Signati™ Medical, Inc. Receives FDA Approval for IDE Study

Providence, RI, Dec. 20, 2023 (GLOBE NEWSWIRE) -- The FDA has officially approved Signati™ Medical’s Investigational Device Exemption (IDE) study! This comes on the company’s 5 year anniversary. "Our investments in research and development along with technological advancements have enabled Signati to develop the first minimally invasive vasectomy product in a market that is on tract to achieve remarkable growth," says William Prentice, Signati Medical CEO. Louisiana State University Medical Center has agreed to conduct the study which should start in January 2024.

Signati’s™ device will be the only surgical device on the market to perform a Sealed Vasectomy Procedure (SVP)™. Dr. Gerard Henry, Chief Medical Officer at Signati Medical adds, "The SVP should make vasectomies faster, easier, and safer for men seeking sterilization with much quicker return to full activity." This marks the beginning of a major shift in the urology space and moves Signati™ Medical one step closer to revolutionizing the way a vasectomy is performed today.

About Signati™ Medical, Inc.

Signati™ Medical, Inc. is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati Sealed Vasectomy Procedure (SVP)™, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.

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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

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