Tag Archive for: cardiology

ViCentra Expands Financing to $98 Million to Accelerate European Commercialization and Ready Next Generation Kaleido Insulin Patch Pump System for U.S. Access

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Secures an additional $13 million, bringing the total to $98 million with new investments from ROM Utrecht Region and a consortium of Dutch investors, including Venturing Tech, plus increased support from Innovation Industries Strengthens manufacturing scale-up and commercial operations in Germany, the Netherlands, and France, and advances U.S. market preparation Validates ViCentra’s strategy and team, […]

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Acesion Pharma starts Phase 2 trial of AP31969 in patients with atrial fibrillation

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AP31969 is a novel, first-in-class, oral SK ion channel inhibitor intended for rhythm control of atrial fibrillation and has recently completed Phase 1 in healthy volunteers Phase 2 trial will assess the efficacy of AP31969 on atrial fibrillation burden and its safety profile using continuous cardiac rhythm monitoring Copenhagen, Denmark, 6 January 2026 – Acesion […]

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Xeltis announces FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial

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Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies First patient treated in US pivotal trial, marking significant clinical milestone EINDHOVEN, The Netherlands, 14 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living […]

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Xeltis expands leadership team with appointment of Luc Verhees as Vice President of Clinical Business Development

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Brings over 30 years of experience in cardiovascular clinical research, business development, training, education, and medical affairs Strengthens Xeltis’ leadership team following IDE approval for initiation of US pivotal study for aXessTM, its restorative vascular access conduit EINDHOVEN, The Netherlands, 5 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural […]

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Xeltis appoints Shawn Gage as Vice President of US Clinical Affairs

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Brings extensive experience in design, development, and implementation of US medtech clinical trial strategy for hemodialysis and vascular access Follows expansion of Xeltis’ clinical presence in the US after recent IDE approval for aXessTM US pivotal trial EINDHOVEN, The Netherlands, 23 July 2024 – Xeltis, a leading developer of transformative implants that enable the natural […]

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