Angelo Gousse, M.D.
Dr. Gousse is a former tenured Professor of Urology at the University of Miami Miller School of Medicine, Department of Urology, Vice-Chairman of the University of Miami Hospital and Clinics Urology service, where he was also the Urology Residency Program Director and Fellowship Director for Female Urology, Urodynamics, and Reconstructive Surgery and the Director of the Urodynamics Laboratory at the VA Medical Center for ten years. After graduating as the valedictorian of the City University of New York (York College) with a perfect GPA in his major, Dr. Gousse received his medical degree with highest honors from the Yale University School of Medicine. He completed his residency at the Baylor College of Medicine in Houston and a postdoctoral fellowship in urodynamics, female urology, and pelvic floor reconstruction at the University of California Los Angeles. He is certified by the American Board of Urology. Dr. Gousse’s research interests have focused on overactive bladder neuropharmacology, reconstruction, neurogenic urinary incontinence, as well as functional recovery from spinal cord injury. An international leader in voiding dysfunction, he has pioneered the optimal dosage of neurotoxins to manage bladder dysfunction. Over the past seven years, he has collaborated on extramural NIH grants with basic scientists to investigate urinary markers for interstitial cystitis. He has authored or co-authored more than 60 peer-reviewed scientific publications and numerous textbook chapters, journal articles, and abstracts, and has participated as a guest professor in the United States and abroad on various aspects of reconstructive urology. For many years, he has been the Section Editor of the Female Urology section in the journal Current Urology Reports. Recently appointed as a Board Member of the Urodynamics Society (SUFU), he also serves on the AUA Female Urology Core Curriculum Committee. His professional awards and honors include a listing in Best Doctors in America 2005 to 2010, America’s Top Urologists by the prestigious Consumer’s Research Council of America 2008, Strathmore’s Who’s Who since 2001, the Miller University of Miami Medical School’s Urology Teacher of the Year Award on numerous occasions, the Pfizer Scholars in Urology Award, and the Cullen Research Award from the Scott Department of Urology, Baylor College of Medicine, and the Dr. Jonas Salk Scholar Award for his work on E.coli microbial genetics. He is also the co-founder and president of the Haitian American Leadership Organization (HALO).

Dr. Gousse has exceptional credentials, and will become a tremendous asset for PMD as we continue our efforts, going forward.

About Precision Medical Devices, Inc. (PMD)
PMD is a medical device company whose products are focused on treating the following medical conditions; urinary incontinence, fecal incontinence, erectile dysfunction and obesity, among others. Founded in 1998, PMD is composed of notable medical professionals and engineers dedicated to the continued progress and pursuit of a cure for the previously listed conditions. These conditions account for over $500 billion worth of expenses, worldwide annually.

Peter Sayet, Public Relations / Investor Relations, 954-565-4580

The new telemetry control system will be able to make incremental adjustments of the pressure exerted on closing-off the urethra of a subject patient implanted with PMD’s patented urethral (Flow Control Device -FCD) valve via the system’s wireless, physician-operated control box unit. The telemetry procedure adjustment of the closing pressure on the urethra can be done as often as necessary to find the optimum closing pressure for each patient, which is expected to result in optimum dryness, but is also expected to result in minimum damage to the urethra itself. The subject patient, will be able to open and close the implanted valve as often as he/she desires when they feel the urge to urinate using their own hand-held, car-key-entry-like remote trigger. When not being triggered to open by the patient, the FCD valve is expected to arrest the unwanted flow of urine in between bathroom visits.

The combination of a remote-controlled open/close system for the subject patient and the remote-controlled telemetry adjustment system for the attending physician will likely make the new PMD Flow Control Device the most efficacious and optimal treatment for severe urinary incontinence. PMD expects to be beginning a new battery of implants within the next 90 days to test all of the features of its FCD in live subjects toward its goal of making application for regulatory approvals in numerous markets throughout the world, after additional clinical trials are completed.

About Precision Medical Devices, Inc. (PMD)
PMD is a medical device company whose products are focused on treating the following medical conditions; urinary incontinence, fecal incontinence, erectile dysfunction and obesity, among others. Founded in 1998, PMD is composed of notable medical professionals and engineers dedicated to the continued progress and pursuit of a cure for the previously listed conditions. These conditions account for over $500 billion worth of expenses, worldwide annually.

About the Flow Control Device (FCD)
The FCD is a first-of-its-kind medical device, focusing on the treatment of severe urinary incontinence. The device itself is a bionic implanted urethral valve that is remotely-controlled and telemetry adjustable. Designed to constrict the urethra to arrest the flow of urine, the FCD is expect to become the optimal treatment for severe urinary incontinence.

Peter Sayet, Public Relations / Investor Relations, 954-565-4580

For instance, most of the current array of pharmaceutical products are targeted at the treatment of only urge UI. There are several drugs on the market that target only stress incontinence, but for the most part the bladder-neck and sling suspension surgical protocols / products are also primarily prescribed for stress UI. Adding to the problem is the fact that many of the UI drug treatment products have demonstrated effectiveness only in the milder cases. If a person has both a more than mild case and also has mixed UI, the probability that she or he will obtain relief for their UI is quite low. This problem is precisely why a treatment product designed to treat all forms of UI, especially in the more severe levels of the condition, would be so well received.

The FCD product will set new standards in the ease of implant, the ease of use, having a more modest adverse events profile and a lower risk profile as compared to all of the other currently-approved severe UI products and procedures. This should account for a fourth of the UI market. The product is expected to last a lifetime, with little or no deterioration in its efficacy.

The FCD product is expected to have such a wide range of use, including being able to treat overflow UI cases, as a result of its simplistic design. The device stops the incontinence at the exact point of the problem – the flow of urine through the urethra.

“SUI affects one in three women across all age groups, with a slight increase (37 per cent) in women ages 35 to 54”

“How incontinence threatens quality of life SUI remains a taboo subject and women who live with it tend to alter their lifestyle for fear of embarrassment, says Dr. Carr. Some may abandon exercise, a common trigger, leading them to become overweight and less healthy. Others will avoid social gatherings and become reclusive, while still others may give up sex to avoid leaking during intercourse. Incontinence can also be a barrier to happiness. According to a Canadian study published in the March-April 2006 issue ofPsychosomatics, 15.5 per cent of women with urinary incontinence (30 per cent of women age 18 to 44) suffer from depression, compared with 9.2 per cent of women without urinary incontinence”.

Even the statistics on this promising new treatment are moderated by the fact that, even in this small hand-picked sample of 29 people, the full continence rate after one year is still only 13.8% (four out of twenty-nine recipients). It should be quite positive then to know that there is a new severe UI treatment product that is going through its advanced stages of testing, which is expected to result in full continence for over 90% of the recipients:

The Precision Medical Devices – Flow Control Device.

The key to the PMD-FCD is its remote adjustability feature, made possible by its uniquely designed, on-board, telemetry control system. No longer will women have to fret about the possibility of embarrassing leaks or accidents just because they are doing routine physical activities. The PMD-FCD will be the new choice in severe UI treatment, and will return its recipients a significant level of QoL.

If it can be roughly extrapolated that there are approximately 46.5 million females in this age group, then approximately 3.25 million women between the ages of 20 to 39 suffer from some level of UI. Further to that, the number of severe UI cases is approximately 25% of the total, then over 800,000 of these women suffer from UI levels that are severe enough to grossly interfere with their lives (and perhaps even more, as even more moderate cases could be quite disastrous to younger women in their prime, socially-active phase).

Unfortunately, these women have nothing to look forward to but the reality of an ever worsening condition, as the prevalence rates accelerate upwards in the subsequent age groups. Even though there have been several treatments (mostly invasive surgical procedures) available over the last 30-plus years to treat severe UI, most of these treatments have been found to lack consistent significant long-term cure-rates, with up to 50% (or more) of the women treated by these products and procedures eventually ending-up incontinent for the longer term.

Women who end-up with severe UI, facing a future wherein their UI overwhelms their diapers and pads, may soon have a dramatic new treatment designed to reduce severe UI to the absolute minimum.

What would it be like for a day without worry of leakage?

It is in the severe UI market that the Precision Medical Devices (PMD) Flow Control Device (FCD), a remote-telemetry-controlled bionic urethra valve implant, is expected to become the new “gold standard” treatment, mostly as a result of its remote adjustability feature. The fact that the FCD product will set new standards in the ease of implant, the ease of use, having a more modest adverse events profile and lower risk profile as compared to all of the other currently-approved severe UI products and procedures (especially the more invasive products and/or procedures) will just add to the benefits derived from using it. The product is expected to last a lifetime, with little or no deterioration in its efficacy.

Herein lies the problem with many special interest groups, as well as, reasonable proponents and opponents alike. In the best of all worlds, it would be great to identify the optimal treatment for all of the medical diseases and conditions that plague our worldwide population, finding the one procedure or product that would simultaneously provide a longer and better quality-of-life (QoL) for the least amount of cost. However, reaching such a reasonable conclusion steps on the territory of many special interest groups, and has become a “hot button” issue for just about everyone in the industry, both pro and con.

We have discussed this issue in past postings, but constructing a new healthcare system based upon a number of more rational primary foundations (like CER) that would likely result in lower overall costs and better care still runs into substantive opposition from many special interests, and seems to be destined to fail in its most potent form.

It is still important to continue CER research as many times, such research, if it is compelling enough, may greatly change behavior in the industry, in the form of convincing clinicians and surgeons that one type of treatment mode may results in significantly better patient outcomes and lower overall costs (although sometimes just significantly better patient outcomes may trump even higher overall healthcare costs). The difficulty of the argument can be seen in the example of an initial choice (by whoever) of not to treat a patient at all (which would seem to have a cost of zero) even though, ultimately, the probable cost of “not treating” will likely result in much higher overall costs throughout the patient’s life down-the-road (it’s the old “Fram Oil Filter”™ argument; “Pay me now, or pay me later”). Accordingly, these comparative treatment costs must be measured for a patient’s entire prospective history, also taking into consideration the QoL outcomes by some non-cost measures.

In many cases, the CER is not a “slam dunk” but a real comparative measure puzzle. However, in many other cases, there are some standout treatment modes that not only vastly improve the QoL of the patient while experiencing less frequent and less severe adverse events, but also do so at a lower overall total historical cost.

We have made the example before as it relates to the product Precision Medical Devices (PMD) is developing (the Flow Control Device – FCD) to treat severe urinary incontinence (UI) by comparing our product, which will likely be shown to be much more effective (with less adverse events) than the myriad of current UI drug products as our product is expected to optimally treat the severe UI yet have a standard lifetime cost of less than $5.00 per day per patient, which is less than the cost of most of the drugs alone (not even considering the other extraneous costs that are still associated with those less effective treatments).

In short, The PMD-(FCD), a remote-telemetry-controlled bionic urethra valve implant, is expected to become the new “gold standard” treatment of severe UI mostly as a result of its remote adjustability feature. The fact that the FCD product will set new standards in the ease of implant, the ease of use, having a more modest adverse events profile and lower risk profile as compared to all of the other currently-approved severe UI products and procedures (especially the more invasive products and/or procedures) will just add to the benefits derived from using it. The product is expected to last a lifetime, with little or no deterioration in its efficacy at an average projected lifetime cost of less than $5.00 per day.

As a result, here have been significant efforts within the medical community to invent and design new procedures that would accomplish invasive prostate treatments using so-called “nerve sparing” techniques. However, the statistics, although seeing some improvement, are still quite dismal. A high number of men undergo these treatments and still come out with permanent UI and / or erectile dysfunction.

As reported before, a multitude of other medical conditions and diseases result in severe UI. Precision Medical Devices Flow Control Device (PMD-FCD) provides the prospect of re-establishing an optimal level of continence for patients that suffer from severe UI after undergoing an invasive prostate procedure. PMD is closer to bringing to market, a product for the treatment of severe UI. The product is a remote-telemetry controlled bionic urethra valve implant called the Flow-Control Device – FCD.

Of course, the FCD will have a major beneficial effect on the tens of millions of people around the world who not only have severe UI, but also for the many more people who are the spouses or companions of those people, who many times are forced to suffer right along with the patient as the condition is a major factor in the reduction of social interaction of the afflicted patients and their companions.

Imagine a world without any more UI “accidents”.