Signati Medical has enrolled the first patient in a clinical trial investigating its device designed to quicken vasectomy procedures.
The trial, operating under an investigative device exemption from the US Food and Drug Administration (FDA) granted in December 2023, will assess the efficacy and safety of Signati’s Separo device for vasectomies.
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A vasectomy is a surgical procedure that cuts and seals each part of vas deferens, the tubes that carry sperm from the epididymis.
Signati states its device can significantly reduce procedure time and offer a minimally invasive approach. Separo can seal each vas deferens in four seconds, according to the US company.
The study’s principal investigator Dr Matthew Mutter alluded to the stagnant nature of the vasectomy space, saying that Signati’s work is the “first major advancement in vasectomy technology in over 40 years.”
Reduced risk of bleeding and faster recovery are amongst the other benefits of the new approach, which Signati calls a Sealed Vasectomy Procedure (SVP). The procedure involves only sealing the tubes as opposed to traditional techniques that include cutting. The system comprises a radiofrequency generator, a handpiece, and clamping forceps. The energy cauterises a part of each vas deferens so that it is permanently separated, with the ends sealed.
Amid increasing restrictions imposed on women seeking abortion in the US, Dr Mutter says Signati’s work could help shift the paradigm of birth control – giving men more responsibility in family planning by offering couples more options.
The number of vasectomies being performed has already risen significantly in the wake of Roe versus Wade.
Whilst there is a lack of data to estimate 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 analysis by GlobalData.
Signati’s CEO William Prentice said: “While highly effective, the traditional vasectomy procedure can be time-consuming and create anxiety for patients. The Signati Separo can potentially transform vasectomies into a faster, more streamlined experience.”
