DRIVe welcomes partner Spire, Inc. of San Francisco. DRIVe, a division of the Biomedical Advanced Research and Development Authority in the HHS Office of the Assistant Secretary for Preparedness and Response, is providing research and development funding for the new Spire Health Tag, a wearable early-warning sensor that measures the body’s heart rate, breathing patterns, and even stress levels, and with the potential to alert users that they are about to get sick.

Currently the Spire Health Tag is available for consumer health and wellness use, including to help monitor sleep, stress and activity. Now with funding from DRIVe, Spire will further develop the product, aiming for U.S. Food and Drug Administration (FDA) 510K clearance. FDA clearance is required to ensure medical devices are safe and effective before they can be marketed for clinical applications.

This Powered by DRIVe project becomes part of DRIVe’s Early Notification to Act Control and Treat (ENACT) portfolio. Products developed under ENACT empower people by letting them know they are sick before the first symptom.

The Spire Health Tag is a small, washable, and attaches to clothing to monitor and report activity and detect changes in the body. The device can send messages to the user’s cell phone to report findings and alert the wearer to real-time bio-signals, like heart-rate and breathing variability, changes in body heat, stress levels, and other changes in the unique health signature of the user. It is designed to be easy to use, can be worn while the person sleeps, and does not need to be recharged.

Innovative technologies like wearable ENACT products hold the potential to also strengthen the nation’s ability to protect Americans from health security threats and to save lives.

Spire and DRIVe, as a true public private partnership, are sharing costs to increase the chances of success. The total project cost is $88,860, with the DRIVe contributing approximately $62,200 and Spire funding the remaining costs.

DRIVe is committed to transforming the speed in which government partners with industry. This award was made within a month of Spire’s DRIVe EZ BAA application!

About Spire

Spire is dedicated to giving every person the power to control their own mental and physical health by capturing real-time bio-signals and making data useful and actionable. Founded in 2013, Spire has become the recognized market-leader in continuous respiration sensing, real-time interventions, and actionable feedback. Spire is based in San Francisco and has backing from Rock Health, Stanford StartX, and other leading medical device investors. Learn more at spire.io

DRIVe welcomes its first partner, EnLiSense of Allen, Texas! DRIVe is providing research and development funding to accelerate development of a wearable device from EnLiSense that detects infections in a person’s sweat.

This Powered by DRIVe award provides non-dilutive funding for up to 18 months and is part of DRIVe’s laser-like focus on transforming health security. DRIVe invests in disruptive innovation to protect Americans against 21st century health security threats.

The first Powered by DRIVe project falls under DRIVe’s Early Notification to Act Control and Treat (ENACT) program. Products developed under ENACT empower people by letting you know you’re sick before you even feel sick.

EnLiSense’s non-invasive SWEATSENSER diagnostics (Dx) Platform could become an easy-to-use wearable sensor to quickly detect or rule out infections. The sensor, which may resemble a wrist-watch, works by detecting and tracking multiple biomarkers, including cytokine levels in sweat; these levels may be an early warning of changes in the body.

The SWEATSENSER could be used in a hospital setting or in the community to identify an influenza infection or other chemical, biological, radiological, or nuclear disasters.

Innovative technologies like the EnLiSense platform have the potential to also strengthen our ability to protect Americans from health security threats and to save lives.

This EnLiSense and DRIVe announcement is a true public private partnership with DRIVe providing just over $550,900 and EnLiSense picking up a share of the cost.

DRIVe is committed to transforming the speed in which government partners with industry. This award was made within one month of EnLiSense’s DRIVe EZ BAA application!

About EnLiSense

Since 2014, EnLiSense is committed to developing Point-of-Need technologies and solutions for enhancing the quality of human life. EnLiSense’s technologies and solutions enable tracking of WELLNESS to ILLNESS and Back to WELLNESS states of users, allowing users and care-givers to make informed and reliable early decisions on their health and lifestyle choices. For additional information, visit https://enlisense.com/. Contact: PR@enlisense.com +1 (972) 736-7059

Timothy G. Buchman, MD has four decades of bedside experience caring for septic patients. He is Professor of Surgery, Anesthesiology, and Biomedical Informatics at Emory University, where he founded the Emory Critical Care Center. Dr. Buchman is past president of the Shock Society, of the Society for Complex Acute Illness and of the Society of Critical Care Medicine. He is Editor-in-Chief of Critical Care Medicine. He is also a member of the External Faculty of the Santa Fe Institute and has served as the Edison Professor of Surgery and Director of Acute and Critical Care Surgery at Washington University in St. Louis. He directed the Surgical Intensive Care Unit and founded the Adult Trauma Service at Johns Hopkins Hospital. Dr. Buchman is widely published in the field of sepsis.

Steven Q. Simpson, MD is a prominent medical researcher and expert in sepsis. He is Professor of Medicine and Interim Director of the Division of Pulmonary and Critical Care Medicine at the University of Kansas. He is past Chair of Interdisciplinary Critical Care at the University of Kansas Hospital and Medical Director of three intensive care units. Dr. Simpson is the Chief Medical Officer for Sepsis Alliance, the country’s largest charitable advocacy organization dedicated to battling and raising awareness about sepsis. He has conducted research in all areas of severe sepsis from molecular and cellular mechanisms, to translational studies, to quality improvement studies. Dr. Simpson is widely published in the field of sepsis.

DRIVe's new application process, called an EZ-BAA, is now open for business! Medical product developers, research teams and companies offering disruptive solutions to health security threats are invited to submit abstracts beginning today using this simplified EZ-BAA process.

We're looking for the most innovative products and technologies to protect Americans from the most serious systemic, natural and intentional health security threats. Our goal is to build a portfolio of products representing disruptive innovative approaches that will transform health security.

Applications accepted through this streamlined process must offer transformative innovation, products and technologies to protect Americans from health security threats. This application process is a business friendly simple abstract.

Applications accepted through this streamlined process must offer transformative innovation, products and technologies to protect Americans from health security threats. This application process is a business friendly simple abstract.

In-scope priority areas include products and solutions to reduce illness and death from sepsis as part of DRIVe's Solving Sepsis initiative; technologies and processes to identify infections and exposures to biological and other health threats, as outlined in the Early Notification to Act, Control, and Treat (ENACT) initiative; and tools and techniques to mitigate the damages and loss of life associated with catastrophic events.

Applying is simple:
Download the application form.
Submit a technical abstract no longer than a 2,000 words.
Include a cost proposal of an additional 2,000 words or less.
Proposed costs should not exceed $749,000.

What happens next:
Once submitted, DRIVe's experts will review the application to ensure it's within scope and meets DRIVe criteria.
As the applicant, you'll be notified of the review results within 30 days of your submission.

Learn more about the DRIVe EZ-BAA review criteria.

Have questions? Looking more information? Contact DRIVeContracting@hhs.gov