# Supplement to Commercialization of an Ultrasound-Based Vascular Access Device

> **NIH NIH SB1** · PERCEPTIVE NAVIGATION, LLC · 2021 · $498,948

## Abstract

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.

## Key facts

- **NIH application ID:** 10134945
- **Project number:** 3SB1HL093879-07S1
- **Recipient organization:** PERCEPTIVE NAVIGATION, LLC
- **Principal Investigator:** IVAN MA
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $498,948
- **Award type:** 3
- **Project period:** 2011-07-15 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10134945

## Citation

> US National Institutes of Health, RePORTER application 10134945, Supplement to Commercialization of an Ultrasound-Based Vascular Access Device (3SB1HL093879-07S1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10134945. Licensed CC0.

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