Urinary bladder

SpineX Closes Recruitment for SCONE™ Clinical Trial

Retrieved on: 
Monday, April 8, 2024
Children, Biotechnology, FDA, Health, Neurology, Health Technology, Medical Devices, Research, Consumer, Science, Clinical Trials, Cord, Brain, Cerebral palsy, Multiple sclerosis, SCIP, Patient, Stroke, Clinical trial, Urinary bladder, Trial of the century, Skin, Spinal cord, Heart, Urinary incontinence, Cauda equina syndrome, Neuromodulation, Pharmaceutical industry

SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.

Key Points: 
  • SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.
  • The clinical trial— Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “CONTINENCE” Clinical Study — began in May 2022.
  • “SCONE has the power to transform the lives of millions of patients with neurogenic bladder,” says Parag Gad, SpineX co-founder & CEO.
  • SpineX anticipates beginning a multi-center pivotal trial for children with Cerebral Palsy in 2024.

BlueWind Medical Revi™ Implantable Tibial Neuromodulation Device Now Available to Patients in Texas

Retrieved on: 
Thursday, March 21, 2024
De novo, American Medical Association, Urinary bladder, Renaissance, Patient, Ankle, Quality of life, Surgeon, CPT, Urinary incontinence, Commercial software, Urology, Medicare, Neuromodulation, USD, FDA, CMS, Health, Food

PARK CITY, Utah, March 21, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Urologists Dr. Henry Ruiz and Dr. Natalia Hernandez at the Urology Institute at Renaissance are the first providers of Revi in the state of Texas.

Key Points: 
  • "Urge Incontinence, although a common condition with profound impacts on quality of life, has long been under-diagnosed and under-treated.
  • With the advent of Revi, we now have a safe and proven patient-centric solution that can be tailored and optimized to meet the needs of patients," stated Dr. Ruiz.
  • In October 2023, the American Medical Association (AMA) CPT Editorial Panel announced the final Current Procedural Terminology (CPT) code to describe the subfascial tibial neuromodulation implant procedure, 0817T.
  • We consider it a privilege to contribute to improving the quality of life for the millions living with urge incontinence," stated Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

BlueWind Medical Brings Revi™ Implantable Tibial Neuromodulation Device to Patients in Central Ohio

Retrieved on: 
Wednesday, February 7, 2024
Medicare, Commercial software, USD, Neuromodulation, Patient, American Medical Association, Urinary bladder, FDA, Food, Quality of life, Ankle, CMS, CPT, De novo, Health, Urinary incontinence

PARK CITY, Utah, Feb. 7, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Springfield, Ohio at Ohio Valley Surgical Hospital with urologist Dr. Eric Espinosa.

Key Points: 
  • "I am thrilled to have a new solution to offer patients with Urge Incontinence—a common condition that has a profound impact on quality of life.
  • In October, the American Medical Association (AMA) CPT Editorial Panel announced the final Current Procedural Terminology (CPT) code to describe the subfascial tibial neuromodulation implant procedure, 0817T.
  • "Revi has the potential to revolutionize the treatment landscape for UUI by giving patients more control, comfort, and convenience.
  • We are honored that Dr. Espinosa is bringing this life-changing technology to the people of Central Ohio.

Phase 4 Study Evaluating Use of ADSTILADRIN® (nadofaragene firadenovec-vncg) in Real-World Setting

Retrieved on: 
Wednesday, January 24, 2024
Research, FDA, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Science, Oncology, Ageing, RWE, Mortality, Carcinoma in situ, Patient, PST, Progression-free survival, Ferring Pharmaceuticals, ASCO, CIS, EQ-5D, BCG, University, Society, Urinary bladder, Recurrence, Food, Carcinoma, Safety, Work, Disease, Bladder cancer, Doctor of Health Science, Progress, Real, Clinical trial, NMIBC, Physician, Pharmaceutical industry

ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.

Key Points: 
  • ABLE-41 (NCT06026332) is an ongoing Phase 4 observational study evaluating the effectiveness, overall experiences, patterns of use, and safety of ADSTILADRIN® (nadofaragene firadenovec-vncg) in a U.S. real-world setting.
  • “I am thrilled to be part of this ongoing research and among the first uro-oncologists to be treating patients with ADSTILADRIN in a clinical setting.
  • Final results from this prospective, multi-institutional study are expected at the end of 2026.
  • Trials in Progress Poster Session B: Urothelial Carcinoma
    Abstract #TPS705, Friday, Jan. 26 at 5:45 - 6:45 p.m. PST

Ferring Announces Full Availability of ADSTILADRIN® (nadofaragene firadenovec-vncg) in the U.S.

Retrieved on: 
Tuesday, January 16, 2024
Oncology, Health, Managed Care, General Health, Clinical Trials, Pharmaceutical, Biotechnology, RWE, Senior, Carcinoma in situ, Patient, Bladder cancer, Ferring Pharmaceuticals, CIS, BCG, Urinary bladder, BCAN, Investment, FDA, NMIBC, Bacillus, Pharmaceutical industry

Approved by the U.S. Food & Drug Administration (FDA) in December 2022, ADSTILADRIN is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy.

Key Points: 
  • Approved by the U.S. Food & Drug Administration (FDA) in December 2022, ADSTILADRIN is the first and only FDA-approved intravesical gene therapy for adults with NMIBC who no longer respond to standard therapy.
  • “With our significant manufacturing investments, we have achieved full product supply ahead of schedule.
  • Now that full product supply is available ahead of schedule, Ferring can end the temporary ADSTILADRIN Early Experience Program and dramatically increase patient access.
  • This ongoing study is exploring early utilization, experiences, and outcomes of ADSTILADRIN in the routine care setting.

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Liver, Medical Subject Headings, Fungal infection, Marketing, European Commission, INN, Stomach, Allergy, Itraconazole, Saquinavir, ATC, Glass, Nelfinavir, Depression, Kidney disease, Bleeding, International, European, Megacolon, Disease, Urinary retention, Language, Muscle weakness, Urinary bladder, Inflammation, Nefazodone, Water, Peanut, Ulcerative colitis, Colitis, Ketoconazole, Ritonavir, Tablet, Hyperkinesia, Indinavir, CYP3A4, Xerostomia, Select, Committee, Urination, Patient, Liver disease, Atazanavir, Anatomy, Medicine, Clarithromycin, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Toviaz, fesoterodine, Date of authorisation: 20/04/2007, Revision: 28, Status: Authorised

Protara Therapeutics Announces Presentation of Additional Encouraging Data from Phase 1a ADVANCED-1 Trial of TARA-002 in NMIBC at the 24th Annual Meeting of the Society of Urologic Oncology

Retrieved on: 
Thursday, November 30, 2023
Chills, Fever, CIS, Carcinoma, Fatigue, Headache, Urinary bladder, Therapy, Cancer, Society, Urination, BCG, Neoplasm, System, SUO, Bacillus, Patient, NMIBC, Pharmaceutical industry

The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Washington, D.C. from November 28, 2023 through December 1, 2023.

Key Points: 
  • The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Washington, D.C. from November 28, 2023 through December 1, 2023.
  • The patient who did not achieve HGRFS was dosed at 10KE, the lowest dose of TARA-002 offered in the trial.
  • Additional details on the trial design will be featured in a Trial in Progress poster at the SUO meeting.
  • A copy of the SUO posters will be available in the Events and Presentations section of the Company’s website: https://ir.protaratx.com .

BlueWind Medical Brings Revi Implantable Tibial Neuromodulation Device to Patients in Shreveport, Louisiana

Retrieved on: 
Thursday, December 21, 2023
Revi, Patient, Marketing, Food, FDA, Commercial software, Health, USD, American Medical Association, Medicare, Neuromodulation, Urinary incontinence, CPT, Urinary bladder, Ankle, De novo, CMS

PARK CITY, Utah, Dec. 21, 2023 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Shreveport, Louisiana at Christus Surgery Center with world-renowned urologist Dr. Gerard Henry.

Key Points: 
  • "As a physician, I am always looking for new therapies that address the unmet needs of my patients.
  • "Revi is a unique device that allows patients to control their own therapy and adjust it to their individual needs.
  • I am delighted to share that I am now offering this groundbreaking treatment to patients who suffer from urge incontinence."
  • Revi has the potential to revolutionize the treatment landscape for UUI by giving patients more control, comfort, and convenience.

Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay

Retrieved on: 
Wednesday, December 20, 2023
Food, Urinary bladder, UTUC, Real-time, Bladder cancer, FDA, Carcinoma, DNA, Hematuria, Cancer, Neoplasm, Methylation, Biomarker, Patient, Clinical research, USC

TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay, intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.

Key Points: 
  • TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay , intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.
  • The Bladder CARE™ Assay measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction.
  • "We anticipate further fruitful partnerships with experts in the field to enhance the accessibility of the Bladder CARE™ Assay."
  • Pangea Laboratory is poised to commence multicenter clinical trials as the next step toward obtaining premarket approval for the Bladder CARE™ Assay.

SpineX close to full recruitment for SCONE™ clinical trial

Retrieved on: 
Wednesday, December 6, 2023
Medical Devices, Health, Clinical Trials, General Health, Cardiology, Biotechnology, Neuromodulation, Brain, Cerebral palsy, Clinical trial, FDA, Heart, Stroke, Urinary incontinence, Multiple sclerosis, Urinary bladder, Cord, Cauda equina syndrome, Skin, Trial of the century, SCIP, Spinal cord, Pharmaceutical industry, Pediatrics

SpineX Inc. is today announcing close to full recruitment -- over 80% -- of the patient cohort for its clinical trial of its proprietary SCONE™ device.

Key Points: 
  • SpineX Inc. is today announcing close to full recruitment -- over 80% -- of the patient cohort for its clinical trial of its proprietary SCONE™ device.
  • The clinical trial— Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “CONTINENCE” Clinical Study — began in May 2022 and is expected to complete in early 2024.
  • SpineX scientists and researchers anticipate participants will experience a statistically significant improvement in symptoms of neurogenic bladder as assessed by the Neurogenic Bladder Symptom Score (NBSS).
  • SpineX anticipates beginning a multi-center pivotal trial for children with Cerebral Palsy in 2024.