September 21, 2017 9:43 PM ET

Healthcare Equipment and Supplies

Company Overview of NxThera, Inc.

Company Overview

NxThera, Inc., a medical device company, specializes in the application of its Convective Water Vapor Energy (WAVE) platform technology to treat endourological conditions. The company develops medical devices to treat patients suffering from urologic conditions, such as benign prostatic hyperplasia (BPH), prostate cancer, and kidney cancer. It provides Rezum System that uses sterile water vapor (steam) to address BPH by delivering targeted controlled doses of stored thermal energy directly to the region of the prostate gland with the obstructive tissue that causes BPH. The company was incorporated in 2008 and is based in Maple Grove, Minnesota.

7351 Kirkwood Lane North

Suite 138

Maple Grove, MN 55369

United States

Founded in 2008

Phone:

763-515-0404

Key Executives for NxThera, Inc.

Chief Executive Officer, President and Director
Age: 60
Co-Founder, Chief Technology Officer and Director
Chief Financial Officer and Senior Vice President of Commercialization
Chief Development & Operations Officer
Age: 62
Director of Program Management
Compensation as of Fiscal Year 2017.

NxThera, Inc. Key Developments

NxThera, Inc. Announces Positive Results of Post-Market Study of its Minimally Invasive Rezum® System to Treat BPH

NxThera, Inc. announced that new data from the first post-market clinical evaluation of its minimally invasive Rezu¯m System demonstrated significant, safe and effective urinary symptom relief, improved quality of life and preserved sexual function for men treated for benign prostatic hyperplasia (BPH). The multi-center, post-FDA clearance study included 131 men in a real-world clinical setting, producing positive, rapid and durable results that align with outcomes demonstrated in the company's earlier pivotal trial. The data was recently published in Research and Reports in Urology. Developed by NxThera, Rezum is performed in a clinic or out-patient setting in the U.S. Rezum 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 extra tissue removed, the urethra opens, reducing BPH symptoms and improving the patient's quality of life. Studies have shown that the Rezum treatment 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 15,000 men have been effectively treated with the Rezum System across the U.S. and Europe. This retrospective study of the Rezum System for treatment of lower urinary tract symptoms (LUTS) caused by BPH is the first "real world" study where there were many differences in the conditions of the patients who were treated, including older patients, patients with significant variations in the size of their prostates, and patients who had previously unsuccessfully tried other options to treat their BPH symptoms, such as long-term medications or more invasive treatments. All Rezum procedures were performed in a clinic or out-patient setting, and all treatments were successfully completed. Pre- and post-procedure assessments included International Prostate Symptom Score (IPSS), quality of life (QoL) index, peak urinary flow rate, voided volume and post void residual (PVR) volume. Clinical and statistical improvement of LUTS based on IPSS, QoL and PVR was observed through 12 months. Additionally, the presence of a median lobe and/or enlarged central zone was identified and treated in 54 patients, with significant improvement in symptoms achieved.

NxThera, Inc. Announces Presentation of Two-Year Outcomes Data for Its Minimally Invasive Rezum® System for Enlarged Prostate Treatment at the 2017 American Urological Association Annual Meeting

NxThera, Inc. announced the two-year outcomes data from the Rezum II pivotal clinical trial of its minimally invasive Rezum® System to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) at the 2017 American Urological Association (AUA) annual meeting in Boston. BPH is one of the top 10 most common and costly conditions affecting 12 million American men aged 50 or older, with nearly 800,000 newly diagnosed each year. BPH causes significant quality of life issues including waking up multiple times during the night to urinate, frequency, urgency, irregular and weak urinary flow, anxiety, challenges with sexual function and limitation in daily activities. The Rezum System uses radiofrequency current to create thermal energy that is convectively delivered to obstructive prostate tissue through targeted, precise treatments. The treated tissue is then resorbed by the body's immune system which alleviates the symptoms of BPH and improves patients' quality of life and ability to urinate, while preserving sexual function. In addition to the obstructive tissue in the lateral lobes or transition zone of the prostate, two-of-three men diagnosed with BPH also have obstructive tissue under the floor of the urethra in the central zone of the prostate which requires treatment. The clinical data from the Rezum pivotal study demonstrates that urologists can use the Rezum System to effectively treat obstructive prostate tissue in either region. The Rezum II randomized, controlled trial enrolled 197 patients across 15 centers in the United States, and one and two-year data from this trial has demonstrated durable symptom reduction and preserved sexual function in patients who were treated with the Rezum System. In addition, of the 61 patients in the control arm of the study, 53 elected and qualified to cross over and receive a treatment with the Rezum System. Key findings of this study include: Clinically significant and durable improvement in urinary symptoms through two years, as measured by a decrease in International Prostate Symptom Score (IPSS) of 11.2 points (-51%). Clinically significant and durable improvement in urinary flow rate (Qmax) of +6.2 mL/sec (increase of 68%) at three months that remained significantly improved at two years. For the 75% of patients in this study who had severe LUTS (a baseline IPSS =19), IPSS improvement was -13.0 points at two years. Without exception, the seven individual IPSS domains, including urgency and nocturia, reflected the significant relief of symptoms over two years, p<0.0001. Overactive bladder bother and impact on quality of life improved significantly through two years, p<0.0001. ICS male incontinence scores improved significantly through two years, p<0.0001. Median lobe treatments were performed in 58 of 188 (31%) patients in both arms of the trial; those with and without median lobe treatments achieved similar improvements in both IPSS and Qmax. Sexual function was preserved in patients treated with the Rezum System, as measured via the International Index of Erectile Function (IIEF-15) and Male Sexual Health Questionnaire (MSHQ).

NxThera, Inc. Presents at 2016 Canaccord Genuity Medical Technology & Diagnostics Forum, Nov-17-2016 02:00 PM

NxThera, Inc. Presents at 2016 Canaccord Genuity Medical Technology & Diagnostics Forum, Nov-17-2016 02:00 PM. Venue: Westin Grand Central, 212 East 42nd Street, New York, New York, United States.

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