BiPAD® raised $1.2M in convertible debt financing to take the BiPAD® cord through FDA 510K clearance.
Work with Primo Medical Group in Massachusetts had already begun in June 2018 in anticipation of this raise.
BiPAD® has initiated commercial manufacturing of the BiPAD® custom cord assembly. Manufacturing specs were finalized and submitted to our overseas manufacturer.
First samples of our custom extruded wire assembly are expected in 8-12 weeks. Design of the custom BiPAD® plug/switch assembly is being finalized and will be submitted for commercial production shortly. First samples of the complete custom cord are expected by the end of the first quarter of 2019.
We have contracted with our manufacturer's in-house regulatory staff to prepare the BiPAD ® FDA 510K application, and this work has begun. We have also acquired a license for QMS software (Quality Management System) required for both FDA clearance and quality management when we initiate commercial manufacturing.