Groundbreaking New Solution for Incontinence: Meet ELITONE

INTRODUCTION
Health and Healing 101 is proud to review a brilliant innovation addressing female incontinence - a most widely prevalent health and medical concern for women. As a team with extensive experience in medical device design and entrepreneurship, co-founders Gloria Kolb and Eric Kolb embarked on development of a wearable medical device called ELITONE to provide a non-intrusive incontinence treatment, capturing the attention of an expanding number of clinicians in the US.  Team Kolb shares their valuable insights on the creation of this remarkable device, while also sharing the process of achieving regulatory success for product launch.  For any aspiring developers of innovation, this interview promises to be a valuable educational tour depicting the journey of how medical technologies come to market.

Product details (sourced from https://elitone.com/)
ELITONE® is FDA cleared to treat stress urinary incontinence (SUI) and is the first transcutaneous pelvic floor muscle stimulation available in the US. The ELITONE device:
- Use externally applied electrical muscle stimulation to exercise the pelvic floor muscles
- Performs pelvic floor muscle exercises more effectively than many women can do alone
- Requires little to no instruction from a healthcare provider.
- Can be used at home, under clothing, making it easy for women to continue their everyday tasks during treatment.
- Is ideal for women with mild to moderate symptoms who would benefit from pelvic floor muscle training. 

* This makes ELITONE easy, external, and effective, which drives high levels of patient adoption and compliance. 

THE ROAD TO PRODUCING A MEDICAL DEVICE 

From an interview with CTO Eric Kolb

One in three women have incontinence. Most of them do not know that there are treatment options and they resign themselves to a life of pads and eventually diapers. Those who do explore their options quickly realize that the predominant solutions are intra-vaginally administered treatments, which many women are hesitant to pursue. 

We developed ELITONE to be externally applied, making it more comfortable and convenient for women to administer at-home. It brings recovery to women with mild-moderate stress incontinence, and in a form factor that is easy to apply.  Treatment takes only 20 minutes a day, 5x/week, for 6-12 weeks.  You can use ELITONE while you're doing other things. You can put it on and go back to work. You can get ready in the morning, sit and talk with the kids, or walk the dog. It really doesn’t interrupt your daily routine.

ORIGINS
Gloria and I started the company and made the first prototypes in our dining room. We are both engineers, both with strong backgrounds in medical device product design. Although our skill sets have a lot of overlap, I tended to work more on design, manufacturing, and quality systems, while Gloria focused on funding, clinical research, and business operations. Over time, we hired other talented people and divested some of those responsibilities to others. 

Research and development was largely funded through SBIR grants from the National Science Foundation, which started in 2015. We also received federal funding from NIH and DOD. ELITONE received FDA clearance in 2019 and we’ve been working since then to create market awareness and generate sales.

FDA

Devices that are new and higher risk are designated as Class 3 and undergo an FDA “approval” process. Moderate risk devices are designated Class 2 and follow a “clearance” process where FDA reviews them against an existing technology (i.e. a predicate). This is referred to as the 510(k) process. Some, but not all, 510(k) applications include clinical data. In the ELITONE submission we provided data that is now published in the Journal of Women’s Health Physical Therapy [link].

I've worked for big companies and small companies, and have had been through the FDA process many times. This allowed us to prepare the submissions and interact with FDA directly, without use of consultants. With ELITONE, the review was slowed because we were initially required to follow the De Novo process, a special process for relatively low-risk devices that don’t have a clear predicate. As we were nearing the end of that process another device entered the market that could be used as a predicate, so we needed to resubmit our application referencing this new predicate. It delayed us by a few months, but we are happy to have that part of development behind us. 

IRB

Muscle stimulators are designated in FDA guidance documents as non-significant risk devices that don’t require an IDE (Investigational Device Exemption) to conduct clinical research. So we use a third-party IRB firm to clear our protocols, and then conduct the clinical studies ourselves. Since ELITONE is an over-the-counter use-at-home device we take a pragmatic approach to study design. This means recruiting participants and administering treatment in ways that best match how our customers use the product. 

MARKETED AS A MEDICAL DEVICE

We have indications for both over-the-counter use and prescription use.  It's actually a lot harder to get the over-the-counter indication because you have to perform usability studies to demonstrate that potential customers can self-identify as appropriate users, that they understand the contraindications, that the Instructions for Use are adequate and correctly interpreted without a clinician's intervention, and that the patients can safely administer the treatment. 

Raising awareness of this new technology within the medical community is largely through medical conferences like the International Incontinence Society, physical therapy conferences, OBGYN conferences, etc.  These are great for having meaningful conversations with healthcare providers. Because COVID-19 limited our ability to meet with clinicians face-to-face, we've been more focused on direct-to-consumer marketing, which means a lot of internet search advertising. This approach is actually very effective because women often don't speak with their doctor about incontinence. Rather, they search online for answers to "Why am I leaking?" and "What are the solutions?"  

TYPES OF INCONTINENCE
Our current Indication for Use is for treating female stress urinary incontinence, which represents about half women with incontinence. Stress incontinence is leaking associated with coughing, sneezing, exercising, or any other increase in abdominal pressure that causes urine to leak. It is primarily affected by pelvic floor muscles, and often starts after childbirth. If untreated, it worsens as the woman ages. Thankfully, with treatment like ELITONE, many of these women can get back to living life without leaks.

Urge incontinence is associated with a sudden sensation that you need to urinate. If you’re able to make it to the bathroom without leaking it’s called Overactive Bladder. If you can’t control the urge, resulting in an accident, it’s called urge incontinence. Here, the issue is with the how nerves in the bladder are stimulated. It affects women and men as they get older, usually starting in their sixties or seventies.

THE FUTURE

We are actively working to offer new products for the other types of incontinence. We look forward to being able to offer a solution to all incontinence suffers who learn about our technology. We are actively raising capital to expand our marketing activities, and have regular conversations with potential strategic partners, including both traditional medical device companies and consumer products companies. We look forward to working with an organization to help us scale and make ELITONE widely available to the one in three women who have incontinence. 

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