UK Government Names UroLift® System to be Fast Track Funded for the NHS as a Strategically Important Product to Improve UK Healthcare

LONDON, November 7, 2016 /PRNewswire/ --

The UK Government's two-year project to identify products and methods to improve patient care and efficiencies in the NHS - the Accelerated Access Review - names the UroLift System as having "transformative designation" and will get new national accelerated funding 

The UroLift System treatment for enlarged prostate has been highlighted as a strategically important product for the future of the NHS, as one of a handful of disruptive healthcare technologies that can improve the UK's public healthcare system, in a new report and funding mechanism for innovations by the UK Government.

     (Logo: http://photos.prnewswire.com/prnh/20161104/436352LOGO )

     (Photo: http://photos.prnewswire.com/prnh/20161104/436350 ) 
 

The Accelerated Access Review (AAR), launched in 2014 and chaired by Sir Hugh Taylor, was asked to make recommendations on how to accelerate access for NHS patients to innovative medicines, medical technologies, diagnostics and digital products and to make the UK the best place in the world to design, develop and deploy these innovations.

NHS England has also announced that, following medical review, six strategically important medtech devices, one of which is the UroLift System, will be fast track funded for the first time. The UroLift System is part of a new Innovation and Technology Tariff, to be deployed from April 1 2017. NHS England says the new tariff will "cut the hassle experienced by clinicians and innovators in getting uptake and spread across the NHS".

NHS England Chief Executive Simon Stevens said: "The NHS has a proud track record of world firsts in medical innovation but getting wide uptake has so far been too slow. Our new payment system brings clarity on fast track funding to get groundbreaking new treatments and technologies to NHS patients. Many of them not only improve care but will save the NHS money too."

Welcoming the AAR report, Lord Prior of Brampton said that the report highlights the ambition of the UK Government to "secure its position as a global leader in medical innovation" and that "the financial pressures on the NHS means it is more important than ever to ensure patients can access the most cost-effective new innovations in a way that is affordable and sustainable."

The news comes as NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, announces key gains in European government healthcare system reimbursement in multiple markets.

In the UK, the UroLift System is now being offered by multiple publicly-funded NHS hospitals in every region of England, as well as in Wales and Northern Ireland, following positive NICE (National Institute for Health and Care Excellence) guidance based on a review of the economic and clinical benefits and revised tariff coding in September of last year.

NeoTract's EMEA Vice President and General Manager, Justin Hall, says: "We at NeoTract are delighted by the announcement that we are one of only six special innovations designated for the new fast track funding mechanism and also that there is also specific mention of the UroLift System in this major strategic government report as one of a small handful of innovations that the Department of Health consider to be capable of eliciting a step change in costs or outcomes.

"It is a considerable honour for the UroLift System to be singled out for both the Innovation and Technology Tariff and as a case study in the AAR report and fully validates the rigorous milestones we've crossed this year - a pivotal year for the UroLift System in Europe. From the presentation of our four-year durability results of the multi-national L.I.F.T. randomised study and the two year results of the multi-national BPH6 randomised study, as well as our new Level 1A endorsement from the European Association of Urology, based on our robust mid range clinical data: we're poised to make our life-changing technology available to every eligible man with BPH in Europe.

"I think the mention in the AAR is just the beginning of payors realizing the huge benefits the treatment can bring to the whole system. 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 impressive cost and efficiency savings we've seen thus far, are, in fact, just the beginning."

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 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 and by age 70, over 80 percent of men suffer from BPH.

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 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.

About NeoTract  

NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company's initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at http://www.NeoTract.com.

UroLift UK-based Customer Services Team: Tel: + 44-330-088-9549 

MAC00368-01 Rev A

SOURCE NeoTract