Signati Medical Announces Completion of Enrollment in First-in-Human Clinical Trial for Groundbreaking Sealed Vasectomy Procedure
2024年7月19日 - 12:17AM
Signati Medical™, a medical device company dedicated to advancing
men’s health, today announced the successful completion of
enrollment in its Investigational Device Exemption (IDE) trial
evaluating the safety and efficacy of its proprietary Signati
Separo™ Vessel Sealing System for vasectomy procedures.
This prospective IDE trial, initiated in April 2024 after
receiving FDA approval, aimed to assess the Separo system’s ability
to perform vasectomies with reduced procedure times and minimal
invasiveness compared to traditional methods.
“We are pleased to announce the completion of enrollment for
this groundbreaking clinical trial,” said William Prentice, CEO of
Signati Medical. “The participation of all eight patients is a
testament to the growing interest in faster and potentially
less-burdensome vasectomy options.”
The study, designed as an Investigational Device Exemption (IDE)
trial with the FDA, enrolled eight patients in the United States.
All participants underwent vasectomy procedures using the Separo
system. The primary objectives focused on evaluating procedural
safety, post-treatment effectiveness, and semen analysis following
the procedure.
“The Separo system has the potential to improve the vasectomy
experience for both patients and physicians significantly,” said
Dr. Matthew Mutter of LSU Medical Center, principal investigator of
the study. “To date, I have been impressed with the device's ease
of use, and we expect final results to be available by the end of
the year.”
Signati Medical anticipates submitting the complete data package
to the FDA for regulatory approval in 2024. Upon approval, the
Separo system would become the first major advancement in vasectomy
technology in over four decades.
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.
William Prentice
President & CEO,
Signati Medical Inc.
128 Dorrance Street
6th Floor
Providence, RI 02903
william.prentice@signatimed.com
https://signatimed.com