MassDevice Q&A: William Rutan

How do you get people to talk to their doctors about something so embarrassing they’ll barely admit it to themselves?

That’s the challenge facing Greenwich, Conn.-based medical device startup Mederi Therapeutics and the minimally invasive treatment for fecal incontinence it says will eliminate the need for drastic colostomy procedures.

Fecal or bowel incontinence is a condition in which adults lose the ability to control their bowel movements, resulting in occasional leakage of stool or even a complete loss of bowel control, according to the Mayo Clinic. It’s an affliction Mederi says is much more common than you think, particularly for women who are both its primary sufferers and the people most likely to keep it a secret.

Mederi’s Secca device delivers radiofrequency energy to the anal canal, causing small tissue contractions to restore sphincter function. According to the company, some of that restoration occurs immediately and some over the six to 12 months following the 45-minute, out-patient procedure.

MassDevice recently spoke with Mederi CEO William Rutan, who told us the company is taking a page out of the pharmaceutical industry’s book, studying the way companies like Pfizer turned erectile dysfunction into a household word to sell Viagra. One challenge for Mederi is replicating that marketing muscle on a shoe-string budget. A bigger and more immediate challenge, Rutan said, is getting physicians to ask patients if they’re suffering from the affliction. If they that proves successful, the 50-year-old CEO says, Mederi might just be onto a tremendous market opportunity.

MassDevice: Tell us about Mederi Therapeutics. What’s the back story, and what’s the market opportunity for your products?

Will Rutan: We acquired the assets of a company called Curon Medical Inc. [Eds. note: Curon filed Chapter 7 bankruptcy in 2006] and those assets included 80 issued patents. Curon had marketed the products; Secca for the treatment of bowel incontinence and Stretta for acid reflux disease. The two devices do essentially the same thing, they’re just constructed differently.

The Stretta is a catheter with a balloon on it and it has the same needle delivery system for RF energy, it just goes in the esophagogastric junction, which is the sphincter that controls the ingress of food into the stomach from the esophagus. Obviously, that’s a huge market; there are hundreds of drugs for gastroesophageal reflux disease. However, those drugs just treat the symptoms, not the underlying mechanical problem, which Stretta does. So we think there’s an enormous market potential because there are a number of studies that show Stretta is an effective treatment for remodeling of the valve that’s responsible for gastric reflux.

It’s been hard for us to choose which is the bigger market, because everybody suffers from GERD. If you get old enough, almost everybody suffers from it, and everybody knows about it. The unknown disease, which is really a tragedy, is bowel incontinence. It depends on what study you want to believe, and there have been several on the prevalence of bowel incontinence, but one study done by the Cleveland Clinic showed that up to 30 percent of women who have had children suffer from this. It causes your eyebrows to go up, because you don’t know anybody who has it, at least you don’t think so, but the truth of the matter is that you do.

There was another study done in Australia that had even higher numbers, but one of the key findings was that unless asked directly by a caregiver patients won’t volunteer that they have this problem. They’re sitting in the doctors office and they’re there for whatever reason, but they won’t bring it up. It’s only when the doctor says, “Do you have any issues with bowel incontinence?” that the subject will come up and the patient will admit that they’re having a problem.

The prevalent cause is normal childbirth, not complicated childbirth, but normal. The more children a woman has, the greater the incidence, just by having normal vaginal birth. Another frightening statistic is that of all patients, 70 percent of sufferers are women. It’s the number two cause of putting a loved one into a nursing home, second only to dementia, and a full 50 percent of patients in nursing homes have bowel incontinence.

So we’re undertaking an effort to educate the patient population, just the same way as pharmaceutical manufacturers of erectile dysfunction had to do years ago, because it wasn’t long ago that people would blanch over the term “erectile dysfunction.” Now there are commercials for it on every television show. It’s the same with urinary incontinence, but bowel incontinence has a little bit more of a hurdle.

MassDevice: So you’re saying that the demographic is there, but it’s a situation where the patient population is embarrassed to admit it. So that presents a challenge?

WR: Yes, but other than Secca there is no solution besides “Eat less and stay near a bathroom,” or “Have a colostomy,” and that’s a big hurdle. A colostomy is permanent, it’s disfiguring and you wear a bag. It’s the compassion that is drawing us to focus on Stretta instead of Secca. There are pills out there if you have GERD; there’s nothing out there if you have bowel incontinence. So part of the reason we believe patients don’t ask is that there’s no answer other than, “Eat less and stay near a bathroom, or I can recommend you to a surgeon,” and they don’t want to do that. We have to get out the message that there’s a very effective treatment. We have clinical trials that show up to 80 percent of patients respond favorably to Secca therapy.

MassDevice: Do you have any idea how often a doctor asks that question directly to a patient?

WR: They don’t ask. Our challenge is getting to the primary care physician, in this case the gynecologist.

MassDevice: So how do you get the message out effectively?

WR: Well, there’s one easy way and that’s to have Oprah do a segment on it, but it’s not so easy to get to Oprah. We are employing guerrilla marketing tactics because we’re a small startup, so there’s not the marketing budget to do national television ads. My daughter’s in advertising and her suggestion was to string together a bunch of people telling poop jokes and put at the end of it, “This isn’t funny if you suffer from bowel incontinence,” and throw it up on YouTube.

We’ve got some pretty good patient brochures and what we’re doing is going to our user physicians, get their referring physicians and distributing these patient brochures for the offices. But the interesting thing is that the pharmaceutical companies go right to the consumers with things like rheumatoid arthritis and depression and they mass-market it like crazy, but the numbers are the exact same as the reported numbers of bowel incontinence. You would think that everybody suffers from depression, because you see ads for Prozac and Lexipro and all that, but 8 percent of adults suffer from depression, 8 percent suffer from rheumatoid arthritis and a reported, and we would say it’s dramatically under-reported, 8 percent of adults suffer from bowel incontinence.

I think that’s kind of surprising. So the message in our brochures is that bowel incontinence is a lot more common than you think and it is equally as common as these two conditions, which most people think are much higher.

MassDevice: How do you get the physician to ask the question? What’s the secret to influencing a physician on changing the way they speak to their patients?

WR: One, by having the referring physician, which in this case is the colorectal surgeon, implore them to. Second is to have the hospitals, where the physicians are on staff, implore them to, or have hospitals do marketing campaigns directly to their patients to educate them, because there’s a lot of business being left on the table here by hospitals. If the solution was better known, if the condition was treated, there’d be a significant uptick in the amount of procedures performed by facilities. Or, have some benefactor like the International Incontinence Society do some direct-to-patient marketing.

We know that people are out there, based on a very small study; it’s just a matter of getting to them. I guess that’s the eternal question for small companies out there with products like us, that solve a problem that’s sort of under the radar. It’s really patient demand that’s going to drive this thing.

MassDevice: Not that we’re doubting the underlying compassion in your choice of markets, but tell us a little about the market opportunity and the economics you looked at in going after the incontinence market vs. the GERD market?

WR: Well, there’s lots of competition in pills with GERD; now they just fix the symptoms but not the underlying disease, which we do. But then again, going head-to-head with Pfizer? No, thank you. We will market Stretta; there are long-term problems with proton pump inhibitors, and the long-term use of these pills is just now occurring. They significantly deplete calcium and if you’re a woman, you have a calcium retention problem anyway. So there’s a significant problem associated with long-term use of PPIs.

But, for us, from a small, privately owned startup company like us, we’re not cowards. But we will always fight a fight where we’ll have less competition and there is nothing that treats bowel incontinence besides either conservative or highly invasive remedies. Conservative remedies don’t work. Highly invasive ones do, but you end up with a bag for the rest of your life.

MassDevice: On the flip side, you have to do a lot of pioneering work.

WR: Correct, there are no coat-tails here.

MassDevice: Is anyone else out there looking at this market?

WR: Medtronic is now attempting an entry into the market with a sacral nerve stimulator, which is approved for urinary incontinence. We would suggest that we’re not in competition with them because that’s a highly invasive, very expensive procedure. It’s a pacemaker essentially; an implantable device that you have for the rest of your life and the cost of device is more than $40,000. That’s both invasive and expensive and the results of their study are less than the results of our product’s study, in terms of results. Other companies have put out an artificial bowel sphincter, which is an implantable device that is essentially a balloon that you manually inflate and then when you have to go to the bathroom you deflate it. But there’s nothing like us out there.

MassDevice: Tell us about the procedure. It’s a minimally invasive device?

WR: I don’t know what the classification is for minimally invasive, but I would say it’s a class below that. The product goes through an existing opening, the anus, and the whole procedure takes place within two inches of the anus. It’s under direct visualization by the doctor. It’s a one-time treatment that takes 45 minutes, either under general anesthetic or conscious, but it’s a same-day procedure and the patient can return to normal activity within 24 to 48 hours. There’s generally no post-operative discomfort and any discomfort can be handled with aspirin or Tylenol.

MassDevice: How is the company funded? What’s Mederi’s status today?

WR: We’re operating off a Series A round from Acadia Woods Partners, which is a New York-based investment partnership, and Paladio Capital, which is out of Grenwhich, Conn., where the company is based. We have seven full-time employees and we outsource all other functions; the product is made by a contract manufacturer and we outsource regulatory and legal. We’re ISO 14385-certified and we’re CE marked.