NxThera Announces Data Demonstrating the Rezūm® System for BPH Provides Effective and Durable Results, Lower Clinical Progression Rates Compared to BPH Medication Use

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Cohort data comes from the Medical Therapy of Prostatic Symptoms (MTOPS) Trial, evaluation recently published in The Journal of Urology

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In contrast with daily use of medical therapy, water vapor thermal therapy is a one-time procedure with transient perioperative side effects, no requirement for general anesthesia, and preservation of sexual function.

NxThera, Inc., a medical device company pioneering the application of its Convective Water Vapor Energy (WAVE®) platform technology to treat endourological conditions, announced study findings that demonstrate its Rezūm® System provides effective and durable improvements in benign prostatic hyperplasia (BPH) symptom scores with clinical progression rates five times lower when compared to daily, long-term use of pharmaceutical agents three years after treatment. These findings were the result of an evaluation of long-term outcomes of treatment for lower urinary tract symptoms due to BPH that compared Rezūm, a one-time water vapor thermal therapy procedure, with daily medical therapy in cohorts from the National Institute of Diabetes and Digestive and Kidney (NIDDK) sponsored Medical Therapy of Prostatic Symptoms (MTOPS) study. The outcomes were recently published in The Journal of Urology.

The evaluation, entitled “Three-year treatment outcomes of water vapor thermal therapy (Rezūm System) compared to doxazosin, finasteride and combination drug therapy for men with benign prostatic hyperplasia: cohort data from the Medical Therapy of Prostatic Symptoms (MTOPS) Trial,” was co-authored by urologists at the Southern Illinois University School of Medicine.

“In contrast with daily use of medical therapy, water vapor thermal therapy is a one-time procedure with transient perioperative side effects, no requirement for general anesthesia, and preservation of sexual function,” said Dr. Kevin McVary. “Adherence to long-term medical therapy with one or a combination of agents is imperative for good clinical outcomes. However, lack of compliance with medications is common, as more than 60 percent of men discontinue BPH medications within the first year. Additionally, these results support that water vapor thermal therapy compares favorably to medication use with advantages in symptom relief, increased urine flow and a very low rate of progression.”

BPH is one of the top 10 most common and costly conditions affecting 14 million American men aged 50 or older, with nearly one million new diagnoses each year. Developed by NxThera, Rezūm is performed in a physician office or outpatient setting. Rezūm uses the natural thermal energy stored in water vapor, or steam, to treat the enlarged and obstructive prostate tissue that causes BPH symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. The water vapor is delivered into the targeted prostate tissue and when the vapor contacts the tissue it condenses, releasing the stored thermal energy, causing the obstructive prostate tissue cells to die. In the weeks following a Rezūm procedure, the body’s natural healing response eliminates the treated tissue, shrinking the prostate. As the extra tissue is removed, the urethra opens, reducing BPH symptoms and improving the patient’s quality of life and ability to urinate, while preserving sexual function. Studies have shown that the Rezūm treatment provides durable symptom relief and allows men to retain sexual function unlike surgical BPH treatments, which typically have higher incidences of long-term sexual side effects. To date, more than 22,000 men have been effectively treated with the Rezūm System across the U.S. and Europe.

“For the past two decades, despite the high cost and lack of compliance, pharmaceutical treatment has been the go-to first-line therapy for the majority of patients suffering from symptoms related to BPH,” said Bob Paulson, president and CEO of NxThera. “The results from this study demonstrate a rate of BPH clinical progression three years after treatment that is five times lower in patients treated with Rezūm as compared to those taking daily BPH medications. We are pleased to offer men a solution that helps them regain their quality of life without the hassle or negative side effects of taking medications daily for the long-term.”

Three-year data from the trial demonstrates durable symptom reduction and preserved sexual function in patients who were treated with the minimally invasive Rezūm System, helping men avoid taking bothersome daily BPH medications to deal with lower urinary tract symptoms caused by BPH -- instead treating the underlying cause of the symptoms and improving their quality of life.

About NxThera and the Rezūm System
NxThera pioneered its Convective Water Vapor Energy (WAVE®) platform technology to treat a variety of endourological conditions, beginning with BPH. The company is conducting advanced development and clinical research to potentially expand application of its technology to include the targeted treatment of cancerous prostate, kidney and bladder tissue as well as OAB. NxThera’s FDA-cleared Rezūm System is indicated to treat symptoms of BPH using thermal energy that is convectively delivered to obstructive prostate tissue in targeted, precise treatments, with minimal discomfort. Three-year clinical data demonstrates sustained improvements in LUTS, urine flow, quality of life, and preservation of sexual function. Founded in 2008, NxThera is located in Maple Grove, Minn. For more information, visit http://www.rezum.com.

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Shelli Lissick
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