Regulatory News:

SpineGuard (FR0011464452 – ALSGD), an innovative company that deploys its DSG (Dynamic Surgical Guidance) sensing technology to secure and streamline the placement of bone implants, and XinRong Medical Group, a China leader in medical technology, announced today that they expanded their collaboration with the signature of three concomitant agreements:

  • China exclusive distribution extension to the whole SpineGuard product portfolio
  • Funding of the NMPA (National Medical Product Administration) registration process for SpineGuard new products via a cash injection of €500K by XinRong Medical in SpineGuard capital
  • Potential co-development of a Smart Screw system for the Chinese spinal surgery market

Until today, XinRong Medical was only selling the SpineGuard’s Classic PediGuard products in China, this new distribution agreement will enable them to commercialize the Curved, the XS, the Canulated and the Threaded versions of SpineGuard’s DSG (Dynamic Surgical Guidance) spinal drilling probes.

The NMPA registration of these new devices for the Chinese market will be funded via a €500K equity injection by XinRong Medical. SpineGuard will issue 500,000 new shares priced at €1.00 per share representing 1.28% of current issued shares with a 18-month lock-up period. SpineGuard will own all product registrations that will be executed through a third-party regulatory agent jointly appointed by both companies.

XinRong Medical and SpineGuard also decided to envision the co-development of a DSG enabled single step pedicle screw system with three key milestones triggering payments:

1) evaluation of the registration process and market access path, 2) product design and submission of the registration dossier, and 3) product clearance.

China’s spine market is the world’s second-largest market after the USA driven by an aging population, increasing disease prevalence and treatment rates, along with access to care growing affordability.

Pierre Jérôme, Chairman, CEO and Co-founder of SpineGuard, said: “This three-pronged agreement is a significant step forward for SpineGuard and the deployment of our x-ray free real time sensing technology in China, the largest market for spinal surgical devices after the United States. With XinRong, we took the time to elaborate a common strategy and tailor our partnership based on our early collaborative experience introducing the original version of PediGuard in China. We now have a clear roadmap and dedicated funds to successfully market our smart drilling devices and secure spinal fusion procedures across Chinese provinces.”

Christine Zhang, CEO of XinRong Medical, added: “I am thrilled about the three-pronged agreement between SpineGuard and XinRong. It is indeed a significant step forward for XinRong, and I commend the board, the company XinRong and SpineGuard team for taking the time to collaborate and develop a common strategy. The dedication to tailoring out partnership based on both sides’ early collaborative experience introducing the original version of PediGuard in China is a testament to SpineGuard commitment to providing innovative medical devices to the global medical community. The dedicated funds to market SpineGuard x-ray free real time guidance technology across Chinese provinces is a great opportunity to expand SpineGuard's presence in the Chinese market. I am confident that this innovative technology will provide more precise and safer spinal surgery for Chinese patients. Once again, I greet this milestone achievement, and I look forward to seeing the continued success of SpineGuard and XinRong.”

About SpineGuard®

Founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an innovative company deploying its proprietary radiation-free real time sensing technology DSG® (Dynamic Surgical Guidance) to secure and streamline the placement of implants in the skeleton. SpineGuard designs, develops and markets medical devices that have been used in over 95,000 surgical procedures worldwide. Twenty-four studies published in peer-reviewed scientific journals have demonstrated the multiple benefits DSG® offers to patients, surgeons, surgical staff and hospitals. Building on these strong fundamentals and several strategic partnerships, SpineGuard has expanded the scope of its DSG® technology in innovative applications such as the « smart » pedicle screw, the DSG Connect visualization and registration interface, dental implantology and surgical robotics. DSG® was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. SpineGuard has engaged in multiple ESG initiatives. For further information, visit www.spineguard.com

About XinRong Medical

XinRong Medical, a China leader in medical technology, is dedicated to increasing patient affordability and providing the most advanced solution for surgeons such that they can deliver the best patient care. XinRong Medical offers innovative solutions in orthopaedic surgery, neurosurgery, and reconstructive surgery. XinRong Medical is a professional orthopaedic implants manufacturing enterprise invested by the world’s leading investment institution The Black Stone Group, (NYSE: BX). It has constantly innovated and moved forward to new materials, new techniques and minimally invasive therapy field. Established in 2000, XinRong Medical was one of the first companies in China cleared by SFDA to manufacture orthopaedic implants. For additional information, visit www.XRBest.Com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

SpineGuard Pierre Jérôme CEO & Chairman Tel: +33 1 45 18 45 19 p.jerome@spineguard.com

SpineGuard Manuel Lanfossi CFO Tel: +33 1 45 18 45 19 m.lanfossi@spineguard.com

NewCap Investor Relations & Financial Communication Mathilde Bohin / Aurélie Manavarere Tel: +33 1 44 71 94 94 spineguard@newcap.eu

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