|
Erectile Dysfunction (ED) is a prevalent condition in the aging male population that can have a significant negative impact on quality of life.
Urodynamix is developing NIRS technology to aid in the diagnosis, characterization and treatment of chronic, drug-refractory erectile dysfunction (ED).
Improved ED Diagnostics
Healthcare providers, economic
planners and the public are
concerned about the economic
impact of the development of
safe and effective therapy for ED
for a number of reasons: ED is
highly prevalent, its incidence is
age related, it is a progressive
condition, and it is currently
under-treated.
In 2006, the American Urological Association’s Erectile Dysfunction Clinical Guidelines Panel noted that “new, clinically applicable instruments are needed to diagnose ED and to assess treatment satisfaction.”
Urodynamix's NIRS Penile Blood Flow Monitor is designed to meet this significant unmet need for a non-invasive diagnostic device to help diagnose and guide the treatment of ED.
NIRS ED Technology
There is a significant need for improved ED diagnosis in men who do not respond to conventional treatment with PDE-5 inhibitors (e.g. Viagra®). Urodynamix's proprietary NIRS ED Technology is designed to address this unmet clinical need and help physicians effectively treat the 3 to 5 million men in North America alone who suffer from this condition.
- NIRS ED Technology is based on the Company’s existing NIRS technology platform and uses a new proprietary disposable sensor.
- Initial clinical studies carried out by Urodynamix have shown that NIRS can objectively and reproducibly measure blood flow throughout the penis. A second study of prostate cancer patients is underway to determine whether NIRS can measure differences in penile blood flow before and after bilateral nerve-sparing radical prostatectomy procedures.
Urudynamix's NIRS ED Technology is currently under clinical investigation and is not available for commercial sale. See the NIRS technology section for additional details.
About Erectile Dysfunction (ED)
- According to the National Institutes of Health, an estimated 15 to 30 million men in North America experience chronic erectile dysfunction, and 85% of cases are attributed to physical (“organic”) conditions.
- The incidence of ED increases with age to 5% by age 40 and 15-25% by age 65. The disease affects 34 to 45% of men with diabetes.
- The worldwide prevalence of ED is very high, and within 20 years 322 million men worldwide will be affected.
Since the advent of oral phosphodiesterase (PDE-5) inhibitors such as Viagra® (sildenafil citrate), Levitra® (vardenafil HCl) and Cialis® (tadalafil), primary care physicians have increasingly become the front line in the management of patients complaining of sexual disorders.
However, PDE-5 inhibitors are not without drawbacks: safety fears have prompted labeling changes by regulatory agencies, the response rate is far from universal, and costs have created controversy over coverage by insurance companies.
- PDE-5 inhibitors have been used by over 38 million men worldwide, and are a first line therapy for most men with ED despite the fact that efficacy ranges from only 71 to 76% (vs. 22 to 24% with placebo).
- More than 20% of men affected by ED, or 3 to 5 million men in the United States alone, do not respond to medical treatment with oral PDE-5 inhibitors and require alternative diagnosis and treatment.
- In addition to sexual issues, the measurement of penile blood flow is of increasing interest because ED may be an early warning sign of heart disease. The Wall Street Journal recently reported that “men who aren’t helped by [oral PDE-5 inhibitors] may be at higher risk for heart troubles and a vascular study of the penile arteries might be recommended.”
Suggested Further Reading and References:
|
