Healthy Profits

By Billie Noakes

Two local companies join forces to promote the first major advance in male incontinence care in more than 50 years.

Build a better mousetrap and the world will beat a path to your door. - Ralph Waldo Emerson

Build a better device for dealing with male incontinence, though, and the world will squirm uncomfortably and try to ignore you.

“I remember making my first presentation to a group of venture capitalists,” says Dennis M. Kay, MD, Chairman, founder, and CEO of Largo-based BioDerm, Inc., “and when I displayed drawings illustrating how the Liberty male incontinence care device works, I heard someone in the back of the room gasp and say, ‘Oh, my God.’”

“We didn’t get funded. Incontinence is a taboo subject in our society,” observes Dr. Kay. “We don’t like to talk about things that happen ‘below the belt.’ My nickname for this is down there syndrome, and it’s been a significant part of our challenge in securing investors for Liberty, our flagship product that helps men who experience uncontrolled loss of urine to stay dry and comfortable.”

Dr. Kay acknowledges that down there syndrome wasn’t the only barrier to investor enthusiasm. The device didn’t offer investors a good exit strategy.

“Innovation in healthcare is largely driven by the cost of an innovation,” he explains. “If someone figures out a new way to make a PET or CT scanner and the modified device is going to cost millions of dollars, investors know they’ll recoup their costs when it’s licensed. There’s a much longer delay and a less predictable return on a relatively inexpensive consumable product.”

Significant problem

More than four million American men live with incontinence. Men with diseases like Parkinson’s, muscular dystrophy, multiple sclerosis, and Alzheimer’s. Men who have cerebral palsy or who have suffered strokes or spinal cord injuries. Men who have had prostate surgery, resulting in temporary or permanent loss of urinary control. These men, and their families and caregivers, cope daily with the restricted lifestyle dictated by urinary incontinence.

“That’s inaccurate,” amends Dr. Kay. “Their restricted lifestyles are the result of ineffective products for controlling and containing the urine, products that haven’t changed much in more than five decades.”

The most commonly used products for dealing with male urinary incontinence are diapers, absorbent briefs, pads, bed pads, condom catheters, and indwelling catheters (catheters that are inserted into the urethra through the penis).

The first four account for about eighty percent of the incontinence care market; they simply absorb escaped urine. But even the most absorbent product traps moisture against the skin, leading to irritation, rash, and bedsores – and extended hospital stays.

Condom catheters are too loose on some men, too tight on others. They’re difficult to apply and fall off at inopportune times, humiliating patients and causing added work for the loved ones and caregivers who must help clean the patient and his clothing and bedding. Condom catheters can chafe and tear the skin on the shaft of the penis, and are a breeding ground for bacteria.

Indwelling catheters are more stable once they are in place, but bacteria can grow inside the catheter and infect the bloodstream. Indwelling Foley catheters (those with a balloon to anchor the device in place), which have been in use since the 1930s, but are responsible for 40 percent of infections that develop in hospitals and nursing homes, and most clinicians agree that it is virtually impossible to prevent a urinary tract infection when an indwelling catheter is in place for more than four days. The Centers for Disease Control report that 560,000 cases of catheter-associated urinary tract infections (CAUTI) develop each year, at a cost of $676 per episode for a total of $424- to $454-million a year. Worse: 6,500 catheterizations (1 in 1,000) performed in acute care hospitals cause a fatal infection.

Together, these unsatisfactory solutions and their complications cost the U.S. healthcare industry more than $5-billion a year in excess expenses, making incontinence and the problems that arise from inadequately treating it a major national health care challenge. “Clearly,” says Dr. Kay, “we need a better solution.”

Observation and Innovation

The solution that Dr. Kay developed was inspired by success in another healthcare sector: ostomy care.

"A material called hydrocolloid was developed about 30 years ago,” informs Dr. Kay. “It could seal to the skin, even in the presence of moisture, and protect the skin and allow patients to discharge waste into a receptacle outside the body. The patient always stayed dry and comfortable.”

A long history in medical product development allowed Dr. Kay to see the potential for hydrocolloid in addressing incontinence. “My goal was to apply the hydrocolloid around the urinary opening so urine would be directed away from the body via a tube and collected in a secure bag without leakage and without damaging the shaft of the penis,” he describes. “The first prototypes were designed in the early to mid 90s, and we performed our first clinical studies at the James A. Haley Veterans Hospital in Tampa. We found that a single application of the External Continence Device could keep a man dry and comfortable for 24 to 72 hours.”

By 1999, the first generation of the External Continence Device had evolved, and NASA adopted it for use in its manned space flight missions. BioDerm changed the product’s name to Liberty Pouch Clean & Dry™ in 2005. In 2006 the device was approved for Medicare reimbursement, a hurdle that, if uncleared, could have broken the company. Health care providers are reluctant to accept and use products that won’t be reimbursed by Medicare.

Last year, the device was rebranded, and the name was shortened to Liberty.

Continuing challenges

Even with Medicare reimbursement, and an eight-year track record of improving the quality of patients’ lives and reducing the complications caused by absorbent products and external and indwelling catheters, Dr. Kay found widespread acceptance elusive. “It costs about $20 million to develop a new technology and then establish adequate awareness so that technology can survive as a viable business,” says Dr. Kay.

“BioDerm has the best new product in incontinence care, but not enough people have heard of it. We’ve seen very promising growth since 2004, but the ability to access growth capital in Florida is limited, so we had to find other ways to get our message out.”

Good match

BioDerm recently partnered with MSL Associates, a Tampa-based marketing, sales, and logistics firm that specialize in marketing medical devices. MSL Associates, in turn, has brought on its affiliate, RI, LLC, which concentrates on sales of medical devices to the health care providers who are the direct link to consumers.

“BioDerm has developed a revolutionary product that has a significant impact on a serious health issue,” says Mike Laky, ATP, President and CEO of RI, LLC. “Over the last 11 years, our company has developed a reputation as an outstanding sales and marketing company. Our strength matches very well with BioDerm’s need.”

The company has a sales force that blankets the country, and that sales force is supported by a multi-faceted marketing approach that includes telemarketing, post card marketing, broadcast e-mail, a website that promotes the products represented by the company, even educational seminars and customer support for their products.

“What excites me about BioDerm’s Liberty is that it answers a need that I’ve observed over 26 years working around people with spinal cord injuries and muscular diseases,” says Laky. “These people all have issues with incontinence, and the most common question they ask when they go for physical therapy is, Can you check my cath before we get started? If they’re using a condom catheter, it often comes off. If they have an indwelling cath, they may have to delay therapy for an extended period of time if it’s dislodged. Failure of these devices is commonplace and embarrassing. Liberty answers the issues that these men are forced to live with in a way that is much more humane and discreet, and allows them to participate more fully in society without worrying about the device malfunctioning.”

Laky admits that convincing health care professionals to try a new product is a challenge. “It’s human nature to resist change,” he points out, “and there are only a few companies that have dominated the incontinence care market for decades.” Doctors, nurses, and therapists may not be satisfied with the complications associated with these companies’ products, but the products are familiar, and they’ve been the recognized standard of care for years.

RI, LLC has made a concerted effort to reach out to ICU nurses and the more visionary physicians who are always looking for better answers. They’ve capitalized on BioDerm’s willingness to provide product samples to introduce Liberty to the marketplace.

“The response is universally positive,” says Laky. “When doctors have provided the device to their patients, the patients have loved it, describing Liberty as giving them a ‘life changing experience.’ That’s no small thing.”

There’s another reason for Laky and Dr. Kay to be optimistic about Liberty’s chances in today’s marketplace.

As of October 1, 2008, Medicare stopped reimbursing for treatment of the pressure hospital acquired sores and urinary tract infections caused by incontinence care products. Reimbursement is also denied for additional inpatient days that result from these complications.

“The dollar will drive a lot of hospitals and nursing homes to embrace Liberty,” predicts Laky.

“Liberty can be a significant factor in reducing complications and reducing the cost of providing care to men living with incontinence,” agrees Dr. Kay. “But on a personal level, it will also improve the health and lifestyles of patients, so they can enjoy their families and participate confidently in society again. It truly offers medicine and patients a win-win situation.”

Dr. Dennis Kay is a Diplomat of the American Board of Emergency Medicine. He was a product development consultant for medical product and pharmaceutical giants Johnson & Johnson, Squibb, and C.R. Bard before he founded BioDerm in 1990 to focus on the research and development of incontinence and wound care products.