Business Wire

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

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

Schlumberger Announces Full-Year and Fourth-Quarter 2017 Results19.1.2018 12:00Pressemelding

Schlumberger Limited (NYSE:SLB) today reported results for full-year 2017 and the fourth quarter of 2017. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2017 Dec. 31, 2016 Year-on-year Revenue $30,440 $27,810 9% Pretax operating income $3,921 $3,273 20% Pretax operating margin 12.9% 11.8% 111 bps Net loss (GAAP basis) $(1,505) $(1,687) n/m Net income, excluding charges and credits* $2,085 $1,550 35% Diluted EPS (loss per share) (GAAP basis) $(1.08) $(1.24) n/m Diluted EPS, excluding charges and credits* $1.50 $1.14 32% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Full-year 2017 revenue of $30.4 billion increased 9% year-on-year. This included a full year’s activity from the acquired Cameron businesses as compared to three quarters of activity in 2016. Excluding the addition of Cameron, revenue growth was driven by land activity in North America, which increa

The Coca-Cola Company Announces New Global Vision to Help Create a World Without Waste19.1.2018 11:55Pressemelding

The Coca-Cola Company announced today that it is fundamentally reshaping its approach to packaging, with a global goal to help collect and recycle the equivalent of 100% of its packaging by 2030. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005104/en/ In 2017, employees from Heartland Coca-Cola Bottling Co. joined with other volunteers in St. Louis to collect and sort 14,480 pounds of debris; 63 percent was diverted for recycling. Coca-Cola then partnered with manufacturer Phoenix Technologies to convert plastic bottles into recycled PET plastic for use in new bottles. (Photo: Business Wire) This goal is the centerpiece of the Company’s new packaging vision for a World Without Waste, which the Coca-Cola system intends to back with a multi-year investment that includes ongoing work to make packaging 100% recyclable. This begins with the understanding that food and beverage containers are an important part of people’s m

Researchers and Scientists from Five Countries Named Winners of King Faisal Prize 201819.1.2018 10:33Pressemelding

Five researchers and scientists from Malaysia, Jordan, Tunisia, the US and the UK have been named winners of the King Faisal Prize 2018 as the 40th edition of the renowned award recognized their distinguished contributions towards humanity. The Prize honours exceptional achievements in five categories: Service to Islam, Islamic Studies, Arabic Language & Literature, Medicine, and Science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005245/en/ His Royal Highness Prince Khalid Al-Faisal, Chairman of King Faisal Prize Board, Abdulaziz (Photo: AETOSWire) Professor Irwandi Jaswir, Deputy Dean of the International Institute for Halal Research and Training (INHART) and Secretary of Council of Professors at the International Islamic University Malaysia (IIUM), has been named the winner in the Service to Islam category for contributions to the development of ‘Halal Science’ and Halal food and consumer goods. Professor Bashar

E.ON Chooses Corinex Broadband over Powerline Technology for their Smart Metering Rollout19.1.2018 06:00Pressemelding

E.ON, an international energy company that serves 32 million customers across multiple countries, has decided to use broadband over powerline (BPL) as the key technology in their communication mix, in the smart metering communication infrastructure for the low voltage part of their grid. E.ON chose Corinex as the solution provider for the initial two years of the deployment. The initial deployment will be several ten thousands of repeaters and head ends providing secure communication for a couple of hundred thousands of households. Corinex Grid Value network management based on IBM Tivoli platform will manage the network. “After extensive field trials, we found that Corinex broadband over powerline technology meets our requirements for mass rollout of smart metering services. We are convinced BPL is ideally suited to address the needs of many other utilities, so E.ON is interested in supporting BPL industry standardization in order to create a broad ecosystem of silicon and system vend

Changes in Executive Management at Sosei19.1.2018 01:54Pressemelding

Sosei Group Corporation (“Sosei” or the “Company”) (TOKYO: 4565), the world leader in GPCR medicine design and development, today announced that Dr. Fiona Marshall has resigned from her position as Executive Vice President and Chief Scientific Officer of Sosei to assume a senior role outside the Company. Dr. Marshall will leave Sosei at the end of February 2018. “As a co-founder of Heptares, I am very proud to have been associated with building a team of talented scientists over the past decade that has made many important breakthroughs in the field of GPCR stabilization and structure-based drug design, a unique technology that now underpins Sosei’s powerful drug discovery capability,” said Dr. Marshall. “With the team in excellent hands, I feel the time is right for me to move on to new challenges and I wish everyone at Sosei the best for what looks set to be an exciting future for the Company.” Peter Bains, Chief Executive Officer of Sosei, added: “Fiona has been a pivotal figure in

DXC Technology Named a 2018 Thomson Reuters Top 100 Global Technology Leader18.1.2018 23:12Pressemelding

DXC Technology (NYSE: DXC) has been recognized as a 2018 Top 100 Global Technology Leader by Thomson Reuters. The inaugural program identifies the tech industry’s most operationally sound and financially successful organizations. The Thomson Reuters Top 100 Global Tech Leaders study, the industry’s first holistic assessment of today’s leading tech companies, utilizes a 28-point data-driven algorithm to objectively identify organizations positioned to thrive in a complex and changing business environment. The patent pending methodology, developed by the Thomson Reuters Boston Innovation Lab, is based on eight principal pillars of performance: Financial Performance, Management and Investor Confidence, Risk and Resilience, Legal Compliance, Innovation, People and Social Responsibility, Environmental Impact, and Reputation. According to Thomson Reuters, these are the companies whose final scores across the pillars outshine over 5,000 other technology companies around the world. “DXC Techno

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

Besøk vårt presserom