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Cardiac Safety Articles & Analysis

15 news found

BIOtechNOW featured IVS’s participating BIO Innovation Zone

BIOtechNOW featured IVS’s participating BIO Innovation Zone

” Tailored to represent diverse human populations and specific diseased states, our cardiac tissue model can offer an exceptional ability to predict potential cardiac safety issues and drug efficacy in clinical studies. While IVS currently focuses on applications of the LITATM in cardiac safety and ...

ByInvivoSciences, Inc. (IVS)


BIO Investor Forum Company Snapshot: InvivoSciences

BIO Investor Forum Company Snapshot: InvivoSciences

Our engineered heart tissue based phenotypic analyzer enables scientists to address cardiac safety issues and identify their mechanisms for rapid optimization. Tailored to represent diverse human populations and specific diseased states, our cardiac tissue model can offer an exceptional ability to predict potential cardiac ...

ByInvivoSciences, Inc. (IVS)


Alnylam Presents Additional Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy at Heart Failure Society of America Annual Meeting

Alnylam Presents Additional Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy at Heart Failure Society of America Annual Meeting

– New Data Further Support Potential for Patisiran to be an Effective Treatment for Cardiomyopathy of ATTR Amyloidosis – – Data from Exploratory Endpoints, Including Cardiac Biomarkers and Imaging, Suggest Favorable Impact of Patisiran on Measures of Cardiac Stress, Injury, Structure, and Function at Month 12 – – Treatment with ...

ByAlnylam Pharmaceuticals, Inc.


Miracor Medical starts 2nd randomized study, targeting expanded indications

Miracor Medical starts 2nd randomized study, targeting expanded indications

Adverse Device Effect (ADE) rate at 30 days post index procedure will be assessed as the primary endpoint. In addition, cardiac function and clinical safety endpoints - including death, heart failure-related hospitalization, new onset or worsening of heart failure – will be assessed. ...

ByMiracor Medical SA


StemBioSys Closes $6.6 Million Series C Financing

StemBioSys Closes $6.6 Million Series C Financing

In November of 2020, StemBioSys announced the publication of data demonstrating that its CELLvo Matrix Plus Technology supports development of an advanced testing protocol for determining the cardiac safety of drugs in development. Hutchens noted that the technology is currently being evaluated by over a dozen biopharmaceutical companies and academic laboratories ...

ByStemBioSys, Inc.


FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System

WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. ...

ByEBR Systems, Inc.


Boston Scientific Exercises Option to Acquire Farapulse, Inc.

Boston Scientific Exercises Option to Acquire Farapulse, Inc.

The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System – a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. "The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of ...

ByBoston Scientific


StemBioSys participates in Biotech Showcase Digital during J.P. Morgan Week 2021

StemBioSys participates in Biotech Showcase Digital during J.P. Morgan Week 2021

StemBioSys, Inc., a privately held biomedical company that manufactures and develops innovative, advanced human stem cell technologies to improve the predictive power of pre-clinical drug safety screening, today announced its President and Chief Executive Officer Bob Hutchens will participate in Biotech Showcase Digital being held January 11-15, 2021. ...

ByStemBioSys, Inc.


StemBioSys and Cartox Announce Publication of Research Demonstrating CELLvo™ Matrix Plus Significantly Enhances the Functionality of hiPSC Cardiomyocytes

StemBioSys and Cartox Announce Publication of Research Demonstrating CELLvo™ Matrix Plus Significantly Enhances the Functionality of hiPSC Cardiomyocytes

Herron and Block conclusively demonstrates that Matrix Plus promotes efficient development of highly functional, biologically-relevant hiPSC-CMs, while enabling a testing environment for human cardiomyocytes that results in experiments with higher verisimilitude that can successfully predict the cardiac safety of drugs in the early development stage." Over the ...

ByStemBioSys, Inc.


First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System

First Patients Treated with Galaxy Medical’s CENTAURI Pulsed Electric Field Cardiac Ablation System

This multicenter trial is designed to assess the safety, efficacy, and interoperability of the Centauri System and is intended to support CE-Mark. ...

ByGalvanize Therapeutics, Inc.


Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

Cardiac Dimensions Announces Australian Therapeutic Goods Administration’s Approval of the Carillon System for the Treatment of Functional Mitral Regurgitation

The TGA’s approval was based on the combined efficacy and safety results from several Cardiac Dimensions’ studies including the most recent REDUCE FMR study. ...

ByCardiac Dimensions, Inc.


EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO

EBR Systems Closes $30M in New Funding, John McCutcheon Joins Company as President and CEO

WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. ...

ByEBR Systems, Inc.


EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health

EBR Systems Awarded Prestigious Forfait Innovation Package for WiSE CRT System by French Ministry of Social Affairs and Health

WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. ...

ByEBR Systems, Inc.


EndoLogic Announces FDA Accepts Cardiac Safety Trial for Renzapride in Patients with Gastroparesis

EndoLogic Announces FDA Accepts Cardiac Safety Trial for Renzapride in Patients with Gastroparesis

EndoLogic announced that the FDA accepted the cardiac safety trial for renzapride in patients with gastroparesis. That study demonstrated no evidence of QTc prolongation in the EKG findings. ...

ByEndoLogic LLC


EBR Systems, Inc. Initiates Global Trial of World’s Only Wireless CRT Pacing Technology

EBR Systems, Inc. Initiates Global Trial of World’s Only Wireless CRT Pacing Technology

EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced enrollment of the first patients in the global SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical trial. ...

ByEBR Systems, Inc.

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