Cardiac muscle

New Data at Heart Rhythm 2023 Suggests that Unipolar Signals May be Used for a More Precise, Accurate Approach to Treating Arrhythmias

Retrieved on: 
Venerdì, Maggio 19, 2023
Abstract, Cardiac electrophysiology, PURE, Cleveland Clinic, PVI, Atrial fibrillation, Stroke, 3D, OH, New product development, Cardiac muscle, Radiofrequency ablation, EGM, MBA, Ablation, Conductor, Hospital, Heart Rhythm, MD, Physician, Risk, Electrophysiology, Arrhythmia, Cleveland, FDA, Pig, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Medical imaging, Medical device

Across all three studies, researchers compared the efficacy of using unipolar signals to guide procedures to the current standard of using an Ablation Index™.

Key Points: 
  • Across all three studies, researchers compared the efficacy of using unipolar signals to guide procedures to the current standard of using an Ablation Index™.
  • "These studies suggest that the preservation of raw cardiac signal enables the use of unipolar signals to help guide ablations, while improving lesion precision and reducing procedure time."
  • The PURE EP™ engineering enables physicians to access the value of unipolar radiofrequency guidance, established by previous studies.
  • A single gap was left in the linear application of the fifth model due to a misinterpretation of the unipolar EGM during pacing.

Dyne Therapeutics’ Preclinical Data Demonstrating FORCE™ Platform Delivery to CNS Featured in Oral Presentation at ASGCT Annual Meeting

Retrieved on: 
Mercoledì, Maggio 17, 2023
DYN, Central nervous system, Asian literature, Therapy, Gene, IV, DM1, Brain, Cardiac muscle, RNA, CNS, CTG, Patient, FORCE, Deficit spending, Cell, DMPK, ASO, Phenotype, Oligonucleotide, Society, Transferrin, Disease, Vaccine, Medical device, Dyne

WALTHAM, Mass., May 17, 2023 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, is delivering an oral presentation today at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles highlighting new preclinical data demonstrating the FORCE™ platform achieved delivery to the central nervous system (CNS) in non-human primates and robust pharmacological effects in the brain in a model of myotonic dystrophy type 1 (DM1).

Key Points: 
  • The presentation will be available in the Scientific Publications & Presentations section of Dyne’s website following the session.
  • The FORCE platform was designed to overcome the limitations of delivering oligonucleotide therapeutics to muscle tissue by leveraging transferrin receptor 1 (TfR1).
  • TfR1-mediated delivery also has been shown by the field to facilitate uptake of therapeutics by the CNS.
  • Highlights from the ASGCT data include:
    In NHPs, FORCE conjugate achieved superior delivery compared to unconjugated ASO when both were administered via IV.

Solid Biosciences to Present at the American Society of Gene and Cell Therapy Annual Meeting

Retrieved on: 
Martedì, Maggio 16, 2023
Tissue, Heart, Abstract, Gene, Senior, Solid, CMC, PDT, Cardiac muscle, Cell, AAV, CNS, FXN, Annual general meeting, NHP, FA, American Society of Gene and Cell Therapy, Research, Society, Vaccine, Management, Chemistry

CHARLESTOWN, Mass., May 16, 2023 (GLOBE NEWSWIRE) --  Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing genetic medicines for neuromuscular and cardiac diseases, will present positive preclinical data from studies of AVB-202, the company’s gene therapy candidate for the treatment of Friedreich’s Ataxia (FA). Grace Pavlath, Ph.D., Vice President, Research at Solid, will present the data in an oral session at 4:45 pm PDT on May 18 at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting, Los Angeles, May 16-20.

Key Points: 
  • Grace Pavlath, Ph.D., Vice President, Research at Solid, will present the data in an oral session at 4:45 pm PDT on May 18 at the American Society of Gene and Cell Therapy (ASGCT) 2023 Annual Meeting, Los Angeles, May 16-20.
  • Key highlights from the AVB-202 presentation at ASGCT include:
    AVB-202 rescued cardiac function and extended survival in a mouse model of FA.
  • In addition to Dr. Pavlath’s oral presentation on AVB-202, Solid will present five abstracts relating to the company’s AAV manufacturing methods and quality assurance assays.
  • Presentation Title: Case Study on Comparability Issues for AAV Products: Solid Biosciences’ Experience

BioSig to Highlight New Data from the PURE EP™ Platform at Heart Rhythm 2023

Retrieved on: 
Mercoledì, Maggio 3, 2023
Radiofrequency ablation, Cardiac muscle, Conductor, Heart Rhythm, Physician, Heart Rhythm Society, Algorithm, Nautilus, Inc. v. Biosig Instruments, Inc., Radio frequency, PURE, Medical imaging, Cleveland Clinic

Westport, CT, May 03, 2023 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that it will be presenting data at Heart Rhythm 2023, the Heart Rhythm Society's 44th annual meeting, on May 19-21, 2023, in New Orleans, Louisiana.

Key Points: 
  • Westport, CT, May 03, 2023 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced that it will be presenting data at Heart Rhythm 2023, the Heart Rhythm Society's 44th annual meeting, on May 19-21, 2023, in New Orleans, Louisiana.
  • At the meeting, new clinical data collected by the Company’s PURE EP™ Platform will be highlighted in three posters, presented by leading physicians from Cleveland Clinic.
  • BioSig will also be exhibiting at booth #2045 where the Company’s executive leadership, clinical and commercial teams will share customizable features and algorithms of the PURE EP™ Platform, showcasing intracardiac signal specificity unavailable on any other signal technology platform.
  • Abstract and presentation details follow:
    Abstract: Feasibility of Unipolar Signal Guided Ablation in Creating Contiguous Lines of Conduction Block: A Proof-of-Concept Study
    Abstract: Comparison of Unipolar Electrogram Monitoring during Radiofrequency ablation in Viable and Ablated Myocardium: Loss of the S-component

Affinia Therapeutics to Present New Data at the American Society of Gene and Cell Therapy Annual Meeting

Retrieved on: 
Mercoledì, Maggio 3, 2023
Gene, Cardiac muscle, Tropism, Capsid, AAV, CNS, Cell, Annual general meeting, American Society of Gene and Cell Therapy, Therapy, Society, Vaccine

WALTHAM, Mass., May 3, 2023 /PRNewswire/ -- Affinia Therapeutics, an innovative gene therapy company with a proprietary platform for rationally designed adeno-associated virus (AAV) vectors and gene therapies for rare and prevalent devastating diseases, today announced that new preclinical data will be presented in an oral and poster sessions at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, being held May 16-20, 2023 in Los Angeles, CA.

Key Points: 
  • WALTHAM, Mass., May 3, 2023 /PRNewswire/ -- Affinia Therapeutics, an innovative gene therapy company with a proprietary platform for rationally designed adeno-associated virus (AAV) vectors and gene therapies for rare and prevalent devastating diseases, today announced that new preclinical data will be presented in an oral and poster sessions at the American Society of Gene and Cell Therapy (ASGCT) 26th Annual Meeting, being held May 16-20, 2023 in Los Angeles, CA.
  • Presentation details are as follows:
    Title: Structure-Activity Relationships Guided Engineering of AAV Capsid with Optimized Skeletal Muscle, Cardiac Muscle, and CNS Tropism

Dyne Therapeutics to Present New Preclinical Data at ASGCT Annual Meeting Demonstrating FORCE™ Platform Delivery to CNS

Retrieved on: 
Martedì, Maggio 2, 2023
DYN, Abstract, Central nervous system, Asian literature, Therapy, Gene, DM1, Brain, Cardiac muscle, CNS, CTG, FORCE, Annual general meeting, Deficit spending, Cell, DMPK, ASO, Phenotype, Society, Transferrin, Disease, Vaccine, Dyne

WALTHAM, Mass., May 02, 2023 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that new preclinical data demonstrating the FORCE™ platform achieved delivery to the central nervous system (CNS) and robust pharmacological effects in the brain will be featured in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting, being held May 16-20, 2023 in Los Angeles.

Key Points: 
  • The FORCE platform was designed to overcome the limitations of delivering oligonucleotide therapeutics to muscle tissue by leveraging transferrin receptor 1 (TfR1).
  • TfR1-mediated delivery has also been shown by the field to facilitate uptake of therapeutics by the CNS.
  • In data to be presented at ASGCT, intravenous (IV) administration of FORCE conjugate achieved delivery to the CNS via TfR1 in both non-human primates (NHPs) and the innovative hTfR1/DMSXL mouse model.
  • “Our initial focus at Dyne has been to harness the power of the FORCE platform to deliver oligonucleotide therapeutics to muscle.

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Lunedì, Maggio 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

Concept Medical received IDE approval to investigate safety and efficacy of its MagicTouch Sirolimus Coated Balloon Catheter for the treatment of small coronary artery disease

Retrieved on: 
Lunedì, Maggio 1, 2023
Stent, Small Vessel, Investigational device exemption, Cardiac muscle, PTA, Restenosis, CAD, ISR, Revascularization, MACE, Trial of the century, PCI, Microangiopathy, Sirolimus, PMA, Patient, Physician, Risk, IDE, Coronary artery disease, FDA, SCB, Cutaneous small-vessel vasculitis, Drug-eluting stent, US FDA, Safety, Pharmaceutical industry, MD, TITAN

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.

Key Points: 
  • TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
  • US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon – MagicTouch SCB.
  • Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
  • The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease.

PreOmics Introduces a Novel BeatBox™ FFPE Workflow for Accelerated, In-depth Tissue Proteomics

Retrieved on: 
Venerdì, Aprile 14, 2023
Other Health, Research, Oncology, Medical Devices, Technology, Health Technology, Clinical Trials, Science, Biotechnology, Other Technology, Other Science, Health, Beatbox, AACR, CV, Research Institute of Molecular Pathology, University, BRKR, Workflow, Bruker, Pathology, Proteomics, Multimedia, Cardiac muscle, Cell, Gesellschaft mit beschränkter Haftung, Sale, Water, LC-MS, Kidney, Histology, IT University of Copenhagen, Research institute, Peptide, Sonication, DIA, Online shopping, Medical imaging

At the AACR Annual Meeting 2023, PreOmics GmbH announced the launch of a BeatBox-based FFPE workflow, which simplifies, speeds up and standardizes FFPE sample preparation for deep, unbiased tissue proteomics by subsequent protein digestion and nanoLC-MS/MS analysis.

Key Points: 
  • At the AACR Annual Meeting 2023, PreOmics GmbH announced the launch of a BeatBox-based FFPE workflow, which simplifies, speeds up and standardizes FFPE sample preparation for deep, unbiased tissue proteomics by subsequent protein digestion and nanoLC-MS/MS analysis.
  • With flexible input amounts from 1-50 mg, it consistently delivers reproducible results for LC-MS-based proteomics with scalable throughput from 1-96 samples.
  • Already successful for fresh tissue and cell-line proteomics, with the novel FFPE protocol the BeatBox can now efficiently process FFPE samples for downstream tissue proteomics.
  • The BeatBox-based FFPE workflow was shown to increase the proteomic depth for FFPE, as well as for fresh frozen tissue on average by 14% to 43%, depending on tissue type.

IPS HEART receives FDA Rare Pediatric Drug Designations for both of its Stem Cell Drugs for Duchenne Muscular Dystrophy

Retrieved on: 
Giovedì, Aprile 13, 2023
FDA, Health, Stem Cells, Clinical Trials, Cardiology, Biotechnology, HEART, GMP, Human, ODD, DMD, Cardiac muscle, Patient, Heart failure, IPS, Disease, Facial muscles, Pharmaceutical industry

IPS HEART has been granted rare pediatric drug designation by the FDA for GIVI-MPC, a first-in-class stem cell therapeutic to create new skeletal muscle with 100% full length dystrophin and for ISX9-CPC, a first-in-class stem cell therapeutic for creating new functional cardiac muscle for the treatment of patients with Duchenne Muscular Dystrophy(DMD).

Key Points: 
  • IPS HEART has been granted rare pediatric drug designation by the FDA for GIVI-MPC, a first-in-class stem cell therapeutic to create new skeletal muscle with 100% full length dystrophin and for ISX9-CPC, a first-in-class stem cell therapeutic for creating new functional cardiac muscle for the treatment of patients with Duchenne Muscular Dystrophy(DMD).
  • The FDA has also recently granted an orphan drug designation (ODD) to GIVI-MPC.
  • ISX9-CPC, a patented therapeutic for heart failure & Duchenne Cardiomyopathy, has created significant new human heart muscle with over 50% Ejection Fraction improvement and 70% scar tissue reduction 90 days after heart attack.
  • With GMP manufacturing in place since 2020, ISX9-CPC will be IPS HEART’s first drug to start clinically in humans.