Vivex Biologics Announces Publication of a Real-World Evidence Study Demonstrating Superior or Similar Outcomes for Cygnus® Amnion-Based Skin Substitutes in Wound Care

MIAMI, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Vivex Biologics, Inc., a leading medical technology company, developing and delivering innovative allografts for musculoskeletal and wound-care applications, today announced the publication of a new peer-reviewed study titled “Comparative evaluation of skin substitutes for diabetic foot ulcers and venous leg ulcers using the Medicare Administrative Claims Database.”

This real-world evidence (RWE) study, authored by Dr. Jason R. Hanft, Travis Tucker, and Todd Gillespie PA, and supported by Vivex Biologics, evaluated the effectiveness of two amnion-based skin substitutes, Cygnus Matrix and Cygnus Dual, compared to Medicare covered skin substitute products for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) in the future effective Skin Substitute Local Coverage Determinations (LCDs), effective January 1, 2026.

Using the Medicare Fee-for-Service database from January 1, 2021, through December 31, 2024, this retrospective study analyzed clinical outcomes between covered products and Cygnus Dual and Cygnus Matrix. The primary measures included treatment utilization, hospitalizations, emergency department visits, amputation rates, and claims-based indicators of wound healing.

Key Findings:

• Cygnus Matrix and Cygnus Dual demonstrated similar or superior performance across multiple metrics when compared with Medicare-covered skin substitutes.
• Patients treated with Cygnus products had a more favorable claims profile indicating improved wound healing in several matched comparisons.
• Cygnus Dual showed a significant reduction in therapy duration compared to 80% of comparators covered, demonstrating potential clinical and economic benefits.
• Cygnus Matrix was associated with lower minor amputation rates in select comparisons, with no significant differences in hospitalization rates or lengths of stay.

The findings underscore the clinical and economic viability of amnion-based products in managing chronic wounds. Despite being non-covered under future Medicare Local Coverage Determinations (LCDs), the Cygnus products performed on par with or better than covered alternatives, reinforcing the case for their inclusion in future Medicare coverage determinations.

“This study delivers compelling, real-world evidence that amnion-based products like Cygnus can deliver outcomes equal to or better than currently covered products,” said John McCallum, CEO of Vivex Biologics. “It strengthens the argument for expanding Medicare coverage to include these advanced wound-care options that meaningfully improve patients’ lives.”

“The use of national claims data provides a unique opportunity to compare real-world performance across multiple skin substitutes,” added Travis Tucker, MA, MBA, Principal Consultant of Woodside Analytics, LLC. “These results demonstrate that Cygnus products not only deliver strong clinical outcomes but also align with the goals of value-based care.”

For more information on Vivex and its innovative solutions, visit www.vivex.com. For more information on VIA Disc NP, visit www.viadiscnp.com.

About Vivex Biologics, Inc.
Vivex is a leading medical technology company focused on the science, development and commercialization of advanced therapies for the regeneration, restoration and repair of the body. Its current therapies help patients suffering from chronic lower back pain, musculoskeletal injuries, wounds and burns. By leveraging its robust and proven R&D capabilities and corporate infrastructure, Vivex seeks to continue to channel the body’s inherent healing qualities to provide patients optimal care and medical professionals with innovative treatment options for a broad range of indications.

Media Contact
Kathryn Larson, VP of Marketing
klarson@vivex.com

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