For the last two decades, little has changed in the way vasectomies are performed, a procedure that more than 500,000 men undergo annually.
Providence-based Signati Medical Inc. is aiming to change that.
On April 5, the medtech company started a trial study at Louisiana State University Medical Center in New Orleans, with doctors conducting a noninvasive vasectomy with a handheld device produced by Signati that uses a radio frequency generator instead of a knife to complete the procedure.
The success of the trial, approved last December by the U.S. Food and Drug Administration, will define the future of the company and CEO William Prentice, who believes Signati is close to upending the urology field by going “from scalpel to no scalpel” to perform vasectomies, he said.
Three years ago, Prentice, a former Wall Street stock trader, was tapped by Signati to take over after the board of directors was searching for a new leader, someone “without an off switch,” Prentice said.
After taking the helm, he gave out his cellphone number to every adviser, board member and each of his investors, taking calls at all hours and from various time zones. “They talked me into it basically,” he said. “They needed help, and they came to me.”
FDA approval for the “investigational device exemption” opened the door to testing the device in a clinical study to confirm its safety and effectiveness. Signati must complete successful trials with eight patients before the device can be brought to the commercial market. If all goes well, that could take more than four months.
Signati says its device will cut costs for both patients and doctors, lessening recovery time using “bipolar energy sealing,” turning what for many is a major procedure into a five-minute visit to a doctor’s office with minimal damage to the surrounding tissue, according to the company.
“Nobody needs to go to a hospital,” Prentice said.
“What we are doing, they already do today in other procedures,” Prentice said. “The only difference is others cost $15,000 and ours is $200. This is just where the technology is going. We are making it more affordable and a lot easier for doctors to use.”
Signati’s proprietary device doesn’t puncture skin but instead seals the sperm-carrying vas deferens tubes with an electronic signal. That shock of energy through the skin does the job that manually cutting and fusing used to, according to Signati.
“The device plugs in to it. And that’s it,” said Prentice, adding that Signati aims to take the onus of birth control off women, who have historically borne the brunt of reproductive medical interventions.
“They are the ones whose bodies are changing,” he said. “If they get their tubes tied, that is a major surgery. Men can do this in five minutes. In this day and age, [men] should be more a part of that responsibility.”
And with the recent U.S. Supreme Court decision leading to more restrictions on abortions, “guys are thinking, I’m not going to have a choice,” Prentice said.
Still, many men are fearful of the procedure’s effects on sexual performance. Prentice thinks that will change as well.
“We are all wimps compared to women,” he said.
Free of debt and with a slimmed-down business model, Signati is based in the Dorrance Street office of Prentice’s lawyer, Brian Dougan. The company has raised $7 million from more than 240 private investors, refusing several offers from private equity firms and a $3 million venture capital pitch.
“We want to do the right thing and benefit the investors who believe in what we are doing,” Prentice said. “We are not focused on anything else. We are only focused on this.”
Dr. Gerard Henry, Signati’s chief medical officer, said the device will make vasectomies “faster, easier and safer for men seeking sterilization, with much quicker return to full activity.
“We need to shift the responsibility of sterilization from women to men by simplifying the procedure and eliminating fear, thus changing the perception of vasectomy,” he said.
Signati is not paying any doctors to implement the device in their practice, executives say. Already, more than 100 doctors have lined up to use the device if it’s given the federal go-ahead. Prentice says the first 200 doctors the company signs on will get the equipment free.
And major companies are now expressing interest.
Prentice says the fallout from abortion restrictions is likely to boost sales. The vasectomy rate had already increased by 26% between 2014 and 2021, before Roe v. Wade was overturned and almost half of U.S. states passed laws to curb access, Prentice says.
Some medical organizations are reporting an increase in vasectomies between 30% to 50%, the company says.
“That is when we really became talked about all over the country,” said Prentice, who feels it’s important to educate the public about the new technology. He is even considering becoming Signati’s patient zero and filming his own procedure on live television.
“If Katie Couric can get a colonoscopy, then I can get a vasectomy,” he said, referring to the TV host who underwent the procedure live on the “Today” show in 2000. “We will be a household name.”
The technology of bipolar energy sealing has been used for decades in other medical procedures, from laparoscopic surgery to hysterectomies.
“We are not reinventing the wheel,” Prentice said. “But for vasectomies, we are the wheel.”
