EAU

Growing Body of Clinical Evidence Points to the Potential of Profound Medical’s TULSA Procedure Becoming a Mainstream Treatment Modality Across the Entire Prostate Disease Spectrum

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星期一, 五月 6, 2024

TORONTO, May 06, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, is pleased to announce that a total of 25 paper, poster and podium presentations highlighting the Transurethral Ultrasound Ablation (“TULSA”) procedure’s ability to effectively, safely and efficiently treat an unrivaled variety of prostate cancer and/or benign prostatic hyperplasia (“BPH”) patients have been made at major medical meetings already in 2024.

Key Points: 
  • “The TACT 5-year clinical trial data, along with multiple real-world reports on the safety, efficacy and durability of TULSA from U.S. commercial centers, such as Mayo Clinic in Florida, Busch Center in Georgia, and UT Southwestern Medical Center in Texas, as well as international user sites, like Sapporo Hokuyu Hospital in Japan, ALTA Klinik in Germany, and Turku University Hospital in Finland, add to the growing body of evidence supporting the potential of TULSA as a mainstream treatment for prostate disease,” said Arun Menawat, Profound’s CEO and Chairman.
  • “The various presentations made at AUA and other major medical conferences have highlighted TULSA’s clinical use across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and BPH; to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer,” added Dr. Menawat.
  • “Importantly, real-world data from top institutions is also consistently demonstrating similar outcomes to the TACT FDA regulatory study.
  • We would like to take this opportunity to thank the many esteemed researchers and clinicians who have contributed to the growing awareness of TULSA among urologists, both at home and abroad, and look forward to continuing to build on that positive momentum as the year progresses.”

TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

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星期日, 五月 5, 2024

SAN ANTONIO, May 5, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from an open-label, multicenter, multi-cohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. These data were featured today in an Oral Presentation Session (Abstract # PD48-02) at the 2024 American Urological Association (AUA) Annual Meeting taking place May 3-6, 2024, in San Antonio, Texas.

Key Points: 
  • First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.
  • "Results presented today further underscore that TAR-210 for the localized treatment of bladder cancer may offer a promising alternative for patients with limited treatment options."
  • At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the 2 cohorts.
  • Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence-free (RF) survival rate was 90%.

EDAP Reports Fourth Quarter and Full-Year 2023 Financial Results

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星期三, 三月 27, 2024

Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.

Key Points: 
  • Total revenue in the HIFU business for the fourth quarter of 2023 was EUR 7.5 million (USD 8.1 million), as compared to EUR 5.4 million (USD 5.5 million) for the fourth quarter of 2022.
  • The increase was driven by 10 Focal One systems sold in the fourth quarter of 2023 versus 7 systems sold in the fourth quarter of 2022.
  • Total revenue in the Distribution business for the fourth quarter of 2023 was EUR 9.9 million (USD 10.7 million), as compared to EUR 6.7 million (USD 7.0 million) for the fourth quarter of 2022.
  • Operating loss for the fourth quarter of 2023 was EUR 3.5 million (USD 3.8 million), compared to an operating loss of EUR 1.6 million (USD 1.6 million) in the fourth quarter of 2022.

Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) in Two Patient Cohorts

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星期一, 四月 8, 2024

“Intravesical gene therapy represents an important innovative treatment option for these patients.

Key Points: 
  • “Intravesical gene therapy represents an important innovative treatment option for these patients.
  • The efficacy analysis included 103 and 48 patients in the CIS and PD cohorts, respectively, who met the protocol definition of BCG-unresponsive NMIBC.
  • In total, 12.1% (13/107) and 20.0% (10/50) of patients in the CIS and PD cohorts, respectively, received ADSTILADRIN at three years.
  • In the CIS cohort, about 53% achieved a complete response (CR) at Month 3 in the primary analysis.

Natera Announces Positive Surveillance Analysis from the Randomized Phase III IMvigor011 Trial in Muscle-Invasive Bladder Cancer

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星期五, 四月 5, 2024

The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

Key Points: 
  • The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.
  • Sponsored by Genentech, a member of the Roche group, IMvigor011 is a global, double-blind, randomized, Phase III trial, in which high-risk MIBC patients are serially tested with Signatera for up to 12 months post cystectomy.
  • Patients who test Signatera MRD-positive at any point during the 12-month surveillance window are randomized to the anti-PDL1 atezolizumab (Tecentriq®) vs. placebo.
  • “We believe the results of this trial will further demonstrate how Signatera can help personalize treatment decisions and improve outcomes for bladder cancer patients.

Quanta System on the Peaks of the Urological Laser World Once Again: Quanta Magneto Technology™

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星期五, 四月 5, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240404169544/en/
    Cyber Ho Magneto with Quanta Magneto Technology™ (Photo: Business Wire)
    On the way to its 40th anniversary Quanta System remains steadfast in its mission: innovate to improve the lives of people around the world; with an unwavering belief that progress is always possible.
  • The global leader in laser technologies continually collaborates with medical professionals, working side by side with doctors to advance healthcare.
  • It is this commitment that drives the latest groundbreaking addition to the Cyber Ho family: Cyber Ho Magneto.
  • Cyber Ho Magneto, in fact, is the first laser system that tamed the peak power of holmium, turning it into a much longer pulse duration providing the superior dusting of a Thulium Fiber Laser.

Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.

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星期三, 三月 13, 2024

Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.

Key Points: 
  • Affluent Medical announces successful first-in-human implantation of its artificial sphincter Artus for the treatment of stress urinary incontinence.
  • This first implantation of the artificial urinary sphincter Artus was successfully performed by Prof. Roman Zachoval, MD, PhD, head of the Department of Urology at Thomayer University Hospital in Prague, Czech Republic, on a 68-year-old male with severe urinary incontinence.
  • “Artus is easy to prepare and implant due to its innovative design compared to the previous generation of urinary sphincters.
  • Artus is an implantable artificial urinary sphincter developed for the treatment of moderate to severe urinary incontinence in both men and women.

Autism Specialists to Host Grand Opening of New Wisconsin Clinic for Young Children

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星期一, 二月 5, 2024

EAU CLAIRE, Wis., Feb. 5, 2024 /PRNewswire/ -- Caravel Autism Health , a leader in the diagnosis and treatment of young children on the autism spectrum, is hosting a ribbon-cutting on February 6 to celebrate the grand opening of a new, state-of-the-art autism therapy clinic.

Key Points: 
  • EAU CLAIRE, Wis., Feb. 5, 2024 /PRNewswire/ -- Caravel Autism Health , a leader in the diagnosis and treatment of young children on the autism spectrum, is hosting a ribbon-cutting on February 6 to celebrate the grand opening of a new, state-of-the-art autism therapy clinic.
  • Caravel specializes in Applied Behavior Analysis therapy, which uses positive reinforcement to help children with autism improve a wide range of skills including communication and social skills.
  • "Providing access to high-quality therapy at a young age is how we ensure that children achieve the best possible outcomes.
  • "We change the lives of families touched by autism by helping children reach their full potential," explained Carly Burish, Caravel's Eau Claire clinic director.

Western Wisconsin Loses Health Systems, but Local Provider Smart Infusion Therapy Services Fills Gap in Care

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星期三, 一月 31, 2024

The professional nursing team at Smart Infusion is uniquely positioned to assist patients in seamlessly transitioning care from a closing hospital.

Key Points: 
  • The professional nursing team at Smart Infusion is uniquely positioned to assist patients in seamlessly transitioning care from a closing hospital.
  • Smart Infusion Therapy Services CEO, William Pickart has spent the last week meeting with employers and brokers throughout the impacted area.
  • Patients seeking care can call Smart Infusion Therapy Services - Eau Claire at (608) 690-7210, or to learn more visit: www.MySmartInfusion.com
    Smart Infusion Therapy Services Eau Claire is located at 3004 Golf Rd Suite 101B, Eau Claire, WI 54701, with additional locations in Weston and Middleton WI.
  • View original content to download multimedia: https://www.prnewswire.com/news-releases/western-wisconsin-loses-health-...
    SOURCE Smart Infusion Therapy Services, LLC

Affluent Medical : Start of the European pilot study with the Artus medical device for the treatment of urinary incontinence.

Retrieved on: 
星期六, 十二月 30, 2023

Affluent Medical : Start of the European pilot study with the Artus medical device for the treatment of urinary incontinence.

Key Points: 
  • Affluent Medical : Start of the European pilot study with the Artus medical device for the treatment of urinary incontinence.
  • Artus is an innovative device adapted for the treatment of incontinence in women and men.
  • Aix-en-Provence, 6 December 2023 – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME), a French clinical-phase MedTech company specialising in the international development and industrialisation of innovative medical prostheses, is announcing the start of the European pilot study, Dry, with its Artus medical device for the treatment of urinary incontinence.
  • Publication of an international study by the European Association of Urology on the economic consequences of urinary incontinence in Europe.