SpineGuard, Omnia Medical Extend Strategic Partnership

SpineGuard and Omnia Medical are strengthening their strategic partnership by expanding their joint efforts to include other products and countries and reallocating SpineGuard resources to support Omnia’s U.S. product launches, including PsiFGuard.

“This agreement 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,” SpineGuard Co-Founder/Chairman/CEO Pierre Jérôme said. “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 U.S. 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 two companies initiated their collaboration in September 2022 with a co-development and exclusive U.S. distribution agreement for adult spine surgery with two devices—a drilling instrument for sacroiliac fusion and a smart pedicle screw system both using the DSG (Dynamic Surgical Guidance) real time, X-ray-free sensing technology.

Last September (2024), SpineGuard won U.S. Food and Drug Administration 510(k) clearance for 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 together to introduce their combined product offering to market later this month at the North American Neuromodulation Society (NANS) Annual Meeting in Orlando, Fla.

SpineGuard’s and Omnia Medical’s missions align well as both firms aim to make spine surgery safer and achieve superior surgical outcomes while reducing overall healthcare costs.

“We are eager to be able to rely on the vast experience that SpineGuard personnel have garnered over the years as we bring a consistently proven technology to a new application,” Omnia Medical Co-Founder/CEO Troy Schifano stated. “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 they are accurately finding the optimal placement for implant success. We look forward to continuing to improve patient lives, as Omnia introduces this technology through training and research efforts in collaboration with its inventors.”

More than 15% of patients suffering from back pain are estimated to have a degenerative sacroiliac joint causing debilitating pain. The global sacroiliac joint fusion market was worth more than $539 million in 2021 and is projected to grow 19% annually through 2030, according to Grandview Research. A new U.S. payment code for sacroiliac joint fusion surgery implemented last January should accelerate this expected growth.

Founded in 2009 in France and the United States by Jérôme and Stéphane Bette, SpineGuard deploys its proprietary radiation-free real time sensing technology DSG (Dynamic Surgical Guidance) to secure and streamline implant placement. The company designs, develops, and markets medical devices embedding its technology. More than 100,000 surgical procedures have been secured worldwide with 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 fundamentals and several strategic partnerships, SpineGuard is expanding the scope of its DSG technology to scoliosis treatment (through an anterior approach), sacroiliac joint fusion, dental implants, and innovations such as a “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.

Top medical device engineers and industry professionals came together in 2014 to form Omnia Medical, an orthopedic implant company located in Morgantown, W.V. The company develops products that reduce operative time through safe and reproducible instrumentation, while achieving superior surgical outcomes. Ongoing surgeon collaboration helps the firm achieve this mission, which leads to critical cost savings for healthcare providers and patients. Omnia Medical has created a 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.