Healthcare Equipment and Supplies
Company Overview of NeoTract, Inc.
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
Pleasanton, CA 94588
Founded in 2004
Key Executives for NeoTract, Inc.
Co-Founder and Vice President of Research & Development
Compensation as of Fiscal Year 2014.
NeoTract, Inc. Key Developments
NeoTract, Inc. Announces CMS Reimbursement for Innovative Minimally Invasive Procedure for Enlarged Prostate
Nov 10 14
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.
NeoTract, Inc. Receives U.S. FDA De Novo Approval for the UroLift(R) Prostate Implant
Sep 16 13
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
May 7 13
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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