#United States #Surgical Solutions #Omnia Medical #PsiF DNA #Morgantown, West Virginia

Omnia Medical’s Commercial Launch of PsiF DNA™ System

Omnia Medical, a pioneering entity in the realm of medical technologies focused on spinal and interventional pain solutions, recently declared the commercial launch of their groundbreaking PsiF DNA™ Sacroiliac Joint Stabilization System. This innovative system has obtained the green light from the U.S. Food and Drug Administration (FDA), showcasing the company's commitment to advancing healthcare solutions.

Background of PsiF DNA™ System

Back in May 2025, the PsiF DNA™ System was awarded FDA 510(k) clearance, marking a significant achievement for Omnia Medical. Following this, the company embarked on an initial alpha launch phase that was pivotal in gathering insights from physicians, allowing for necessary refinements before the broader market introduction. This phase was instrumental, providing invaluable feedback that enriched the product's final iteration.

The PsiF DNA™ System is specifically crafted for sacroiliac joint fusion, targeting conditions such as degenerative sacroiliitis and sacroiliac joint disruptions. Designed with a minimally invasive posterior approach, it aims to stabilize the sacroiliac joint effectively while promoting successful fusion.

Key Features and Engineering

Abigail Mann, a Project Manager at Omnia Medical, highlighted the significance of these milestones, stating, "The FDA clearance and commercial launch of PsiF DNA™ represent important milestones for Omnia Medical. They reflect our commitment to delivering physician-driven technologies that support procedural consistency while addressing the complexity of SI joint pathology."

The design of the PsiF DNA™ implant is unique; it allows for insertion through the ilium, piercing its medial cortex, extending across the sacroiliac joint, and reaching into the sacrum to puncture its lateral cortex. This design not only enhances fixation but also minimizes the risk of implant migration, a common concern in similar procedures.

One of the standout features of the PsiF DNA™ System is its double-helix architecture. This innovative structure utilizes autograft bone from both the ilium and sacrum, essentially fostering a biological environment conducive for arthrodesis and long-term joint stabilization. Troy Schifano, the Chief Executive Officer, reiterated the advantages of this architecture, emphasizing its compatibility with natural anatomy to maximize fusion potential while ensuring procedural efficiency.

Moreover, the PsiF DNA™ System comes equipped with PsiF Guard™, a proprietary surgical guidance technology in collaboration with SpineGuard. This technology offers real-time feedback during surgeries, enhancing the accuracy of implant placement and confirming proper positioning, which can significantly improve patient outcomes.

Upcoming Events and Engagement

The formal unveiling of the PsiF DNA™ System is scheduled for January 23, 2026, during the North American Neuromodulation Society Annual Meeting in Las Vegas, Nevada. Healthcare professionals interested in this innovative system are encouraged to visit booth number 639 for detailed information and training opportunities.

For more inquiries regarding the PsiF DNA™ System, Abigail Mann can be contacted directly for scheduling and further details.

About Omnia Medical

Based in Morgantown, West Virginia, Omnia Medical focuses on developing and marketing state-of-the-art medical technologies aimed at enhancing surgical procedures for spine, interventional pain, and orthopedic specialists. Their mission revolves around providing minimally invasive solutions that not only boost procedural confidence but also ensure improved patient safety and overall outcomes. More information is available on their website, www.omniamedical.com.

For media inquiries, Christopher Henneforth can be reached at [email protected].