European Urology

Blue Earth Diagnostics Announces Publication of Post-hoc Analysis Evaluating Impact of Urinary Activity on Image Interpretation of POSLUMA® (Flotufolastat F 18) PET in Prostate Cancer

Retrieved on: 
Tuesday, November 28, 2023
Oncology, Health, FDA, Radiology, Clinical Trials, Pharmaceutical, Biotechnology, The Journal of Urology, DOI, Prostate, Safety, PET/CT, Literature, PSA, Data, Patient, Multimedia, Radiopharmaceutical, Journal, Molecular Imaging and Biology, Doctor of Philosophy, European Urology, Molecular imaging, Prostate cancer, Lymph, PSMA, Neoplasm, Cystectomy, Kidney, MD, Urinary bladder, University, Medical imaging, University of Arizona, PET, Recurrence, Physician, Biomedical engineering, Metastasis, Medicine, Urology, Biology

The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE1 and SPOTLIGHT2 studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer.

Key Points: 
  • The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE1 and SPOTLIGHT2 studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer.
  • Halo artifacts, which can inhibit image assessment, were very rare, and were absent in 99.7% (710/712) of patients by majority read.
  • Ureteric activity, which can also limit assessment of lymph nodes distant to the bladder, was also absent in a majority of patients (56%, 401/712).
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

Vesica Health Announces Publication of Study Demonstrating AssureDx Meaningfully Improves Identification of Hematuria Patients at High Risk for Bladder Cancer

Retrieved on: 
Monday, October 9, 2023
OTX1, Probability, AUA, Physician, Department of Urology, University of Virginia, National Capital FreeNet, American Urological Association, TERT, Johns Hopkins University, DNA, Risk, AUC, Capital city, Microhematuria, Urology, Hematuria, Health, HEALTH, Cancer, Carcinoma, TWIST1, Alvin J. Siteman Cancer Center, HRAS, DNA methylation, European Urology, Medical school, Patient, Bladder cancer, FGFR3, Liquid biopsy, Risk assessment, Barnes-Jewish Hospital

The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.

Key Points: 
  • The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.
  • The study analyzed a prospectively collected cohort of 838 hematuria subjects previously tested by AssureDx.
  • Subjects were classified into the AUA risk categories for bladder cancer based on their sex, age, and type of hematuria, also known as urothelial carcinoma (UC).
  • "Publication of this pivotal study in a leading international urology journal, demonstrating AssureDx enhances the AUA Guidelines, underscores the importance of the test for risk stratification of hematuria patients and identification of those at increased risk for bladder cancer," stated Christopher Thibodeau, Chief Executive Officer of Vesica Health.

Blue Earth Diagnostics Announces Addition of POSLUMA® (Flotufolastat F 18) Injection to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer

Retrieved on: 
Tuesday, July 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MBBS, Prostate cancer, Education, PSMA, Food, Policy, Cancer, PET, Research, Medicine, RH, Radiopharmaceutical, Journal of the National Comprehensive Cancer Network, NCCN, Organization, Pharmacist, FRCR, Journal, Guideline, Physician, Nursing, Patient, FDA, The Journal of Urology, Recurrence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PSA, MRCP, Metastasis, Safety, Medical imaging, Medical device, European Urology, Urology

POSLUMA has been added to the NCCN guideline recommendations alongside and for all the same categories as other currently FDA-approved PSMA PET agents.

Key Points: 
  • POSLUMA has been added to the NCCN guideline recommendations alongside and for all the same categories as other currently FDA-approved PSMA PET agents.
  • POSLUMA is widely available through 36 radiopharmacies in the national network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor.
  • “The addition of POSLUMA to the highly respected NCCN Guidelines is a major milestone for Blue Earth Diagnostics,” said David E. Gauden, D.
  • The NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine.

EDAP Announces Live Procedure Broadcast of Focal One High Intensity Focused Ultrasound (HIFU) to Global Clinical Audience

Retrieved on: 
Monday, April 10, 2023
Abstract, The New England Journal of Medicine, Katherine, Assistant professor, High, Intensity, University, Prostate cancer, High-intensity focused ultrasound, Teaching, 3D, EDAP, JAMA Surgery, PDT, Keck School of Medicine of USC, Research, Prostate, Nature Reviews Urology, EDT, Bangladesh Technical Education Board, National Cancer Institute, MRI, USC Institute of Armenian Studies, Magnetic resonance imaging, MD, Patient, Physician, Webcast, Cancer, Kidney, Health, Distinguishing, Medical imaging, Nursing, Medical device, European Urology, Cryoablation, USC, Urology

LYON, France, April 10, 2023 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), a global leader in robotic energy-based therapies, today announced that the Company will host a webcast that will feature a live procedure broadcast of its Focal One HIFU as a potential treatment for ablating cancer tissue in patients who are diagnosed with prostate cancer. The webcast is scheduled for Tuesday, April 18th at 12:00 p.m. PDT (3:00 p.m. EDT).

Key Points: 
  • The procedure will be performed by Andre Abreu, MD and Amir H. Lebastchi, MD, Assistant Professors of Clinical Urology at Keck Medicine of the University of Southern California (USC).
  • Teaching and sharing best practices in new clinical treatments are critical to ensuring more patients can avail themselves of the latest technologies with the absolute best results.
  • Andre Luis de Castro Abreu, MD has expertise in MRI/TRUS fusion prostate biopsy and focal therapy, including High Intensity Focused Ultrasound (HIFU) and Cryoablation, for prostate cancer.
  • He also specialized in focal therapy for prostate cancer, including noninvasive techniques such as High Intensity Focused Ultrasound (HIFU) and cryoablation.

PROSTATE CANCER FOUNDATION-FUNDED GENETIC STUDY OF MEN OF AFRICAN ANCESTRY FINDS NEW RISK FACTORS FOR PROSTATE CANCER

Retrieved on: 
Friday, March 3, 2023
RESPOND, Saliva, Keck School of Medicine of USC, Disease, LOS, Risk, Health equity, Prostate Cancer Foundation, MD, National Institute on Minority Health and Health Disparities, Social stress, Blood, Genetic epidemiology, USC Norris Comprehensive Cancer Center, Smith, PCF, USC, National Cancer Institute, Medicine, Research, AFLAC, Role, Vista Equity Partners, Prostate cancer, European Urology, Doctor of Science, Neoplasm, Diagnosis, Recurrence, Meta-analysis, Patient, Medical imaging, Dairy, Pharmaceutical industry, Black, Genetics

LOS ANGELES, March 3, 2023 /PRNewswire/ -- One in six Black men in the United States will be diagnosed with prostate cancer in his lifetime versus one in eight white men. Black men are more likely to be diagnosed at a younger age, with more aggressive disease, and are more than twice as likely to die of prostate cancer. New findings from Prostate Cancer Foundation (PCF)-funded investigators shed light on the genetic underpinnings of this racial disparity and point the way toward more effective screening strategies.

Key Points: 
  • Studies have identified close to 270 genetic variants linked to prostate cancer risk, but genetic researchers have yet to explain the disproportionate risk among men of African ancestry.
  • Nor have they been able to predict which Black men face a high risk for aggressive prostate cancer.
  • The researchers found nine previously undiscovered genetic variants that increased the risk for prostate cancer in men of African ancestry, seven of which are found either largely or exclusively in Black men.
  • One new variant in the 8q24 region, long known to influence prostate cancer risk, is found only in men of African ancestry.

New study demonstrates that tumor removal in the outpatient setting is as good as TURBT under general anesthesia

Retrieved on: 
Tuesday, September 20, 2022
NMIBC, Safety, Cystoscopy, Cancer, ASA, BLC, Prevalence, OSE, Capital region, Bladder cancer, Neoplasm, Urinary bladder, Laser, Carcinoma in situ, Population, Program, Patient, Disease, CEO, OPD, Technology, Pain, Cell, Solution, Diagnosis, Lead, Death, CIS, Research, Man, Oslo Stock Exchange, Recurrence, Medical imaging, Pharmaceutical industry, T4, Urology, European Urology, TURBT, MD, MIBC, Photocure

The study is part of a systematic program aimed at verifying the safe treatment of bladder tumors in the outpatient setting.

Key Points: 
  • The study is part of a systematic program aimed at verifying the safe treatment of bladder tumors in the outpatient setting.
  • Laser III results demonstrate the non-inferiority of outpatient laser-mediated destruction of bladder tumors in conjunction with blue light cystoscopy (BLC) and Hexvixversus inpatient BLC TURBT* under general anesthesia.
  • The first results, now published in European Urology, evaluated 4-month non-inferiority of outpatient laser-mediated ablation of recurrent Ta tumors with flexible cystoscopes under local anesthesia, compared to TURBT under general anesthesia.
  • The study authors conclude that laser intervention in the outpatient setting is as good as TURBT with general anesthesia, and has less complications.

Ipsen Receives Positive Opinion in Europe for Dysport® in the Management of Urinary Incontinence in Adults With Neurogenic Detrusor Overactivity Due to Multiple Sclerosis or Spinal Cord Injury

Retrieved on: 
Thursday, June 9, 2022
Professional Services, Health, Other Health, Finance, Clinical Trials, Pharmaceutical, Biotechnology, ADR, Bont, SCI, Powder, Research, III, Medicine, Product, Medication package insert, Patent, Ipsen, Epidemiology, Torticollis, NDO, CIC, IPN, MS, Face, Risk, Safety, Social isolation, Quality of life, UI, Union, Clinical trial, Neurogenic bladder dysfunction, Catheter, Toxin (comics), Heart, European Urology, Pathophysiology, Birth control, Pharmaceutical industry, Euronext, Botulinum toxin, Botulinum toxin, Neuroscience, Patient

In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union.

Key Points: 
  • In addition, Ipsen is also currently in the process of obtaining approvals in other countries outside the European Union.
  • Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience.
  • The forward-looking statements, objectives and targets contained herein are based on Ipsens management strategy, current views and assumptions.
  • Evaluation, treatment, and surveillance of neurogenic detrusor overactivity in spinal cord injury patients.

BlueWind Medical Ltd. Appoints Charles F. Cargile as Chief Financial Officer

Retrieved on: 
Tuesday, April 12, 2022
Urine, Company, IDE, Journal of Managed Care & Specialty Pharmacy, Urinary incontinence, American Urological Association, Marketing, United Kingdom, Chuck, Business, Board, Oklahoma State University–Stillwater, European Urology, PARK, OASIS, CFO, Mental health, Effectiveness, Overactive bladder, Kopp, Audit committee, Woman, CEO, Food, Newport Corporation, Director, OAB, Financial compensation, Regulation of tobacco by the U.S. Food and Drug Administration, Commercial software, Housing, Communities and Local Government Committee, FDA, University, Patient, Committee, Accounting, Management, Silviculture, Mirabegron, Man

PARK CITY, Utah, and HERZLIYA, Israel, April 12, 2022 /PRNewswire/ -- BlueWind Medical, Ltd., developer of the innovative RENOVA iStim™ implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. ("Chuck") Cargile to its leadership team as Chief Financial Officer.

Key Points: 
  • PARK CITY, Utah, and HERZLIYA, Israel, April 12, 2022 /PRNewswire/ -- BlueWind Medical, Ltd., developer of the innovative RENOVA iStim implantable tibial neuromodulation (iTNM) device for treatment of Overactive Bladder, today announced the addition of Charles F. ("Chuck") Cargile to its leadership team as Chief Financial Officer.
  • He will be a strong partner and an invaluable addition to the team," said Dan Lemaitre, Chairman and CEO of BlueWind Medical.
  • "With the potential for FDA marketing clearance in 2023, the addition of Chuck further prepares BlueWind Medical for commercialization and our next phase of corporate growth."
  • Mr. Cargile has more than 25 years of public company executive experience including 16 years as Chief Financial Officer of Newport Corporation from 2000 to 2016; 4 years as Chief Executive Officer and Chairman of the Board of Sunworks, Inc. from 2017 to 2021; and Chief Financial Officer of The Tattooed Chef from 2020 to 2021.

BlueWind Medical™ Ltd. Makes Key Additions to Leadership Team

Retrieved on: 
Thursday, January 6, 2022
United Kingdom, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Woman, University of California, Irvine Medical Center, Goal, M.B.A, Emerson University, Multan, PARK, Overactive bladder, European Urology, NHS, FDA, Human resources, Physical therapy, SVKM's NMIMS, Urine, R, University, Northwestern University, University of Northern Colorado, Kopp, Physician, Business, Mental health, American Urological Association, Communication, Food, Patient, Medtronic, CEO, IDE, HR, OAB, Industry, Roger W. Jones Award for Executive Leadership, Urinary incontinence, History of the National Health Service (England), National Health Service, St. Jude Medical, Kellogg School, Management, Pharmaceutical industry, Man, Guidant, Marketing

These new executive appointments will enhance our ability to build an effective and strategic team.

Key Points: 
  • These new executive appointments will enhance our ability to build an effective and strategic team.
  • Sandra Muhlfeld brings 20 years of experience commercializing new medical technologies in both early stage and large medical device companies.
  • Prior to joining Caldera Medical, Sandra held a variety of positions in global and U.S. marketing at Guidant and St. Jude Medical.
  • Lisa Mead brings over 30 years of Human Resources experience to BlueWind Medical including 20 years in the healthcare and medical device industry.

Affluent Medical : Financial results for the first half of 2021 and main clinical update.

Retrieved on: 
Wednesday, September 22, 2021
ESC, Man, Review, American College of Cardiology, Feedback, FCCP, Death, University, Icahn School of Medicine at Mount Sinai, Silver, Cotignola, Degenerative disease, University of Paris, Mitral valve, FAHA, Heart, Neuro, Group, Education, Committee, Journal, IFRS, Andreas, Cardiovascular disease, Urinary incontinence, EAU, Professor, Company, FESC, Health policy, BJU International, Kalio, Mehran, SAIME, NYHA, The Journal of Urology, Surgeon, COVID-19, Patient, FACC, FACP, American College, Ethics, Adrenal insufficiency, Nature Reviews Urology, Trial of the century, Mount Sinai Hospital, IPO, European Urology, Artus, Animal, Security (finance), Medical device, Pharmaceutical industry, Medicine

During the first half of 2021, purchases consumed fell by 158 thousand compared to the first half of 2020.

Key Points: 
  • During the first half of 2021, purchases consumed fell by 158 thousand compared to the first half of 2020.
  • On 9 June 2021, Affluent Medical announced the success of its IPO on the regulated market of Euronext Paris.
  • Starting in 2018 he broadened his field of expertise by engaging in various entrepreneurial projects before joining Affluent Medical.
  • Affluent Medical develops innovative, next-generation minimally invasive implants to restore essential physiological functions in these areas.