SpineGuard Debuts New Smart Drilling Device for Sacroiliac Joint Fusion

SpineGuard’s commercial partner Omnia Medical has launched the pair’s codeveloped product, PsiFGuard, in the United States.

“We are particularly excited to collaborate with Omnia Medical to launch PsiFGuard in the market with the support of the clinical experts from our team who recently joined Omnia. PsiFGuard is part of an innovative solution combining our technologies into an integrated kit matching perfectly the practical needs of healthcare providers offering ambulatory sacro-iliac joint fusion procedures to patients,” SpineGuard Co-Founder/Deputy CEO Stéphane Bette stated. “Omnia Medical is the pioneer company in this area and continues to deliver to physicians a clinical value proposition thanks to the efficacy of our PsiFGuard device in locating the SI joint. For SpineGuard, this new sacroiliac application of our DSG technology embedded in a well reimbursed, fast-growing procedure represents a game-changing opportunity of fast adoption by the market and significant contribution to the growth of our revenue.”

“The NANS convention served to strengthen our conviction that PsiFGuard is an enabling technology needed by the market to bolster physicians’ confidence that they are properly placing the implant in the sacroiliac joint for maximum efficacy,” Omnia Medical Co-Founder/CEO Troy Schifano added. “… many physicians are eager to be trained on our procedure with this technology. When coupled with the results and feedback from the procedures we did prior to NANS, we expect solid growth through the year and beyond from a rapidly expanding base of physicians.”

This year, SpineGuard aims to sustain its sales momentum by introducing new products—the Threaded PediGuard for scoliosis correction via anterior approach, which recently received CE mark approval, and the PsiFGuard device, which obtained U.S. Food and Drug Administration clearance. The company is also registering its entire PediGuard product range in China.

Moreover, SpineGuard is working on building strategic partnerships and strengthening its financial position by exploring various financing options. To date, the Board of Directors has adopted the going-concern principle based on the company’s consolidated cash position, cash equivalents, forecast inflows, ongoing commercial growth, the recent signature of a bond contract for a maximum €1 million, and the measures implemented by the management to secure financing.

Related: SpineGuard, Omnia Medical Extend Strategic Partnership

Founded in 2009 in France and the United States by Pierre Jérôme and Bette, SpineGuard is deploying its proprietary radiation-free real time sensing technology DSG (Dynamic Surgical Guidance) to secure and streamline implant placement. 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 DSG’s multiple benefits 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 treating scoliosis via the 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.

Top medical device engineers and industry professionals came together in 2014 to form Omnia Medical, an orthopedic implant company in Morgantown, W.V. Omnia Medical’s develops 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 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 posterior sacroiliac joint (SIJ) fusion.