Longtime OC medical device executive Thomas Berryman is back in business with a new company and device to battle female stress urinary incontinence.
His Aliso Viejo-based Soft Health Technologies LLC has rolled out the Finess device primarily through its own website and Seattle-based Amazon.com Inc.
Finess is an external device designed to prevent urine leakage rather than absorb it. A patient places the device over her urethral opening, and a hydrogel adhesive seals it in place until it’s removed.
The Food and Drug Administration-approved device “challenges the age-old thinking of catching urine in pads and puts science to work, enabling women to reclaim their active lifestyles,” according to the company.
Stress urinary incontinence affects about 15 million American women, according to the Charleston, S.C.-based National Association for Continence. The mean age of women with stress urinary incontinence is in the 50s; the condition is often found concurrently with menopause.
“With menopause, estrogen production goes down, and with the decrease in estrogen production, all the tissues in the pelvic floor atrophy somewhat,” said Berryman, Soft’s founder and chief executive. “Gravity starts to win over a little bit, if you will.”
Soft is continuing what Berryman refers to as a controlled rollout of Finess that started last April. The company has only three employees and estimates that its 2016 revenue will come in the “high six figures.” It said it will likely make more hires in the future.
“In 2017, we expect to ramp up the spread,” Berryman said, adding that Soft plans to sell Finess in Europe and Canada once it receives regulatory approval.
E-Commerce Market
Soft intends Finess to be marketed only through e-commerce channels, according to Berryman.
“My rationale being I don’t want to raise $20 million in venture capital to try and get it on the shelves at CVS. I just want to get in the market and get some traction,” he said. “I’ve done enough venture capital-funded startups over my career. I wasn’t really interested in doing it again.”
Berryman said he’s learned several things about Finess customers, including their tendency to buy the product via mobile devices.
Finess’ history actually dates back to the 1990s. Berryman said he was involved in developing it at an OC venture-backed startup known as Advanced Surgical Interventions.
The device, which had never been brought to market, passed through the hands of a few different companies before eventually ending up under the auspices of a Fortune 100 company that Berryman wouldn’t name, saying that’s where it “disappeared.”
Four years ago, Berryman after a business-related chat with his wife decided to find out Finess’ fate. He approached the Fortune 100 company, and a year later he and the company signed a licensing deal.
He then raised capital and resurrected the device.
Finess is now being made by Soft at its OC headquarters, but he said the company hopes to shift production to a Midwestern contract manufacturer.
Deep History
Berryman has a deep history in Orange County’s medical device ranks.
One of his jobs was serving as chief executive of WaveTec Vision Systems Inc., which was also in Aliso Viejo and developed a diagnostic device used with intraocular lenses in eye surgeries. Alcon Inc., a Fort Worth, Texas-based unit of Switzerland’s Novartis AG, bought WaveTec in 2014 for an undisclosed price.
Berryman also started Genyx Inc., yet another Aliso Viejo-based device maker, selling it to Murray Hill, N.J.-based C.R. Bard Inc. in 2005 for $60 million.
His career also includes a stint as chief financial officer of Irvine-based VLI Corp., which developed the Today Sponge contraceptive in the 1980s.
