CLEVELAND – As the sixth edition of the Medical Innovation Summit sponsored by the Cleveland Clinic geared up this week, the focus was on innovation in an area not previously highlighted at this gathering, the urology/gynecology segment.

Seeking to enlighten the audience as to the value of this space was Karen Licitra, company group chairman of the Ethicon Endo-Surgery (Cincinnati) unit of Johnson & Johnson (New Brunswick, New Jersey). She said that from treatments in fertility, incontinence, erectile dysfunction to the invention of laparoscopic and endoscopic surgery "urology and gynecology have been at the forefront of technological advancement."

The question, of course, is what is the future of innovation in this field? "Consider that every three seconds, someone in the world turns 65; that's 25,000 new seniors a day," she said. "And that translates to a continually growing population of patients needing treatment for gynecological and urological conditions."

Licitra said she believes that the opportunity for urology and gynecology market is "there for the taking." But to be successful, she noted that the medical device industry will have to "change our paradigms about what makes medical innovation, the kind of innovation that drives market creation in today's healthcare environment."

To achieve successful innovation in today's market she said that technology must be combined with information, service, education and ultimately patient outcomes. "That will be the difference between a market-share play or a market-creation play."

Fortunately for companies working in this space, said Licitra, is the willingness of physicians in the sector to try out new technology. She noted that gynecologists and urologists have developed and used some of the most beneficial and frequently used technologies of the past 20 years.

"From ultrasound to MRI, laparoscopy and endoscopy and robotics, the industry has understood how to make use of the benefits of newer procedures and improve upon those procedures in helping to diagnose and treat patients," she said. "So clearly innovation is embraced by these specialties."

According to Licitra nearly 4 million urological and gynecological procedures are performed in the U.S. alone, with a similar number estimated for Europe. She said that a recent report by the Lewin Group found that roughly one-third of U.S. women will have a pelvic health problem by age 60. Spotlighted by the report were the specific areas of abnormally heavy periods, uterine fibroids, pelvic organ prolapse and stress urinary incontinence.

Licitra said that urinary incontinence is the most common urological ailment affecting both men and women with nearly $18 billion on diagnosis, pretreatment and surgical or behavioral procedures. Nearly 14 million Americans are affected by urinary incontinence and more than 800,000 cases of urinary incontinence are diagnosed in the U.S. each year.

Stress incontinence continues to be the most common form of the condition for women and surgery is still the primary method of treatment as Licitra noted that there is currently no pharmacological treatment for this type of incontinence.

She said that the urological surgical device market was valued at more than $178 million in 2004 and that number is expected to rise to more than $520 million in 2011, a compounded annual growth rate of 16.6%. "Most of this market is derived from the treatment of incontinence in the aging Baby Boom generation."

In the gynecological device market, she said that ablation procedures will continue to be a "driving force." In 2005, the total thermal ablation market was estimated at almost $400 million. This is expected to remain a very robust market, growing to more than $659 million by 2010, influenced by changing treatment guidelines and more physicians transitioning to performing procedures in their offices.

Despite the fact that pelvic organ prolapse (a hernia of the bladder, uterus or bowel) affects up to half of all women age 50 or older, Licitra said that the market is underpenetrated, with only about 225,000 surgeries performed in the U.S. annually because women are often embarrassed about the condition and are often reluctant to seek treatment despite the pain. Because of this, the market in this area, currently valued at about $60 million is only expected to grow to about $95 million by 2012.

Another market of interest is that of prostate cancer, with 182,000 men diagnosed with the condition in the U.S. and nearly 29,000 die from the condition. The good news is that early diagnosis and more affective treatment have increased the five-year survivability of the condition over the past 20 years from about 67% to nearly 100%. About $650 million is spent annually to treat the condition.

Another male condition that promises to have a markedly increased market is that of benign prostatic hyperplasia (BPH), with nearly half of all men in the U.S. being identified as having the condition by age 60 and by age 85, the prevalence is about 90%. Over 300,000 surgical procedures are performed every year to treat BPH. The overall market for BPH in the U.S., including drugs is expected to grow from $1.4 billon to $3.4 billion by 2011.

As for the future of the urology/gynecology market, Licitra said that not only will less-invasive be the ticket to entry, but advancements will likely be driven by technologies such as nanoparticles, imaging, miniaturization and electronics.

A recent innovation in treating uterine fibroids is MR-guided focused ultrasound (MRgFUS), in which the MR images give the doctor the precise location of the fibroids while the focused ultrasound transducer sends focused soundwaves into the fibroid to heat and destroy small areas of tissue.

This procedure, she said, is less costly than conventional surgery requires no overnight hospital stay, uses no general anesthesia, doesn't require an incision and it preserves the uterus.

Another interesting technology being talked about at the summit is Doppler-guided uterine artery occlusion that is intended to allow a gynecologist to treat a uterine fibroid using a minimally invasive surgical approach that temporarily shuts off blood flow to the uterine arteries. The device is currently under development and is undergoing clinical trials.

Another area that holds much promise is the area of robotics. Nowhere is this more evident than in urology, where robotically-assisted radical prostatectomy now accounts for 40% of all radical prostatectomies in the U.S.

Licita said that while the promise of this new technology is great, "industry needs to do a much better job of promoting it and helping to obtain reimbursement for these technologies."

She also noted that it is no longer okay just to show safety and efficacy for new technology. For wide adoption, clinical trials "must also prove superiority and cost-effectiveness versus existing treatments."

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