The Latest Cardiac and Vascular News
CHICAGO–(BUSINESS WIRE)–Please replace the release with the following corrected version due to multiple revisions. “This isn’t just about predicting business risks that arise from workforce health outcomes; it’s about preventing them with actionable insights that help inform risk-reduction strategies to help employers reduce healthcare costs, bolster employee retention, and ultimately, […]
G3 is trailblazing the next frontier of cardiovascular disease SAN FRANCISCO, Jan. 4, 2024 /PRNewswire/ — G3 Therapeutics (“G3”), a global leader in the use of multiomic biological Big Data, has initiated a groundbreaking initiative to unravel the contribution of Lipoprotein(a) [“Lp(a)”]…
MOUNTAIN VIEW, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) — HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary care solutions, today announced that it has surpassed 250,000 patients receiving a HeartFlow FFRCT Analysis. This accomplishment is a testament to HeartFlow’s dedication to driving a new standard of care […]
MINNEAPOLIS, Jan. 3, 2024 /PRNewswire/ — Cardionomic, Inc., a Minneapolis medical device company, is pleased to announce the completion of enrollment in both their STIM-ADHF and STOP-ADHF pilot studies. Both studies were designed to evaluate the safety and performance of the Cardiac…
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company primarily focused on leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology for the treatment of atrial fibrillation, today announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel […]
TORONTO, Dec. 21, 2023 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee to proceed with a Phase II trial for LSALT peptide, targeting the prevention and […]
SHANGHAI, Dec. 17, 2023 /PRNewswire/ — YolTech Therapeutics today announced that the first patient has been dosed with YOLT-201, the company’s first in vivo genome editing candidate being developed as a single dose, potentially curative therapy for hereditary transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
The study by YolTech is a single-arm, open-label, dose-escalation clinical trial (Clinicaltrials.gov: NCT06082050). This trial’s primary objectives are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of YOLT-201 as well as the identification of an Optimal Biologically Active Dose (OBD).
ATTR-CM, a rare, progressive and debilitating disease. It is caused by the misfolding of unstable Transthyretin Protein (TTR), leading to the deposition of amyloid-like buildup in the myocardial interstitium, causing stiffening of the heart muscle and subsequent heart failure. Studies have reported the median survival time of approximately 3.5 years from the first diagnosis of ATTR-CM if left untreated.
Dr. Yuxuan Wu, Founder and CEO of YolTech, expressed, “The successful FPI in this trial is a significant milestone, representing YolTech’s relentless efforts in the field of in vivo gene editing are gradually becoming a reality. We extend our gratitude to all researchers, partners, and supporters involved in the YOLT-201 project, especially to the dedicated research team at FAHZU for their steadfast support of drug development in vivo gene editing. We believe through this therapeutic intervention, we will provide a novel treatment option for ATTR-CM patients, offering them new hope and an improved quality of life.”
This study is a part of YolTech’s series of clinical trials in vivo gene editing. The company remains committed to advancing research in the treatment of ATTR and other diseases. Through close collaboration with the clinical community, we will continue to pursue excellence, push the boundaries of medical technology, and provide more advanced and innovative medical solutions for patients worldwide.
About YOLT-201
YOLT-201 Injection utilizes several lipid components including ionizable lipids as primary excipients to encapsulate mRNA and sgRNA raw materials, forming lipid nanoparticles (LNP). Upon intravenous injection into the body, plasma ApoE protein binds to the surface of LNP particles. Liver cells expressing the LDLR receptor recognize ApoE protein and engulf the LNP through endocytosis, forming endosomes. The decrease in pH within endosomes promotes electrostatic interactions between ionizable lipids and endosomal membranes, leading to membrane disruption and the release of mRNA and sgRNA. mRNA, in the cytoplasm, binds to ribosomes, translating the base editor protein. The base editor protein, in combination with sgRNA, enters the cell nucleus. sgRNA specifically locates the base editor to the TTR gene sequence, and the base editor protein modifies the bases on the target TTR gene, preventing its normal transcription into mRNA. This process stops the production of the TTR protein, achieving the goal of a one-time administration for a comprehensive cure of ATTR diseases.
About YolTech
YolTech Therapeutics is a pioneering gene editing company dedicated to develop a robust gene editing medicines to treat patients with serious diseases, which has built leading high-throughput evolution platform and innovative LNP deliver system. It possesses strong capability of novel Cas and base editor discovery and exceptional in-house LNP production capacity for GMP manufactory, with independent intellectual property rights and core patent protection globally. It has created a pipeline with 10+ genetic medicines focusing on cardiovascular diseases, metabolic diseases, infectious diseases as well as more common and rare diseases. Leading asset will enter phase I trial by end of 2023.
For more information, please visit: www.yoltx.com
SOURCE YolTech Therapeutics
TORONTO, Dec. 13, 2023 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment […]
WALTHAM, Mass., Dec. 12, 2023 /PRNewswire/ — FluidForm Bio, a leader in developing life-like human tissue to treat disease, shares recent advancements in building human cardiac tissues using FRESH™ 3D bioprinting. Recently published in APL Bioengineering, the research article FRESH™ 3D bioprinted cardiac tissue, a bioengineered platform for in vitro pharmacology addresses the critical need for a predictive model of human cardiac physiology in drug development. There are significant gaps in existing models due to their incomplete recapitulation of adult human cardiovascular physiology. FluidForm Bio has demonstrated potential for bridging this gap using human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) in three-dimensional tissue structure.
“We are not aware of any other biofabrication or tissue engineering approaches that can achieve comparable cell densities and uniaxial alignment on the market today, both of which contribute to more advanced physiologic function” said FluidForm Bio CTO and Co-founder Adam Feinberg.
The FRESH™ technology overcomes many of the limitations of other engineered cardiac tissues because it enables a high degree of cardiomyocyte alignment while minimizing hypoxia and cell death. Furthermore, by leveraging robotic fabrication, tissues are highly viable and reproducible, maintaining functional response across tissues and batches.
“This study was conducted by scientists at FluidForm and Merck & Co.,” explained FluidForm Bio CEO and Co-founder Mike Graffeo. “This is further evidence that we build the most lifelike tissue in the world with FRESH™. As we develop tissue therapeutic applications on this platform, we are thrilled to collaborate with top scientists and look forward to sharing further data.”
About FluidForm Bio FluidForm Bio is creating living human tissue for better treatment of disease. Our patented FRESH™ technology is a revolutionary platform designed to build tissue using cells, proteins, and nothing else. Through partnerships with top life science companies, our technology has been validated to produce the highest quality tissue in a variety of applications. We deliver human tissue that is indistinguishable from the real thing. Our living tissue will offer therapies to countless patients who deserve better treatment options.
FluidForm Bio was founded in 2018 on the belief that the world needs transformational technologies led by creative and passionate experts that help people lead better lives. Headquartered in Waltham, MA, learn more at http://www.fluidformbio.com/or connect on Twitter and LinkedIn.
Naomi Phaneuf, [email protected], 781-691-0978
SOURCE FluidForm Bio
Software Release Affirms CathVision’s Dedication to Advancing Data-Driven Clinical Diagnosis and TreatmentCOPENHAGEN, Denmark, Dec. 12, 2023 /PRNewswire/ — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the launch of ECGenius 3.1, an advanced version of the ECGenius™ System software. The new version improves workflow and streamlines processes to accelerate adoption as electrophysiologists integrate AI analyses into the EP lab, increasing the demand for high-quality signal data.1
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Intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.
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ECGenius 3.1 is an advanced version of the ECGenius System software. The new version improves workflow and streamlines processes to accelerate adoption as electrophysiologists integrate AI analyses into the EP lab, increasing the demand for high-quality signal data
ECGenius 3.1 delivers several new and enhanced features to provide an improved user experience throughout, including:
Advanced trigger function with automatic calipers for precise local activation analyses
Enhanced comparison functionality featuring pre-sized multiple windows for virtually effortless electrogram comparisons
Increased display sweep speed of up to 800 mm/s to help identify crucial EGM details
Expanded and improved connectivity with RF generators and large monitor displays
The release of ECGenius 3.1 follows the Q3 launch of the PVI Analyzer™ and Signal Complexity™ algorithms. These algorithms are part of the CARDIALYTICS™ suite of artificial intelligence-powered analytics integrated into the ECGenius System, making it the only EP recording system with an AI algorithm to facilitate electrogram interpretation and deliver unprecedented levels of intelligent, automated analyses designed to help physicians improve ablation outcomes in complex atrial arrhythmia procedures by measuring the success of cardiac ablation.2″The enhanced features and overall clinical maturity of ECGenius 3.1 clearly demonstrate this state-of-the-art EP recording system will provide advanced clinical utility to the broader EP community throughout the US,” said Dr. Larry Chinitz, Director of Electrophysiology at NYU Langone Health. “EPs are looking for opportunities to take our work to a higher level, and there is no other recording system better positioned to help us do that. We now have the technology to replace outdated systems.””These consecutive, major software launches highlight CathVision’s considerable momentum and our expertise in developing software features that streamline procedure workflows and enhance the physician experience,” said Mads Matthiesen, CEO, CathVision. “EPs are eager to access better quality signal data. ECGenius 3.1 makes the workflow transition seamless and strengthens our leadership position in equipping electrophysiologists with the technology necessary to elevate patient outcomes.”ECGenius System is CathVision’s innovative EP recording technology and proprietary hardware amplifier that acquires high-fidelity, low-noise cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including AF. Unlike traditional EP recording systems that often capture electrogram signals marred by noise and artifact, ECGenius delivers a necessary evolution in the quality of intracardiac and ECG signal acquisition, the accuracy of electrogram interpretation, and the advancement of therapy support. With exceptional data from the ECGenius System, intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.For more information about ECGenius System and CARDIALYTICS, please visit www.cathvision.com or email [email protected].About CathVisionCathVision is a medical technology company that develops electrophysiology solutions centered around an innovative EP recording system and AI algorithm platform – the ECGenius System with CARDIALYTICS. Committed to empowering physicians to make more informed clinical decisions in the EP lab, CathVision is redefining the necessity of exceptional cardiac electrical signals to diagnose, characterize, and treat the most common heart rhythm disorders. CathVision was founded in 2013 and is headquartered in Denmark with a U.S. office in Minnesota.Follow CathVision: Twitter/X and LinkedIn 1 ECGenius System is cleared for sale in the US. Not approved for sale in the rest of the world. 2 PVI Analyzer and Signal Complexity are cleared for sale in the US. Not approved for sale in the rest of the world.SOURCE CathVision
