1 The EIC Accelerator Project

EIC Accelerator Program Overview

The EIC Accelerator (formerly known as the SME Instrument) is a pivotal funding initiative under the European Innovation Council (EIC), designed to support innovative small and medium-sized enterprises (SMEs) and startups in Europe, particularly within the deep-tech sector. This program aims to bridge the gap between research and market, providing essential funding that can help scale groundbreaking innovations.

Funding Structure

The EIC Accelerator offers a blended finance model, combining grants and equity investments:

Purpose in the European DeepTech and Startup Ecosystem

The EIC Accelerator plays a crucial role in fostering innovation within the European deep-tech and startup ecosystem. Its objectives include:

• Encouraging Innovation: By providing financial support, the EIC Accelerator incentivizes companies to develop and bring innovative products and services to market, particularly in high-tech fields such as biotechnology, artificial intelligence, and advanced materials.
• Enhancing Competitiveness: The program seeks to improve the competitiveness of European firms in the global market by supporting the commercialization of cutting-edge technologies.
• Stimulating Economic Growth: By backing innovative SMEs, the EIC Accelerator contributes to job creation, economic development, and technological leadership within Europe.

Role in Scaling and Securing Private Funding

The EIC Accelerator not only provides funding but also plays a significant role in helping companies scale and secure additional funding from private sectors. This is achieved through:

• Networking Opportunities: EIC Accelerator winners gain access to a network of investors, industry experts, and potential partners, which is invaluable for scaling operations and attracting further investment.
• Business Development Support: The program offers tailored business coaching and mentoring, helping companies refine their business models, develop go-to-market strategies, and improve their investment readiness.
• Validation and Credibility: Being an EIC Accelerator winner enhances a company’s credibility, making it easier to attract private investors who may be more willing to invest in a project that has already received backing from a prestigious European program.

Summary of ZYGOFIX LTD and the zLOCK Project

Company Name: ZYGOFIX LTD
Project Acronym: zLOCK
Description: The zLOCK project is centered around developing the first true minimally-invasive spinal fusion system. This innovative system promises to revolutionize spinal surgery by reducing recovery times and minimizing the risks associated with traditional surgical procedures.

Funding Type: Blended finance
Website: zygofix.com
Country: Israel
Date of Cut-off Proposal Submission: June 16, 2021

Technology Basics and Background

The zLOCK project is aimed at addressing the challenges associated with spinal fusion surgeries, which are often invasive and require long recovery periods. Traditional spinal fusion techniques involve significant tissue disruption, leading to complications such as infection, prolonged pain, and extended rehabilitation times.

Key Technological Aspects:

• Minimally-Invasive Approach: The zLOCK system utilizes advanced techniques to facilitate spinal fusion with minimal disruption to surrounding tissues. This approach not only reduces the physical trauma experienced by patients but also shortens recovery times significantly.
• Innovative Design: The technology behind zLOCK likely incorporates innovative materials and designs that promote rapid bone healing and integration. This can include bio-compatible materials that enhance the body’s natural healing processes.
• Enhanced Patient Outcomes: By minimizing invasiveness, the zLOCK system aims to improve patient outcomes, reduce hospital stays, and enhance overall satisfaction with surgical procedures.

In summary, ZYGOFIX LTD’s zLOCK project represents a significant advancement in spinal surgery technology, aligning with the EIC Accelerator's mission to support pioneering innovations that can transform industries and improve lives. The funding and support from the EIC Accelerator will provide ZYGOFIX with the resources necessary to bring this breakthrough technology to market effectively.

2 The Funding Rounds

Since receiving the EIC Accelerator funding on June 16, 2021, ZygoFix Ltd., an Israeli medical device company specializing in spinal fusion solutions, has secured additional funding and achieved significant regulatory milestones.

Funding Rounds:

• March 9, 2021: Prior to the EIC Accelerator funding, ZygoFix completed a $2 million funding round. This round was led by Agriline (a trust of which Vincent Tchenguiz is a discretionary beneficiary) and Trendlines Group Ltd. Additional private investors and the Israel Innovation Authority also participated. The funds were allocated for further clinical studies, enhancement of implant systems and tools, and regulatory clearance. (prnewswire.com)
• June 17, 2024: ZygoFix secured an additional $506,000 in a later-stage venture capital funding round. This investment was part of a series of funding activities, including accelerator/incubator support in June and January 2023, and a grant in May 2019. (pitchbook.com)

Regulatory Milestones:

• June 28, 2021: ZygoFix received the CE mark for its zLOCK Spinal Fusion System, a minimally invasive screwless implant designed for the treatment of chronic back pain. This certification was based on clinical studies demonstrating the system's safety and efficacy. (biospace.com)
• May 6, 2024: The company obtained FDA clearance for its zLOCK Lumbar Facet Fixation System, supported by compelling clinical evidence from ongoing European clinical studies. This clearance marks a significant advancement in spinal fusion technology. (stockhouse.com)

Investor Information:

ZygoFix's investors include Agriline, Trendlines Group Ltd., the Israel Innovation Authority, Plug and Play Tech Center, Medlim, the European Innovation Council Fund, and Sirius Venture Capital. (pitchbook.com)

Company Valuations:

As of June 17, 2024, ZygoFix's latest funding round was a later-stage venture capital investment of $506,000. The company's valuation details are not publicly disclosed. (pitchbook.com)

In summary, since receiving the EIC Accelerator funding in June 2021, ZygoFix has secured additional funding, achieved significant regulatory approvals, and expanded its investor base, positioning itself as a key player in the spinal fusion medical device market.

3 The Press Releases

Since receiving the EIC Accelerator funding on June 16, 2021, ZygoFix Ltd. has made significant advancements in spinal fusion technology, as detailed in their press releases:

1. CE Mark Certification for zLOCK Spinal Fusion System (June 28, 2021): ZygoFix obtained the CE mark for its zLOCK Spinal Fusion System, a minimally invasive, screwless implant designed for lumbar spine stabilization. This certification followed successful clinical studies demonstrating the system's safety and efficacy. The zLOCK implant utilizes the spine's anatomy for stability, reducing risks associated with traditional screw-based methods and offering a less invasive procedure suitable for outpatient settings. (prnewswire.com)

2. FDA Clearance for zLOCK Lumbar Facet Fixation System (May 6, 2024): ZygoFix received FDA clearance for its zLOCK Lumbar Facet Fixation System, supported by compelling clinical evidence from ongoing European studies. This system offers a minimally invasive alternative to traditional spinal fusion methods, adapting to the joint's anatomy during insertion and providing stability with a simple procedure. The clearance paves the way for introducing this innovative solution to the U.S. market, aiming to enhance patient care and foster collaboration with leading surgeons. (nasdaq.com)

3. $2 Million Funding Round and New Clinical Study in Israel (March 9, 2021): Prior to the EIC Accelerator funding, ZygoFix completed a $2 million funding round led by Agriline and Trendlines, with additional support from private investors and the Israel Innovation Authority. The funds were allocated for further clinical studies, enhancement of the implant system, and regulatory clearance. A new clinical study was launched in Israel, following the ongoing study in Hungary, demonstrating meaningful and sustained reduction in pain and increased quality of life for patients through a minimally invasive procedure. (stockhouse.com)

Partnerships and Team Updates: ZygoFix is a portfolio company of The Trendlines Group Ltd., a leading Israel- and Singapore-based investment group focused on high-growth medical technologies. The company's leadership includes CEO Ofer Levy, with over 20 years of experience in engineering, product, and regulatory domains; Co-Founder and CTO Uri Arnin, a serial entrepreneur in spinal implants with over 30 years of experience and numerous patents; and Co-Founder Dr. Yizhar Floman, Medical Director and Chairman of the Israel Spine Center at Assuta Hospital, and President of the Israel Orthopedic Association. (zygofix.com)

Technology Advancements: The zLOCK system is based on a miniature 3D-printed bendable titanium implant designed to stabilize the spine by anchoring within the facet joint. Its unique bendable design ensures a personalized and precise fit, fitting any anatomy and providing comparable stability to a pedicle screw construct through a miniature internal facet fixation device. The system has been clinically tested in the EU under clinical studies since 2018, showing long-term pain reduction and radiographic signs of bone growth. (zygofix.com)

For more detailed information, you can visit ZygoFix's official website at zygofix.com.

4 The Technology Advancements

ZygoFix Ltd., established in 2017 and based in Israel, specializes in innovative spinal fusion solutions. Their flagship product, the zLOCK™ system, is a miniature, screwless implant designed to provide spinal stability and fusion with minimal invasiveness. The zLOCK implant's patented bendable features enable it to adjust to specific joint anatomies during insertion, offering a personalized fit.

Advancements Since EIC Accelerator Funding:

Since receiving EIC Accelerator funding on June 16, 2021, ZygoFix has achieved several significant milestones:

• FDA Clearance: In May 2024, ZygoFix received clearance from the U.S. Food and Drug Administration (FDA) for its zLOCK Lumbar Facet Fixation System, positioning the company to revolutionize spinal fusion surgery in the U.S. market. (ruthfullyyours.com)
• CE Mark: In August 2021, ZygoFix obtained the European CE mark for its minimally invasive screwless zLOCK Spinal Fusion system, which had been in clinical use for over three years in Hungary and Israel. (unitedwithisrael.org)

• Hungary: An ongoing clinical study in Hungary, initiated in 2018, has demonstrated meaningful and sustained reductions in pain and improvements in quality of life for patients undergoing the zLOCK procedure. (prnewswire.com)
• Israel: In March 2021, ZygoFix launched a new clinical study in Israel, with the first case performed by Dr. Lior Merom at the Rambam Health Care Campus. The procedure, which included laminotomy and facet stabilization using two zLOCK implants, was completed successfully, with implant placement taking less than 30 minutes. (prnewswire.com)

ZygoFix has focused on enhancing the zLOCK system by refining the implant design and surgical tools to improve ease of use and patient outcomes. (prnewswire.com)

The company has secured multiple patents for the zLOCK implant design, with granted patents in the European Union and pending applications in the United States, Japan, China, and Brazil. (exitvalley.com)

Market Demonstrations:

ZygoFix has demonstrated its technology in the market through:

• Clinical Trials: The ongoing studies in Hungary and Israel serve as real-world demonstrations of the zLOCK system's efficacy and safety.
• Regulatory Approvals: The receipt of FDA clearance and the CE mark indicates successful market entry and acceptance of the technology.

Publications and Whitepapers:

While specific publications or whitepapers authored by ZygoFix are not readily available, the company's active participation in clinical studies and receipt of regulatory approvals suggest ongoing research and development efforts.

For more detailed information, you can visit ZygoFix's official website at www.zygofix.com.

5 The Partnerships and Customers

Since receiving the EIC Accelerator funding on June 16, 2021, ZygoFix Ltd., an Israeli medical device company specializing in spinal fusion technology, has achieved several significant milestones:

Regulatory Approvals:

• CE Mark Certification (June 28, 2021): ZygoFix obtained the CE mark for its zLOCK Spinal Fusion System, a minimally invasive, screwless implant designed for lumbar spine stabilization. This certification validates the system's safety and efficacy, facilitating its commercialization in European markets. (prnewswire.com)
• FDA Clearance (May 6, 2024): The company received 510(k) clearance from the U.S. Food and Drug Administration for its zLOCK Lumbar Facet Fixation System. This clearance enables ZygoFix to introduce its innovative solution to the U.S. market, aiming to collaborate with leading surgeons and enhance patient care. (orthospinenews.com)

Clinical Studies:

European Clinical Study: ZygoFix has been conducting a multi-center pivotal study in the European Union to collect further clinical data on the zLOCK system. This study aims to support regulatory marketing and reimbursement purposes, demonstrating the system's long-term pain reduction and bone growth benefits. (lifesciencemarketresearch.com)

Strategic Partnerships:

The Trendlines Group Ltd.: ZygoFix is a portfolio company of The Trendlines Group, an Israel- and Singapore-based investment group focused on high-growth medical technologies. This partnership provides ZygoFix with strategic guidance and access to a network of investors and industry experts. (prnewswire.com)

Market Positioning and Technological Advancements:

The regulatory clearances and ongoing clinical studies position ZygoFix to expand its market presence in both European and U.S. markets. The zLOCK system's innovative design offers a minimally invasive alternative to traditional spinal fusion methods, potentially reducing surgical trauma and improving patient outcomes. The support from The Trendlines Group Ltd. enhances ZygoFix's capabilities in technology development and scaling, facilitating the commercialization of its products and the establishment of strategic partnerships with healthcare providers and distributors.

These developments underscore ZygoFix's commitment to revolutionizing spinal fusion procedures through innovative, patient-friendly solutions.

6 The Hiring and Company Growth

ZygoFix Ltd., an Israeli medical device company specializing in spinal fusion solutions, received EIC Accelerator funding on June 16, 2021. Since then, the company has demonstrated notable growth and strategic developments.

Current Team Size and Hiring Status:

Specific details regarding ZygoFix's current headcount are not publicly disclosed. However, the company has been actively expanding its team to support its growth initiatives. Notably, in March 2021, ZygoFix completed a $2 million funding round, which was allocated towards conducting further clinical studies, enhancing implant systems and tools, and obtaining regulatory clearance. (prnewswire.com) This financial boost likely facilitated the hiring of additional personnel to advance these objectives.

Growth and Key Hires:

While specific information about recent key hires is limited, the company's leadership includes:

• Ofer Levy, CEO: With over 20 years of experience in the medical device industry, Ofer has a deep understanding of medical device development and lifecycle.
• Uri Arnin, Co-founder and CTO: A serial entrepreneur with over 30 years in the medical device industry, Uri holds 29 issued patents and 43 pending, all in the spine sector.
• Prof. Yizhar Floman, Co-founder and Medical Director: Chairman and Director of the Israel Spine Center at Assuta Hospital, Prof. Floman is a leading figure in orthopedic surgery.

The addition of these experienced professionals has been instrumental in advancing ZygoFix's innovative zLOCK™ technology, a miniature screwless implant designed to provide spinal stability and fusion. Their expertise has been crucial in conducting clinical studies and obtaining regulatory approvals, positioning the company for future growth.

Management Changes:

As of the latest available information, there have been no major changes in ZygoFix's management or founding team. The company's leadership remains consistent, with Ofer Levy serving as CEO, Uri Arnin as CTO, and Prof. Yizhar Floman as Medical Director.

In summary, since receiving the EIC Accelerator funding in June 2021, ZygoFix Ltd. has focused on expanding its team and enhancing its technological offerings, laying a solid foundation for future growth and innovation in the spinal fusion sector.

7 The Media Features and Publications

Since receiving EIC Accelerator funding on June 16, 2021, ZygoFix Ltd. has been featured in several media outlets, publications, and events. Below is a summary of these engagements:

Media Features:

• CTECH (May 18, 2022): ZygoFix's CEO, Ofer Levy, discussed the company's zLOCK technology during a visit to their offices in Misgav. (zygofix.com)
• Ortho Spine News (June 28, 2021): Reported on ZygoFix receiving CE clearance for its zLOCK Spinal Fusion System. (orthospinenews.com)
• FDAnews (June 29, 2021): Announced that ZygoFix's zLOCK Spinal Fusion System received CE mark certification. (fdanews.com)
• BioSpace (June 28, 2021): Covered ZygoFix obtaining CE clearance for its zLOCK Spinal Fusion System. (biospace.com)
• BioSpace (May 6, 2024): Reported on ZygoFix receiving FDA clearance for its zLOCK Lumbar Facet Fixation System. (biospace.com)
• SPINEMarketGroup (May 6, 2024): Announced that ZygoFix received FDA clearance for its zLOCK Lumbar Facet Fixation System. (thespinemarketgroup.com)

Publications:

• Ortho Spine News (June 28, 2021): Featured an article on ZygoFix receiving CE clearance for its zLOCK Spinal Fusion System. (orthospinenews.com)
• FDAnews (June 29, 2021): Published a piece about ZygoFix's zLOCK Spinal Fusion System obtaining CE mark certification. (fdanews.com)
• BioSpace (June 28, 2021): Reported on ZygoFix receiving CE clearance for its zLOCK Spinal Fusion System. (biospace.com)
• BioSpace (May 6, 2024): Covered ZygoFix receiving FDA clearance for its zLOCK Lumbar Facet Fixation System. (biospace.com)
• SPINEMarketGroup (May 6, 2024): Announced that ZygoFix received FDA clearance for its zLOCK Lumbar Facet Fixation System. (thespinemarketgroup.com)

Podcasts or Interviews:

LSI USA '23 Conference: Ofer Levy, CEO of ZygoFix, presented the company's zLOCK technology at the Life Science Intelligence USA '23 conference. (lifesciencemarketresearch.com)

Conferences and Events:

LSI USA '23 Conference: Ofer Levy presented ZygoFix's zLOCK technology at this event. (lifesciencemarketresearch.com)

Involvement in Events:

Israeli Clinical Study Launch (March 9, 2021): ZygoFix completed a $2 million funding round and launched a new clinical study in Israel for its zLOCK system. (biospace.com)

These engagements highlight ZygoFix Ltd.'s active participation in advancing spinal fusion technology and its commitment to addressing chronic back pain through innovative solutions.