Supplement to Commercialization of an Ultrasound-Based Vascular Access Device

Safe and reliable access to major blood vessels will be beneficial to patients with cardiovascular and lung disease. Perceptive has on ongoing Phase IIB award to commercialize an innovative, ultrasound based device to facilitate safe and reliable vascular access. This CRP application seeks to address 2 unanticipated issues that will result in substantial delays in completion of the phase IIB, namely, a concern with our current third-party needle guide vendor and a newly announced FDA guideline on ultrasound devices that was published in June 2019. Building on significant technological progress, Perceptive has patented an atraumatic forward-viewing ultrasound-based imaging device that will allow surgeons to perform single-handed, real-time image-guided access of major blood vessels. Previous experiments demonstrated feasibility of building a high resolution, forward viewing ultrasound array and its ability to yield clinical quality images of ex-vivo tissue. Further validation was performed in pre-clinical models and in a human pilot. Our ongoing Phase IIB seeks to address all key commercialization milestones including FDA clearance such that our device will be on market at the conclusion of the Phase IIB award. The unforeseen issues are: 1) during a routine on-site audit we noted deficiencies in the quality control process for our 3D printed needle guides. These process issues led us to have concerns about batch to batch variability in product safety. 2) The new FDA guidelines require additional software that will allow transducer performance testing every time the transducer is connected to the ultrasound machine. In the proposed CRP we plan to: 1) Bring our 3D printing process in-house to maintain strict quality and safety control; and 2) expand our regulatory and engineering effort to address the new FDA guidelines. We have already hired polymer and mechanical engineers to help with transitioning our 3D printed parts to injection-molded parts. These experts will now help identify suitable polymers and initiate 3D printing internally to generate our needle-guide, a critical component of the device. Similarly, our ultrasound engineers will collaborate with our ultrasound vendor to develop new software that will allow us to test transducer element performance every time the transducer is operated. At the conclusion of the CRP project work, we will have the capability of production grade 3D printed single-use needle guides in-house and have completed all the additional software development needed to fulfill the 2019 FDA guidelines.This CRP proposal seeks to address 2 unforeseen impediments pertaining to quality and safety of a plastic part and new FDA guidelines that threaten to impact timely completion of an ongoing Phase IIB award and on-time market launch of an ultrasound- guided, vascular access device.