Subject: ACC
NeoDynamics Receives Regulatory Approval for new Breast Cancer Biopsy System
STOCKHOLM, Oct. 29, 2019 /PRNewswire/ -- NeoDynamics today received confirmation from Intertek (Notified Body) that the improved version of the new system for breast cancer biopsy, NeoNavia, is accepted as an update to the already EU approved study version. The upgraded pulse biopsy system including three needle types, is added to the product list on the company's EC certificate.
The confirmation that Intertek has accepted the new improved version as an update to the already EU approved system used in clinical trials in Germany, UK and Sweden, eliminates uncertainty and significantly shortens time to market.
The EC certificate permits NeoDynamics to CE-mark the new products as soon as the company's procedures for CE-marking are fulfilled.
"The regulatory approval is a major milestone for NeoDynamics. We can now fully focus on finalizing formal verification and validation of the updated system while accelerating all remaining activities before the planned launch mid-2020", says Anna Eriksrud, CEO NeoDynamics. "The introduction of NeoNavia has the potential to set a new standard for precision biopsy in breast cancer".
CONTACT:
For further information about NeoDynamics, please contact:
Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46-8-522-79-667, e-mail: [email protected], or
Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46-708-519-648, email: [email protected]
This information is information that NeoDynamics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication by the contact person above on 29 October, 2019
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