Mercury (element)

Cytokinetics Announces Results From Cohort 3 of Redwood-HCM Presented at American College of Cardiology 71st Annual Scientific Session

Retrieved on: 
Saturday, April 2, 2022

All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance.

Key Points: 
  • All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance.
  • The doses of aficamten employed were the same as those used in Cohort 1 of REDWOOD-HCM.
  • 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.

Windtree Completes Enrollment of Phase 2 Study of Istaroxime in Early Cardiogenic Shock

Retrieved on: 
Tuesday, March 15, 2022

The study is an international, randomized double-blind, placebo-controlled study designed to assess the efficacy and safety of istaroxime and to support an intended pathway for the development in early cardiogenic shock.

Key Points: 
  • The study is an international, randomized double-blind, placebo-controlled study designed to assess the efficacy and safety of istaroxime and to support an intended pathway for the development in early cardiogenic shock.
  • The study has enrolled 60 Society for Cardiovascular Angiography & Interventions (SCAI) class B early cardiogenic shock patients with severe heart failure (30 assigned to istaroxime and 30 assigned to placebo) and systolic blood pressures (SBP) between 75-90 mmHg.
  • We are very pleased to have completed enrollment in the study of istaroxime in early cardiogenic shock due to heart failure.
  • Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed.

Cytokinetics Reports Fourth Quarter 2021 Financial Results

Retrieved on: 
Thursday, February 24, 2022

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021. Net loss for the fourth quarter was $30.6 million or $0.36 per share and the net loss for the year 2021 was $215.3 million or $2.80 per share. Net loss for the fourth quarter of 2020 was $43.9 million or $0.62 per share and net loss for the year 2020 was $127.3 million or $1.97 per share. Cash, cash equivalents and investments totaled $623.7 million at December 31, 2021. This cash balance does not include $150 million in proceeds received from transactions executed in late 2021 and early 2022.

Key Points: 
  • Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of November 30, 2022
    Company Provides 2022 Financial Guidance;
    SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021.
  • Members of Cytokinetics senior management team will review the companys fourth quarter results on a conference call today at4:30 PM Eastern Time.
  • 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 Quarterly Report on Form 10-Q for the third quarter 2021.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Valbiotis Announces Approval to Launch the Two Phase II/III INSIGHT and INSIGHT 2 Clinical Studies, the Last Step in the Development of TOTUM•854 For the Reduction of Blood Pressure

Retrieved on: 
Thursday, February 17, 2022

The authorizations received enable the launch of clinical recruitment, scheduled to be completed in the first half of 2023.

Key Points: 
  • The authorizations received enable the launch of clinical recruitment, scheduled to be completed in the first half of 2023.
  • They allow us to begin an ambitious recruitment phase - 800 volunteers in total - for these international Phase II/III studies.
  • The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM854 group and the placebo group.
  • The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM854 group and the placebo group.

Cytokinetics Announces Positive Topline Results from Cohort 3 of REDWOOD-HCM

Retrieved on: 
Tuesday, February 1, 2022

SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten, an investigational next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM).

Key Points: 
  • New York Heart Association functional class was improved in the majority of patients participating in Cohort 3 of the trial.
  • The results from Cohort 3 of REDWOOD-HCM have been accepted for presentation at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, DC in April.
  • We look forward to initiating screening of patients in SEQUOIA-HCM soon and look forward to sharing these results from Cohort 3 with the medical community in April.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Pulnovo Medical Announced Results From PADN-CFDA Pivotal Trial For The Treatment Of Pulmonary Arterial Hypertension (PAH) Meet The Efficacy Primary Endpoint

Retrieved on: 
Saturday, January 1, 2022

The data from the PADN-CFDA pivotal study meet the primary efficacy and safety endpoint.

Key Points: 
  • The data from the PADN-CFDA pivotal study meet the primary efficacy and safety endpoint.
  • Because of its pioneering nature, PADN has captured the attention from the medical experts from the cardiovascular and respiratory field.
  • Pulnovo Medical Limited, a Global OTM Innovative Platform, is a globally recognized device pioneer in treatment for cardiopulmonary disease.
  • Established in 2013, Pulnovo Medical starts our research and development effort at the operating table by doctors with the goal to market for patients.

Give the Gift of Healthy Skin with Skineez® Compression Sleeves

Retrieved on: 
Monday, December 6, 2021

Now, those people can get relief from dry skin pain and dry skin cracks when they use Skineez Skin-Reparative Compression, the first FDA approved fabric that hydrates and repairs your skin.

Key Points: 
  • Now, those people can get relief from dry skin pain and dry skin cracks when they use Skineez Skin-Reparative Compression, the first FDA approved fabric that hydrates and repairs your skin.
  • The Skineez fabric delivers five essential vitamins and nutrients over time to protect and repair your skin.
  • Skineez Skin-Reparative Compression Sleeves treat swelling due to trauma, surgery, lymphedema, edema, DVT, varicose veins, radiation therapy, or other circulatory conditions .
  • Skineez Skin-Reparative compression garments continuously deliver healthy and natural nutrients to your skin.

Valbiotis Announces That It Has Submitted to the Competent Authorities the Three Clinical Protocols for TOTUM•854 Indicated in the Reduction of Blood Pressure and Presents Its Comprehensive Clinical Development Plan

Retrieved on: 
Wednesday, December 1, 2021

It will include two groups: a TOTUM854 group with a dose of 3.7 g/day and a placebo group.

Key Points: 
  • It will include two groups: a TOTUM854 group with a dose of 3.7 g/day and a placebo group.
  • Its main objective will be to reduce systolic blood pressure in the TOTUM854 group after 3 months of supplementation versus the placebo group.
  • Its main objective will be to reduce systolic blood pressure in the TOTUM854 group after 3 months of supplementation versus the placebo group.
  • It will thus assess the effect of a reduced dose of TOTUM854 (2.6 g/day) on blood pressure.

Orchestra BioMed™ Announces Presentations at TCT 2021 of Positive Long-Term Clinical Results from the MODERATO II Study Showing the Significant Clinical Impact of BackBeat CNT™ on Isolated Systolic Hypertension and Pulse Pressure

Retrieved on: 
Friday, November 5, 2021

NEW HOPE, Pa., Nov. 05, 2021 (GLOBE NEWSWIRE) -- Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company focused on developing transformative therapeutic products for large unmet clinical needs in procedure-based medicine, today announced multiple presentations of long-term clinical results and ISH subgroup data from the MODERATO II study of BackBeat Cardiac Neuromodulation Therapy™ (BackBeat CNT™) in patients with hypertension and an indication for a pacemaker at the Transcatheter Cardiovascular Therapeutics (TCT) 2021 annual conference being held in-person in Orlando, Florida, and virtually from November 4 – 6, 2021.

Key Points: 
  • Results showed a mean reduction of 17.5 mmHg in office systolic blood pressure (oSBP) among all BackBeat CNT treated patients who completed 24-month follow-up.
  • Further, in patients with ISH, BackBeat CNT drove statistically significant reductions of 9.4 mmHg in ambulatory Pulse Pressure and 13.3 mmHg in office Pulse Pressure at 6 months as compared to control patients.
  • There was a significant reduction in ambulatory Pulse Pressure of 9.4 mmHg in BackBeat CNT treated patients at 6 months vs. control (p=0.01).
  • We are excited by BackBeat CNTs significant and durable impact on blood pressure in the MODERATO II study, said David Hochman, chairman and CEO of Orchestra BioMed.

CureApp Hypertension Therapeutics App: Clinical Trial Results Announced at ESC Congress 2021 and Published in the European Heart Journal, a Leading Cardiovascular Journal

Retrieved on: 
Monday, September 13, 2021

The results of this trial were also published in the European Heart Journal, one of the worlds leading journals on cardiovascular disease.

Key Points: 
  • The results of this trial were also published in the European Heart Journal, one of the worlds leading journals on cardiovascular disease.
  • (Graphic: Business Wire)
    This clinical trial*1 ran from January 2020 to December 2020 evaluating the efficacy and safety of the therapeutic app for patients with essential hypertension.
  • This represented the worlds first trial of a therapeutic app for the purpose of regulatory approval in the field of hypertension.
  • A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial.