LVOT

Cytokinetics Presents New Data at CMR 2024 From FOREST-HCM, the Open Label Extension Clinical Trial of Aficamten

Retrieved on: 
Thursday, January 25, 2024

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM).
  • At the time of this analysis, 16 patients in FOREST-HCM had completed a CMR at baseline and at Week 48.
  • Baseline characteristics of the CMR cohort were comparable to the overall patient population in FOREST-HCM.
  • We look forward to expanding on these data in the future.”

ReValve Solutions Announces Successful First-in-Human with Next Generation TMVR Technology

Retrieved on: 
Wednesday, November 29, 2023

ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.

Key Points: 
  • ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.
  • ReValve’s technology is designed to replace the Mitral Valve while also preserving the heart’s natural basal left ventricular function.
  • Our flexibility and four-point securement system provide a patent LVOT and maintains left ventricular function throughout recovery,” said Julie Logan Sands, Founder and CEO ReValve Solutions.
  • ReValve’s first-of-its-kind TMVR is thoughtfully designed to expand the treatable population of patients suffering from Mitral Valve Disease,” added Sands.

Cytokinetics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023. Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.

Key Points: 
  • On Track for Topline Results from SEQUOIA-HCM,
    a Pivotal Phase 3 Clinical Trial of Aficamten in Obstructive HCM,
    the Open-Label Extension Study of Aficamten,
    SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023.
  • Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share.
  • “During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority.
  • During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.

Cytokinetics Presents Baseline Characteristics From SEQUOIA-HCM at the HCM Society Scientific Sessions

Retrieved on: 
Friday, October 6, 2023

SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.

Key Points: 
  • SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.
  • Background medical therapy consisted of beta-blockers (61%), calcium channel blockers (26.6%), and disopyramide (12.8%); combination background therapy was permitted.
  • At baseline, 75.9% of patients were NYHA functional class II, 23.8% were functional class III, and 0.4% were functional class IV.
  • Key baseline characteristics that remain blinded include left ventricular ejection fraction (LVEF), resting and Valsalva LVOT-G, and NT-proBNP.

Affluent Medical announces positive clinical results and further insights to enhance its strategy on Structural Heart activities.

Retrieved on: 
Saturday, September 16, 2023

Affluent Medical announces positive clinical results and further insights to enhance its strategy on Structural Heart activities.

Key Points: 
  • Affluent Medical announces positive clinical results and further insights to enhance its strategy on Structural Heart activities.
  • The results reported today consists of an interim data package of the first 20 patients treated at five centers across Europe at 1 year after implantation.
  • The clinical pilot study ‘Minerva’ evaluating the minimally invasive Epygon medical device to treat mitral valve regurgitation is currently being conducted in several clinical trial centers.
  • As the clinical study is progressing, Affluent Medical recently advanced 2 new valve sizes (40 & 42 size).

EQS-News: Affluent Medical announces positive clinical results and further insights to enhance its strategy on Structural Heart activities

Retrieved on: 
Saturday, September 16, 2023

The results reported today consists of an interim data package of the first 20 patients treated at five centers across Europe at 1 year after implantation.

Key Points: 
  • The results reported today consists of an interim data package of the first 20 patients treated at five centers across Europe at 1 year after implantation.
  • From the 4 patients adjusted peri operatively excellent results were observed (residual mitral regurgitation (MR) grade
  • The clinical pilot study ‘Minerva’ evaluating the minimally invasive Epygon medical device to treat mitral valve regurgitation is currently being conducted in several clinical trial centers.
  • As the clinical study is progressing, Affluent Medical recently advanced 2 new valve sizes (40 & 42 size).

HighLife Launches a New Large Annulus Valve in Ongoing Clinical Studies for Patients Suffering From Mitral Regurgitation

Retrieved on: 
Wednesday, September 6, 2023

HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today the introduction of a new valve size in its clinical trials, the Large Annulus Valve (LAV), designed for patients with larger anatomies.

Key Points: 
  • HighLife SAS, a medtech company focused on the development of a novel Trans-Septal Mitral Valve Replacement (“TSMVR”) system to treat patients suffering from moderate to severe mitral regurgitation (MR), announced today the introduction of a new valve size in its clinical trials, the Large Annulus Valve (LAV), designed for patients with larger anatomies.
  • Among patients with moderate to severe MR, there has been a lack of treatment options for patients with large annuli.
  • “HighLife’s solution and this new valve size are a game-changer for our patients with Mitral Regurgitation.
  • We look forward to enroll and treat more patients in HighLife’s clinical study !”
    “We are excited to launch the Large Annulus Valve.

LianBio Announces Results from Phase 3 EXPLORER-CN Trial of Mavacamten Presented at the European Society of Cardiology Congress and Simultaneous Publication in JAMA Cardiology

Retrieved on: 
Monday, August 28, 2023

Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.

Key Points: 
  • Mavacamten also demonstrated improvement across all secondary endpoints, including LVOT obstruction, clinical symptoms, and health status.
  • The data presented at ESC 2023 and published in JAMA Cardiology continue to demonstrate robust evidence of mavacamten’s therapeutic benefit.
  • As previously reported, safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
  • “The EXPLORER-CN trial demonstrates that the well-established therapeutic benefit of this drug also extends to Chinese patients.

LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in the Macau Special Administrative Region (SAR) of China

Retrieved on: 
Thursday, May 11, 2023

“Hypertrophic cardiomyopathy is a cardiovascular disease that significantly impacts the quality of life of patients,” said Dr. Xiuhua Feng, Consultant of Cardiology at Kiang Wu Hospital.

Key Points: 
  • “Hypertrophic cardiomyopathy is a cardiovascular disease that significantly impacts the quality of life of patients,” said Dr. Xiuhua Feng, Consultant of Cardiology at Kiang Wu Hospital.
  • “We are very pleased to see the approval of mavacamten in Macau, as it will bring hope to local patients living with this chronic and debilitating condition.”
    "Macau marks mavacamten’s first approval in LianBio’s licensed territories,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio.
  • In April 2023, LianBio announced positive topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for the treatment of Chinese patients with symptomatic oHCM.
  • Safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.

LianBio Announces Positive Topline Results from Phase 3 EXPLORER-CN Trial Evaluating Mavacamten in Chinese Patients

Retrieved on: 
Wednesday, April 26, 2023

SHANGHAI, China and PRINCETON, N.J., April 26, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced positive topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Key Points: 
  • Safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported.
  • The Phase 3 EXPLORER-CN trial enrolled a total of 81 patients in China with symptomatic (NYHA Class II or III) oHCM.
  • The NDA is based on data from the global pivotal Phase 3 EXPLORER-HCM trial, which evaluated the safety and efficacy of mavacamten in patients with symptomatic oHCM compared to placebo.
  • A replay of the webcast and accompanying slides will be available on the LianBio website for 90 days following the call.