THT

Nuwellis Announces Purchase Agreement with a 50 Hospital Network for Aquadex Ultrafiltration Therapy

Retrieved on: 
Jeudi, mai 9, 2024
Hospital, Health, Nursing care plan, THT, Patient, Ultrafiltration, IDN, Diuretic, History, Heart failure

This new network-wide agreement signifies a broader commitment to providing advanced ultrafiltration technology to improve patient care across the entire 50 hospital system.

Key Points: 
  • This new network-wide agreement signifies a broader commitment to providing advanced ultrafiltration technology to improve patient care across the entire 50 hospital system.
  • “We are thrilled to be working with this leading hospital network to expand access to Aquadex therapy for a wider range of heart failure, critical care, and pediatric patients,” said Nestor Jaramillo, Jr., President and Chief Executive Officer at Nuwellis.
  • During a late-breaking clinical trials session, the data showed a clinically and statistically significant reduction in both 30-day hospitalizations and heart failure events for patients treated with Aquadex.
  • This clinical data milestone aligns with Nuwellis' ongoing commitment to build a robust body of clinical and economic evidence supporting the use of Aquadex for managing fluid overload in patients unresponsive to diuretics.1

Chip Mounter Market, 47% of Growth to Originate from APAC, Technavio

Retrieved on: 
Lundi, mai 6, 2024
USD, Internet of things, PCB, THT, Workflow, Semiconductor, Rest, LED, Electronics, Telecommunications, MP3, SMT, Polychlorinated biphenyl, Growth, Printed circuit board

The demand for chip mounters is further fueled by the need for smaller electronic devices like smart wearables, phones, and MP3 players.

Key Points: 
  • The demand for chip mounters is further fueled by the need for smaller electronic devices like smart wearables, phones, and MP3 players.
  • As the demand for smaller, faster, and more energy-efficient electronic devices continues to grow, the chip mounter market is poised for significant expansion.
  • The chip mounter market is experiencing growth driven by industries like automotive, aerospace, and electronics.
  • In this dynamic landscape, chip mounters play a pivotal role, ensuring efficient production and quality assembly across various sectors.

CVRx announces availability of additional data supporting long-term benefits of Barostim

Retrieved on: 
Lundi, avril 15, 2024
Pain, FDA, Patient, CCM, GDMT, Risk, Abstract, Vanderbilt University, Death, THT, Depression, Heart failure, NYHA, Science, European Journal, Fatigue, CRT, Manuscript, Hospital, LVAD, Quality of life, Therapy, HF, Hykes, Pharmaceutical industry

MINNEAPOLIS, Minn., April 15, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure. These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.

Key Points: 
  • (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the availability of additional data, including the publication of results of the post-market phase of the BeAT-HF trial in the European Journal of Heart Failure.
  • These data highlight long-term sustained benefits of Barostim in heart failure patients with reduced ejection fraction.
  • CVRx previously announced some of these data as part of expanded labeling granted by FDA on December 23, 2023.
  • We look forward to the generation of additional evidence about Barostim from the BeAT-HF trial, as well as from real-world experience through our REBALANCE post-market registry and investigator-initiated research,” said Hykes.

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

Retrieved on: 
Jeudi, mars 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: 
Jeudi, mars 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: 
Jeudi, mars 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: 
Jeudi, mars 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: 
Vendredi, mars 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: 
Jeudi, mars 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: 
Mardi, mars 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.