SpineGuard was granted FDA 510(k) clearance to market the PsiFGuard smart drilling device, designed to secure the Posterior sacroiliac Fusion (PsiF) surgical procedure.
In 2H24, SpineGuard is focused on accelerating its sales growth, particularly in the United States, rolling out PsiFGuard as well as other new products, and registering its full line in China. The company is also working on building strategic partnerships and strengthening its financial position.
Stéphane Bette, Deputy CEO and Co-Founder of SpineGuard, 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 innovative solution combining our technologies to address unmet clinical needs.”
Troy Schifano, CEO and Co-Founder of Omnia Medical, added: “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. However, the data SpineGuard provided to 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 that they will have the highest chance of SI joint fusion success. Like Omnia, SpineGuard continues to be a leader and innovator in their respective field, and we could not be more excited about our partnership with them.”
SpineGuard was granted FDA 510(k) clearance to market the PsiFGuard smart drilling device, designed to secure the Posterior sacroiliac Fusion (PsiF) surgical procedure.
In 2H24, SpineGuard is focused on accelerating its sales growth, particularly in the United States, rolling out PsiFGuard as well as other new products, and registering its...
SpineGuard was granted FDA 510(k) clearance to market the PsiFGuard smart drilling device, designed to secure the Posterior sacroiliac Fusion (PsiF) surgical procedure.
In 2H24, SpineGuard is focused on accelerating its sales growth, particularly in the United States, rolling out PsiFGuard as well as other new products, and registering its full line in China. The company is also working on building strategic partnerships and strengthening its financial position.
Stéphane Bette, Deputy CEO and Co-Founder of SpineGuard, 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 innovative solution combining our technologies to address unmet clinical needs.”
Troy Schifano, CEO and Co-Founder of Omnia Medical, added: “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. However, the data SpineGuard provided to 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 that they will have the highest chance of SI joint fusion success. Like Omnia, SpineGuard continues to be a leader and innovator in their respective field, and we could not be more excited about our partnership with them.”
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