Wearable Patch Reader for Peripheral Artery Disease

Michael Daniele
Alper Yusuf Bozkurt

Project runs from 09/03/2016 to 06/30/2020
$747,156

Current treatment of peripheral artery disease (PAD) rely heavily on the angiographic appearance of the arteries following re-vacularization without information on tissue oxygen levels. Ensuring tissue oxygen levels are adequately restored during treatment and continually monitored post-procedure is highly desirable. There is currently no reliable methodology by which physicians can ascertain if there is adequate tissue oxygen to heal an ulcer and ensure tissue oxygen levels persist post-procedure. To remedy this practice gap, Profusa’s continuous, injectable micro-oxygen sensing hydrogel provides a low-cost, real-time, mobile, peripheral tissue oxygen measurement before, during and after revascularization therapies. We propose the use our O2 sensors before, during, and after vascular interventions to improve therapeutic decision-making and outcomes. However, there is an imminent need for a wearable optical reader for continuous monitoring to make a significant impact and transform the way healthcare is provided for PAD patients`. The goals of this Phase II SBIR are: 1) to convert Profusa’s bulky optical reader into a flexible format that conforms to the foot, and 2) to demonstrate skin biocompatibility of the flexible reader patch per ISO 10993 standards as well as clinically validate the flexible reader in comparison to Profusa’s current reader system (i.e characterized sensor response to acute and chronic blood flow changes in the extremities).