Omnia Medical Announces Commercial Launch of FDA-Cleared PsiF DNA™ System

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 U.S. Food and Drug Administration (FDA) 510(k) clearance 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 early launch provided Omnia with a springboard to proceed with a broader market introduction.

The PsiF DNA™ System is intended for sacroiliac joint fusion for treating conditions including degenerative sacroiliitis and sacroiliac joint disruptions. Thoughtfully engineered for the minimally invasive posterior approach, the system is designed to stabilize and promote fusion of the sacroiliac joint.

"The FDA clearance and commercial launch of PsiF DNA™ represent important milestones for Omnia Medical," said Abigail Mann, Project Manager, 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, across the sacroiliac joint, and into the sacrum to pierce its lateral cortex, a design created to enhance fixation and reduce the risk of migration. Bone graft material is placed within 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 the sacrum to support arthrodesis and long-term joint stabilization.

"The double helix design was engineered to work in harmony with native anatomy," said Troy Schifano, Chief Executive Officer of Omnia Medical. "By utilizing autograft bone from both sides of the joint, PsiF DNA™ supports the biological environment needed for fusion while maintaining procedural efficiency."

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

Omnia Medical will formally introduce the PsiF DNA™ System at the North American Neuromodulation Society Annual Meeting in Las Vegas, Nevada, on January 23, 2026 at booth number 639. Physicians interested in learning more or scheduling training may contact Abigail Mann, Project Manager, SI Technologies, Omnia Medical. [email protected]

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 focuses on delivering minimally invasive, clinically relevant solutions that enhance procedural confidence, patient safety, and outcomes.

For more information, visit [www.omniamedical.com].

For media inquiries, please contact:
Christopher Henneforth
[email protected]

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SOURCE Omnia Medical