Ischemia News
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Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program
The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims to uncouple efficacy from ...
By Bayer AG
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Cellvie CEO Dr. Alexander Schueller was Awarded the Prestigious De Vigier Award
The W.A. de Vigier Foundation promotes and supports innovative entrepreneurial spirit in Switzerland. Since 1987, the goal of the foundation has been to invigorate emerging companies, providing support to young entrepreneurs, who stand out in the country's innovation-rich startup environment. Today, the De Vigier Award is one of the most respected prizes for young entrepreneurs in Switzerland, ...
By cellvie Inc.
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CELLVIE wins the prestigious MedTech Innovator Value Award
MedTech Innovator is the leading program for medical devices, digital health and diagnostic companies and is the largest accelerator for life science companies globally. Every year, start-ups from all over the world are invited to present their solution and vision for a chance to be selected to join the MedTech Innovator Accelerator. The program culminates in a competition for a grand prize of ...
By cellvie Inc.
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Ultravist by Bayer now approved for contrast-enhanced mammography in EU
Ultravist-300, -370 receives green light for indication extension for use in contrast-enhanced mammography (CEM) in a European Workshare Procedure CEM is emerging modality combining digital mammography with the administration of a contrast agent Strategically expands Bayer’s portfolio in breast imaging, including contrast agents and injectors Bayer announced today that its ...
By Bayer AG
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CELLVIE presents at the Rejuvenation Startup Summit organized by Kizoo in Berlin
The Rejuvenation Startup Summit created by the Forever Healthy Foundation, is a vibrant networking event that aims to accelerate the development of the rejuvenation biotech industry. It is the world's largest gathering of Longevity startups in-person. The Summit brings together startups, members of the longevity venture capital/investor ecosystem, and researchers interested in founding or joining ...
By cellvie Inc.
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Imricor Submits for Approval to Commence VT Trial in Europe
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
By Imricor
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Shockwave Medical Initiates All-Female Coronary IVL Study
EMPOWER CAD is the First Prospective, Female-Only Study of Coronary Interventions Study Seeks to Confirm Benefits of Shockwave’s Coronary IVL in Females Who Historically Have Suffered Less Favorable Clinical Outcomes than Male Patients with Traditional Therapies Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely ...
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Biotricity wins NIH Grant from the National Heart, Blood, and Lung Institute for AI-Enabled real-time monitoring and predictive analytics for stroke due to chronic kidney failure
Biotricity Inc. (NASDAQ:BTCY) (“Biotricity” or the “Company”), a medical diagnostic and consumer healthcare technology company, today announced that it will be carrying out an NIH-sponsored Phase I study of Bioflux-AI, Biotricity’s innovative artificial intelligence-driven (‘AI’) system of real-time monitoring and prediction technology, in subjects with ...
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Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack involving up to 30,000 patients Bayer drives the development of its FXIa inhibitor, with the goal of offering a ...
By Bayer AG
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Amsel Medical Announces $1.5 million AFWERX TACFI Grant Award
Amsel Medical Corporation today announced receipt of award and signing of a contract for a non-dilutive AFWERX Tactical Funding Increase (TACFI) of $1.5 million augmenting its original $1M Phase II SBIR Grant. This effort is sponsored by the Air Force Research Laboratory and will enable Amsel Medical to bridge its Phase II efforts towards Phase III commercial scaling. It facilitates the delivery ...
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Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
Reflow Medical, Inc., a California-based medical device company, has completed enrollment in the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Temporary Spur Stent System, a patented device designed to treat long, diffuse and severely calcified infrapopliteal disease. The system allows for uniform expansion of the stent to maximize lumen diameter and may reduce acute vessel recoil ...
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One-stop Mitochondria-focused Testing Services Targeting to Preclinical Studies of Cardiac Diseases
New York, United States—June 28, 2022—Creative Biogene offers one-stop mitochondria-focused testing services for the evaluation of a variety of cardiac diseases associated with mitochondrial dysfunction, which can provide insights and potential treatments for mitochondrial disorders in the preclinical stages. With its ready-to-use models and assays for cardiac diseases, customers can accurately ...
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Elucid Raises $27 Million Series B Funding Round to Commercialize a New Paradigm in Heart Disease Diagnosis
BOSTON – June 22, 2022 – Elucid, a company developing a novel, non-invasive medical software to comprehensively characterize cardiovascular disease, announced the closing of a $27 Million Series B financing round. The round was led by an undisclosed strategic investor, with participation from Biovision Ventures, a new Europe-based fund, and existing investors, including MedTex ...
By Elucid
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Reva Medical Presents 6-Month Results from Motiv BTK Pilot Study
REVA Medical, LLC. (“REVA” or the “Company”), a leader in bioresorbable polymer technologies for vascular applications, is pleased to announce the presentation of the 6- month clinical outcomes data from a post market study of the Company’s MOTIV Below The Knee (BTK) scaffold. Prof. Thomas Rand, MD from the Klinik Floridsdorf Vienna, Austria presented the initial ...
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Hemostemix Announces Pete Pavlin, P.Eng., Vice-President Operations
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF; FSE: 2VFO.F) is pleased to announce the appointment of Mr. Peter Pavlin, P.Eng. to the position of Vice President Operations. Mr. Pavlin earned his Bachelor of Applied Science and Master of Engineering degrees in Mechanical Engineering from the University of Toronto, Canada’s top ranked ...
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XyloCor Therapeutics Announces Presentation of Preliminary Clinical Data from Phase 1 Portion of the EXACT Phase 1/2 Study of XC001 Novel Gene Therapy for Refractory Angina at AATS and ASGCT
Data from the Phase 1 dose-escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well-tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the study – Preliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment options – Treatment strategy is to use local ...
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Hemostemix Announces Rick Groome as Special Advisor to the CEO
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF; FSE: 2VFO.F) is pleased to announce Mr. Richard (“Rick”) Groome has joined Hemostemix as a special advisor to the CEO, focused on completing a series of financing transactions. Over the last three decades Mr. Groome was instrumental in creating and building two securities firms, Marleau ...
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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress due to COVID-19
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive ...
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Hemostemix Announces Settlement Agreement
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF; FSE: 2VFO.F) Calgary, Alberta — Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM; OTC: HMTXF; FSE: 2VFO.F) is pleased to announce that it has entered into a settlement agreement (the “Settlement Agreement”) with Aspire Health Science, LLC ...
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BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure
BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, announces the designation of a new reimbursement code for the CardiAMP® Cell Therapy procedure to transplant autologous bone marrow cells to treat heart failure from the U.S. Center for Medicare and Medicaid Services (CMS). This new CMS code to ...
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