Signati™ Medical Receives FDA IDE Approval for Pivotal Study of the Separo™ Vessel Sealing System
Providence, RI, June 02, 2026 (GLOBE NEWSWIRE) -- Signati™ Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application for a randomized pivotal clinical study of the Signati™ Separo™ Vessel Sealing System, a device designed to enable physicians to perform vasectomies with greater precision and consistency.
The IDE approval authorizes Signati™ to initiate a randomized, controlled, open-label, multi-center, non-inferiority clinical investigation comparing the Separo™ System to mucosal cautery vasectomy, the current standard of care, at up to 5 U.S. institutions enrolling 120 adult male subjects.
THE UNMET NEED
Vasectomy is among the most effective and cost-efficient forms of contraception available, yet it remains underutilized. Despite being safe, minimally invasive, and permanent, vasectomy uptake has consistently lagged behind female sterilization — in the U.S., female sterilization rates are roughly three times higher than male sterilization rates nationally¹ — a disparity driven by patient awareness gaps, provider variation, and the absence of purpose-built tools to standardize the procedure and support a confident patient experience.
Signati™ Medical was founded on the premise that family planning is a shared responsibility and that men deserve modern options to participate in it. The Separo™ Vessel Sealing System gives urologists and surgeons an energy-based vessel sealing platform designed specifically for vasectomy, thereby reducing technical variability, improving procedural efficiency, and expanding access for men who want to take an active role in their family’s reproductive decisions.
ABOUT THE CLINICAL STUDY
The pivotal study is a randomized, controlled, non-inferiority investigation. The primary effectiveness endpoint is azoospermia or rare non-motile sperm (≤100,000 non-motile sperm/mL) on post-vasectomy semen analysis within six months, the accepted clinical standard for confirming sterility. Subjects will be randomized to the Separo™ System or mucosal cautery vasectomy across up to 5 U.S. centers.
BUILDING THE EVIDENCE BASE FOR GUIDELINE AND PAYOR ADOPTION
The Separo™ pivotal RCT was designed with guideline and coverage adoption as explicit goals. A head-to-head randomized comparison against the established standard of care generates the class of evidence that professional societies and payers require before incorporating new technologies into clinical guidelines and reimbursement policies. The study’s non-inferiority design, multi-center structure, and objective semen analysis endpoint are calibrated to meet the evidentiary standards of leading urology and reproductive health organizations, as well as the documentation requirements of public and commercial payers. Signati’s™ view is that a well-executed RCT is the most direct path to broad clinical adoption, ensuring the Separo™ System reaches not just regulatory clearance, but routine use and covered reimbursement.
¹ Mock et al. “Explaining sex discrepancies in sterilization rates in the United States: An evidence-informed commentary.” Perspectives on Sexual and Reproductive Health, 2023. https://onlinelibrary.wiley.com/doi/full/10.1363/psrh.12243
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.
“Leading Innovation in Men's Health”
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.
William Prentice President & CEO, Signati Medical Inc. 128 Dorrance Street 6th Floor Providence, RI 02903 william.prentice@signatimed.com https://signatimed.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
