NeoTract Announces Publication of Five-Year Results from Pivotal Trial of the UroLift® System
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.
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.
for NeoTract, Inc.
Nicole Osmer, 650-454-0504
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 22:40 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 17:00 | Tiedote
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 16:13 | Tiedote
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 15:00 | Tiedote
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-
JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 15:00 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.
Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 14:01 | Tiedote
Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme