September 22, 2014 4:49 AM 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
Co-Founder and Chairman
Age: 50
Founder
Co-Founder and Vice President of Research & Development
Chief Financial Officer
Compensation as of Fiscal Year 2014.

NeoTract, Inc. Key Developments

NeoTract, Inc. Receives U.S. FDA De Novo Approval for the UroLift(R) Prostate Implant

NeoTract, Inc. announced that it received De Novo approval from the U.S. Food and Drug Administration (FDA) to market the novel UroLift(R) System, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with Benign Prostatic Hyperplasia (BPH), also known as enlarged prostate. The FDA's action will provide U.S. surgeons and patients access to a treatment option that uniquely reduces urinary symptoms without chemically altering or surgically ablating, cutting or removing prostatic tissue. Data from the recent 206-patient randomized controlled L.I.F.T. study showed patients receiving UroLift implants reported rapid symptomatic improvement, improved urinary flow rates, and sustained sexual function. Patients also experienced a significant improvement in quality of life. BPH is a urological condition in which the prostate gland becomes enlarged with advancing age and begins to obstruct the urinary system. The condition is common, with about one in four men experiencing BPH-related symptoms by age 55, and affecting up to 90% of men in their 70s and 80s. BPH symptoms include sleepless nights and urinary problems can cause loss of productivity, depression and decreased quality of life. The UroLift Prostate Implant provides a minimally invasive alternative to tissue removing surgery for the treatment of BPH. UroLift permanent implants are individually tailored during delivery to transprostatically reshape the prostate thus reducing urethral obstruction directly without incisions, surgical resection or thermal effects on the prostate, often in an outpatient setting which may require only local anesthesia.

NeoTract Announces the Results of the 206-Patient L.I.F.T. IDE Study

NeoTract, Inc. announced the results of the 206-patient L.I.F.T. IDE Study, a multi-center, randomized, blinded study in patients with Benign Prostatic Hyperplasia (BPH). All primary and secondary endpoints were met and the study results corroborated prior published data on the novel UroLift(R) System treatment, a minimally invasive procedure to place permanent UroLift implants. Patients receiving the UroLift implants reported rapid symptomatic improvement, increased urinary flow rates, and preserved sexual function. The final analysis from the L.I.F.T. study shows an 88% superiority of treatment (n=140) over control (n=66) and a sustained therapeutic effect in the UroLift implanted patients, as demonstrated by an 11 point AUA Symptom Index improvement from baseline to 1 year. Importantly, this symptom relief was obtained from a local anesthesia procedure with minimal adverse effects contributing to more rapid relief versus other surgical procedures. Safety analysis (reviewed by an independent data monitoring committee) showed predominantly mild to moderate transurethral side effects (e.g. dysuria, hematuria, urgency) that typically resolved by two weeks. Postoperative catheterization was low with 68% subjects not receiving a catheter and a mean duration of catheter use less than a day. UroLift patients demonstrated a 4 mL/s maximum urinary flow rate improvement that was statistically superior to control. Also, by not chemically altering or surgically damaging the prostate, as with BPH drugs or surgical approaches, a goal of treatment with the UroLift implant is to preserve sexual function while treating lower urinary tract symptoms. There was no occurrence of loss of ejaculatory or erectile function in any study patient.

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