PROFUSA, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant The goal of this Fast Track SBIR is to demonstrate the functionality of PROFUSAandapos s novel injectable tissue oxygen monitors in patients with peripheral arterial disease PAD and to determine the its ability to detect restenosis in critical limb ischemia CLI PAD is a manifestation of systemic atherosclerosis that affects million people in the U S with prevalence increasing with age PAD ranges from mild accompanied by intermittent claudication or pain with exercise to severe accompanied by CLI and gangrene and is associated with high rates of amputation mortality and poor quality of life With the appropriate monitoring and treatment disease progression can be halted and even reversed but easy to use accurate monitoring products to indicate when a change in therapy is needed do not exist PROFUSAandapos s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear In this Fast Track SBIR we propose to confirm biocompatibility according to ISO standards to enhance user experience for commercialization by minimizing sensor size and to clinically verify the ability of PROFUSAandapos s tissue oxygen sensors to detect restenosis in PAD CLI patients In addition to the strong scientific and pre clinical teams medical clinical regulatory and business personnel will be an integral part of this project to provide early strategy for successful product development These data will be crucial in advancing PROFUSA towards commercialization and regulatory approvals PUBLIC HEALTH RELEVANCE Peripheral arterial disease PAD in which plaque buildup obstructs arteries causing decreased tissue oxygen levels is estimated to affect to million people in the U S creating an annual economic burden of more than $ B Decreased tissue oxygen levels can lead to intermittent claudication or in more advanced cases gangrene and amputation PROFUSAandapos s oxygen sensing technology can help salvage limbs from amputation by providing a way to measure real time tissue oxygen levels in the ischemic limb before during and after treatment thus enabling appropriate therapy to be administered in a timely fashion before advanced symptoms appear