Business Wire

NeoTract Announces Publication of Five-Year Results from Pivotal Trial of the UroLift® System

30.6.2017 12:00 | Business Wire

Del

NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced publication of the five-year results of the company’s pivotal, randomized L.I.F.T. IDE study in the Canadian Journal of Urology. The study evaluated the safety and effectiveness of the company’s novel UroLift® System as a treatment for patients with symptomatic benign prostatic hyperplasia (BPH), or enlarged prostate.

In the publication, the authors conclude that the five-year results from the study demonstrate that the UroLift System “has reached maturity as a standard of care for BPH.”

“These results demonstrate both the clinical advantages of the minimally invasive UroLift System as well as its definitive five-year durability,” said Claus Roehrborn, M.D., lead author of the study and professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas, who served as co-principal investigator for the L.I.F.T. clinical program. “From the clinician’s perspective, the procedure is easily learned and quickly performed. For men, it can offer a solution with a better risk profile than traditional BPH surgery, the lowest postoperative catheter requirement of any available BPH procedure, significant improvement of symptoms by two weeks, with sustained relief to five years.”

The study’s authors note that BPH is a quality of life disease, and that treatment options focus on improving quality of life. For many men, improving lower urinary symptoms while inadvertently damaging sexual function, causing incontinence, or exposing them to other safety concerns “may not result in a net positive health outcome.” UroLift System treatment, in contrast, “has been demonstrated to be tolerable under local anesthesia in the office setting, to offer rapid recovery and relief typically without the need for postoperative catheter, to provide improvements in symptoms, flow and quality of life through five years, and to uniquely preserve both ejaculatory and erectile function.”

“We’re thrilled about the positive momentum for this treatment, with growing clinical adoption around the world and tens of thousands of men with lives that have been changed for the better,” said Dave Amerson, president and CEO, NeoTract, Inc. “Payors are recognizing the value of the UroLift System as well, as we estimate more than 70 percent of American men with BPH now covered. We look forward to continuing to make a positive impact for men with this extremely common condition.”

Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:

• A highly tolerable, minimally invasive procedural experience;

• Rapid reduction of symptoms after the procedure while preserving sexual function;

• Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively;

• Quality of life (QoL) score improvement of 50% over five years;

• A durable treatment with a low surgical retreatment rate of 2-3% per year.

The prospective, randomized, sham controlled, blinded study of the safety and effectiveness of the procedure was performed across 19 centers in the United States, Canada and Australia. A total of 430 subjects were assessed, from which 206 were deemed eligible and enrolled between February and December of 2011. Of those assessed for randomization, 23 (5.3%) were excluded for an obstructive median lobe. Subjects were excluded only if it was deemed cystoscopically that lateral lobe distraction would not mitigate obstruction.

The trial participants were men 50 years of age or older, with International Prostate Symptom Scores of 13 or higher. The subjects were followed 5 years and assessed on symptom response (IPSS), quality of life (IPSS QOL and BPH Impact Index, BPHII), peak flow rate (Qmax), sexual function (International Index of Erectile Function, IIEF, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction, MSHQ-EjD) and adverse events.

Nearly 40 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include interrupted sleep 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 medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the alternative has traditionally been surgery that cuts, heats or removes prostate tissue to open the blocked urethra.

About the UroLift System

The FDA-cleared UroLift System is a proven, 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 is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.UroLift.com.

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 www.NeoTract.com.

Contact information

for NeoTract, Inc.
Nicole Osmer, 650-454-0504
nicole@healthandcommerce.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Wipro and Hewlett Packard Enterprise Partner to Offer Consumption-Based IT Infrastructure Solutions25.7.2017 06:30Pressemelding

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced a partnership with Hewlett Packard Enterprise (HPE) to offer IT infrastructure solutions in a consumption-based or pay-per-use business model for enterprises. This model for IT infrastructure procurement and provisioning will be offered to both Wipro and HPE’s customers, globally. As a part of this alliance, Wipro will leverage HPE Flexible Capacity to offer flexible and scalable IT infrastructure services in a consumption-based IT model, accelerate growth and enable digital transformation for its customers. HPE’s scalable, consumption-based IT model of provisioning and procurement coupled with Wipro’s industry-proven end-to-end suite of IT infrastructure services, and global delivery capabilities will enhance the security, agili

Logitech Delivers Double-Digit Growth and Raises Outlook25.7.2017 01:00Pressemelding

Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the first quarter of Fiscal Year 2018. Q1 sales were $530 million, up 13 percent in constant currency compared to Q1 of the prior year. Q1 sales grew 10 percent in USD. Q1 GAAP operating income grew 22 percent to $31 million, compared to $26 million a year ago. Q1 GAAP earnings per share (EPS) grew 69 percent to $0.22, compared to $0.13 a year ago. Q1 non-GAAP operating income grew 14 percent to $43 million, compared to $38 million a year ago. Q1 non-GAAP EPS grew 20 percent to $0.24, compared to $0.20 a year ago. “We’re off to a strong start,” said Bracken Darrell, Logitech president and chief executive officer. “Our innovative and diverse portfolio is delivering, with growth and profitability exceeding expectations this

Senseonics Leads Development Efforts of a Long-Term “Artificial Pancreas” System for Use in the International Diabetes Closed Loop Trial24.7.2017 20:30Pressemelding

Senseonics Holdings, Inc. (NYSE-MKT: SENS), a medical technology company focused on the development and commercialization of transformative glucose monitoring products, today announced a collaboration with TypeZero Technologies, Inc., a personalized diabetes management company, and Roche Diabetes Care, Inc., a global leader for diabetes management systems and services, to develop a long-term automated insulin delivery system. The collaboration is part of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial, which was designed to test automated insulin delivery systems. “This partnership is an example of how industry, research and clinical care work together to move innovative technologies from research to development and then to patients to minimize the burden of diabetes,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technolo

IFF to Release Second Quarter 2017 Results August 824.7.2017 20:15Pressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, announced that it will release its second quarter 2017 earnings results following the market close on Tuesday, August 8, 2017. The management team will host a live webcast on Wednesday, August 9, 2017 at 10:00 a.m. EDT to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) is a leading innovator of sensorial experiences that move the world. At the heart of our company, we are fueled b

Alisha A. Alaimo Appointed SVP of Biogen’s US Therapeutic Operations24.7.2017 20:15Pressemelding

Biogen (NASDAQ: BIIB) announced today the appointment of Alisha A. Alaimo to Senior Vice President of US Therapeutic Operations, where she will lead sales and marketing, market access, patient services and commercial operations and strategy. Alaimo will join Biogen from Novartis, where she was Vice President and Head of its Cardiovascular Business Unit. At Biogen she will work to drive the uptake of the company’s industry-leading portfolio of multiple sclerosis (MS) therapies and increase access for SPINRAZA®, the first and only approved treatment for spinal muscular atrophy. Alaimo will also work to prepare the US market for potential approvals of new therapies from across the company’s late-stage neuroscience pipeline. She will report directly to Chief Executive Officer Michel Vounatsos. “Alisha has a remarkable track record of success within highly competitive ther

Great Lakes Brewing Company Quenches Increased Demand with Manufacturing Analytics Solution from Rockwell Automation24.7.2017 20:04Pressemelding

Craft beer is booming business in the United States, and even seasoned breweries are finding themselves looking for creative ways to keep up with thirsty consumers. Cleveland-based Great Lakes Brewing Company (GLBC), an independent craft brewery founded in 1988, recently tapped into new manufacturing analytics technology that helps scale production without sacrificing product quality. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170724006189/en/ Microsoft technology and Rockwell Automation's manufacturing analytics solution enables Great Lakes Brewing staff to identify and address equipment challenges in real time. (Photo: Business Wire) GLBC deployed the FactoryTalk Analytics for Devices appliance from Rockwell Automation to bring the power of the internet of things (IoT) and analytics to its factory

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom