Diuretic

Nuwellis Announces Launch of Ultrafiltration Therapy Using Aquadex Smartflow® System at Henry Ford Health

Retrieved on: 
Tuesday, April 9, 2024

MINNEAPOLIS, April 09, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) today announced that Detroit, Michigan-based health system, Henry Ford Health, has begun offering ultrafiltration therapy to heart failure patients suffering from fluid overload using the company’s Aquadex SmartFlow system as part of Nuwellis’ pivotal REVERSE-HF clinical study.

Key Points: 
  • MINNEAPOLIS, April 09, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) today announced that Detroit, Michigan-based health system, Henry Ford Health, has begun offering ultrafiltration therapy to heart failure patients suffering from fluid overload using the company’s Aquadex SmartFlow system as part of Nuwellis’ pivotal REVERSE-HF clinical study.
  • “We are excited to study the impact of Aquadex SmartFlow therapy on our heart failure patients who are suffering from severe fluid overload,” said Dr. Jennifer Cowger, Section Head of the heart failure program at Henry Ford.
  • “We are eager to see if ultrafiltration can affect clinical outcomes of our heart failure patients resistant to diuretics.
  • “We are proud and honored to be working with Henry Ford Health and look forward to partnering with Dr. Cowger and the team of heart failure experts through the REVERSE-HF trial.

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
Wednesday, April 3, 2024

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

NSF Marks Milestones in Personal Care for Athletes

Retrieved on: 
Thursday, March 21, 2024

These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.

Key Points: 
  • These certifications mark two major milestones: CBDHCC is NSF’s first client in the world to comply with NSF Guideline 527, which demonstrates the product formula meets strict limits and is free of unsafe levels of impurities and adulterants; it is also the first personal care product to earn NSF Certified for Sport® certification.
  • "The spirit of clean athletic competition is something we all connect with,” said David Trosin, Senior Director, Global Certification at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

CBD Healthcare Company Becomes the First-Ever Worldwide to Earn Prestigious NSF International Certifications in Personal Care for Athletes (NSF Guideline 527 and NSF Certified for Sport)

Retrieved on: 
Friday, March 15, 2024

CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.

Key Points: 
  • CBD Healthcare Company (CBDHCC) has become the First-Ever Personal Care Product to have earned certification to NSF Guideline 527 and NSF Certified for Sport® for its Broad-Spectrum CBD Balancing Massage and Body Oil.
  • "The spirit of clean athletic competition is something we all connect with,” said David Lonza, Vice President, Health Sciences at NSF.
  • NSF Certified for Sport® certifies dietary supplements, functional foods, cosmetics and personal care products to be free from substances banned by major sporting organizations.
  • Products Certified for Sport® must also be certified to either NSF/ANSI 173, NSF 229 or NSF 527 to ensure their contents match their claims.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

High Prevalence of Cognitive Impairment in Patients with Heart Failure Shown to Negatively Impact Disease Self-Management

Retrieved on: 
Tuesday, March 12, 2024

The Cognitive Impairment in Heart Failure: A Heart Failure Society of America Scientific Statement published today in the Journal of Cardiac Failure (JCF), indicates that clinicians have a responsibility to recognize and address cognitive impairment as an integral component of personalized care for patients with heart failure (HF).

Key Points: 
  • The Cognitive Impairment in Heart Failure: A Heart Failure Society of America Scientific Statement published today in the Journal of Cardiac Failure (JCF), indicates that clinicians have a responsibility to recognize and address cognitive impairment as an integral component of personalized care for patients with heart failure (HF).
  • Heart failure clinicians should be equipped with tools to assess and identify markers for cognitive impairment.
  • Cognitive Impairment in Heart Failure outlines several domains affected by cognitive impairment including learning and memory, executive function, complex attention, perceptual-motor function, language, and social cognition.
  • The Cognitive Impairment in Heart Failure: A Heart Failure Society of America Scientific Statement is available online in the JCF at www.onlinejcf.com .

Late-Breaking Data Highlighting Benefits of Ultrafiltration Therapy Using the Aquadex System for Heart Failure Patients was Presented at the Technology and Heart Failure Therapeutics Conference

Retrieved on: 
Thursday, March 7, 2024

MINNEAPOLIS, March 07, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, announced results from two new clinical data analyses from the AVOID-HF trial, which demonstrate the benefits of its Aquadex System in reducing heart failure readmissions at 30 days. Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.

Key Points: 
  • Results from the analyses were presented in a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.
  • Key findings demonstrating the benefits of AUF include:
    Fewer heart failure events and heart failure hospitalizations: AUF patients had significantly fewer heart failure events within 30 days compared to ALD (90% vs 77.3% p=0.0138) and fewer heart failure hospitalizations for the AUF patients compared to the ALD patients (90.0% vs. 79.2% p=0.0321) within 30 days.
  • Key findings from the analysis include:
    Top predictors for 90-day heart failure events: Using ML, the study identified the top 10 predictors for 90-day heart failure events.
  • Strong results for super-responders: 90% of patients categorized as super-responders to AUF therapy within this model did not experience any 90-day heart failure events.

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024

Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.

Key Points: 
  • Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.
  • Gross margin was 54.4% for the fourth quarter of 2023, compared to 56.9% in the prior-year period, a decrease of 250 basis points.
  • Selling, general and administrative expenses for the fourth quarter of 2023 were $3.6 million, compared to $4.7 million in the prior-year period.
  • Total operating expenses for the fourth quarter of 2023 were $5.0 million, a 15% decrease compared to $5.9 million in the prior-year period.

Strong data from DSR® proof-of-concept studies in heart failure accepted for late-breaking presentation at THT 2024

Retrieved on: 
Wednesday, February 28, 2024

Presentation by Key Opinion Leader Dr. Testani on Wednesday, March 6th 2024

Key Points: 
  • Presentation by Key Opinion Leader Dr. Testani on Wednesday, March 6th 2024
    Ghent, Belgium – 28 February 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the late-breaking abstract including data from the RED DESERT and SAHARA proof-of-concept studies of the Company’s DSR therapy in patients with diuretic-resistant heart failure have been selected for a late-breaking presentation at THT 2024 .
  • Technology and Heart failure Therapeutics (THT) will be held from March 4th to 6th, 2024 in Boston, US and is an international conference on the latest heart failure innovations, focusing on device- and technology-based treatments within the context of drug therapies.
  • The abstract “Serial Direct Sodium Removal in Patients with Heart Failure and Diuretic Resistance” will be presented on Wednesday March 6th, 2024 by Dr. Jeffrey Testani, Associate Professor of Medicine and Director of Heart Failure Research at Yale University School of Medicine and will become available on the website of THT prior to the start of the conference.