Profusa wins $1.75m NIH grant for tissue-integrated biosensors

San Francisco-based tissue-integrated sensor maker Profusa said today it won a $1.75 million grant from the National Institutes of Health’s Small Business Innovation Research program.

Funding is slated to help support the company’s fast-tracked Phase I and Phase II studies of its Lumee tissue-integrated biosensors designed for continuous oxygen monitoring to improve outcomes in patients with peripheral artery disease.

“This NIH award is further validation of the potential of our biosensor technology for having a significant impact in transforming clinical outcomes for patients with PAD. These studies will be crucial in advancing our technology and products towards regulatory approvals and commercialization,” CEO Ben Hwang said in a press release.

Phase I of the grant will fund safety studies of Lumee, Profusa said, and Phase II is slated to fund a clinical study of the company’s tech at the University of California San Francisco. Profusa said the grant is the 2nd fast-track small business grant it has received from the NHLBI to develop its tissue-integrated oxygen biosensor for PAD patients.

“Our goal is to further demonstrate the functionality of Profusa’s novel Lumee oxygen biosensor technology in patients with PAD, and to determine its ability to predict surgical outcomes and to guide additional therapies to avoid amputation,” CTO and study co-principal investigator Natalie Wisniewski said in a prepared statement.

The Phase I trial of the program aims to verify the biocompatibility of the biosensors which the company said has been shown to be functional for more than 2 years within the body. Phase II will include a 50-patient clinical trial, Profusa said.

Profusa is developing next-gen tissue-integrated sensors to allow for the monitoring of body chemistry to allow for more personalized health and disease management.

“Profusa’s oxygen-sensing technology may allow doctors for the first time to know the tissue oxygen levels in the ischemic limb before, during, and after treatment. We’ll be able to more accurately select patients who will need a revascularization procedure to heal their wounds, and we will be able to monitor the change in tissue oxygen during and after the procedure in order to guide our treatment and know when it is complete. The upside for our patients will be less pain and disability, improved function, and fewer amputations,” co-principal investigator Dr. Christopher Owens said in prepared remarks.

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