Incontinence is an unwanted and often embarrassing physical condition, whether the result of a collateral health issue or the natural aging process.

But today, thanks to a pair of Newtown bio-medical experts, women living with incontinence have access to a discrete, non-invasive, and FDA approved product called Elitone that can help restore some or all normal functions in that department.

According to the inventor Gloria Kolb and her husband / marketing creative director Eric — who endured the process of carrying an initial “napkin sketch” through to a proven “FemTech” device with retail availability — the couple has their sights set on offering a similar product for men in the coming months.

“We met after we both got out of school in the early stages of our careers at Johnson & Johnson,” Eric Kolb recalled during a visit with The Newtown Bee at their Monroe office situated above a compound pharmacy on Main Street. “We started working together developing medical implants. We both were involved with product design.”

Gloria Kolb said the first company she started was focused on urology issues, so she was well aware there was a need for a product like Elitone.

“That was up in Boston,” she said. “And I knew the doctors weren’t doing anything different — they were basically doing surgery. But the surgery was a big issue, there’s countless lawsuits going on now,” she added, referring to transvaginal mesh complications associated with treatments for pelvic floor disorders.

Ms Kolb said one in three women suffer from stress urinary incontinence, and her Elitone is the first and only medical device that offers women a non-invasive treatment option without a prescription. The discreet device is worn under clothing and works by applying gentle stimulation to the pelvic floor muscles, ultimately improving leakage and improving incontinence.

“Women don’t want to talk about it,” Ms Kolb said. “It wasn’t until after we started this company that I started hearing more and more from friends and family members who were going through that.”

Non-Invasive & Convenient

The local couple’s company, Elidah, is not only committed to developing products for the growing medical device market, but to helping women through the development of new technologies and innovative therapeutic solutions that are non-invasive, comfortable, and convenient. Elidah is developing these technologies by integrating recent advances in wearable devices, biomaterials, and mobile interfaces to deliver innovative therapeutic solutions.

Mr Kolb said virtually all the products and therapies involved in treating incontinence were invasive.

“But we found some literature out of Brazil and other parts of the world where they were applying therapies externally,” he said. “The data was pretty strong, but it could only be done in a clinic.”

It was not invasive, but it was still very inconvenient.

“So we found a way to put it in a product a woman could easily self apply and do at home — it takes away all the negative aspects of the experience, and it’s really effective,” Mr Kolb added. “Depending on the data we’re looking at, we’re finding our device is between 60 and 90 percent effective.”

Ms Kolb, who serves as CEO of Elidah, is an MIT and Stanford trained engineer whose recognitions include being named among Boston’s 40 Under 40, and one of MIT Technology Review’s World Top Innovators Under 35 when she and her husband lived in Massachusetts.

Most recently, Elitone was awarded best “New Product of the Year” Award at the 2019 My Face My Body Global Aesthetic Awards show held on November 25 in Las Vegas. The international awards event recognized the best products, clinical practices and healthcare providers in the aesthetics industry.

Elitone took one of the top awards from among 1,500 entries. Elidah also won the inaugural CTNext Mentor Network Pitch Event on June 27, which came with a $20,000 grant, Ms Kolb said.

She reportedly pitched against 15 other companies, all members of the first cohort of companies to participate in the new CTNext Mentor Network program, a partnership between CTNext and The Refinery launched earlier this year creating a network of experienced entrepreneurs, executives, and investors to help accelerate the growth of Connecticut’s most promising early-stage ventures.

The network gives participating companies the opportunity to get objective feedback and guidance on growing a company and to learn about valuable resources and tools that can help them succeed faster.

“Elidah is the perfect example of the kind of company this Mentor Network was created to support,” said CTNext interim Executive Director Glendowlyn Thames in a release. “They are at a true inflection point with a tremendous product already in market, a distinctive value proposition, substantial opportunity to grow, and impressive leadership.”

How Elitone Works

Used at-home, the local inventor’s device is worn under clothes for a short amount of time each day — essentially doing Kegel exercises for women — but for longer and stronger durations.

Ms Kolb said in a recent clinical study 95 percent of women achieved a reduction in bladder leaks, with an average reduction of 71 percent within a short time after they started using Elitone.

The Kolb’s said the lengthy, multi-phase process of obtaining FDA approval for releasing the device to the general public as an over-the-counter product was extremely challenging — but ultimately rewarding.

“We had to go through a more rigorous process, called a De Novo process,” Ms Kold explained. “In the end, there was a new product code [initiated] for this surface electrical stimulation.”

Fda.gov identifies the De Novo process as providing a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

“There was our device and another product going through the process at the same time,” Mr Kolb said of the new and groundbreaking development. “It involved getting feedback on the negative things. Once you submit data, the FDA gives you the opportunity to make corrections. It involved several rounds with the FDA before it gave us the clearance to sell this over the counter — which is actually more challenging than for prescriptive products.”

Immediate Treatment Advised

“The issue up to now has been women are not getting treated,” Ms Kolb said. “And if it’s not treated, the issue keeps getting worse,” Mr Kolb said.

“Then it eventually gets to the point where it can’t be treated,” Ms Kolb said.

“Which could explain why today, adult diaper sales have surpassed baby diaper sales,” Mr Kolb said. “And those companies are trying to make it acceptable to wear them when for most people, this is a treatable condition.”

“So it’s important that women and men seek out treatment early,” Ms Kolb said. “Stress incontinence is caused by simple muscle weakness — so we’re exercising the pelvic floor muscles with this product.”

It was just about a year ago, after an 18-month process, that the Kolb’s were announcing that Elidah received a grant from the National Science Foundation (NSF) to continue development of its wearable device. Additionally, the Defense Health Agency (DHA) Small Business Innovation Research (SBIR) Program in the Department of Defense (DoD) awarded Elidah a contract to develop and adapt its Elitone technology for the treatment of injured Service members.

The NSF grant, part of the Technology Enhancement for Commercial Partnerships (TECP) program, is intended to support product refinement in advance of a potential business relationship with an established corporate partner, one of US’s largest medical device manufacturers.

The DoD contract funds development of new technologies that restore urinary function and control to injured service members, including those with spinal cord injury. Building on the existing Elitone technology, Elidah will develop a diagnostic and therapeutic device to treat these injured military personnel.

Broader application of this technology may treat civilian men who suffer from urinary incontinence, often a side effect of prostate surgery. This work is supported by the Combat Casualty Care Research Program and the US Army Medical Research and Materiel Command.

Elitone is sold online and at select Medispas — for information, visit elitone.com/product/elitone.