Tag Archive for: FDA

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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Renovos Biologics strengthens its Board’s US expertise with appointment of Lisa Ferrara

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Lisa Ferrara, Ph.D., brings over 30 years of experience in orthopaedic medical device innovation and regulatory strategy in the USA Dr Ferrara will play a pivotal role in advancing Renovos’ lead product RENOVITE® BMP-2 through FDA regulatory approval in the USA RENOVITE® is a synthetic, biodegradable nanoclay carrier that is a novel therapeutic delivery platform […]

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXessTM, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel EINDHOVEN, The Netherlands, 13 June 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US […]

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US FDA grants Orphan Drug Designation for iOnctura’s first-in-class autotaxin cancer therapy

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Autotaxin inhibitor, IOA-289, recently received the proposed INN cambritaxestat Cambritaxestat is in the Phase I AION-02 trial in combination with chemotherapy in metastatic pancreatic cancer It is the first autotaxin inhibitor to be investigated in cancer patients Amsterdam, The Netherlands and Geneva, Switzerland, 7 March 2024 – iOnctura, a pioneering, clinical-stage biotechnology company developing transformative cancer […]

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Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2

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RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product based on RENOVITE®, Renovos’ novel nanoclay therapeutic delivery platform for precision regenerative medicine Keele, UK, 4 January 2024 – Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating […]

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