American Urological Association

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

Retrieved on: 
Montag, Mai 6, 2024
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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.”

Real-World, Long-Term Data Demonstrate Sustained Benefits of Aquablation Therapy for Men with Benign Prostatic Hyperplasia

Retrieved on: 
Montag, Mai 6, 2024
FDA, Bleeding, Safety, Risk, American Urological Association, Abstract, LUTS, ASC, Surgeon, TURP, International Prostate Symptom Score, Patient, SDD, AUA, Health, Patient satisfaction, Clinical trial, SAN, BPH, IPSS, Benign prostatic hyperplasia

The results were presented this past weekend at the American Urological Association (AUA) Annual Meeting in San Antonio, Texas.

Key Points: 
  • The results were presented this past weekend at the American Urological Association (AUA) Annual Meeting in San Antonio, Texas.
  • “The data presented at AUA confirm the safety and long-term durability of Aquablation therapy in treating men with symptomatic benign prostatic hyperplasia, regardless of prostate size or shape," said Reza Zadno, CEO of PROCEPT BioRobotics.
  • Three surgeons at Potomac Urology collected data on 812 consecutive men treated with Aquablation therapy.
  • We have treated more than 800 men with Aquablation therapy and feel that the results truly speak for themselves,” said Shawn Marhamati, MD, MS, at Potomac Urology.

Studies Show Diabetes Medicine Can Cause Urologic Complications

Retrieved on: 
Sonntag, Mai 5, 2024
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Researchers will present their study findings covering important updates on diabetes medicine and urologic complications in San Antonio, Texas, from May 3 to 6.

Key Points: 
  • Researchers will present their study findings covering important updates on diabetes medicine and urologic complications in San Antonio, Texas, from May 3 to 6.
  • “These meds are increasingly popular due to their ability to lower cardiovascular events and the risk of end stage renal disease.
  • They are now first line therapies for diabetes management in patients with cardiovascular disease, chronic kidney disease and heart failure,” said Dr. Inouye.
  • All three of these talks discuss the urologic sequelae we see in our clinics.”
    The following abstracts are covered in the moderated panel:

Research Presented at AUA 2024 Indicates the Cost of Prescription Drugs Is A Significant Barrier To Care

Retrieved on: 
Sonntag, Mai 5, 2024
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Researchers will present their study findings covering important updates on the cost of care in San Antonio, Texas, from May 3 to 6.

Key Points: 
  • Researchers will present their study findings covering important updates on the cost of care in San Antonio, Texas, from May 3 to 6.
  • Ruchika Talwar, MD, urologist and clinical instructor in the Vanderbilt University School of Medicine’s Department of Urology, moderated a virtual press session with the abstract authors, providing key insights into their research.
  • “The more we highlight and disseminate these findings, the more we can make both urologists and patients aware of the resources that exist to help mitigate the financial burden of prescription drugs,” said Dr. Talwar.
  • To arrange an interview with an expert, please contact the AUA Communications Team at [email protected].

Results from Pivotal Clinical Study Demonstrate Potential of Nucleix’s Bladder EpiCheck® to Improve Disease Recurrence Detection in Non-Muscle Invasive Bladder Cancer (NMIBC) Surveillance

Retrieved on: 
Montag, Mai 6, 2024
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The data presented demonstrated Bladder EpiCheck’s potential to improve timely disease recurrence detection and compliance with NMIBC surveillance.

Key Points: 
  • The data presented demonstrated Bladder EpiCheck’s potential to improve timely disease recurrence detection and compliance with NMIBC surveillance.
  • “The results from our pivotal clinical study not only underscore the potential of Bladder EpiCheck as a non-invasive method for tumor recurrence detection in patients previously diagnosed with NMIBC but also signal a transformative shift in NMIBC surveillance,” said Aharona Shuali, MD, MBA, Vice President of Medical Affairs at Nucleix.
  • “The performance of Bladder EpiCheck in this clinical trial demonstrates its potential to be used as a non-invasive test for detecting bladder cancer recurrence.
  • Ongoing research will determine if Bladder EpiCheck can be used to replace some cystoscopies and thereby reduce the burden of bladder cancer surveillance for patients and health systems alike.”
    During the AUA Annual Meeting on May 5, 2024, these results were presented by Dr. Inman in a podium presentation titled “Pivotal Study Evaluating Performance of Bladder EpiCheck, an FDA cleared test, in Non-Muscle Invasive Bladder Cancer.”

14 Studies Presented at AUA 2024 Show Decipher Tests’ Ability to Help Personalize Care for Prostate and Bladder Cancer Patients and Advance Disease Understanding

Retrieved on: 
Montag, Mai 6, 2024
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(Nasdaq: VCYT), a leading cancer diagnostics company, today announced that data from 14 presentations at AUA 2024, the annual meeting of the American Urological Association, show that the Decipher Prostate and Decipher Bladder Genomic Classifiers provide better prognostic information for patients with prostate and bladder cancer, compared to standard approaches.

Key Points: 
  • (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that data from 14 presentations at AUA 2024, the annual meeting of the American Urological Association, show that the Decipher Prostate and Decipher Bladder Genomic Classifiers provide better prognostic information for patients with prostate and bladder cancer, compared to standard approaches.
  • They also show that the research-use-only Decipher GRID (Genomic Resource for Intelligent Discovery) tool is helping to advance scientific understanding of these diseases.
  • Summary: The Decipher Prostate Genomic Classifier is associated with adverse pathology in patients eligible for Active Surveillance (AS) who were treated with radical prostatectomy (RP).
  • Podium Presentation PD42-03 : Understanding Population-Wide Genomic Risk Distribution and Integrating Clinical-Genomic Risk for Prognostication in Prostate Cancer.

Favorable Clinical Data for Applaud Medical’s Novel Technology for Treating Urinary Stones Presented During the 2024 AUA Annual Meeting

Retrieved on: 
Montag, Mai 6, 2024
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Applaud Medical, an emerging leader in the treatment of urinary stones, today announced positive results from a prospective, multicenter study of the company’s BRIO Enhanced Lithotripsy System (ELS) for the treatment of obstructive ureteral stones.

Key Points: 
  • Applaud Medical, an emerging leader in the treatment of urinary stones, today announced positive results from a prospective, multicenter study of the company’s BRIO Enhanced Lithotripsy System (ELS) for the treatment of obstructive ureteral stones.
  • The results were presented as a podium presentation during the American Urological Association's (AUA) 2024 Annual Meeting held in San Antonio, Texas.
  • The study combined Applaud Medical’s proprietary acoustically enhanced microbubbles with a low-pressure ultrasound system to treat ureteral stones.
  • Our solution aims to eliminate ureteral stones quickly, affordably, and without general anesthesia or fluoroscopy, bringing it to a physician’s office and other non-hospital settings.”

Final Five-Year Analysis of Phase 3 Data With ADSTILADRIN® (nadofaragene firadenovec-vncg) Shows Durable Bladder Preservation and Consistent Long-Term Safety in BCG-unresponsive NMIBC

Retrieved on: 
Montag, Mai 6, 2024
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Ferring Pharmaceuticals today announced the final 60-month follow-up data from the Phase 3 study of ADSTILADRIN® (nadofaragene firadenovec-vncg) were presented at the American Urological Association (AUA) 2024 Annual Meeting.

Key Points: 
  • Ferring Pharmaceuticals today announced the final 60-month follow-up data from the Phase 3 study of ADSTILADRIN® (nadofaragene firadenovec-vncg) were presented at the American Urological Association (AUA) 2024 Annual Meeting.
  • These data, which are the longest follow-up of efficacy and safety data reported for a novel agent for BCG-unresponsive NMIBC, were simultaneously published ahead of print and will be included in the July issue of The Journal of Urology®.
  • ADSTILADRIN is the first and only intravesical non-replicating adenoviral vector-based gene therapy approved by the U.S. Food and Drug Administration (FDA) in patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors.
  • The mechanism of action of ADSTILADRIN is designed to deliver the human interferon-alfa 2b gene (IFNα2b) directly into the bladder to enable secretion of interferon alfa-2b protein with a single treatment every three months.

New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy

Retrieved on: 
Sonntag, Mai 5, 2024
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Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.

Key Points: 
  • Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.
  • “Notably, there seems to be no discernible difference in disease recurrence based on tumor characteristics or timing of administration, including primary chemoablation or post-endoscopic ablation.
  • Data was collected from 15 centers on patients treated with JELMYTO for upper tract urothelial cancers (UTUC).
  • Recurrence-free survival was calculated in 53 patients with LGTa disease at baseline who had no evidence of disease following JELMYTO induction.

New Study Demonstrates Avenda Health's Unfold AI to Better Predict Focal Therapy Success by 77% Percent as Compared to Standard Methods

Retrieved on: 
Mittwoch, Mai 8, 2024
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CULVER CITY, Calif., May 8, 2024 /PRNewswire/ -- Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, unveils the results of a new UCLA study examining the role of AI in identifying tumor margins and predicting the efficacy of focal therapy treatments. The study titled "Software to Determine Extent of Tumor Margins in Focal Therapy," was presented at the 2024 American Urological Association's (AUA) annual meeting by Wayne Brisbane, MD, assistant professor at UCLA Health. It demonstrated that Unfold AI, Avenda Health's AI-powered cancer mapping technology, was a better predictor of focal therapy success than other factors, including the size or grade of the tumor.

Key Points: 
  • It demonstrated that Unfold AI , Avenda Health's AI-powered cancer mapping technology, was a better predictor of focal therapy success than other factors, including the size or grade of the tumor.
  • In the study, FDA-cleared Unfold AI technology was retrospectively applied to 118 previously untreated men undergoing hemi-gland cryotherapy for prostate cancer ablation.
  • MRI-guided biopsies, both targeted and systematic, were performed before cryotherapy and six months after cryotherapy to assess treatment outcomes.
  • "This more comprehensive approach enhances our ability to predict treatment outcomes and tailor interventions effectively to individual patient needs."