet screw system.

Latest developments

The company's site describes an FDA-cleared system consisting of the zLOCK spacer and zLOCK trans-facet screw, cleared for use with an interbody fusion device, and outlines indications spanning posterior stabilization in ALIF and LLIF, ipsilateral stabilization in TLIF, and stand-alone stabilization with or without decompression.