Kidney

Limmi Disease Insights Platform to be used in university hospital setting to improve detection of kidney stone disease recurrence

Retrieved on: 
Tuesday, January 16, 2024

CARLSBAD, Calif., Jan. 16, 2024 /PRNewswire/ -- Limmi, a startup specializing in Artificial Intelligence and Data Insights for life sciences, today announced it will be using Limmi's disease insights platform in hospitals with an initial focus on kidney stone disease recurrence.

Key Points: 
  • CARLSBAD, Calif., Jan. 16, 2024 /PRNewswire/ -- Limmi, a startup specializing in Artificial Intelligence and Data Insights for life sciences, today announced it will be using Limmi's disease insights platform in hospitals with an initial focus on kidney stone disease recurrence.
  • Limmi's Disease Insights Platform has been meticulously designed to address the common challenges researchers face when dealing with large sets of data, particularly complex health data.
  • "We know that recurring kidney stones affect approximately 50% of patients—but we don't have a personalized risk predictor for individual patients.
  • We have fortunately collected years of high quality kidney stone patient data to apply to Artificial Intelligence (AI).

IceCure Medical's ProSense® Featured at Indian Society of Vascular and Interventional Radiology Conference: Key Opinion Leaders Highlight Benefits of Cryoablation

Retrieved on: 
Tuesday, January 16, 2024

CAESAREA, Israel, Jan. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that it participated at the Indian Society of Vascular and Interventional Radiology (ISVIR) 24th Annual Conference in Jaipur, India that took place from January 11th-14th, 2024.

Key Points: 
  • IceCure, along with its in-country distributor, Novomed, exhibited and conducted hands-on ProSense® demonstrations and training.
  • In his presentation titled "Ablation for Bone and Soft Tissue Masses: How I Do It", ISVIR President Dr. Suyash Kulkarni, described the benefits of using a liquid nitrogen cryoablation system.
  • Dr. Kulkarni gave several specific examples of how his team performed cryoablation to successfully treat bone and soft tissue masses.
  • "At this year's ISVIR conference, more interventional radiologists evaluated the advantages of using cryoablation in their practices and hospitals."

EQS-News: AiCuris Received 15 Million Euros Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS® for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients

Retrieved on: 
Saturday, January 13, 2024

“Following the U.S. approval mid-2023, we are excited that our partner MSD now also received European approval for PREVYMIS® (letermovir) in its second indication, the prophylaxis of CMV infection in adult kidney transplanted patients at high risk.

Key Points: 
  • “Following the U.S. approval mid-2023, we are excited that our partner MSD now also received European approval for PREVYMIS® (letermovir) in its second indication, the prophylaxis of CMV infection in adult kidney transplanted patients at high risk.
  • In June 2023, the FDA and in December 2023 the EMA approved PREVYMIS® for prophylaxis of CMV disease in adult kidney transplant recipients at high risk.
  • Moreover, extended 200-day dosing for PREVYMIS® for CMV prophylaxis in adult HSCT recipients at risk for late CMV infection and disease was approved by the FDA in August 2023.
  • Approvals by national authorities was supported by a Phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-).

Walden Biosciences Expands Research Collaboration with the University of Michigan

Retrieved on: 
Wednesday, January 10, 2024

CAMBRIDGE, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company focused on transforming the treatment of kidney disease, today announced that it has broadened its research collaboration with the University of Michigan at Ann Arbor (U-M).

Key Points: 
  • Includes biomarker analysis from Walden’s Phase 1+ clinical study with Walden’s humanized anti-suPAR antibody, WAL0921
    CAMBRIDGE, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- Walden Biosciences, Inc. (Walden), a private, venture-backed biotechnology company focused on transforming the treatment of kidney disease, today announced that it has broadened its research collaboration with the University of Michigan at Ann Arbor (U-M).
  • A key element of the expansion of the collaboration is the inclusion of biomarker analysis of plasma samples from Walden’s Phase 1+ clinical study of WAL0921.
  • Walden and U-M’s Principal Investigator, Salim Hayek, M.D., previously announced a collaboration, in July 2022, to advance cutting-edge research in the area of genetics and the Mendelian randomization analysis of suPAR.
  • “Our collaboration with Walden continues to be productive and underscores the importance of collaborations between companies and universities in driving innovation.

Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 10, 2024

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

New published data demonstrates KidneyIntelX™ has broad implications for winning war on chronic kidney disease

Retrieved on: 
Wednesday, January 10, 2024

LONDON and SALT LAKE CITY, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces publication of Real World Evidence (“RWE”) after 12 months of follow-up in 2,569 patients with Type 2 diabetes and diabetic kidney disease (“DKD”) at a major U.S. health system in Primary Care and Community Health. Results in the diverse cohort, including 27% black patients, demonstrate that electronic health record deployment of KidneyIntelX in vitro prognostic testing was associated with clinical actions that led to a significant slowing of chronic kidney disease progression and improved Type 2 diabetes control most notably in the highest risk patients.

Key Points: 
  • Improved kidney health was evidenced by reduction in the rate of kidney function decline (eGFR slope) and diabetes control was evidenced by improved A1C levels.
  • KidneyIntelX testing achieved scale through electronic health record integration, deploying directly to large treating groups of primary care physicians.
  • KidneyIntelX has received broad insurance payment coverage including through Medicare, Medicaid, and Blue Cross Blue Shield programs.
  • “The demonstrated benefits of KidneyIntelX early risk assessment at one year are significant and go to the core of chronic disease preventative medicine.

World’s First Kidney Tumor Treated Using the HistoSonics’ Edison® Histotripsy System

Retrieved on: 
Tuesday, January 9, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240109791302/en/
    Example of HistoSonics technology targeting kidney tissue to be destroyed in a non-invasive histotripsy procedure.
  • While surgical intervention is the “gold standard” in removing kidney tumors, a non-invasive approach with histotripsy provides the potential to destroy targeted tumors without damaging non-targeted kidney tissue.
  • Use of the Edison System in kidney applications is limited by federal law to investigational use.
  • The #HOPE4KIDNEY Trial is expected to support a future expansion of the indication to include the destruction of kidney tissue/tumors.

IceCure Medical CEO Issues Letter to Shareholders & Reports Increase in Sales in Preliminary Unaudited 2023 Results

Retrieved on: 
Wednesday, January 10, 2024

Increased Revenues, System, and Probe Sales: Based on our expected preliminary unaudited 2023 results, ProSense® system and disposable probe sales increased by 26% globally over 2022.

Key Points: 
  • Increased Revenues, System, and Probe Sales: Based on our expected preliminary unaudited 2023 results, ProSense® system and disposable probe sales increased by 26% globally over 2022.
  • On a preliminary unaudited basis, as of December 31, 2023, we had cash and cash equivalents, including short-term deposits, of $11 million.
  • The above information reflects preliminary unaudited estimates with respect to certain results of IceCure for the full year ended December 31, 2023, based on currently available information.
  • Because the audit for 2023 is not yet complete, the Company's final results may vary from the preliminary estimates provided herein.

Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024

Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised

Scilex Holding Company Chief Executive Officer and President Issues Letter to Stockholders Highlighting 2023 Accomplishments and Outlook for 2024

Retrieved on: 
Monday, January 8, 2024

PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.

Key Points: 
  • PALO ALTO, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today issued a letter from Jaisim Shah, its Chief Executive Officer and President, to its stockholders highlighting the Company’s accomplishments in 2023 and its forward outlook for 2024.
  • Dear Scilex Holding Company Stockholders,
    I would like to express my deepest gratitude for your unwavering support, patience, and invaluable feedback throughout the transformative year in 2023.
  • As we continue to navigate the complexities of the pharmaceutical landscape, your role as stockholders in this journey is invaluable.
  • Despite the challenges that remain ahead, we are setting ambitious goals for the Company in 2024, including:
    Expected launch of Gloperba®.