A Rhode Island medical device company that’s working to transform the vasectomy process is celebrating a milestone.
Signati Medical, based in Providence, in December gained FDA approval for a clinical study, and hopes to bring its noninvasive vasectomy device to market in the third quarter, CEO William Prentice told Business First.
The device will let a doctor perform a “sealed vasectomy procedure,” or SVP, in a matter of minutes using a desktop generator and hand-held device. The proprietary device doesn’t puncture a man’s scrotum, and instead seals the vas deferens via an electronic signal.
That’s opposed to current methods for male sterilization, which are far more invasive and uncomfortable, Prentice said.
He called it the first real innovation in vasectomy in 20 years, adding that his company is poised for growth in a nation where access to abortion is no longer guaranteed.
“When the Supreme Court overturned Roe v. Wade, we received a lot of attention,” he said. “There’s a growing market for vasectomies. It’s a lot easier for a man to get the procedure than for a woman to undergo tubal ligation. No woman should have to go through that.”
Prentice said he and like-minded investors bootstrapped Signati over the course of five years. Among them, the group raised $6 million to fund the company – all while eschewing salaries or compensation, except for paying a CFO and an engineer.
“We turned down venture capital money,” said Prentice, a former Wall Street trader. “We raised funds through friends, family, acquaintances and doctors. I haven’t received a dime (of outside private equity).”
Urologists around the country have expressed interest in the procedure, which takes “five seconds per side,” Prentice said.
Prentice said his clinical advisory board contains top urology talent, including Doug Stein, a global physician who invented “World Urology Day.” Stein provides vasectomy services at 21 locations across Florida, many under the federal Title 10 program for low-income men without insurance, according to his bio.
As for the recent milestone, Signati last month gained an investigational device exemption, or IDE, from the FDA. The exemption lets the device be shipped lawfully for the purpose of conducting a clinical investigation. The study, involving eight patients, will be conducted this month at Louisiana State University.
The investigational device study is the final step – short of receiving final FDA approval – before Signati can market its device to the public, the company said in a release.
Prentice added that he, personally, plans to be the first person to undergo the procedure – and that he’d like to do so on live TV. He said in his view, it’s important to educate the public about the new vasectomy technology.
“I can see doing it on Good Morning America,” Prentice said. “If Katie Couric can get a colonoscopy on live TV, I can get a vasectomy.”