FDA Clears SpineGuard’s New Smart Drilling Device

SpineGuard has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its new PsiFGuard device, designed to secure the Posterior sacroiliac Fusion (PsiF) surgical procedure.
 
“We are very pleased by this new clearance that will help us accelerate our growth as we continue to deliver on our new product road map,” SpineGuard Co-Founder/Deputy CEO Stéphane Bette stated. “The efficacy of our PsiFGuard device in locating the SI joint was clearly demonstrated in the submitted pre-clinical testing, which allowed for a smooth clearance process. With this new sacroiliac application, after the previously cleared anterior approach to the spine, we keep broadening the scope of our DSG technology. We are particularly excited to collaborate with Omnia Medical to bring to the market such a solution combining our technologies to address unmet clinical needs.”

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 in 2021 and is projected to grow 19% annually through 2030, according to Grandview Research. A new U.S. payment code implemented in January 2024 for posterior sacroiliac joint fusion surgery should accelerate this growth.
 
“We’ve seen that proper placement of the implant is essential to a successful SI Joint fusion. Locating the joint is critical for this to occur but can be very challenging,” Omnia Medical Co-Founder/CEO Troy Schifano said. “However, the data SpineGuard provided to the FDA during the clearance process has confirmed PsiFGuard drastically enhances the accuracy of the placement of the wire guiding the implant. We are thrilled about bringing this technology to market as it will give physicians and patients comfort knowing they will have the highest chance of SI joint fusion success.”

In the second half of 2024, SpineGuard is focused on accelerating its sales growth, particularly in the United States, rolling-out PsiFGuard as well other new products, and registering its full line in China. The company is also working on building strategic partnerships and strengthening its financial position.
 
Founded in 2009 in France and the United States by Bette and Pierre Jérôme, SpineGuard is deploying its proprietary radiation-free real time sensing technology DSG (Dynamic Surgical Guidance) to secure and streamline implant placement in the skeleton. SpineGuard designs, develops, and markets medical devices embedding its technology. More than 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. SpineGuard is expanding the scope of its DSG technology to treat scoliosis through an 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, a biomedical engineer. SpineGuard has engaged in multiple ESG initiatives.
 
Top medical device engineers and industry professionals came together in 2014 to form Omnia Medical, an orthopedic implant company located in Morgantown, W.V. Omnia Medical aims to develop 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 posterior sacroiliac joint (SIJ) fusion.