Prostate disease is dramatically increasing in prevalence, and more than 100 million digital rectal exams are performed each year in the United States, Europe, and Japan to screen for prostate cancer. 

Urodynamix is developing NIRS technology to aid in the diagnosis and treatment of prostate cancer and prostate enlargement (BPH).

NIRS Prostate Cancer Imaging

Urodynamix's NIRS DRE™ Technology is designed to provide the world’s first office based imaging device for the measurement of blood flow in the prostate to aid in the diagnosis and treatment of prostate cancer.

The digital rectal exam, or DRE, is a common prostate cancer screening test used to examine the rectum. A doctor or nurse inserts a lubricated, gloved finger into the lower part of the rectum to feel the prostate for lumps or anything else that seems unusual.

Unfortunately, Current prostate cancer screening tests like the DRE and the prostate specific antigen (PSA) blood test are plagued by false negatives and inconclusive positives, and as a result patients are often forced to endure the uncertain circumstance known as watchful waiting.

NIRS DRE™ Technology

Published reports indicate that the sensitivity of conventional DRE may be as low as 53.2% [1]. Urodynamix beleives that measuring blood flow in the prostate gland during DRE could improve doctors’ ability to detect and localize regions of abnormal blood flow caused by prostate cancer (see below).

NIRS DRE™ Technology may also increase the sensitivity of DRE and more accurately determine where cancer is located within the prostate, allowing doctors to deliver more targeted local treatments such as drugs, radiation seeds or probes that deliver energy to destroy cancer cells to reduce side effects such as ED and incontinence.

The NIRS DRE™ system consists of a finger-mounted NIRS sensor that transmits light into the prostate gland during the DRE. A detector monitors blood flow in the various quadrants of the prostate gland, and the physician's tactile sensation is preserved.

In the United States, Europe and Japan, the target market for Urodynamix's NIRS DRE™ prostate imaging test consists of an estimated 150 million men whom the American Cancer Society believes should be offered a DRE yearly beginning at age 50 in average risk populations and at age 45 in high risk populations, such as African Americans and men who have a first-degree relative diagnosed with prostate cancer [2].

Prostate Cancer Statistics

• Prostate cancer is the most commonly diagnosed non-skin cancer in North America and the third most common cause of cancer death in men. 

• Every year an estimated 250,000 new cases of prostate cancer are diagnosed in North America and over 30,000 men die from the disease

• One in 10 men in United States will have prostate cancer diagnosed in his lifetime [3].

[1] Mistry, K et al. Meta-Analysis of Prostate-Specific Antigen and Digital Rectal Examination as Screening Tests for Prostate Carcinoma. The Journal of the American Board of Family Practice 2003; 16:95-101.

[2] Smith RA et al. American Cancer Society Guidelines for the Early Detection of Cancer. A Cancer Journal for Clinicians 2006; 56:11-25.

[3] Godley PA. Prostate cancer screening: promise and peril—a review. Cancer Detection Prevention 1999;  23:316-24.

Benign Prostatic Hyperplasia (BPH)

Over 23 million men in the United States, Europe, and Japan suffer from moderate to severe symptoms of prostate enlargement or BPH.

• Benign prostatic hyperplasia (BPH), a non-malignant enlargement of the prostate, is a chronic condition that is often accompanied by lower urinary tract symptoms and an inability to urinate normally.

• In the United States, approximately 20 million men over the age of 50 years suffer from BPH, resulting in an estimated 6.4 million office visits and 400,000 hospital admissions annually.

• Over the last decade there has been a dramatic increase in minimally invasive surgical therapies like transurethral microwave thermotherapy or TUMT [1].

•  Data from the Centers for Medicare and Medicaid Services (CMS) indicate 38% annual growth in the number of TUMT procedures performed on Medicare patients in the United States over the past five years [2]. It is believed that the volume of these procedures will continue to increase dramatically as the population ages and the use of more invasive surgical procedures continues to decline.

• Minimally invasive therapies for BPH are usually performed in a urologist’s office or clinic using local anaesthesia and result in less pain and faster recovery than conventional transurethral resection of the prostate (TURP). Minimally invasive therapies are also more cost effective than TURP since no hospital admission is required.

• The trend toward less invasive, in-office thermotherapy is changing the face of medical management for BPH, and in 2005 TUMT ranked among the top 110 procedures in allowed charges at the U.S. Centers for Medicare and Medicaid Services (CMS).

[1] Harkaway RC and Issa MM. Medical and minimally invasive therapies for the treatment of benign prostatic hyperplasia. Prostate Cancer and Prostatic Diseases 2006; 9: 204-214

[2] Centers for Medicare and Medicaid Services (CMS) utilization data - Part B claims data