Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical device.
aXess Technology and its Benefits
aXess is manufactured using electrospinning technology, which results in dense porous microstructures that allow the patient’s own tissue to quickly integrate into them. This process ultimately forms a “live” blood vessel that closely resembles the patient’s own blood vessel. The technology used by aXess, known as endogenous tissue repair (ETR), is a groundbreaking treatment method that enables the patient’s body to naturally restore new blood vessels or heart valves.
Partnership and Regional Rights
Grand Pharmaceutical (HKG: 0512) entered into a partnership with Xeltis in July 2022, securing exclusive rights to develop, manufacture, and commercialize the aXess product for use in hemodialysis patients with end-stage renal disease (ESRD) in Greater China. This partnership underscores the global recognition and potential impact of Xeltis’ aXess technology in the medical field.-Fineline Info & Tech
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