Author Archives: clinicalaccelerator

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

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Clinical Accelerator announces collaboration with LARRK Bio Inc

Clinical Accelerator is excited to announce that it has entered into a collaboration with LARRK Bio Inc, a US based biotech start-up company focusing on skin health and dermatology. The company is currently in “stealth mode”. LARRK Bio is led … Continue reading

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Replicor announces publication of the REP 401 study achieving high rates of virologic control and functional cure in patients with chronic hepatitis B infection

Below, we are re-publishing with permission the press-release issued by Replicor Inc. on March 09, 2020 MONTREAL, March 9, 2020 – Replicor Inc., a privately held biopharmaceutical company targeting functional cure for patients with chronic hepatitis B and D infection, … Continue reading

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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

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Clinical Accelerator collaborates with CroíValve on a study for Tricuspid Regurgitation

  Clinical Accelerator has recently entered into a new collaboration with CroíValve – a medical device company from Ireland – who is developing a novel, easy to use percutaneous solution for treating patients with severe Tricuspid Regurgitation (TR). Tricuspid Regurgitation … Continue reading

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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

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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

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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

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VisCardia Announces Its Novel Heart Failure Therapy Receives Breakthrough Device Designation From the FDA

Below, we are re-publishing with permission the press-release issued by VisCardia Inc. on April 23, 2020 PORTLAND, Ore., April 23, 2020 (Newswire.com) – VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation … Continue reading

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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

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