CA-NEOTRACT-INC
NeoTract, Inc., today announced that the UK’s National Institute for Health and Clinical Excellence (NICE) has issued an interventional Procedure Guidance (IPG) approving the UroLift® prostatic lift system for use by UK doctors. The NICE guidance was made following consultations with independent clinical experts and a literature review.
NICE says: “The specialist advisers listed key efficacy outcomes as symptom improvement, improvement in quality of life, reducing or stopping medical therapy [drug therapy], flow improvement, reduction in residual volume and maintenance of sexual and ejaculatory function”.
The NICE IPG means that UK urologists will be able to routinely offer the novel UroLift system to their patients for the first time outside of a clinical trial. The implants are used to treat BPH – a condition caused by an enlarged prostate that begins to obstruct the urinary system. The condition is common, affecting over 40% of men over 50 years of age. BPH symptoms can include urgency, hesitation, straining, dribbling, incomplete emptying (the sensation that the bladder is not empty after urinating), weak urine flow, increased frequency of urination, nocturia, dysuria, and depression resulting in a decreased quality of life.
Patients receiving the UroLift implants report rapid symptomatic improvement, increased urinary flow rates, and preserved sexual function. A significant improvement in Quality of Life for patients was also observed.
Unlike all other permanent treatment options for enlarged prostates that require administration of a spinal or a general anesthetic, the minimally invasive procedure to insert the UroLift implants typically lasts less than an hour, can be carried out under local anesthesia and the patient is able to go home shortly afterwards; the procedure provides significant Improvements without significant downsides and rapid symptom relief.
Mr Neil Barber, Consultant Urologist at Frimley Park Hospital in Surrey says: "Up to now, men with BPH have had two pretty unattractive options - either lifelong drug treatment which is less effective than surgery and has possible side effects including sexual dysfunction, dizziness and headaches, or cutting away parts of the prostate - known as TURP - that is really good at relieving BPH symptoms but has a significant chance of causing permanent dry orgasms and erection problems, and a small chance of developing urinary incontinence. That's not much of a choice. Many men I see in clinic are, understandably, very nervous of having TURP - they may be older but they are men - so whatever their age, they don't want to have an operation which may make them feel less of a man. [The] UroLift [implant] involves retracting and holding back the enlarged prostate so it's gentler than TURP with minimal side effects and it's more effective than drugs. I think it's a really exciting, game changing treatment for men. UroLift [implants] add another option in the armamentarium for some men and is particularly useful in those who want to quickly return to their normal activities and preserve sexual function.”
Urologist Professor Tom McNicholas, who works at the London Clinic and Spire Hospital, Harpenden, as well as in the NHS, has been involved since the start of the project. He says: “Several leading UK surgeons have been using UroLift [implants] for a while now. But there are always difficulties in introducing a new idea and it's reassuring and encouraging that NICE have rigorously assessed [the] UroLift [system treatment] and regard it as both safe and effective. We now hope to use UroLift more widely in the NHS and in the private sector now that NICE has supported it. I have been involved in an NHS pilot research study on the UroLift device because we saw that, aside from the clinical value of the procedure, there were savings and efficiencies that could be achieved by reduced bed stays for this day case procedure - compared to the other, more invasive surgical procedures that are available. I am looking forward to offering it to my NHS patients because UroLift [implants] improve symptoms whilst preserving men's sexual function and these are worthwhile and important outcomes."
Mr Mark Speakman, Consultant Urologist at Taunton's Musgrove Park Hospital, says: “The UroLift [prostatic implant] procedure is a middle ground option for men sitting between drug treatment and surgical transurethral resection of the prostate (TURP). The problem of drug treatment is compliance - men aren't good at taking drugs - and the problem with TURP is the potential side effects, including ejaculatory problems. UroLift [implantation] beats drugs on efficacy and TURP on side effects. Many men have contacted us wanting UroLift, and the announcement will make life easier for British surgeons who want to offer it."
“Receiving NICE interventional procedure guidance is another huge milestone for UroLift® and NeoTract.” commented Dave Amerson, president and CEO of NeoTract. “We are extremely pleased to bring our innovative UroLift System to more physicians and patients in the U.K. as we believe it will make a significant difference in the lives of aging men.”
About BPH and the UroLift System Treatment
BPH is a common condition afflicting more than 500 million ageing men worldwide. Chronic lower urinary tract symptoms (LUTS) associated with BPH can cause loss of productivity and sleep, depression and decreased quality of life. Medication is often the first line therapy but relief can be inadequate and temporary. Side-effects 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 heats prostate tissue to open the blocked urethra. Although effective, patients have to 'earn' their symptom relief after a difficult period of irritative voiding symptoms and catheterization. Even the 'gold standard' surgery, TURP (Transurethral Resection of the Prostate), can leave patients with permanent side-effects such as urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
The UroLift System is designed to open the urethra directly without applying incisions, surgical resection or thermal injury to the prostate. Obstructive prostate lobes are transurethrally pushed aside and small permanent UroLift implants hold the lobes in the retracted position, thus opening the urethra while leaving the prostate intact. Learn more at www.UroLift.co.uk .
The UroLift System is currently available for patients in Europe, Australia and Canada and was FDA approved in 2013.
About NeoTract
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent device designed to treat lower urinary tract symptoms (LUTS).
Contact:
Gloucester Road Communications
Amanda Hayhurst
Mobile: +44
0772 0205581
Amanda@amandahayhurst.com
Link:
Information om Business Wire
Følg pressemeddelelser fra Business Wire
Skriv dig op her, og modtag pressemeddelelser på e-mail. Indtast din e-mail, klik på abonner, og følg instruktionerne i den udsendte e-mail.
Flere pressemeddelelser fra Business Wire
Andersen Consulting tilføjer Stratence Partners30.5.2025 16:07:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform med en samarbejdsaftale med Stratence Partners, der er et konsulentfirma med base i Storbritannien, som hjælper globale virksomheder med at øge markedsandele og forbedre rentabiliteten gennem deres ekspertise inden for prisfastsættelse, strategisk optimering, kommerciel effektivitet og digital transformation. Stratence Partners har en resultatorienteret tilgang og er forpligtet på bæredygtig forandring, hvorved de hjælper deres kunder gennem en unik kombination af konsulentbistand, midlertidige ledelsesindsater og oplæringskurser samt deres egne metoder og løsninger inden for datastyring, datavidenskab (AI), værktøjer og systemer. "Samarbejdet med Andersen Consulting er et spændende skridt for vores firma," sagde Fernando Ventureira, administrerende direktør for Stratence Partners. "I vores arbejde med hos ledere over hele verden har vi erfaret, at deres behov rækker ud over strategisk prisfastsættelse og driftsoptimering. Vores kunder værdsætte
You Up? Grindr’s “Right Now” Goes Global30.5.2025 15:00:00 CEST | Press release
More places, more people – Grindr’s real-time hookup feature makes connecting faster than ever Grindr, the Global Gayborhood in Your Pocket™ with more than 14.6M average monthly active users, today announced the global launch of Right Now, their newest intent-based feature designed to instantly connect people looking for immediate encounters. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250530651954/en/ Grindr's Right Now feature. Right Now is a real-time feed—separate from the app’s main grid that displays profiles—where Grindr users can post text and share photos displayed for one hour, letting other like-minded users know exactly what they’re looking for. “Right Now empowers our users to find exactly what they want, when they want it – without the guesswork,” said AJ Balance, Chief Product Officer at Grindr. “We built this intention-based feature based on feedback from our community so they can connect with like-minded
CAR T Vision Coalition Launches with Ambitious Goal to Double Patients Treated with the Curative Potential of CAR T-cell Therapy by 203030.5.2025 14:00:00 CEST | Press release
Only approximately 2 out of 10 people in the US and 3 out of 10 people in Europe with certain rare, advanced blood cancers receive access to CAR T-cell therapy1,2,3New roadmap report aims to inspire collective action of stakeholder groups and invites additional CAR T-cell therapy leaders to join the coalition Today an international coalition announces the launch of CAR T Vision to unite stakeholders around the shared ambition that every eligible patient should have the opportunity for cure with CAR T-cell therapy. By 2030, the aim is to double the proportion of eligible patients treated with CAR T-cell therapy. As outlined in the new roadmap report, the coalition will work to address access challenges and drive meaningful change in the CAR T-cell therapy healthcare ecosystem with a focus on three critical priorities: increasing awareness and understanding of CAR T-cell therapy; expanding resources and capacity to deliver CAR T-cell therapy; and developing sustainable and innovative fin
Indian Educationist Dr. Achyuta Samanta Recognised With Research Institute in His Name at CUNY, USA30.5.2025 11:17:00 CEST | Press release
In a noteworthy development underscoring growing academic collaboration between India and the United States, the City University of New York (CUNY) has launched a dedicated research platform—the Achyuta Samanta India Initiative of the CUNY CREST Institute (ASIICCI). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250529012005/en/ Dr. Milton Santiago, President of Bronx Community College, and Dr. Achyuta Samanta, Founder of KIIT & KISS, jointly inaugurate the Achyuta Samanta India Initiative of CUNY CREST Institute (ASIICCI) with a ribbon-cutting ceremony in New York. Named after Dr. Achyuta Samanta, a noted Indian educationist and social worker, the initiative focuses on academic research in Indian social and educational sectors, with a particular lens on Odisha. This marks one of the rare instances of a living Indian being honoured with such a naming in an American public university system. Dr. Samanta, who hails from Odisha
FDA Grants De Novo Clearance for Reflow Medical's Spur® Peripheral Retrievable Stent System30.5.2025 06:08:00 CEST | Press release
Reflow Medical, Inc., a leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for the company’s Spur Peripheral Retrievable Stent System, a unique clinical solution for the treatment of de novo or restenotic lesions following predilatation in patients with infrapopliteal arterial disease. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250529610368/en/ The first and only retrievable stent system that features a self-expanding stent with an integrated dilatation balloon catheter on an over-the-wire system. It is designed for controlled lesion penetration and treatment through a series of radially expandable spikes. Known as Retrievable Scaffold Therapy (RST), the spikes on the Spur Stent penetrate the lesion to increase the acute luminal diameter and modify the lesion morphology to change vessel complia
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter samt finde vores kontaktoplysninger.
Besøg vores nyhedsrum