Systole

Casana Announces the Appointment of Shikha Anand, M.D., As Chief Medical Officer

Retrieved on: 
Tuesday, June 13, 2023
Well, Blood pressure, University of Massachusetts, Village, Public, Systole, Health equity, Research, Federally Qualified Health Center, Bangladesh Technical Education Board, Rochester Institute of Technology, Algorithm, Heart rate, Health, FDA, MPH, Data science, Medical device, Withings, Teodoro Casana Robles

ROCHESTER, N.Y., June 13, 2023 (GLOBE NEWSWIRE) -- Today, Casana , the industry leader in monitoring heart health through smart toilets, announced the appointment of Shikha Anand, M.D.

Key Points: 
  • ROCHESTER, N.Y., June 13, 2023 (GLOBE NEWSWIRE) -- Today, Casana , the industry leader in monitoring heart health through smart toilets, announced the appointment of Shikha Anand, M.D.
  • MPH, as Chief Medical Officer.
  • Casana’s Heart Seat™ helps people and their care teams capture FDA cleared clinical values, including heart rate and blood oxygenation.
  • Prior to joining Casana, Dr. Anand served as the Chief Medical Officer at Well, the on-demand healthcare guidance platform, and Withings, a world leader in connected health technology.

Casana Receives FDA Clearance for Heart Health Smart Toilet Seat

Retrieved on: 
Monday, May 1, 2023
Systole, University of Chicago, Medicine, Heart rate, USD, BP, Oxygen saturation (medicine), Patient, Health, FDA, Medical device, Pharmaceutical industry, Teodoro Casana Robles

Casana will pursue subsequent filings, including Systolic and Diastolic Blood Pressure (BP), with the target of an initial product market launch by the end of 2023

Key Points: 
  • Casana will pursue subsequent filings, including Systolic and Diastolic Blood Pressure (BP), with the target of an initial product market launch by the end of 2023
    ROCHESTER, N.Y., May 01, 2023 (GLOBE NEWSWIRE) -- Today, Casana - the industry leader in monitoring heart health through smart toilets - announced receipt of U.S.A. Food and Drug Administration (FDA) clearance of the Heart Seat™ for measuring Heart Rate and Oxygen Saturation (SpO2).
  • The clearance marks a significant milestone for Casana in its pursuit to enable effortless home health monitoring.
  • Alongside Heart Rate and Oxygen Saturation (SpO2), Casana has partnered with researchers to conduct validation studies of additional clinical measurements.
  • "This clearance is a critical step on our journey to commercialize the Heart Seat,” said Casana CEO, Austin McChord .

BlueStar Reduces Systolic Blood Pressure in 42% of Patients in Remote Patient Monitoring Program Using Cellular-Enabled Blood Pressure Monitors

Retrieved on: 
Thursday, February 9, 2023
General Health, Mobile, Wireless, Telemedicine, Virtual Medicine, Biometrics, Technology, Medical Devices, Hospitals, Health Technology, 5G, Online Privacy, Cardiology, Practice Management, Health, RPM, Smart meter, HRSA, FQHC, Health Resources and Services Administration, Diastole, AHA, Stroke, Remote patient monitoring, Systole, Splenic infarction, Patient, Software, Systolic Blood Pressure Intervention Trial, CDC, Federally Qualified Health Center, Hypertension, Health care, Vital signs, Blue star, Switch, HIPAA, Blood pressure, Pharmaceutical industry, Payment, Hospital

As part of an 18-week Remote Patient Monitoring program, 42% of the 524 FQHC patients with AHA Stage II Hypertension had their Hypertension “controlled” within 10 weeks, with an average drop in Systolic Blood Pressure of 16 mmHG.

Key Points: 
  • As part of an 18-week Remote Patient Monitoring program, 42% of the 524 FQHC patients with AHA Stage II Hypertension had their Hypertension “controlled” within 10 weeks, with an average drop in Systolic Blood Pressure of 16 mmHG.
  • BlueStar enrolled patients, shipped equipment, and monitored the patient populations over the 18-week period.
  • All of the patients who participated in the program were provided a cellular-connected iBloodPressure® monitoring device from Smart Meter to help monitor their blood pressure at home.
  • The ease of use supports improved patient adherence to care plan instructions leading to improved outcomes and higher patient satisfaction.

Cytokinetics Stock Trading Halted Today

Retrieved on: 
Tuesday, December 13, 2022
CV, Mechanics, Heart failure, Intellectual property, Cytokinetics, Hospital, SAN, Pharmacology, Prescription Drug User Fee Act, Systole, Security (finance), FDA, ALS, Marketing, Sale, HCM, Muscle weakness, PDUFA, Heart, Death, New Drug Application, Prognosis, Safe harbor, The Act, Amyotrophic lateral sclerosis, NDA, Act, History, Patent, Standard of care, Risk, Patient, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company’s common stock.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Nasdaq has halted the trading of the Company’s common stock.
  • The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM ET today.
  • Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Cytokinetics Announces Availability of Briefing Documents for FDA Advisory Committee Meeting on Omecamtiv Mecarbil

Retrieved on: 
Friday, December 9, 2022
CV, Mechanics, Heart failure, Intellectual property, Cytokinetics, Hospital, SAN, Pharmacology, Prescription Drug User Fee Act, Systole, Security (finance), ALS, FDA, Marketing, Circulatory system, Sale, HCM, Muscle weakness, PDUFA, Heart, Death, New Drug Application, Prognosis, Safe harbor, The Act, Amyotrophic lateral sclerosis, NDA, Act, History, Patent, Standard of care, Risk, Patient, Pharmaceutical industry

The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM ET on December 13, 2022.

Key Points: 
  • The advisory committee meeting, which is being held virtually, is scheduled to begin at 9:00 AM ET on December 13, 2022.
  • The Company is not responsible for the content of, nor the statements made in, the briefing materials that were prepared by the FDA.
  • The NDA for omecamtiv mecarbil is based on the results from GALACTIC-HF, the Phase 3 clinical trial of omecamtiv mecarbil.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Verve Medical Announces Results of Feasibility Trial for Transurethral Renal Pelvic Denervation for Uncontrolled Hypertension

Retrieved on: 
Wednesday, November 16, 2022
Medical Devices, Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Blood pressure, FACC, FACP, American Heart, AHA, Systole, BP, Glomerular filtration rate, Randomized controlled trial, Hypertension, Safety, SPRINT, Renal artery, Denervation, FAPC, Death, FAHA, Urethra, Medicine, MD, FASN, Patient, Pharmaceutical industry, Verve

The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.

Key Points: 
  • The Verve trial demonstrated the efficacy and safety of this minimally invasive, non-vascular renal pelvic denervation.
  • We are pleased that we were able to complete this feasibility study of renal denervation for people with uncontrolled hypertension.
  • Verve Medical, headquartered in Phoenix, AZ, is an early-stage medical device company that is committed to developing novel transurethral (natural orifice) renal denervation devices to ameliorate uncontrolled hypertension and associated diseases for the benefit of patients worldwide.
  • Verve Medical and Verve RPD are registered trademarks of Verve Medical, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221116006004/en/

Cytokinetics Provides Regulatory Update for Omecamtiv Mecarbil

Retrieved on: 
Friday, June 17, 2022
Heart, Systole, Intellectual property, Review, Security (finance), FDA, NDA, Patent, The Act, Cytokinetics, Prescription Drug User Fee Act, Amyotrophic lateral sclerosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Mechanics, Research, Private Securities Litigation Reform Act, LinkedIn, PDUFA, Act, Heart failure, HCM, Safe harbor, YouTube, Sale, Pharmacology, CV, History, Death, Twitter, Standard of care, Food, Patient, Facebook, Hospital, Muscle weakness, SAN, ALS, GLOBE, Risk, Pharmaceutical industry, Medical device

We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil, said Robert I. Blum, Cytokinetics President and Chief Executive Officer.

Key Points: 
  • We are working collaboratively with the FDA as they conduct their review of omecamtiv mecarbil, said Robert I. Blum, Cytokinetics President and Chief Executive Officer.
  • Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4
    The development program for omecamtiv mecarbil is assessing its potential for the treatment of HFrEF.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Provides Regulatory Update Related to New Drug Application for Omecamtiv Mecarbil

Retrieved on: 
Tuesday, May 17, 2022
PDUFA, Death, Risk, Mechanics, Company, History, Pharmacology, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, Agency, Hospital, New Drug Application, Patient, HCM, Amyotrophic lateral sclerosis, Heart, Advisory Committee, Systole, FDA, SAN, Facebook, CV, Time, YouTube, Safe harbor, Communication, Heart failure, Cytokinetics, Standard of care, Muscle weakness, NDA, Act, LinkedIn, Twitter, GLOBE, Security (finance), ALS, Medical device, Pharmaceutical industry

Cytokinetics expects the FDA to inform it of the date and topics for the Advisory Committee Meeting in a subsequent communication.

Key Points: 
  • Cytokinetics expects the FDA to inform it of the date and topics for the Advisory Committee Meeting in a subsequent communication.
  • Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).
  • Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4
    The development program for omecamtiv mecarbil is assessing its potential for the treatment of HFrEF.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Announces Results From METEORIC-HF and Additional Data From GALACTIC-HF Presented at the American College of Cardiology 71st Annual Scientific Session

Retrieved on: 
Sunday, April 3, 2022
Hospital, Kidney, Exercise, Risk, Heart failure, University, HF, CV, Heart, Yale School of Medicine, NYHA, Death, Health, Blood, University of Glasgow, Digoxin, RRR, NNT, Patient, Evaluation, MPH, Standard of care, Associate, New York Heart Association Functional Classification, Cardiology, ARR, Center, Systole, Outcomes research, Duke University School of Medicine, American College, Institute, GLOBE, Cytokinetics, Medicine, LVEF, NDA, EF, Contractility, Prescription Drug User Fee Act, Atrial fibrillation, PDUFA, CPET, SAN, Research and development, FDA, Prognosis, Functional, Pharmaceutical industry, Medical device

SOUTH SAN FRANCISCO, Calif., April 03, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the full results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF), were presented by Michael Felker, M.D., Professor of Medicine, Duke Clinical Research Institute, at the American College of Cardiology 71st Annual Scientific Session (ACC.22). Additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were also presented including a healthcare resource utilization analysis and an analysis of the effect of treatment with omecamtiv mecarbil in hospitalized patients compared to outpatients.

Key Points: 
  • After 20 weeks of treatment, there was no change in pVO2 in patients treated with omecamtiv mecarbil versus placebo.
  • Adverse events, including major cardiac events, were similar between the treatment arms, even with patients reaching peak exercise.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Announces Topline Results From METEORIC-HF

Retrieved on: 
Tuesday, February 15, 2022
Amyotrophic lateral sclerosis, LVEF, History, Heart, CPET, American College, New Drug Application, Patient, Systole, Time, Act, Risk, YouTube, Facebook, NJCAA National Football Championship, ACC, U.S. Securities and Exchange Commission, Death, Heart failure, SAN, Private Securities Litigation Reform Act, Security (finance), Standard of care, Muscle weakness, Pharmacology, ALS, Contractility, HCM, LinkedIn, CV, Twitter, FDA, PDUFA, Research and development, Safe harbor, NDA, 71st Expeditionary Military Intelligence Brigade, Hypertrophic cardiomyopathy, Mechanics, Hospital, Cohort, Caregiver, Prescription Drug User Fee Act, Exercise, GLOBE, Blood, Cytokinetics, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction.

Key Points: 
  • Cytokinetics recently announced that the U.S. Food & Drug Administration (FDA) has accepted and filed the companys New Drug Application (NDA) for omecamtiv mecarbil.
  • Cytokinetics is readying for the potential commercialization of omecamtiv mecarbil, its cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure.
  • For further information regarding these and other risks related to Cytokinetics business, investors should consult Cytokinetics filings with the Securities and Exchange Commission, particularly under the caption Risk Factors in Cytokinetics latest Quarterly Report on Form 10-Q.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.