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Devices Urology Product Launch

 News Release - March 23, 2017

Revolutionary UroLift(R) System Launches in Ireland

Innovative UroLift System to Treat Enlarged Prostate ready for roll out to Irish patients nationally

PLEASANTON, California, March 23, 2017 -- (Healthcare Sales & Marketing Network) -- NeoTract, Inc., announced today that the largest private health insurer in Ireland, Vhi Group, is to reimburse the minimally invasive UroLift System in the country - making a day case surgical treatment requiring no cutting, heating or removal of tissue available for the first time to thousands of Irish men with a urological condition described as very common in older males.

The UroLift System treats symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men. Delivered during a minimally-invasive procedure, the UroLift implants act like window curtain tie-backs to hold the lobes of an enlarged prostate open. Patients typically recover from the procedure quickly, and often return to their normal routines with minimal downtime.

"We're delighted that a major health insurer like Vhi has backed the uniquely robust clinical data showing the benefits of the UroLift System to make it available in Ireland," says Justin Hall, VP and General Manager EMEA for NeoTract Inc. "Given the very long waiting lists for men awaiting urological treatment in Ireland, we think this decision by Vhi is timely. In Northern Ireland's capital, Belfast, the largest NHS Trust in the whole of the UK, is now offering the UroLift System as well. The waiting time to access this treatment in the NHS may be in excess of 12 months due to long public waiting lists in Northern Ireland. However, Kingsbridge Private Hospital Belfast does offer the treatment immediately for patients who are able to avail of this option.

Across Europe, government payors and private health insurers alike are realizing the benefits the treatment can bring to the whole system. This procedure would allow more patients to be treated as the procedure is quicker and more cost effective to perform than conventional treatment and has fewer complications associated with it. As the UroLift System is used more widely and patient pathways across Europe are improved, we will see further benefits as the treatment is used in an ambulatory, rather than just a day case setting, so the benefits for patients that we've seen thus far, is, in fact, just the beginning."

The first hospital to offer the treatment in the Republic of Ireland is the Kingsbridge Hospital in Sligo, to start imminently.

Founder of 3fivetwo Hospital Group, which runs Kingsbridge Private Hospital in Sligo, Dr Suresh Tharma, says: "We are very excited to be able to offer the UroLift System to patients in the Republic of Ireland for the first time. This is a game changing treatment - offering demonstrably sound evidence of reduced risk of downsides compared to conventional treatment. The UroLift System reduces the likelihood for surgical complications such as hemorrhage - a common event that remains a risk even days after surgery[1], the need for a long recuperation and catheterisation post surgery. The UroLift System is a procedure delivering a long-term solution with lower risks and is great news for Irish men with the prevalent condition of symptoms arising from an enlarged prostate. 3fivetwo pioneered this treatment in our Kingsbridge Private Hospital in Belfast, and we know what a life changing difference it can make to our patients."

Mr. Rustom Manecksha, Consultant Urological Surgeon at St. James' & Tallaght Hospitals, and Senior Clinical Lecturer, Trinity College, Dublin, was involved in trials of the UroLift device 6 years ago when he worked in Australia. Mr. Manecksha says: "Published data about the UroLift device and the experience of public healthcare systems around Europe has demonstrated the treatment's potential to help tackle waiting list, theatre and ward capacity issues within Government-funded health systems.

"In my view, an early evaluation of its potential positive impact for the HSE would be an excellent step forward."

Data from clinical trials showed that patients receiving the UroLift System treatment reported rapid improvement in urinary symptoms and flow rate, while not experiencing new onset, sustained sexual dysfunction, an otherwise common side effect of surgery. Patients also experienced a significant improvement in quality of life.

About Benign Prostatic Hyperplasia (BPH)

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 500 million men worldwide. BPH symptoms include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life.

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 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).

About the UroLift® System

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. The UroLift System received positive NICE guidance and is FDA-cleared. It is available in the U.S., Europe, Australia, Canada and Mexico. Learn more at http://www.UroLift.co.uk.

[1] Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate Chi-Hang Yee, Joseph Hon-Ming Wong, Peter Ka-Fung Chiu, Jeremy Yuen-Chun Teoh, Chi-Kwok Chan, Eddie Shu-Yin Chan, See-Ming Hou, Chi-Fai Ng Urology Annals Dec 2016


Source: NeoTract

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