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Ischemic Heart Articles & Analysis

23 news found

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

The company also plans other clinical studies in additional cardiovascular indications, including heart failure caused by ischemic heart disease and as adjunctive therapy to percutaneous coronary intervention. ...

ByXyloCor Therapeutics


Shockwave Medical Initiates All-Female Coronary IVL Study

Shockwave Medical Initiates All-Female Coronary IVL Study

This prospective, multicenter registry will enroll up to 400 female patients with symptomatic ischemic heart disease in up to 50 investigational centers in the United States and Europe and will include a 3-year follow-up. EMPOWER CAD co-principal investigators Margaret McEntegart, MD, PhD, Director of Complex Percutaneous Coronary Intervention Program at ...

ByShockwave Medical Inc.


One-stop Mitochondria-focused Testing Services Targeting to Preclinical Studies of Cardiac Diseases

One-stop Mitochondria-focused Testing Services Targeting to Preclinical Studies of Cardiac Diseases

Mitochondrial DNA (mtDNA) plays an important role in the pathogenesis of the cardiovascular disease (CVD), especially in heart failure and ischemic heart disease. With the deepening of study, elevated evidence has suggested that mtDNA is regulated by the occurrence and development of CVD. ...

ByCreative Biogene-Mitochondrial Research


XyloCor Therapeutics Achieves Target Enrollment in Phase 2 EXACT Study of XC001 Novel Gene Therapy for Ischemic Heart Disease

XyloCor Therapeutics Achieves Target Enrollment in Phase 2 EXACT Study of XC001 Novel Gene Therapy for Ischemic Heart Disease

Positive Phase 1 results reported at the American Association for Thoracic Surgery (AATS) and the American Society of Gene and Cell Therapy (ASGCT) revealed XC001 is well tolerated at all dose levels Phase I data support XC001 therapeutic effect and potential dose response Topline Phase 2 data readout expected in February 2023 with interim results in the second half of this year XyloCor ...

ByXyloCor Therapeutics


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 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

” "In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its ...

ByBiocardia, Inc.


BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

“This most recent action by CMS further represents its commitment to improving the way ischemic heart failure is treated and is supportive of BioCardia’s therapeutic investigational product candidates furnished by a comprehensive approach to bone marrow cell harvest, processing, and delivery in a single procedure,” commented Peter Altman, Ph.D., ...

ByBiocardia, Inc.


BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

BioCardia Receives No Objection Letter from Health Canada, Enabling Company to Expand CardiAMP Cell Therapy Heart Failure Trial into Canada

The Company expects to announce these sites in the coming months. The CardiAMP Cell Therapy Heart Failure Trial is evaluating the effectiveness of the CardiAMP Cell Therapy System for improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for New York Heart Association (NYHA) Class II and III ...

ByBiocardia, Inc.


BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

In fact, we believe that the trial now has the largest enrollment of any trial of intramyocardial bone marrow mononuclear cells performed in ischemic heart failure to date,” said BioCardia CEO Peter Altman, Ph.D. ...

ByBiocardia, Inc.


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

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

CardiAMP Cell Therapy is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart. This is a different mechanism of action from other therapies that have sought to transform stem cells into new heart cells, a method that has presented patient risks, such as rhythm abnormalities and ...

ByBiocardia, Inc.


BioVentrix Expands Heart Failure Treatment Portfolio with Acquisition of MateraCor, Inc.

BioVentrix Expands Heart Failure Treatment Portfolio with Acquisition of MateraCor, Inc.

“This is an exciting time for BioVentrix as we build a platform of synergistic therapies to treat a dilated left ventricle, the root cause of ischemic and idiopathic heart failure,” said Jim Dillon, President and CEO, BioVentrix. ...

ByBioVentrix, Inc.


BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights

BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights

Q2 and Recent Business Highlights: CardiAMP® Autologous Cell Therapy for ischemic heart failure (BCDA-01) The independent Data Safety Monitoring Board (DSMB) completed its fourth prespecified data review for the Phase III pivotal CardiAMP Heart Failure Trial on June 22, 2021. ...

ByBiocardia, Inc.


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

Once in position, the balloon is inflated cyclically and used to intermittently block the coronary sinus outflow in order to ensure blood reaches the ischemic heart tissue. Balloon deflation helps wash out harmful agents from the microcirculation. ...

ByAnuncia Medical, Inc.


BioVentrix Names Jim Dillon President and CEO

BioVentrix Names Jim Dillon President and CEO

He most recently co-founded Reprieve Cardiovascular and led the company’s financing and development of a highly unique therapy for acute decompensated heart failure (ADHF). Mr. Dillon's career focus in heart failure has included developing therapies to enable native heart recovery, reduce the size of a patient’s myocardial infarction, ...

ByBioVentrix, Inc.


Cardior`s pioneering miRNA approach in heart failure endorsed by expert opinions in the European Heart Journal

Cardior`s pioneering miRNA approach in heart failure endorsed by expert opinions in the European Heart Journal

Hanover, Germany, February 9, 2021 - Cardior Pharmaceuticals GmbH, a clinical-stage biotech company focused on the development of non-coding RNA (ncRNA) based therapeutics for patients with cardiovascular diseases, announced today that the Phase Ib results as well as preclinical and large-animal data of the Company’s lead compound CDR132L were published alongside with two editorials from ...

ByCardior Pharmaceuticals GmbH


BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System

BioVentrix Receives 2021 NUB Status 1 Reimbursement Renewal in Germany for the Revivent TC TransCatheter Ventricular Enhancement System

“We are very pleased that the InEK continues to support patient access to our innovative LIVE Therapy, which published studies have shown improves heart function, patient symptoms, activity level and quality of life for patients with scarred hearts after a heart attack,” said BioVentrix CEO Ken Miller LIVE™ Therapy uses the ...

ByBioVentrix, Inc.


BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

BioVentrix Announces Jerry Estep, MD, as Co-Principal Investigator for ALIVE Pivotal Trial Studying a Transcatheter Device for Heart Failure

Estep specializes in managing advanced heart failure patients and is the Head of the Section of Heart Failure and Transplantation in the Tomsich Family Department of Cardiovascular Medicine in the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at the prestigious Cleveland Clinic. ...

ByBioVentrix, Inc.


BioVentrix Announces the Appointment of Cardiac Device Veteran Chris Wolff as Vice President of U.S. Sales

BioVentrix Announces the Appointment of Cardiac Device Veteran Chris Wolff as Vice President of U.S. Sales

I am excited to be joining a company that is pioneering the only less-invasive therapy option to treat left ventricular dysfunction caused by a heart attack for congestive heart failure patients. I look forward to working with the BioVentrix team to drive procedural growth and bring this life-saving technology to patients in ...

ByBioVentrix, Inc.


BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause

BioVentrix Announces Pivotal ALIVE Trial Resumes with First Patients Treated with LIVE Therapy Since COVID-19 Pause

“COVID-19 has been reported to cause or worsen heart damage, and with the progressive nature of heart failure, delays in treatment can worsen the prognosis for patients. ...

ByBioVentrix, Inc.


BioVentrix Announces Appointment of Accredited Public Company Director, Raymond W. Cohen, to its Board of Directors

BioVentrix Announces Appointment of Accredited Public Company Director, Raymond W. Cohen, to its Board of Directors

BioVentrix, Inc., a privately held medical device company focused on treating congestive heart failure via Transcatheter Ventricular Restoration (TCVR), today announced the appointment of Raymond W. ...

ByBioVentrix, Inc.


FierceMedTech Names BioVentrix as One of Its “Fierce 15” Companies of 2019

FierceMedTech Names BioVentrix as One of Its “Fierce 15” Companies of 2019

The company offers Less Invasive Ventricular Enhancement, or the LIVE™ Therapy, which uses the Revivent TC™ Transcatheter Ventricular Enhancement System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. ...

ByBioVentrix, Inc.

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