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    Aortic Valve-Sparing Operations Made Safer and Easier
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Progress


In 2022 we aim to finalize the feasibility phase, achieving the following milestones:

Patent registration finalised - priority date of patent application 2 December 2021
Successful trials of the prototype device in wet tests on porcine hearts
3 congress presentations and publications in the cardiac surgeons community
Verified assumptions on international market size
Verified assumptions on savings during and after the surgical procedures

In 2023, we pursue to finalize the development phase:

Design freeze of the AVP Device product
Approval from CMO for multi center (preferentially international) clinical trials
Building of end-user community via weblogs and conferences
CE dossier ready (under MDR)

In 2024, we plan to finalize the manufacturing and supply phase:

Estabilishment of a legal entity, and/or agreement with legal manufacturer
Supply agreement with distributor(s)
Manufacturing agreement with contract manufacturing organization
Start of distribution in UK and Continental Europe
Transformation of the AVP project organization into a firm

Regulatory path approach


AVP BV runs the design verification and validation together with LUMC
Nimbler medical will construct and finalize the AVP product file (a.o. technical summary and manufacturing plan) according to the MDR
Application and execution of product validation organized by Nimbler medical
End point for CE submission is a full product technical file, design history file and master record
Legal manufacturer submits documentation at notified body for audit and CE registration
Preparations for FDA submission and approval