Signati Medical has announced the successful completion of its Investigational Device Exemption (IDE) trial for the Separo Vessel Sealing System, designed for use in vasectomy procedures. The trial's positive outcomes pave the way for a De Novo submission to the U.S. Food and Drug Administration (FDA) for market clearance.
The IDE trial, initiated in April 2024 (NCT06402773), enrolled eight patients, all of whom met the primary endpoint of achieving azoospermia or rare, non-motile sperm at six months post-procedure. This outcome aligns with the American Urological Association (AUA) guidelines for successful vasectomy, according to Matthew J. Mutter, MD, the principal investigator of the study and a urologist in New Orleans.
Safety and Efficacy Data
The Separo system demonstrated a strong safety profile during the trial. "No one experienced a device-related adverse event," Dr. Mutter stated. Pain scores were minimal, with only one instance of a score above zero recorded throughout the study's duration. Preclinical data, which demonstrated sealing effectiveness, minimal thermal spread, and clinically documented wound healing, were confirmed by the human data.
Streamlining Vasectomy Procedures
The Separo system is designed as a bipolar instrument with jaws that seal the vas deferens, either within or outside the vasal sheath. Signati Medical envisions a future transdermal vasectomy using the device. Currently, the procedure involves delivering the vas through the skin, similar to a no-scalpel vasectomy, followed by application of the Separo device to seal and remove a segment of the vas deferens in a single energy delivery.
Dr. Mutter highlighted the efficiency gains offered by the Separo system. "The biggest thing that I took away from using the device is that it allowed me to do the procedure by myself, without an assistant," he noted. This frees up other staff members to attend to other clinic duties. He also noted that the procedure was quick, allowing for efficient patient throughput.
Addressing Unmet Needs in Men's Health
William Prentice, CEO of Signati Medical, expressed enthusiasm about the trial results and the company's progress in advancing men's health solutions. He emphasized Signati Medical's commitment to developing cutting-edge technologies that address unmet clinical needs and expressed anticipation for collaborating with the FDA during the De Novo process.
The Current Landscape of Vasectomy
Vasectomy is a common and effective method of contraception. The no-scalpel vasectomy technique, introduced in the late 1970s, significantly improved the procedure's accessibility and reduced downtime. However, innovation in vasectomy techniques has been limited in recent decades. The Separo system represents a potential advancement, offering a streamlined and efficient approach to the procedure.
Signati Medical's Separo system is currently not approved by the FDA and is not available for sale. The company is focused on securing market clearance through the De Novo pathway.
