THT

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Q&A, Exercise, Patient, Pulmonary hypertension, Cardiovascular Research, Clinical trial, IP, Therapy, LINK, Research, Science, LEVEL, Public expenditure, Heart failure, Development, Tenax, Disease, KOL, TNX-102, First, Research and development, MPH, Cardiology, Conference, Patent, Doctor of Philosophy, Faculty, MBA, Levosimendan, THT, Feinberg School of Medicine, Pharmaceutical industry

We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.

Key Points: 
  • We also made important progress in further expanding levosimendan’s U.S. intellectual property protections, securing the future commercial value of TNX-103.
  • In February 2024, Tenax Therapeutics announced that the first patient had enrolled in the Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) ( NCT05983250 ).
  • LINK TO REGISTER
    Tenax Therapeutics reported cash and cash equivalents of $9.8 million as of December 31, 2023.
  • Tenax Therapeutics reported a net loss for 2023 of $7.7 million, compared to a net loss of $11.0 million in 2022.

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.

Revamp Medical Announces Appointment of Mike Favet as CEO

Retrieved on: 
Thursday, March 21, 2024
Mechanical, Champaign–Urbana metropolitan area, Acute decompensated heart failure, Boston Scientific, Business administration, Patient, Revamp, University, Medtech, THT, FDA, Pharmaceutical industry

NETANYA, Israel, March 21, 2024 /PRNewswire/ -- Revamp Medical , Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced the appointment of Mike Favet as Chief Executive Officer and member of the Board of Directors.

Key Points: 
  • NETANYA, Israel, March 21, 2024 /PRNewswire/ -- Revamp Medical , Inc., a privately held clinical-stage medical technology company committed to developing solutions for Heart Failure congestion management, today announced the appointment of Mike Favet as Chief Executive Officer and member of the Board of Directors.
  • "Mike brings a distinguished track record of successful leadership in medtech and is ideally suited to build Revamp Medical from the solid foundation being demonstrated in the U.S.
  • Early Feasibility Study through the pivotal trial to support FDA approval" said Mike Berman, a Board Director of Revamp Medical.
  • "I am thrilled for the opportunity to join Revamp Medical at this significant juncture," said Mr. Favet.

Multi-Center Study Presented by Duke at Heart Failure Therapeutics Conference Highlights Daxor’s Unique Clinical Utility for Heart Failure Patients

Retrieved on: 
Friday, March 8, 2024
BVA, Anemia, Blood, Kidney, Duke University Hospital, Risk, Conference, Heart failure, Prevalence, Patient, Kidney disease, Diagnosis, Correlation, THT, Pressure, Medical imaging

Oak Ridge, TN, March 08, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces new data from Duke University Medical Center validating the benefits of blood volume analysis (BVA) in optimizing individualized therapy for heart failure patients with impaired renal function. Data were presented on 259 patients from three centers at the Technology and Heart Failure Therapeutics Conference (THT), which brought together the world’s leading experts in heart failure innovations at the Westin Boston Seaport in Boston, Massachusetts March 4-6, 2024.

Key Points: 
  • Data were presented on 259 patients from three centers at the Technology and Heart Failure Therapeutics Conference (THT), which brought together the world’s leading experts in heart failure innovations at the Westin Boston Seaport in Boston, Massachusetts March 4-6, 2024.
  • The study, titled, ‘Blood Volume Profiles and Correlations with Pressures in Heart Failure with Impaired Renal Function,’ aimed to answer if the degree of renal impairment in heart failure patients impacts volume status, the pressure-volume relationship, and the prevalence and types of anemia.
  • Veraprapas Kittipibul M.D., lead investigator of the study concluded that:
    Heterogeneity in volume exists across renal function which can only be accurately measured with BVA.
  • Patients with large volume expansion had worsening renal function, showing the urgent need for care.

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
Diuretic, Ultrafiltration, Hospital, Section, Artificial intelligence, Randomized controlled trial, Mount Sinai Health System, Quality of life, Acute decompensated heart failure, Hierarchy, Aquapheresis, Valvular heart disease, Risk, Heart failure, Arrhythmia, AUF, ALD, History, Yale School of Medicine, Patient, HF, Machine learning, Cerebrovascular disease, THT, Mortality, Roflumilast, Pharmaceutical industry

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
Diuretic, Operating cost, Absorption, FDA, Growth, SCD, Cirrhosis, IDE, SeaStar, Nephrology, Webcast, Patient, Pediatrics, CRRT, CRRC, THT, Research, PIK, Pharmaceutical industry

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.

BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

Retrieved on: 
Monday, March 4, 2024
Stroke, Incidence, Randomized controlled trial, FDA, University, Hospital, Splenic infarction, Heart failure, Safety, Arrhythmia, Death, Patient, MSC, HF, Phase, THT, Mortality, Pharmaceutical industry

Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.

Key Points: 
  • Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress.
  • Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively).
  • CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.
  • “These positive results for CardiAMP cell therapy are very encouraging, especially for patients with elevated NTproBNP, who encompass the majority of heart failure patients that we see in our daily practice,” said trial co-principal investigator Dr. Raval.

Tenax Therapeutics Announces Oral Presentation of Levosimendan for the Treatment of PH-HFpEF at THT 2024

Retrieved on: 
Thursday, February 29, 2024
Research, Pulmonary hypertension, Conference, Heart failure, Therapy, Patient, Feinberg School of Medicine, THT, Pharmaceutical industry

CHAPEL HILL, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced Dr. Sanjiv Shah, Stone Endowed Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, will present data and review the scientific basis for the use of levosimendan in PH-HFpEF. Dr Shah’s presentation will occur during a scientific session focused on the treatment of pulmonary hypertension in patients with heart failure at the upcoming Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics (THT) Conference in Boston.

Key Points: 
  • Dr. Sanjiv Shah, a renowned, global expert in the treatment of HFpEF and PH-HFpEF, will present data highlighting the use of levosimendan for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF)
    Presentation will occur at Technology and Heart Failure Therapeutics (THT-2024) – in Boston, MA, on March 6, 2024
    CHAPEL HILL, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced Dr. Sanjiv Shah, Stone Endowed Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine, will present data and review the scientific basis for the use of levosimendan in PH-HFpEF.
  • Dr Shah’s presentation will occur during a scientific session focused on the treatment of pulmonary hypertension in patients with heart failure at the upcoming Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics (THT) Conference in Boston.

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
Research, Liver disease, Overload, RED, Heart failure, Therapy, Diuretic, Associate, Brussels Stock Exchange, Yale School of Medicine, THT, Cancer, Pharmaceutical industry

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.