SpineGuard and Omnia Medical Obtain a New U.S. Patent for Their Innovative Application of DSG Technology to Sacroiliac Joint Fusion

• Innovation codeveloped in partnership
• Acceleration of commercial deployment in the United States

Regulatory News:

SpineGuard (FR0011464452 - ALSGD), an innovative company specializing in Dynamic Surgical Guidance (DSG®) technology to enhance the safety and efficiency of bone implant placement, and Omnia Medical, an orthopedic implant company focused on innovative spine and sacroiliac solutions, today announced that their U.S. patent application has received notice of allowance from the USPTO (United States Patent and Trademark Office) for their innovative application of DSG technology to sacroiliac joint fusion.

The recently allowed patent applications by the USPTO, applied jointly by SpineGuard and Omnia Medical, describes the utilization of the DSG tissue differentiating feedback technology to the precise positioning of sacroiliac fusion implants. It is the fruit of a co-development effort to offer to the U.S. market a reliable, while simple and efficient procedural solution for successful treatment of sacroiliac joint degeneration and pain. The sterile-delivered surgical kit that includes Omnia’s implants, instruments, biologics, as well as SpineGuard’s PsiFGuard guidance tool, is particularly well suited for light operative setups such as ambulatory centers or offices. The commercial launch acceleration of the product combination in the U.S., with its now fully protected surgical technique, is a key step of the common roadmap announced by both companies early 2025.

Stéphane Bette, Deputy CEO and cofounder of SpineGuard, stated: “The SpineGuard team is proud to collaborate with Omnia Medical to offer the best solution to patients and physicians in an already large and fast-growing market segment: the posterior sacroiliac joint fusion in the USA. This represents for our DSG technology a very promising application that should contribute more and more to increasing our top line and reaching our operational profitability goal.”

Troy Schifano, CEO and Co-Founder of Omnia Medical, added: “This patent allowance further strengthens Omnia Medical's leadership in posterior sacroiliac fusion and reflects the power of our collaboration with SpineGuard. Together, we've developed the only enabling technology specifically designed to identify the sacroiliac joint during posterior SI fusion procedures. Innovation is what defines Omnia, and we will continue to protect the technologies we create in a market where innovation is too often met with imitation. Accurate implant placement is the prerequisite for a successful fusion, yet implant misplacement remains an ever-growing challenge in posterior SI fusion. SpineGuard's DSG technology is a much-needed solution to that problem, and Omnia is proud to be the only company providing enabling technology specifically designed to objectively identify the sacroiliac joint before implant placement. If the implant isn't in the right place, a successful fusion simply cannot occur.”

The sacroiliac fusion market

More than 15% of patients suffering from back pain are estimated to have a degenerative sacroiliac joint causing debilitating pain. The global market of sacroiliac joint fusion reached more than 800 million dollars in 2021, projected to grow at a 16-20% CAGR (compound annual growth rate) through 2030 according to Mordor Intelligence. A new payment code implemented in the United States in January 2024 for posterior sacroiliac joint fusion surgery should accelerate this progression.

Since its foundation, SpineGuard has developed and maintained a significant IP portfolio currently including 11 patent families as well as 3 trademarks, in the major geographies such as Europe, USA, China and Japan.

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 embedding its technology. Over 110,000 surgical procedures have been secured worldwide thanks to DSG® and 39 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 is expanding the scope of its DSG® technology to the treatment of scoliosis via anterior approach, sacroiliac joint fusion, dental implantology and innovations such as the « smart » pedicle screw and power drill or 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 Omnia Medical

Founded in 2014 and headquartered in Morgantown, West Virginia, Omnia Medical is an orthopedic implant company focused on developing innovative spine and sacroiliac solutions. The company’s mission is to deliver safe, reproducible surgical products that improve clinical outcomes while reducing operative time and overall healthcare costs. Omnia Medical offers a comprehensive portfolio of spine implants, including a proprietary line of interbodies featuring TiBrid™ osseointegrative surface technology, and is a recognized innovator in sacroiliac joint fusion. For more information, visit www.omniamedical.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.

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SpineGuard Pierre Jérôme CEO & Chairman Tel: +33 1 45 18 45 19 p.jerome@spineguard.com Anne-Charlotte Millard CFO Tél. : +33 1 45 18 45 19 ac.millard@spineguard.com

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