Report
David Seynnaeve, PhD

Onward Medical NV - BCI dialogue with FDA intensifying

• As only the 2nd BCI company, ONWD announced its acceptance into the FDA's new Total Product Lifecycle Advisory Program (TAP): this program aims to help bridge the so-called valley of death from technology concept to commercialization. This acceptance, combined with the recently received Breakthrough Device Designation, clearly signals the FDA's support for ONWD's ARC-BCI ongoing and future development plans. • We welcome this news as the clinical path forward for ARC-BCI is currently rather blurry due to its innovativeness. Remember that all currently ongoing work with ARC-BCI is grant-funded and in collaboration with Clinatec. Upon successful completion of early
Underlying
ONWARD MEDICAL NV

Provider
Degroof Petercam
Degroof Petercam

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Analysts
David Seynnaeve, PhD

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