HEART FAILURE

Salubris Biotherapeutics Announces $32 Million Financing to Advance Novel Complex Biologics for Cardiovascular, Oncology, and Neurodegenerative Diseases

Retrieved on: 
Monday, March 7, 2022

Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd.

Key Points: 
  • Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd.
  • We are focused on advancing our programs and securing additional funding to progress the development of our portfolio of antibody fusion proteins and other complex biologics.
  • Since its inception, SalubrisBio has built a drug discovery and development platform to address significant unmet medical needs in cardiovascular diseases, cancer and neurodegenerative diseases.
  • SalubrisBio is a clinical-stage biotechnology company dedicated to discovering and developing complex biologics for cardiovascular, oncology, and neurodegenerative diseases.

Olatec Announces High-Impact Coverage of Dapansutrile in Leading Journal on Cardiovascular Disease as well as Another Publication from New Preclinical Data in a Heart Failure Model

Retrieved on: 
Tuesday, February 15, 2022

Changes to heart architecture through age, genetics, and/or lifestyle factors gradually weaken the hearts mechanical function and add stress to cardiac tissue.

Key Points: 
  • Changes to heart architecture through age, genetics, and/or lifestyle factors gradually weaken the hearts mechanical function and add stress to cardiac tissue.
  • Activation and upregulation of IL-1-dependent inflammation drives additional structural changes that further compromise heart function and contribute to the development and exacerbation of CVD.
  • Olatec is also pleased to report on another publication in CVD, covering dapansutriles new preclinical data demonstrating its cardio protective effects in this model.
  • Data in mice show significant preservation of contractile reserve and diastolic function in an experimental model of heart failure due to severe ischemic cardiomyopathy.

BioCardia Receives FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

Retrieved on: 
Thursday, February 3, 2022

The CardiAMP Cell Therapy Heart Failure Trial is a U.S. pivotal trial currently enrolling patients to evaluate the effectiveness of the CardiAMP Cell Therapy System in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients.

Key Points: 
  • The CardiAMP Cell Therapy Heart Failure Trial is a U.S. pivotal trial currently enrolling patients to evaluate the effectiveness of the CardiAMP Cell Therapy System in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients.
  • We thank the FDA for granting Breakthrough Device Designation to the CardiAMP Cell Therapy System and recognizing its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy, said Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia.
  • Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort.
  • High Doses of CD34+ Cells Delivered to Patients in the CardiAMP Cell Therapy Heart Failure Trial, presented at the European Society of Cardiology Heart Failure Annual Meeting, June 2021.

CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction

Retrieved on: 
Friday, January 28, 2022

Half of all heart failure patients are those with a preserved left ventricular ejection fraction.

Key Points: 
  • Half of all heart failure patients are those with a preserved left ventricular ejection fraction.
  • Todays positive opinion of EMA is a significant step forward in redefining clinical practice and will provide an additional lifeline to the millions of patients in Europe diagnosed with HFpEF.
  • We are proud to provide renewed hope to underserved patients, underscored by the unprecedented clinical benefit seen in the EMPEROR-Preserved clinical trial.
  • Todays positive opinion addresses the single largest unmet need in cardiovascular medicine, confirming the potential of empagliflozin across the full spectrum of ejection fraction.

Empagliflozin shows consistent cardio-renal benefits in adults with heart failure with left ventricular ejection fraction over 40 percent regardless of chronic kidney disease status

Retrieved on: 
Saturday, November 6, 2021

The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for both patients and physicians.

Key Points: 
  • The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for both patients and physicians.
  • The findings underscore the potential value of empagliflozin across a wide range of kidney function in this heart failure population that includes people with preserved ejection fraction.
  • It is very encouraging to see the evidence from EMPEROR-Preserved, which shows cardiovascular and kidney benefits in these patients with heart failure, including those with HFpEF, and concomitant chronic kidney disease.
  • People with left-sided heart failure have either a reduced or a preserved ejection fraction.

Empagliflozin reduced the risk of cardiovascular events and hospitalization for heart failure compared to DPP-4 inhibitors in people with type 2 diabetes

Retrieved on: 
Monday, June 28, 2021

Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.

Key Points: 
  • Empagliflozin was not associated with a risk of acute kidney injury - analyses showed a 51 percent RRR in acute kidney injury requiring dialysis.
  • There was a similar risk of lower limb amputation and bone fractures as with DPP-4 inhibitors.
  • In addition, there was an increased risk of diabetic ketoacidosis, which is consistent with empagliflozins known safety information.1
    The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes.
  • 9 It is a widespread condition affecting over 60 million people worldwide and expected to increase as the population ages.

Severe Heart Failure Treatment: FineHeart Successfully Raises €15 million Series B funding With Industrial and Independent Investors

Retrieved on: 
Tuesday, June 1, 2021

FineHeart Founders' Holding, brings together international private investors, mainly from the cardiology sector, and the European investment fund Verve Ventures.

Key Points: 
  • FineHeart Founders' Holding, brings together international private investors, mainly from the cardiology sector, and the European investment fund Verve Ventures.
  • They join historical shareholders Irdi, Aquiti, Galia, Broadview Ventures, and M Capital, who have renewed their support for FineHeart.
  • Cardiologists represent a substantial weighting, together with investors who have seen family members suffer from severe heart failure.
  • It has the potential to be a first-in-class treatment for thousands of severe heart failure patients.

CHMP issues positive opinion for Jardiance® (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction

Retrieved on: 
Friday, May 21, 2021

b'This press release features multimedia.

Key Points: 
  • b'This press release features multimedia.
  • Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent and significantly slowed kidney function decline.4\n\xe2\x80\x9cWe are delighted with the CHMP\xe2\x80\x99s decision to recommend empagliflozin as a treatment for people living with symptomatic chronic heart failure with reduced ejection fraction,\xe2\x80\x9d said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim.
  • \xe2\x80\x9cToday\xe2\x80\x99s decision marks our entrance into a new chapter of heart failure management, enabling us to help address the challenges heart failure patients are facing in the EU and beyond.\xe2\x80\x9d\n\xe2\x80\x9cLater this year, we expect trial results from our study in people with heart failure with preserved ejection fraction, another serious form of the condition.
  • People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.7,8\nThe EMPEROR-Reduced trial is part of the EMPOWER clinical program, the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.\nThe EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with heart failure with preserved or reduced ejection fraction, both with and without diabetes, who are receiving current standard of care:\n'

FineHeart Breaks New Ground With Successful Removal of the ICOMS FLOWMAKER® in a 90-day In-vivo Trial

Retrieved on: 
Tuesday, May 4, 2021

The device\'s unique fixation system allows for easy removal performed on a beating heart, unchanged blood flow, and without trauma to the myocardium.

Key Points: 
  • The device\'s unique fixation system allows for easy removal performed on a beating heart, unchanged blood flow, and without trauma to the myocardium.
  • Once the device was removed, a fully sealed occluder was introduced, and after 60 days, no structural, histological, or embolic tissue damage occured.
  • "This operation to remove a cardiac assistance device with a beating heart is a world first.
  • These results underpin the confidence of the medical community in our approach to treat patients suffering from severe heart failure.