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MAPLE GROVE, Minn., Jan. 3, 2018 /PRNewswire/ -- NxThera, Inc., a medical device company pioneering the application of its Convective Water Vapor Energy (WAVE®) platform technology to treat endourological conditions, announced the three-year outcomes data from the Rez?m II pivotal clinical trial of its minimally invasive Rez?m® System, demonstrating significant, effective and durable lower urinary tract symptom (LUTS) relief, improved quality of life and preserved sexual function for men treated for benign prostatic hyperplasia (BPH). The outcomes were recently published in the January 2018 issue of Urology.
The study, entitled, "Three-Year Outcomes of the Prospective, Randomized Controlled Rez?m System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia," was co-authored by Dr. Kevin McVary, co-principal investigator and professor, Division of Urology at Southern Illinois University School of Medicine, and Dr. Claus Roehrborn, co-principal investigator and professor and chair, Division of Urology at University of Texas Southwestern Medical Center. The outcomes demonstrate significant LUTS relief that remained durable at three years after treatment with the Rez?m System, which can be performed in an office or outpatient setting.
"Rez?m warrants consideration as a first-line treatment for BPH due to the durability of LUTS relief out to three years, along with its exceptional safety profile and no reported occurrences of erectile dysfunction. Additionally, Rez?m is a highly cost-effective solution for the healthcare system due to its low medical or surgical retreatment rate, including the ability to treat men with median lobe and hyperplastic central zone tissue," said Dr. McVary. "Symptomatic men who wish to move beyond watchful waiting or who have become dissatisfied with medical management should consider Rez?m as a low-risk treatment that is positioned between classical medical management and more invasive surgical approaches. The one-time procedure provides rapid, significant and durable relief of LUTS/BPH in contrast to a lifetime commitment of pharmaceutical agents in which there are undesirable side effects and an inferior symptom improvement."
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, Rez?m uses the natural thermal energy stored in water vapor, or steam, to treat the enlarged 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. Over the next few weeks, the body's natural healing response eliminates the treated tissue, shrinking the prostate. With the obstructive tissue removed, the urethra opens, reducing BPH symptoms and improving the patient's quality of life and ability to urinate, while preserving sexual function. To date, more than 17,000 men have been effectively treated with the Rez?m System across the U.S. and Europe.
"This positive three-year data clearly demonstrates compelling sustained clinical outcomes that provide urologists with an effective minimally invasive treatment option for their patients who may have been watchfully waiting, or treating their LUTS with medications," said Bob Paulson, president and CEO of NxThera. "Rez?m is transforming the BPH treatment experience for urologists and their patients by providing a versatile, in-office or outpatient treatment option that allows men suffering from BPH to resume their quality of life and preserve sexual function."
The Rez?m II randomized, controlled trial enrolled 197 men from 15 sites in the United States, and one-, two- and now three-year data from this trial has demonstrated durable symptom relief with preserved sexual function in patients who were treated with the Rez?m System. Key findings of this study include:
About NxThera and the Rez?m SystemNxThera 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 Rez?m 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 www.rezum.com.
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The study, entitled, "Three-Year Outcomes of the Prospective, Randomized Controlled Rez?m System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia," was co-authored by Dr. Kevin McVary, co-principal investigator and professor, Division of Urology at Southern Illinois University School of Medicine, and Dr. Claus Roehrborn, co-principal investigator and professor and chair, Division of Urology at University of Texas Southwestern Medical Center. The outcomes demonstrate significant LUTS relief that remained durable at three years after treatment with the Rez?m System, which can be performed in an office or outpatient setting.
"Rez?m warrants consideration as a first-line treatment for BPH due to the durability of LUTS relief out to three years, along with its exceptional safety profile and no reported occurrences of erectile dysfunction. Additionally, Rez?m is a highly cost-effective solution for the healthcare system due to its low medical or surgical retreatment rate, including the ability to treat men with median lobe and hyperplastic central zone tissue," said Dr. McVary. "Symptomatic men who wish to move beyond watchful waiting or who have become dissatisfied with medical management should consider Rez?m as a low-risk treatment that is positioned between classical medical management and more invasive surgical approaches. The one-time procedure provides rapid, significant and durable relief of LUTS/BPH in contrast to a lifetime commitment of pharmaceutical agents in which there are undesirable side effects and an inferior symptom improvement."
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, Rez?m uses the natural thermal energy stored in water vapor, or steam, to treat the enlarged 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. Over the next few weeks, the body's natural healing response eliminates the treated tissue, shrinking the prostate. With the obstructive tissue removed, the urethra opens, reducing BPH symptoms and improving the patient's quality of life and ability to urinate, while preserving sexual function. To date, more than 17,000 men have been effectively treated with the Rez?m System across the U.S. and Europe.
"This positive three-year data clearly demonstrates compelling sustained clinical outcomes that provide urologists with an effective minimally invasive treatment option for their patients who may have been watchfully waiting, or treating their LUTS with medications," said Bob Paulson, president and CEO of NxThera. "Rez?m is transforming the BPH treatment experience for urologists and their patients by providing a versatile, in-office or outpatient treatment option that allows men suffering from BPH to resume their quality of life and preserve sexual function."
The Rez?m II randomized, controlled trial enrolled 197 men from 15 sites in the United States, and one-, two- and now three-year data from this trial has demonstrated durable symptom relief with preserved sexual function in patients who were treated with the Rez?m System. Key findings of this study include:
- Clinically significant and durable improvement in symptomatic relief reflected in International Prostate Symptom Score (IPSS) and urinary flow rate (Qmax) outcomes in subjects with moderate to severe LUTS through three years (p<0.0001).
- The seven individual IPSS domains, including urgency and nocturia, indicated significant relief of symptoms at one month and remained significant throughout three years (p<0.0001).
- No latent related adverse events occurred and no de novo erectile dysfunction was reported.
- Sexual function was preserved in patients treated with the Rez?m System, as measured via the International Index of Erectile Function (IIEF-15) and Male Sexual Health Questionnaire (MSHQ) through three years of follow-up. The ejaculatory bother score (MSHQ-EjD) improved over baseline from 12 to 36 months (p<0.004).
- Thirty of the patients received treatment to the median lobe or elevated central zone, in addition to treating the lateral lobes; these 30 patients not only demonstrated significant improvements in symptom (IPSS) and urinary flow rates (Qmax), but also demonstrated decreased post-voiding residual (PVR) urine from 24 months to 36 months (p<0.04).
- Surgical retreatment rate was 4.4 percent (six out of 135 subjects) over three years of follow-up. Four of these six secondary interventions were related to an untreated median lobe at baseline.
About NxThera and the Rez?m SystemNxThera 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 Rez?m 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 www.rezum.com.
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SOURCE NxThera, Inc.
