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May 04, 2015 12:37 PM ET

Healthcare Equipment and Supplies

Company Overview of NeoTract, Inc.

Company Overview

NeoTract, Inc. develops and manufactures medical devices for urologists. It offers UroLift System, a minimally invasive device to treat lower urinary tract symptoms due to benign prostatic hyperplasia. The company was incorporated in 2004 and is based in Pleasanton, California.

4473 Willow Road

Suite 100

Pleasanton, CA 94588

United States

Founded in 2004

Phone:

925-401-0700

Fax:

925-401-0697

Key Executives for NeoTract, Inc.

Chief Executive Officer, President and Director
Co-Founder and Chairman
Age: 50
Founder, Chief Technical Officer and Director
Co-Founder and Vice President of Research & Development
Chief Financial Officer
Compensation as of Fiscal Year 2014.

NeoTract, Inc. Key Developments

NeoTract Announces Positive Guidelines from European Association of Urology for Minimally Invasive Treatment for Benign Prostatic Hyperplasia

NeoTract, Inc. announced that the European Association of Urology (EAU) has given the UroLift® System a positive recommendation for the treatment of patients with benign prostatic hyperplasia (BPH) in its newly updated ‘Guidelines for the Management of Non-Neurogenic Male Lower Urinary Tract Symptoms, Including Benign Prostatic Obstruction,’ published in European Urology The guidelines assist practicing urologists in Europe in making informed decisions based on the highest-quality scientific data. The guidelines and recommendations were based on a rigorous systematic review of the published literature on the UroLift System, performed by a panel of experts with urological and epidemiological backgrounds. The review panel graded the clinical evidence supporting the UroLift device Level 1-b, the second-highest level of evidence, denoting evidence obtained from at least one properly designed randomized controlled trial that suggests that the benefits of the clinical service outweigh the potential risks. Three-year results of the L.I.F.T. IDE Study, a multi-center, randomized, blinded U.S. clinical trial, as well as one-year results from the randomized BPH-6 European multi-center randomized study comparing UroLift to transurethral resection of the prostate (TURP), will be presented at the American Urological Association’s annual conference taking place May 15-19 in New Orleans. The UroLift device has received regulatory clearance in the United States, is CE marked in Europe, and is currently available in Denmark, Finland, France, Germany, Italy, The Netherlands, Norway, Spain, Sweden, Turkey and the United Kingdom.

NeoTract, Inc. Announces Publication Showing Sustained Safety and Efficacy Benefits for the Minimally Invasive UroLift® System Treatment for Enlarged Prostate

NeoTract, Inc. announced publication of two-year results from the 206-patient L.I.F.T. IDE Study, a multi-center, randomized, blinded study of the novel UroLift® System for patients with benign prostatic hyperplasia (BPH). The analysis from the L.I.F.T. study shows an 88% superiority of treatment (n=140) over control (n=66) at three months and a sustained therapeutic effect in the UroLift implanted patients at two years. The peak urinary flow rate was increased 4.2 ml per second at three months and two years (p <0.0001). By two years only 7.5% of patients required an additional procedure for lower urinary tract symptoms. Adverse events were typically early, mild and transient. Encrustation did not develop on implants properly placed in the prostate. There was no occurrence of de novo sustained ejaculatory or erectile dysfunction.

NeoTract, Inc. Announces CMS Reimbursement for Innovative Minimally Invasive Procedure for Enlarged Prostate

NeoTract, Inc. announced that the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), has approved two new Category I Current Procedure Terminology (CPT(R)) codes for the UroLift(R) System treatment for benign prostatic hyperplasia (BPH), effective January 1, 2015. BPH, also known as enlarged prostate, is a medical condition in which the prostate gland that surrounds the male urethra becomes enlarged with advancing age and begins to obstruct the urinary system. The condition is common, affecting approximately 37 million men in the United States alone. BPH symptoms include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life. About one in four men experience BPH-related symptoms by age 55, with 90% of men over 70 symptomatic. Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts or ablates prostate tissue to open the blocked urethra. While current surgical options, such as transurethral resection of the prostate (TURP), can be very effective in relieving symptoms, it can also leave patients with permanent side effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm). Treatment with the FDA-cleared UroLift System, the only transprostatic implant system indicated for BPH, involves an outpatient procedure with no cutting, heating, or removing prostate tissue. Category I status, which is reserved for procedures consistent with contemporary medical practice and performed by many physicians in multiple locations, was awarded based on the numerous peer-reviewed publications detailing top-tier clinical studies of the UroLift implant procedure, which demonstrate rapid and durable relief from the urinary symptoms associated with BPH without compromising sexual function. CPT codes 52441 and 52442 were approved by the American Medical Association (AMA) to describe the UroLift transprostatic implant procedure, also known as Prostatic Urethral Lift (PUL). Because of the minimally invasive nature of the treatment, the new codes have been assigned a zero-day global period. The UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure.

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