MORGANTOWN, W.Va. & BOULDER, Colo. & PARIS--(BUSINESS WIRE)--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 Omnia Medical, a medical device company focused on innovative solutions utilizing proven techniques, announced today the strengthening of their strategic partnership with the signing of a new agreement establishing the foundation for an expansion of their collaboration to other products and countries and a reallocating of SpineGuard resources to support Omnia’s product launches, including PsiFGuard, in the United States.
For reference, on September 12, 2022, SpineGuard and Omnia Medical signed a co-development and exclusive distribution agreement for adult spine surgery in the United States focused on two innovative devices: a drilling instrument for sacroiliac fusion and a smart pedicle screw system both utilizing the DSG (Dynamic Surgical Guidance) real time, x-ray free, sensing technology.
On September 30, 2024, SpineGuard announced the 510k clearance by the FDA of its new PsiFGuard cannulated probe designed to secure sacroiliac implant placement. Since then, many cases have been performed with the device by various physicians and their feedback has been extremely positive. It confirms that PsiFGuard greatly facilitates the placement of Omnia’s implant into the optimal position for success within the sacroiliac joint .
The two companies are working hand in hand on the preparation of the official market introduction of this combined product offering scheduled for the end of January 2025 at the North American Neuromodulation Society (NANS) Annual Meeting in Orlando, an annual event where thousands of medical professionals come together in the spirit of innovation and collaboration.
SpineGuard’s and Omnia Medical’s missions perfectly align as they both aim to make spine surgery safer and achieve superior surgical outcomes while reducing overall healthcare costs.
Troy Schifano, Co-Founder and CEO Of Omnia Medical says: “We are eager to be able to rely on the vast experience that these SpineGuard personnel have garnered over the years as we bring a consistently proven technology to a new application. PsiFGuard is the first clinician enabling technology developed specifically for the sacroiliac joint and will allow our solution to be brought to more patients as an increasing number of physicians become confident that they are accurately finding the optimal placement for implant success. We look forward to continuing to improve patient lives, as Omnia introduces this leading technology through robust training and research efforts in collaboration with its inventors.”
Pierre Jérôme, Co-Founder, Chairman and CEO of SpineGuard, adds: “This agreement that we just signed marks a pivotal step in our partnership with Omnia Medical. Its purpose is to expand the scope of our collaboration while optimizing our respective strengths and assets. It has come about through the mutual trust built between our teams over the last two years and our common willingness to capitalize on our early achievements. We are enthused by the very positive feedback received from the numberous physicians having already used PsiFGuard during its limited release phase. Certain members of our US team mastering DSG clinically will join Omnia to support its upcoming commercial launch. I am thrilled about the conclusion of this expanded collaboration agreement as it opens very exciting perspectives for SpineGuard.”
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 539 million dollars in 2021, projected to grow at a 19% CAGR (compound annual growth rate) from 2022 to 2030 according to Grandview Research. A new payment code implemented in the United States in January 2024 for sacroiliac joint fusion surgery should accelerate this progression.
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 100,000 surgical procedures have been secured worldwide thanks to DSG® and 34 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
Top medical device engineers and industry professionals came together in 2014 to form Omnia Medical, an orthopedic implant company located in Morgantown, WV. Omnia Medical's mission is to develop novel products that reduce operative time through safe and reproducible instrumentation, while achieving superior surgical outcomes. Ongoing surgeon collaboration helps the company achieve this mission, which leads to critical cost savings for healthcare providers and their patients. Omnia Medical has created a comprehensive range of spine implants, including a proprietary line of interbodies with TiBrid osseointegrative surface technology, and is notable for being among the pioneers in sacroiliac joint (SIJ) 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.
