Signati states its device can significantly reduce vasectomy procedure time and offers a minimally invasive approach. Image credit: Shutterstock/ Anicka S.

Signati Medical has completed a trial evaluating its device that aims to streamline vasectomy procedures, and submitted a De Novo application to the US Food and Drug Administration (FDA) for its approval.

Whilst the company said in a press release it will initiate the submission process, Signati’s CEO William Prentice confirmed to Medical Device Network that the company has “officially applied for FDA approval” on Friday 20 December. Prentice added that the company will also “file for our CE mark and every approval needed to be a global enterprise”.

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Signati did not publicly share data from the prospective trial evaluating its product, called the Separo Vessel Sealing System, though stated that all eight patients enrolled in the study met the primary endpoint. The study evaluated the incidence of adverse events as its primary endpoint, and the rate of successful vasectomy and pain after the procedure, amongst the secondary endpoints, as per ClinicalTrials.gov.

Signati reported its procedure was well tolerated with no device-related adverse events. The company said only that the trial demonstrated “promising results” that “reflect the potential of the Separo Vessel Sealing System.”

Separo is designed to provide a safer, more efficient, and minimally invasive solution for men undergoing vasectomy. Vasectomies are conducted by cutting or sealing the vas deferens, the tubes that carry sperm from the testicles to the urethra.

Signati states its device Separo can seal each vas deferens in four seconds. A reduced procedure time and risk of bleeding alongwith  faster recovery are amongst the other benefits of the new approach. The system comprises a radiofrequency generator, a handpiece, and clamping forceps. The energy from the radiofrequency generator cauterises a part of each vas deferens so that it is permanently separated with the ends sealed.

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Prentice said in a statement: “We are thrilled with the trial results and the progress we’ve made in advancing men’s health solutions.

“We look forward to collaborating with the FDA during the De Novo process and to the eventual launch of the Separo Vessel Sealing System.”

Whilst there is a lack of data estimating the market size of the male birth control device market, the global market for women’s sterilisation devices – which includes tubal clips and rings – was estimated to be worth $40m in 2023, according to an analysis by GlobalData.

The number of vasectomies being performed has already risen significantly in the wake of the US Supreme Court overturning Roe versus Wade, which granted widescale access to abortions. Dr. Matthew Mutter, principal investigator of Signati’s study, previously said technology advancements such as Signati’s could help shift the paradigm of birth control – giving men more responsibility in family planning by offering couples more options.