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Omnia Medical Announces Commercial Launch of FDA-Cleared PsiF DNA™ System – Ortho Spine News

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January 20, 2026
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Omnia Medical Announces Commercial Launch of FDA-Cleared PsiF DNA™ System – Ortho Spine News

MORGANTOWN, W.Va., Jan. 20, 2026 /PRNewswire/ — Omnia Medical, a medical technology company developing surgical solutions for spine and interventional pain physicians, today announced the commercial launch of its FDA-cleared PsiF DNA™ sacroiliac joint stabilization system.

In May 2025, Omnia Medical received 510(k) clearance from the US Food and Drug Administration (FDA) for the PsiF DNA™ System. Following clearance, the company conducted an initial alpha launch to gather physician feedback and refine commercial readiness. The success of this initial launch provided Omnia with a springboard to proceed with a broader market introduction.

The PsiF DNA™ System is designed for sacroiliac joint fusion for the treatment of conditions including degenerative sacroiliitis and sacroiliac joint disorders. Carefully designed for the minimally invasive posterior approach, the system is designed to stabilize and promote fusion of the sacroiliac joint.

“The FDA approval and commercial launch of PsiF DNA™ represent important milestones for Omnia Medical,” said Abigail Mann, project manager at SI Technologies. “They reflect our commitment to delivering physician-driven technologies that support procedural consistency while addressing the complexity of SI joint pathology.”

During the procedure, the PsiF DNA™ implant is inserted through the ilium to pierce its medial cortex, through the sacroiliac joint, and into the sacrum to pierce its lateral cortex, a design created to improve fixation and reduce the risk of migration. Bone graft material is placed inside the implant to facilitate additional bone incorporation after surgery.

A key feature of the system is its double-helix architecture, which leverages autograft bone from both the ilium and sacrum to support arthrodesis and long-term joint stabilization.

“The double helix design was designed to work in harmony with native anatomy,” said Troy Schifano, CEO of Omnia Medical. “By using autograft bone from both sides of the joint, PsiF DNA™ supports the biological environment necessary for fusion while maintaining the efficiency of the procedure.”

The system also includes PsiF Guard™, a patented surgical guidance technology developed through a partnership with SpineGuard. PsiF Guard™ provides real-time intraoperative feedback to support accurate implant placement and positioning confirmation.

Omnia Medical will formally introduce the PsiF DNA™ system at the North American Society for Neuromodulation annual meeting in Las Vegas, Nevada, on January 23, 2026 at booth number 639. Clinicians interested in learning more or scheduling training can contact Abigail Mann, Project Manager, SI Technologies, Omnia Medical. aosborne@omniamedical.com

About Omnia Medical

Omnia Medical, headquartered in Morgantown, West Virginia, develops and markets innovative medical technologies for spine, interventional pain and orthopedic specialists. The company is focused on delivering minimally invasive and clinically relevant solutions that improve procedural confidence, patient safety and outcomes.

For more information, please visit (www.omniamedical.com).

For media inquiries please contact:
Christopher Henneforth
chenneforth@omniamedical.com

SOURCE Omnia Médica

Omnia Medical Announces Commercial Launch of FDA-Cleared PsiF DNA™ System – Ortho Spine News

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