Category Archives: Medical Devices
Axon Therapies Announces Positive Results From First-In-Human Clinical Study in Late-Breaking Clinical Trial Session At 2020 Virtual HFSA Conference
Below, we are re-publishing with permission the press-release issued by Axon Therapies, Inc. on October 09, 2020 Satera™ Ablation System demonstrates success as a frontline treatment of heart failure NEW YORK, Oct. 9, 2020 /PRNewswire/ — Axon Therapies, a Coridea portfolio company focused … Continue reading
Sequana Medical announces strong interim results from RED DESERT alfapump® DSR study and provides business update
Below, we are re-publishing with permission the press-release issued by Sequana Medical on October 22, 2020 RED DESERT: Results from first five patients indicate repeated dose alfapump DSR therapy to be safe and effective Interim data support DSR hypothesis: kidneys … Continue reading
Posted in Central and Eastern Europe, Clinical Accelerator, Medical Devices
Tagged clinical trials
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Clinical Accelerator to collaborate with Second Heart Assist on a Phase I study in Heart Failure
Clinical Accelerator and Second Heart Assist have recently entered into an exciting new collaboration, focused on developing a novel device for heart failure patients. An early feasibility trial will be conducted on Second Heart’s aortic stent based circulatory assist pump. … Continue reading
Second Heart Assist Announces Successful Completion of Long-Duration Pre-Clinical Studies
Below, we are re-publishing with permission the press-release issued by Second Heart Assist Inc. on June 22, 2020 Salt Lake City, Utah, June 22nd, 2020 /PRDistribution/ — Second Heart Assist Inc., inventors of the first, true, aortic stent-based circulatory assist pump … Continue reading
Clinical Accelerator continues its collaboration with Sequana Medical, a medical device company developing the alfapump DSR System for the treatment of Diuretic Resistant Heart Failure
Clinical Accelerator, a full-service contract research organization with a strong focus on medical device investigations, is pleased to report that despite the global disruption caused by Covid-19, work has been continued in the Republic of Georgia on RED DESERT – … Continue reading
Clinical Accelerator and BetaGlue Technologies to conduct First in Human Medical Device Investigations in Breast Cancer and Liver Cancer
Clinical Accelerator is pleased to announce an exciting new collaboration with BetaGlue Technologies SpA. Two studies will be conducted, one on radio-ablation of surgical margins following resection of breast ductal carcinoma in situ (DCIS), in 20 patients and one of … Continue reading
Clinical Accelerator collaborates with Axon Therapies on a First-In-Human Feasibility Study for Heart Failure
Clinical Accelerator, a full-service contract research organization is pleased to report on its continuous collaboration with Axon Therapies, an early-stage, US-based medical technology company. Axon Therapies has developed a novel device – the Axon System – with a neuromodulation approach … Continue reading
The effects of the New FDA Rule for medical device investigations conducted outside the United States
On February 21, 2019 the new US FDA rule on medical device clinical investigations conducted outside the United States (OUS) became effective. In this post, we would like to discuss the difference between the old and the new regulation and … Continue reading
The ongoing search for the better early-stage clinical trial location: a case study on Australia and Georgia
International biotech and medtech companies are constantly searching for optimal locations for their early stage and proof-of-concept clinical trials. An example of a location that has become increasingly popular is Australia. This is in large part due to the great … Continue reading
Clinical Accelerator announces collaboration with Reprieve Cardiovascular for developing a Cardiovascular system to treat Acute Decompensated Heart Failure
Clinical Accelerator, a full-service contract research organization, is pleased to announce that it has entered into a collaboration with Reprieve Cardiovascular, LLC for conducting a study aimed at optimally decongesting patients with Acute Decompensated Heart Failure (ADHF). The study will … Continue reading
