Three Year Published Data Demonstrates Durability of VidaMed's TUNA Procedure
FREMONT, Calif., Oct. 22 /PRNewswire/ -- VidaMed, Inc. (Nasdaq: VIDA) announced today the publication of a two part article in a peer reviewed urological journal, Infections in Urology. The article, authored by Dr. Muta Issa of Emory University, confirmed the long-term efficacy, cost effectiveness and durability of VidaMed's TUNA Procedure, used to treat the symptoms associated with enlarged prostate disease, or Benign Prostatic Hyperplasia (BPH).
The article reviewed the results of 11 studies conducted worldwide of 546 men, treated for BPH with the TUNA Procedure, and resulted in a statistically significant reduction in the symptoms of the condition. Follow-up monitoring of 88 patients, 36 months after treatment, demonstrated sustained improvement. Additionally, the article concluded that for the experienced urologist, more than 90% of patients can undergo the TUNA Procedure under local anesthesia.
Further documentation of the TUNA Procedure's safety and durability was presented by Dr. Michael J. Naslund of the University of Maryland at the Mid-Atlantic American Urological Association (AUA) meeting earlier this month. Dr. Naslund presented one-, two-, and three-year results from the randomized U.S. clinical trial of 121 patients. This is follow-up data to the 1-year U.S. randomized trial as published in The Journal of Urology, May 1998 by Dr. Reginald Bruskewitz of the University of Wisconsin and was included in the 11 study summary as published in Infections in Urology. Similar to the worldwide summary results, this study resulted in improved symptoms with few side effects and with no sexual dysfunction. This data will continue to be presented at various AUA Sectional meetings in the coming months.
David Illingworth, VidaMed President and Chief Executive Officer said, "The article published in Infections in Urology and the follow-up data presented, provide additional clinical evidence that the TUNA Procedure is efficacious, cost effective and durable over three years. The availability of long-term peer reviewed data in the past has been instrumental in placing TUNA on the agenda of several state Medicare review meetings and subsequently obtaining Medicare reimbursement approval. We are confident that this new data will continue to assist in VidaMed's efforts to secure favorable reimbursement in those states not yet providing reimbursement for the TUNA Procedure. To date, 14 states have approved Medicare reimbursement. We are projecting a minimum of eight additional states to announce positive Medicare coverage by the end of the year, with more states to follow shortly thereafter."
Illingworth added, "We are very pleased that this data supports our belief and that of many leading urologists, that the TUNA Procedure is an ideal minimally invasive BPH treatment for patients who have failed drug therapy, while avoiding the risks associated with an invasive and costly surgical treatment."
VidaMed designs, develops, manufactures and markets technologically and clinically advanced cost-effective systems for the treatment of urological conditions. The company's primary product, the VidaMed TUNA System, is designed to offer a minimally invasive alternative for the treatment of symptoms associated with enlarged prostate disease, or Benign Prostatic Hyperplasia (BPH). Approximately 23 million men worldwide, including 13 million men in the United States suffer from BPH. VidaMed's TUNA Procedure requires minimal anesthesia, and based upon currently available published clinical data, has the least post-procedural complications of any thermal or surgical procedure to treat BPH. Founded in 1992, VidaMed is headquartered in the Silicon Valley in Fremont, California.
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A minimum of Eight states by years end... that's almost a state per week.
-DavidCG |
