Urinary bladder

Amber Therapeutics Closes $100 Million Series A Financing to Advance Breakthrough Amber-UI Neuromodulation Therapy for Mixed Urinary Incontinence towards US FDA Approval

Retrieved on: 
Montag, Juni 10, 2024
Patient, Research, Standard of care, Pudendal nerve, MUI, Therapy, Urinary bladder, Safety, NEA, Class, New Enterprise Associates, Lifting, Amber, Urinary incontinence, Capital, Health care, Stress incontinence, Woman, UI, Pharmaceutical industry

10th June 2024 - Amber Therapeutics, a UK-based medical technology company developing a breakthrough adaptive neuromodulation therapy to treat mixed urinary incontinence (MUI), announces the successful closing of its Series A financing raising a total of $100 million (£80 million) from leading healthcare and technology investors in the US and UK.

Key Points: 
  • 10th June 2024 - Amber Therapeutics, a UK-based medical technology company developing a breakthrough adaptive neuromodulation therapy to treat mixed urinary incontinence (MUI), announces the successful closing of its Series A financing raising a total of $100 million (£80 million) from leading healthcare and technology investors in the US and UK.
  • The proceeds of the financing will be used to fund the development of Amber-UI through pilot and pivotal studies towards regulatory approval in the US.
  • Urinary incontinence (UI) is a debilitating medical condition that affects millions of women globally.
  • “We believe Amber Therapeutics has the potential to become the first ever approved therapy for a significantly under-addressed patient population,” said Tiffany Le, Principal at NEA.

Blue Earth Diagnostics Highlights Results of Studies Evaluating Impact of Urinary Activity on Image Interpretation and Performance of POSLUMA® (Flotufolastat F 18) and 18F-Flotufolastat PET in Prostate Cancer

Retrieved on: 
Montag, Juni 10, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Antiandrogen, Doctor of Philosophy, Safety, BCR, PET/CT, PSMA, PSA, MD, Annual general meeting, Recurrence, School, Institute of technology, Pelvis, Serum, Prostate cancer, System, Interim, Parameter, Medicine, PET, Emory University, Radiation, Food, SUV, Cancer, Furosemide, FRCR, Lymph, Radiology, Neoplasm, Radiopharmaceutical, Blood pressure, ADT, Diuresis, Risk, F 18, Society, MBBS, Diarrhea, Urinary bladder, SNMMI, MRCP, Physician, FDA, Metastasis, Urine, Molecular imaging, Abstract, Medical imaging

“Activity in the urinary tract, especially in the urinary bladder, is a common feature of FDA-approved PSMA-PET radiopharmaceuticals which are excreted via the urine.

Key Points: 
  • “Activity in the urinary tract, especially in the urinary bladder, is a common feature of FDA-approved PSMA-PET radiopharmaceuticals which are excreted via the urine.
  • “POSLUMA provides physicians with useful information based on its performance at low PSA levels, PSMA binding and low urinary bladder activity.
  • The authors concluded that interpretation of 68Ga-PSMA-11 PET was significantly more impacted by bladder activity than 18F-flotufolastat PET in the matched populations of primary prostate cancer patients.
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

Butterfly Network Enters the Bladder Scanning Market With First Specialty Product, iQ+ Bladder, in the United States

Retrieved on: 
Mittwoch, Mai 15, 2024
Surgery, Baby, Maternity, Other Technology, Public Policy, Government, Radiology, Software, Oncology, Hardware, Medical Devices, Healthcare Reform, Hospitals, Technology, Semiconductor, Clinical Trials, Cardiology, Women, Practice Management, Seniors, Veterinary, Physical Therapy, Nursing, Managed Care, Pets, FDA, Health, Health Technology, Consumer, Butterfly, MD, Network, Multimedia, Urinary bladder, Butterfly network, Medical imaging

The bundled solution includes an iQ+ Bladder probe, streamlined software, compact rolling cart, tablet and power splitter, paired with premium assembly.

Key Points: 
  • The bundled solution includes an iQ+ Bladder probe, streamlined software, compact rolling cart, tablet and power splitter, paired with premium assembly.
  • Combined, the solution offers a fit-for-purpose ultrasound-based bladder scanner that helps nurses get automated bladder volume calculations, with 3D visualizations, in seconds.
  • View the full release here: https://www.businesswire.com/news/home/20240515835233/en/
    Butterfly iQ+ Bladder includes an iQ+ Bladder probe, streamlined software, compact rolling cart, tablet and power splitter, paired with premium assembly.
  • “With iQ+ Bladder, we move outside of our core point-of-care ultrasound market to better address the bladder scanning market, which has long awaited a more affordable, user-friendly solution.

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
Biotechnology, FDA, Health, General Health, Oncology, Health Technology, Other Science, Medical Devices, Research, Science, Clinical Trials, Western University, Cystoscopy, Risk, Food, Urinary bladder, American Urological Association, Recurrence, Trial of the century, PCR, Patient, AUA, MBA, Neoplasm, Clinical trial, Annual general meeting, Bladder cancer, Liquid biopsy, Medical imaging

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.”

Bladder Cancer: Long-Term Benefits of Blue Light Cystoscopy and Enhanced Detection with HD Technology Unveiled at AUA 2024

Retrieved on: 
Dienstag, Mai 7, 2024
Congress, Patient, Cystoscopy, HAL, University Challenge 2013–14, Meta-analysis, Risk, Urinary bladder, WLC, Survival, Health care, Recurrence, Pivotal trial, BLC, BCG, CIS, Bladder cancer, Detection, Principal, Access, AUA, BRAVO, RCT, Clinical trial, Overalls, Medical imaging

On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."

Key Points: 
  • On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."
  • The study addresses a lack of practical real-world data comparing the impact of BLC versus WLC, specifically for recurrence, progression, and survival.
  • The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes.
  • A total of 177 patients were enrolled, 128 patients underwent blue light cystoscopy (BLC) with Cysview (HAL) and were included in the full analysis set.

Bladder Cancer: Long-Term Benefits of Blue Light Cystoscopy and Enhanced Detection with HD Technology Unveiled at AUA 2024

Retrieved on: 
Dienstag, Mai 7, 2024
Congress, Patient, Cystoscopy, HAL, University Challenge 2013–14, Meta-analysis, Risk, Urinary bladder, WLC, Survival, Health care, Recurrence, Pivotal trial, BLC, BCG, CIS, Bladder cancer, Detection, Principal, Access, AUA, BRAVO, RCT, Clinical trial, Overalls, Medical imaging

On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."

Key Points: 
  • On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."
  • The study addresses a lack of practical real-world data comparing the impact of BLC versus WLC, specifically for recurrence, progression, and survival.
  • The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes.
  • A total of 177 patients were enrolled, 128 patients underwent blue light cystoscopy (BLC) with Cysview (HAL) and were included in the full analysis set.

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

Retrieved on: 
Sonntag, Mai 5, 2024
UTI, Congress, FDA, FGFR, Cancer, Urinary diversion, Pyelonephritis, Erdafitinib, Hospital, Safety, Food, American Urological Association, Survival rate, FGFR3, Johnson & Johnson, Recurrence, Abstract, Cohort, BCG, PD-1, PD-L1, Disease, Bladder cancer, Patient, Medicine, AUA, Urinary bladder, MUC, Face, SAN, Sepsis, EAU, Pharmaceutical industry

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%.

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Freitag, Mai 3, 2024
FDA, Mayo Clinic, Safety, Food, American Urological Association, Urinary bladder, Carcinoma, Immunotherapy, Hematuria, Abstract, BCG, CIS, Patient, Face, NMIBC, AUA, Urination, Rush University Medical Center, Death, Clinical trial, Annual general meeting, Quality of life, Pharmaceutical industry

IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024. These data were featured today at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX. In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.

Key Points: 
  • 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.
  • “The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients.
  • “Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction.
  • A webcast replay will be available in the investor relations section on the company's website following the completion of the call.

Ferring Adds Three New Studies to Non-Muscle Invasive Bladder Cancer Clinical Trial Program With ADSTILADRIN® (nadofaragene firadenovec-vncg)

Retrieved on: 
Dienstag, April 16, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Real-World Evidence, FDA, RWE, Investment, Safety, Food, Pembrolizumab, Immunotherapy, Health care, ABLE, Carcinoma in situ, Physician, Research, BCG, Docetaxel, Observation, CIS, Senior, Patient, Ferring Pharmaceuticals, NMIBC, Bacillus, Clinical trial, Urinary bladder, Bladder cancer, Ageing, Pharmaceutical industry

Ferring Pharmaceuticals today announced start up of new studies in the United States (U.S.) for three new ADSTILADRIN in BLadder cancEr (ABLE) clinical trials in patients with non-muscle invasive bladder cancer (NMIBC) with plans to expand select clinical trials outside of the U.S. later this year.

Key Points: 
  • Ferring Pharmaceuticals today announced start up of new studies in the United States (U.S.) for three new ADSTILADRIN in BLadder cancEr (ABLE) clinical trials in patients with non-muscle invasive bladder cancer (NMIBC) with plans to expand select clinical trials outside of the U.S. later this year.
  • ABLE-32: A Phase 3b randomized, controlled clinical study to evaluate the safety and efficacy of ADSTILADRIN versus observation in patients with intermediate-risk NMIBC.
  • The ABLE-22, ABLE-32 and ABLE-42 clinical trials announced today are yet another milestone for this comprehensive research program.
  • Healthcare providers in the U.S. can learn more about the ADSTILADRIN clinical trial program by calling 1-888-FERRING (888-337-7464) and selecting option number one or emailing [email protected] .

SpineX Closes Recruitment for SCONE™ Clinical Trial

Retrieved on: 
Montag, 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.