Archives for March 2024

Providence, RI, Dec. 20, 2023 (GLOBE NEWSWIRE) — The FDA has officially approved Signati™ Medical’s Investigational Device Exemption (IDE) study! This comes on the company’s 5 year anniversary. “Our investments in research and development along with technological advancements have enabled Signati to develop the first minimally invasive vasectomy product in a market that is on tract to achieve remarkable growth,” says William Prentice, Signati Medical CEO. Louisiana State University Medical Center has agreed to conduct the study which should start in January 2024.

Signati’s™ device will be the only surgical device on the market to perform a Sealed Vasectomy Procedure (SVP)™. Dr. Gerard Henry, Chief Medical Officer at Signati Medical adds, “The SVP should make vasectomies faster, easier, and safer for men seeking sterilization with much quicker return to full activity.” This marks the beginning of a major shift in the urology space and moves Signati™ Medical one step closer to revolutionizing the way a vasectomy is performed today.

About Signati™ Medical, Inc.

Signati™ Medical, Inc. is a medical device company that endeavors to take vasectomy to a new level of comfort, safety, and speed. A medical device company dedicated to advancing men’s health, Signati plans to launch the first innovation in vasectomy in more than 20 years with a procedure that would be fast for physicians and comfortable for patients. The Signati Sealed Vasectomy Procedure (SVP)™, designed to take just minutes, could be done right in the urologist’s office and would offer advantages for patients including easier recovery compared to some current vasectomy techniques.

To learn more, visit www.signatimed.com.

Not approved by the Food and Drug Administration (FDA). These statements and the subject product have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease. The device is not currently being marketed, nor is it available for sale in any country.CONTACT: William Prentice President & CEO, Signati Medical Inc. 128 Dorrance Street 6th Floor Providence, RI 02903 william.prentice@signatimed.com https://signatimed.com

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.”

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A Providence medtech firm says it has developed a device to make the procedure simpler, safer, and faster

• The Boston Globe
• 16 Jan 2024
• By Robert Weisman GLOBE STAFF

PROVIDENCE — At a time when increased abortion restrictions are stoking the demand for shared responsibility, Bill Prentice wants to reinvent the vasectomy.

Prentice, 58, a Wall Street traderturned-entrepreneur, has received regulatory clearance for his five-year-old company, Signati Medical, to test a device he says will bring “a new level of comfort, safety, and speed” to a procedure that’s seen little innovation in the past century.

Using a hand-held device plugged into a radio frequency generator, the company’s “sealed vasectomy procedure” obstructs a pair of sperm-carrying tubes, called the vas deferens, by sending a shock of energy through the skin rather than manually cutting and fusing the tubes.

The device resembles the handles for jumper cables. The toaster-size generator is equipped with an algorithm that guides doctors through the process and shuts off automatically when the tubes are sealed.

For a procedure that has generally inspired squeamishness in many men, “the beauty of the Signati device is that you’re not opening the skin,” said Dr. Doug Stein, a Florida urologist who has performed tens of thousands of vasectomies and serves as a Signati clinical adviser.

If the Food and Drug Administration green-lights Signati’s device, Prentice, the CEO, wants to broadcast the first approved use of the company’s procedure — on himself — on live television.

Vasectomies, which sometimes cause swelling and bruising, are most often undergone by middle-aged fathers who no longer want more children. They remain far less common and risky than a more invasive female sterilization procedure known as tubal ligation or, more commonly, getting one’s “tubes tied.”

“Men need to step up,” said Prentice, who admitted he abandoned his own plan to have a vasectomy many years ago. “This is going to be less painful, less bruising, and get you back to your normal activity much faster. You’ll be in and out of the procedure in five minutes.”

Prentice hasn’t yet reached out to television stations — he’s waiting for FDA approval — but he thinks the procedure can be portrayed tastefully while educating doctors and potential patients. He likens it to television journalist Katie Couric’s colonoscopy on the “Today” show in 2018, which raised awareness of the im

portance of colon cancer screening.

While the nation’s fragmented health insurance system makes precise data hard to come by, health care providers estimate between 300,000 and 500,000 American men undergo vasectomies annually. They represent roughly 5 percent of men of reproductive age.

A trio of University of Chicago researchers, who analyzed health insurance data last year, found the vasectomy rate among privately insured men rose 26 percent between 2014 and 2021, the most recent year for which data is available. “We expect demand will be increasing further,” said Dr. Omer Raheem, a urologist and assistant professor of surgery at the University of Chicago Pritzker School of Medicine.

One factor driving the demand, Raheem said, is the Supreme Court’s Dobbs decision in 2022, which overturned federal constitutional protections for abortions and was followed by abortion bans or restrictions in nearly two dozen states.

Many urologists, especially in states that have outlawed abortions, have said they are already performing more vasectomies, though data on the trend is not yet available.

“The Dobbs verdict brought this to the forefront,” Prentice said. “Men are finally looking at this and saying to their wives, ‘I’m going to do it. I’m going to do it for you, and I’m going to do it for me.’”

Prentice, a Paterson, N.J., native whose first job was at a hot dog stand called Johnny & Hanges, later helped start the trading desk for financial firm Pershing. He made the jump to entrepreneurship after business associates shared an idea from a Georgia surgeon, Dr. William Pannell, who sits on Signati’s board, for a kinder and gentler vasectomy.

To turn that idea into reality, Prentice raised $5.9 million from friends, family, and angel investors. The medical device was designed under contract at Veranex, a private research lab in Providence, and is being built by contract manufacturer Global Interconnect in Bourne.

Providence-based Signati runs on a shoestring. Prentice works out of the law office of Brian Dougan, the company’s legal counsel. The company has a small staff of unpaid consultants, along with a couple of paid employees, who work remotely from around the country.

Signati got the FDA nod to begin clinical trials later this month on eight volunteers at the Louisiana State University medical center in New Orleans. The company could market the device and procedure as early as this fall if FDA regulators deem it safe and effective, Prentice said.

Prentice understands why many men are reluctant to undergo vasectomies. While today’s procedure is relatively simple and can later be reversed, some men experience post-operative pain and a small number get infections or immune reactions.

Patients are advised to rest for at least 24 hours after surgery and avoid sports, lifting, and heavy work for at least a week. (Urologists say they often see an uptick of vasectomies during the March Madness basketball tournament.)

Years ago, when Prentice went to a doctor in New Jersey to have a vasectomy, the doctor couldn’t perform the procedure that day. He never went back.

“I’m a typical man,” he said. “I was scared. Because I heard these horror stories.”

With the Signati procedure, Prentice is willing to set his earlier qualms aside.

“When I tell you that I will do this live on TV to prove how easy it is,” he said, “it’s because it’s important for men to open their eyes and not make their wife or partner go through a [tubal ligation] procedure.”

Article Name:Putting a jolt into vasectomies

Publication:The Boston Globe

Author:By Robert Weisman GLOBE STAFF

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