SpineGuard Obtains FDA Clearance for Commercial Release of Its “PsiFGuard” New Smart Drilling Device Dedicated to Sacroiliac Joint Fusion

Innovation developed in partnership with the US firm Omnia Medical
Key milestone for the deployment of the DSG^® expertise in america

PARIS & BOULDER, Colo., September 30, 2024- (BUSINESS WIRE) – SpineGuard (FR0011464452 – ALSGD), an progressive firm that deploys its DSG^® (Dynamic Surgical Steering) native conductivity sensing expertise to safe and streamline the position of bone implants, introduced at present the authorization below 510K #241895 by the FDA (Food and Drug Administration) to commercialize in america its new PsiFGuard system designed to safe the Posterior sacroiliac Fusion (PsiF) surgical process.

Stéphane Bette, Deputy CEO and Co-Founding father of SpineGuard, acknowledged: “We’re more than happy by this new clearance that can assist us speed up our development as we proceed to ship persistently on our new product street map. The efficacy of our PsiFGuard system in finding the SI joint was clearly demonstrated within the submitted pre-clinical testing which allowed for a easy clearance course of. With this new sacroiliac utility, after the beforehand cleared anterior method to the spine, we preserve broadening the scope of our DSG expertise. We’re notably excited to collaborate with Omnia Medical to convey to the market such progressive answer combining our applied sciences to handle unmet scientific wants.”

Troy Schifano, CEO and Co-Founding father of Omnia Medical, added: “We’ve seen that correct placement of the implant is crucial to a profitable SI Joint fusion. Finding the joint is important for this to happen however could be very difficult. Nevertheless, the information SpineGuard supplied to the FDA through the clearance course of has confirmed PsiFGuard drastically enhances the accuracy of the position of the wire guiding the implant. We’re thrilled about bringing this expertise to market as it’ll give physicians and sufferers consolation understanding that they may have the best likelihood of SI joint fusion success. Like Omnia, SpineGuard continues to be a pacesetter and innovator of their respective area, and we couldn’t be extra enthusiastic about our partnership with them.”

The sacroiliac fusion market

Greater than 15% of sufferers affected by again ache are estimated to have a degenerative sacroiliac joint inflicting debilitating ache. The worldwide market of sacroiliac joint fusion reached greater than 539 million {dollars} in 2021, projected to develop at a 19% CAGR (compound annual development fee) from 2022 to 2030 in keeping with Grandview Analysis. A brand new fee code carried out in america in January 2024 for posterior sacroiliac joint fusion surgical procedure ought to speed up this development.

H2 2024 outlook

Within the second half of 2024, SpineGuard is targeted on accelerating its gross sales development, notably in america, rolling-out PsiFGuard as nicely different new merchandise, and registering its full line in China. The Firm can also be engaged on constructing strategic partnerships and strengthening its monetary place.

About SpineGuard^®

Based in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard is an progressive firm deploying its proprietary radiation-free actual time sensing expertise DSG^® (Dynamic Surgical Steering) to safe and streamline the position of implants within the skeleton. SpineGuard designs, develops and markets medical gadgets embedding its expertise. Over 100,000 surgical procedures have been secured worldwide due to DSG^® and 34 research printed in peer-reviewed scientific journals have demonstrated the a number of advantages DSG^® gives to sufferers, surgeons, surgical workers and hospitals. Constructing on these sturdy fundamentals and a number of other strategic partnerships, SpineGuard is increasing the scope of its DSG^® expertise to the remedy of scoliosis by way of anterior method, sacroiliac joint fusion, dental implantology and improvements such because the « good » pedicle screw and energy 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 a number of ESG initiatives.

For additional info, go to www.spineguard.com

About Omnia Medical

Prime medical system engineers and trade professionals got here collectively in 2014 to type Omnia Medical, an orthopedic implant firm situated in Morgantown, WV. Omnia Medical’s mission is to develop novel merchandise that scale back operative time by means of secure and reproducible instrumentation, whereas attaining superior surgical outcomes. Ongoing surgeon collaboration helps the corporate obtain this mission, which results in important value financial savings for healthcare suppliers and their sufferers. Omnia Medical has created a complete vary of spine implants, together with a proprietary line of interbodies with TiBrid osseointegrative floor expertise, and is notable for being among the many pioneers in posterior sacroiliac joint (SIJ) fusion. For extra info, go to www.OmniaMedical.com.

Disclaimer

The SpineGuard securities is probably not supplied or offered in america as they haven’t been and won’t be registered below the Securities Act or any United States state securities legal guidelines, and SpineGuard doesn’t intend to make a public supply of its securities in america. That is an announcement and never a prospectus, and the data contained herein does and shall not represent a suggestion to promote or the solicitation of a suggestion to purchase, nor shall there be any sale of the securities referred to herein in america during which such supply, solicitation or sale could be illegal previous to registration or exemption from registration.