Signati Medical Successfully Completes IDE Trial for Separo Vessel Sealing System and Initiates FDA Market Clearance Process

Providence, RI, Dec. 23, 2024 (GLOBE NEWSWIRE) — Signati Medical is proud to announce the successful completion of its Investigational Device Exemption (IDE) trial evaluating the Separo Vessel Sealing System for vasectomy procedures. All eight patients enrolled in the study met the primary endpoint, marking a significant milestone in the development of this groundbreaking technology.

The procedure was well-tolerated, with no device-related adverse events. The human data confirmed the preclinical data the company has developed. These promising results reflect the potential of the Separo Vessel Sealing System to redefine vasectomy procedures by providing a safer, more efficient, and minimally invasive solution.

Signati Medical extends its deepest gratitude to the Principal Investigator, Dr. Matthew Mutter, whose expertise and dedication were instrumental in the success of this study. We also thank the patients who volunteered to be part of this important research, contributing to advancements in men’s health.

Building on this success, Signati Medical will initiate the De Novo submission process with the U.S. Food and Drug Administration (FDA). This regulatory pathway aims to achieve market clearance for the Separo Vessel Sealing System, bringing this innovative device one step closer to transforming clinical practice for men’s health.

“We are thrilled with the trial results and the progress we’ve made in advancing men’s health solutions,” said William Prentice, CEO of Signati Medical. “This achievement underscores our commitment to developing cutting-edge technologies that address unmet clinical needs. We look forward to collaborating with the FDA during the De Novo process and to the eventual launch of the Separo Vessel Sealing System.”

About Signati Medical

Signati Medical is a medical device company dedicated to developing innovative solutions that improve men’s health. The company’s flagship product, the Signati Separo, is a revolutionary new device designed to streamline the vasectomy procedure. Signati Medical is committed to providing men with safe, effective, and accessible options for family planning.

To learn more, visit www.signatimed.com.

Not approved by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease. The device is not currently being marketed, nor is it available for sale in any country.

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