The Journal of Urology

Immunis.AI Announces Publication, in The Journal of Urology, of Results from Blood-Based Immune Profiling Study for Prostate Cancer Patients

Retrieved on: 
Friday, March 1, 2024

The results validate the ability of the platform to accurately stratify risk for patients with diagnosed prostate cancer.

Key Points: 
  • The results validate the ability of the platform to accurately stratify risk for patients with diagnosed prostate cancer.
  • “One of the big challenges in prostate cancer management is distinguishing those patients with early prostate cancer who are appropriate for active surveillance from those who need to be aggressively treated.
  • In the study, peripheral blood samples were collected from 706 subjects with confirmed prostate cancer based on positive biopsy.
  • Using AI predictive modeling, the normalized immune profile of each patient was evaluated against known immune signatures for indolent or aggressive prostate cancer.

American Urological Association Names New Assistant Secretary

Retrieved on: 
Tuesday, January 9, 2024

BALTIMORE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is pleased to announce Jaspreet S. Sandhu, MD, has been named by the Board of Directors as AUA Associate Secretary for the Asia and Australia region.

Key Points: 
  • BALTIMORE, Jan. 09, 2024 (GLOBE NEWSWIRE) -- The American Urological Association (AUA) is pleased to announce Jaspreet S. Sandhu, MD, has been named by the Board of Directors as AUA Associate Secretary for the Asia and Australia region.
  • Dr. Sandhu will begin his three-year term as Associate Secretary on June 1, 2024.
  • As Associate Secretary for this distinct geographic region, Dr. Sandhu will be responsible for shaping and executing the Association's international strategy, programming and activities within the Asia and Australia regions.
  • "Dr. Sandhu's impressive experience and established international connections make him the ideal candidate for this role," said AUA Secretary David Penson, MD.

Calyxo Closes on $50 Million Equity Financing to Support Broad Launch of CVAC Kidney Stone Treatment

Retrieved on: 
Tuesday, December 12, 2023

Calyxo is commercializing the CVAC Aspiration System which uses irrigation and aspiration to remove kidney stones with the goal of minimizing residual stone burden.

Key Points: 
  • Calyxo is commercializing the CVAC Aspiration System which uses irrigation and aspiration to remove kidney stones with the goal of minimizing residual stone burden.
  • Our kidney stone treatment innovations will improve care for patients and have the opportunity to transform the way this condition is treated.
  • “Calyxo has an opportunity to alter the kidney stone treatment category and deliver a new generation of devices that can significantly improve care and comfort for millions of people afflicted by kidney stones.
  • The most commonly used kidney stone treatments today do not reliably remove all of the stone fragments created.

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

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.

SpineX Demonstrates Ground Breaking Technology to Improve Bladder Function in Stroke Survivors

Retrieved on: 
Thursday, November 9, 2023

The publication, entitled A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms after Stroke shows improved bladder function and restoration of brain activity associated with normal voiding in stroke survivors who completed SpineX SCONE ™ therapy.

Key Points: 
  • The publication, entitled A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms after Stroke shows improved bladder function and restoration of brain activity associated with normal voiding in stroke survivors who completed SpineX SCONE ™ therapy.
  • View the full release here: https://www.businesswire.com/news/home/20231109708091/en/
    This publication demonstrates improved brain function, which is directly associated with clinically significant improvement in bladder function.
  • The publication demonstrates that SCONE therapy corrects brain activity changes after stroke, bringing post-stroke brain activity associated with bladder control to a level similar to that of healthy individuals.
  • This improved brain function is directly associated with clinically significant improvement in bladder function.

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

Retrieved on: 
Thursday, August 10, 2023

“We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.

Key Points: 
  • “We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.
  • UroGen hosted an event to discuss and highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials on July 27th, 2023.
  • Generated record quarterly net product revenue of $21.1 million for the second quarter of 2023, representing ~27% growth over the second quarter of 2022.
  • The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMYTO in 2022.

The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, August 8, 2023

TURBT is the current standard of care for patients with this type of cancer.

Key Points: 
  • TURBT is the current standard of care for patients with this type of cancer.
  • UroGen recently announced positive topline data from ATLAS and the Phase 3 ENVISION trial.
  • UGN-102 was generally well tolerated, with a side effect profile similar to that of previous clinical trials.
  • Assuming positive findings, a New Drug Application (NDA) is anticipated to be submitted to the U.S. Food and Drug Administration (FDA) in the same year.

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

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.

AB Science receives Notice of Allowance for European patent covering masitinib in the treatment of metastatic castrate refractory prostate cancer (mCRPC)

Retrieved on: 
Monday, June 26, 2023

This new European patent provides intellectual property protection for masitinib in the treatment of mCRPC until 2042.

Key Points: 
  • This new European patent provides intellectual property protection for masitinib in the treatment of mCRPC until 2042.
  • Masitinib is positioned in combination with docetaxel as a treatment of mCRPC patients who are eligible to chemotherapy; that is to say, it is administered directly following the metastatic hormone-sensitive prostate cancer (mHSPC) treatment space.
  • The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patent application, EP4175639A1, after the completion of certain formal procedural steps.
  • A European NOA is issued after an examiner determines that a patent application satisfies all requirements for patentability under the European Patent Convention.

Blue Earth Diagnostics Announces Results of Post-hoc Analysis Assessing Impact of Urinary Activity on Interpretation of POSLUMA® (Flotufolastat F 18) Injection PET/CT in Prostate Cancer

Retrieved on: 
Monday, June 26, 2023

The analysis was based on data from Blue Earth Diagnostics’ prospective Phase 3 LIGHTHOUSE and SPOTLIGHT 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 LIGHTHOUSE and SPOTLIGHT studies that evaluated the diagnostic performance and safety of POSLUMA in newly diagnosed and recurrent prostate cancer.
  • The results as reported expanded on the initial data from a single reader that were detailed in the abstract.
  • The results were reported at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, held June 24 – 27, in Chicago, Ill.
  • Results from the SPOTLIGHT study were published online on April 26, 2023 in the Journal of Urology: DOI: 10.1097/JU.0000000000003493 .3