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ARGOMED GETS FDA APPROVAL FOR TREATMENT OF BPH.


ArgoMed Inc., Research Triangle, N.C., an emerging developer and marketer of minimally invasive medical devices for the treatment of urological disorders, has introduced the Thermoflex System Thermoflex system Urology A water-induced thermotherapy system for treating BPH and associated urinary obstruction. See Benign prostatic hypertrophy. , an effective new treatment for benign prostatic hyperplasia benign prostatic hyperplasia
n. Abbr. BPH
A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine.
 (BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
). The Thermoflex System represents a new, effective, and low-cost treatment option for the millions of men with BPH, a non-malignant enlargement of the prostate gland common in older men. In the year 2000, in the U.S. alone, nearly $1 billion will be spent on therapeutic medical products and procedures to treat this condition. With the "baby boomers" now entering their fifties, the age when symptoms of prostatic enlargement begin to appear, that market will continue to grow significantly. In fact, eight out of ten men will, at some time in their lives, develop symptoms of BPH.

"Argomed's new water-induced thermotherapy water-induced thermotherapy Urology An outpatient procedure for managing BPH by introducing heated–60ºC water into the prostatic urethra via a heat-transmitting balloon catheter, destroying a predictable amount of tissue, which is reabsorbed, and the  (WIT) procedure, administered by the Thermoflex System, is a simple, low-cost, pain-free therapy that requires no sedation. WIT is ideally suited for the outpatient setting, and reflects the trend of surgical procedures away from traditional hospital settings," said Richard B. Klein, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of ArgoMed Inc. "Thermotherapy ther·mo·ther·a·py
n.
Medical therapy involving the application of heat.


thermotherapy
 represents an entirely new approach and may have promise to treat other urological conditions in the future, such as chronic prostatitis chronic prostatitis Urology Inflammation of the prostate due to a bacterial infection, associated with UTI, cystitis, urethritis, epididymitis, or acute prostatitis Risk factors Alcoholism, perineal injury, and certain sexual practices, especially anal intercourse.  and prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. ."

The Thermoflex System circulates heated water, precisely controlled at 60 degrees C, through a proprietary catheter, thereby destroying obstructive prostatic tissue. More than 800 procedures have already been performed in an earlier select product launch in Germany and in Italy. ArgoMed's Thermoflex System represents several advantages over existing treatment options such as surgery and prescription medications, which are sometimes associated with complications and side effects Side effects

Effects of a proposed project on other parts of the firm.
 such as sexual dysfunction and incontinence.

In addition, the Thermoflex system requires only topical anesthetic gel and can be performed in a physician's office, thereby eliminating risks associated with general anesthesia. Like other alternative therapies, WIT uses heat to destroy obstructing prostatic tissue. However, WIT uses conductive heat (hot water balloon and pressure) versus radiant energy, which other alternative BPH therapies employ. The result is a more controlled, predictable homogenous homogenous - homogeneous  ablation of the obstructing prostatic tissue. With WIT, urologists will now have the ability to target diseased prostatic tissue while preserving non-affected tissue, and maintaining patient comfort.

ArgoMed recently raised $6 million in a private equity round that was led by Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ.  venture firm, A. M. Pappas & Associates, and included investors from previous financing rounds including Venrock Associates (New York, California), Oxford Bioscience Partners (Boston) and Global Life Sciences (United Kingdom, Germany).

"As a company in the business of developing life science ventures, we immediately recognized the tremendous potential in ArgoMed as it prepared the U.S. launch of an entirely new technology for the treatment of BPH," said Art Pappas, Chairman and CEO of A. M. Pappas & Associates. "As we have done with several other promising companies, AMP&A was able to act as a bridge between investors and ArgoMed."

The capital will be used to support the launch of the Thermoflex System in the U.S., to expand the technology to additional applications, and to hire professional staff in the next year. The combination of receiving FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 clearance to market, as well as a new round of financing, now enables ArgoMed to work with urologists and progressive medical centers to bring the technology to BPH patients nationwide.

Symptoms commonly associated with BPH include the inability to completely empty the bladder, urinary urgency and the need to urinate urinate /uri·nate/ (u´ri-nat) to discharge urine.

u·ri·nate
v.
To excrete urine.



urinate

to void urine.
 frequently. Initial studies indicate that the Thermoflex System results in significant improvement of urinary flow rate. Patients reported a corresponding increase in the quality of their lives after undergoing WIT.

ArgoMed Inc. develops, manufactures and markets minimally invasive thermotherapy technologies to treat BPH and other urologic disorders. The company has developed the Thermoflex(TM) System, a non-surgical, anesthesia- free catheter-based therapy that uses a proprietary technology for the treatment of BPH. The Thermoflex System is currently sold in selected European markets. ArgoMed's corporate offices are in the Research Triangle Park area of North Carolina and the European sales office is based in Hamburg, Germany. An engineering and manufacturing subsidiary is located in Herzilia, Israel.

To receive further details, contact ArgoMed Inc. directly at 1-877-ARGOMED, email to info@argomed.com or send correspondence to 3800 Gateway Centre Boulevard, Suite 308, Morrisville, NC 27560.
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Title Annotation:Thermoflex System for treatment of benign prostatic hyperplasia
Comment:ARGOMED GETS FDA APPROVAL FOR TREATMENT OF BPH.(Thermoflex System for treatment of benign prostatic hyperplasia)
Publication:Biotech Business
Article Type:Product Announcement
Geographic Code:1USA
Date:Nov 1, 1999
Words:717
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