DRIVe partners with Biobeat Technologies of Israel to develop a wearable monitoring device that diagnoses the flu and infections before any symptoms appear. The BARDA Division of Research, Innovation, and Ventures (DRIVe) is pleased to announce it is partnering with Biobeat Technologies Ltd. of Israel to develop a wearable early-warning device that monitors vital signs and alerts users they are getting sick before they feel symptoms. The project builds on Biobeat’s Wrist Watch, an FDA-cleared monitoring device that continuously measures blood pressure, heart rate, heart rate variability, oxygen saturation, respiratory rate, stroke volume, cardiac output and index, systemic vascular resistance, sweat, skin temperature, and more. With funding from DRIVe, Biobeat will further develop the technology to track bodily changes that signal the user has potentially been exposed to an influenza virus or other pathogen.

This Powered by DRIVe project is part of DRIVe’s Early Notification to Act, Control, and Treat (ENACT) portfolio. Products developed under ENACT aim to empower people by letting them know they are getting sick before the first symptom appears, encouraging early treatment of the disease and potentially reducing the spread of virus. Innovative technologies like wearable products also hold the potential to strengthen the nation’s ability to protect Americans from health security threats and to save lives.

Biobeat’s technology is based on reflective photoplethysmography, a low-cost technique to detect blood volume changes in the smallest blood vessels of human tissue and often used non-invasively to make measurements at the skin surface. The data is recorded and analyzed to produce alerts and recommendations of clinical significance. This also potentially allows prediction and early warning before severe physiological emergencies occur. Information can be transmitted via the cloud to a cell phone application or data base. DRIVe and Biobeat are committed to a public-private partnership, with DRIVe contributing $599,000 of the total $954,800 project cost. Biobeat will provide the remaining development costs.

DRIVe, a division of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Assistant Secretary for Preparedness and Response (ASPR) was established in June 2018 to transform health security innovation to protect Americans from 21st century health security threats. DRIVe’s business-friendly EZ-BAA application process streamlines the ways government partners with industry. This award was made in 85 days from submission to award. About Biobeat Technologies Ltd.

Biobeat is a technology company that has developed continuous, wireless, non-invasive, accurate medical-grade monitoring devices that measure and record vital signs and other physiologically relevant parameters. The Biobeat sensor platform can detect and monitor physiological parameters regarded as markers for health status. This could be used to identify those who are pre-exposed, pre-symptomatic; post-exposed, pre-symptomatic; and/or post-exposed, symptomatic and asymptomatic. Moreover, combining these parameters with laboratory results could help validate and predict symptom onset. Another aim would be to monitor close contacts of individuals diagnosed as having flu, follow their health, and look for signs of infection among them, thus allowing us to understand the natural history of flu infection, validated by the use of multiple parameter analysis, supported by blood tests conducted during the study to identify flu or other infectious agents. For more information visit https://www.biobeat.cloud/.

DRIVe is pleased to announce it is partnering with Cytovale, Inc. of San Francisco to develop new technology to diagnose sepsis in under 10 minutes. Using a simple blood test, Cytovale’s technology is intended to measure physical changes in immune cells that occur when someone is sick to indicate whether a patient has sepsis.

Support for the project is part of DRIVe’s ambitious Solving Sepsis initiative to accelerate the development of products that have potential to revolutionize the way sepsis is diagnosed and treated.

Sepsis kills an estimated 270,000 Americans each year, with a health care cost of over $24 billion annually. Sepsis occurs when an infection or other insult to the body produces a dysregulated immune response in a patient, which can cause serious tissue damage, organ failure, and even death. The disease is difficult to diagnose, and with current laboratory testing, can take a long time - sometimes days - to confirm.

Cytovale’s low-cost diagnostic holds the potential to provide the quick information emergency room healthcare providers need in the critical first hours and days of this often-deadly disease.

The Cytovale technology takes advantage of advances in microfluidics, ultra-high speed imaging, computer vision, and machine learning to rapidly quantify immune cell dysregulation from a blood sample in minutes. It uses deformability cytometry to measure immune cell changes, like inflammation and other changes that occur when a person is getting sick.

DRIVe’s Solving Sepsis initiative supports innovative technologies to prevent and reduce sepsis incidence, morbidity, and mortality. Sepsis is already a major public health threat, and it could pose an even bigger health security threat in the event of a chemical, biological, radiological, or nuclear attack or incident, or as a complication from influenza or other infectious diseases.

DRIVe and Cytovale are committed to a public-private partnership, with DRIVe contributing $749,000 of the total $1.397 million project cost. Cytovale will cover the remaining development costs for this phase of development as a part of a cost share.

DRIVe is transforming the speed in which government partners with industry. To streamline funding, DRIVe implemented a new business-friendly EZ-BAA application process enabling this award to be made in less than two months (55 days from submission to award).

About Cytovale

Cytovale is a venture backed, clinical-stage medical diagnostics company developing a novel platform that rapidly interrogates thousands of single cells to quantify the mechanical signatures of disease. The company’s lead product is focused on early sepsis detection in the Emergency Department setting to dramatically improve patient outcomes and reduce healthcare costs. With promising data in multiple studies across hundreds of patients, the system is currently under development with FDA clearance studies planned in the near future. Cytovale’s investors include Breakout Ventures, Blackhorn Ventures & other major healthcare oriented technology investors. For more information contact info@cytovale.com or visit Cytovale.com.

The Biomedical Advanced Research and Development Authority (BARDA) within the Assistant Secretary of Preparedness and Response (ASPR) at Health and Human Services (HHS) is seeking to recruit an exceptionally talented and forward-looking leader to serve as Director of its Division of Research, Innovation, and Ventures (DRIVe). DRIVe was launched in June 2018 to transform health security and support ASPR’s mission to Save Lives and Protect Americans from 21st century health security threats by investing in disruptive innovation.

The DRIVe Director will provide vision and strategic direction to identify and accelerate the development and availability of transformational technology and medical countermeasures. BARDA is looking for a dynamic executive, to lead an extraordinary team of restless innovators and industry experts who are building a portfolio of innovative products that transform the way we prevent, detect and respond to major health security threats. The Director will establish investment priorities, strategies and build novel partnerships to drive innovation that will solve critical and complex health care challenges and strengthen our nation’s health security. Initial DRIVe areas of focus include "Solving Sepsis" to reduce morbidity and mortality associated with sepsis, and "Early Notification to Act, Control, and Treat" (ENACT), to identify infections and exposures before people know they are ill.

Candidates must have a Ph.D., M.D. or other earned doctorate and have significant specialized experience leading, directing, and managing an innovative and dynamic organization focused on the development or use of medical countermeasures (e.g. vaccines, drugs, diagnostics tools, medical devices) or technologies that address public health threats. The DRIVe Director position will be based in Washington, DC.

Applications for this position are welcome until November 30, 2018 December 7, 2018. The time is now to serve and help Save Lives and Protect Americans from 21st century health security threats. Take the first step today by clicking here to learn more about the job and submit an application.

DRIVe’s Solving Sepsis program is excited to partner with InnaMed of Philadelphia. InnaMed is developing a point-of-care rapid blood testing device to help diagnose sepsis, determine risk stratification of patients and monitor the response to treatments. DRIVe is providing funding to InnaMed to develop a promising biomarker associated with sepsis to be integrated into this portable device.

InnaMed will develop its proprietary electrochemical proximity assay (ECPA) technology to rapidly test blood for the sepsis-associated biomarker, a recently identified peptide that has shown increased sensitivity, specificity and prognostic ability compared to currently used sepsis indicators. The ECPA platform will be combined with analytics to determine a “sepsis score” to triage and monitor patients.

Solving Sepsis accelerates the development of transformational technologies, including preventative and mitigation measures to reduce sepsis incidence, morbidity and mortality.

Sepsis is the body’s dysregulated immune response to infection that can cause serious tissue damage, organ failure, and death. Sepsis kills more than 270,000 Americans each year but is often difficult to diagnose. In the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication from influenza or other infectious diseases, sepsis could occur as a secondary confounder and is therefore a major health security threat.

DRIVe and InnaMed are committed to a true public private partnership, with DRIVe contributing $200,000 of the $285,750 estimated project costs. InnaMed will fund the remaining development costs.

DRIVe is committed to transforming the speed in which government partners with industry. This contract was awarded within 30 days of InnaMed’s DRIVe EZ BAA Solving Sepsis application.

About InnaMed

InnaMed is developing a comprehensive care management platform. Using InnaMed's products, patients can perform painless blood tests to quantify established biomarkers, answer condition specific symptom surveys, and report vitals like BP, HR and weight. These high-resolution data streams are then combined to measure disease activity at the biological level, identify meaningful changes in status to alert care teams and guide changes in treatment strategy. Founded in 2016, InnaMed is focused on improving the management of complex chronic conditions. The company is headquartered in Philadelphia. www.InnaMed.com

The BARDA DRIVe Solving Sepsis program welcomes its first partner, Prenosis of Chicago, IL. Prenosis is developing analytic systems that may help doctors predict the progression of sepsis in a patient. With DRIVe funding, Prenosis will develop a precision-medicine technology that could transform the clinical management of sepsis.

Prenosis’ ImmunoMatch™ technology uses machine learning algorithms trained by its proprietary dataset (NOSIS) which combines critical biological information with existing electronic medical record data, to perform intelligent patient matching. With technology to predict how a sepsis patient’s condition will progress, doctors can determine more quickly what is needed to improve outcomes over the continuum of sepsis care.

Solving Sepsis supports development of transformational technologies, including preventative and mitigation measures to reduce sepsis incidence, morbidity and mortality.

Sepsis kills more than 270,000 Americans each year and occurs when the body’s overwhelming response to infection results in a dysregulated immune response that can cause serious tissue damage, organ failure and death. In the event of a chemical, biological, radiological or nuclear attack or incident, or as a complication from influenza or other infectious diseases, sepsis could potentially occur as a secondary confounder, and therefore poses a major health security threat.

DRIVe and Prenosis are committed to a true public-private partnership, with DRIVe contributing $749,000 of the total $1.07 million estimated project cost. Prenosis will fund the remaining development costs.

DRIVe is transforming the speed in which government partners with industry. To streamline its funding mechanism, DRIVe implemented a new EZ-BAA application, a business friendly simple abstract. The contract with Prenosis was awarded within 30 days of its EZ-BAA application submission.

About Prenosis

Prenosis develops predictive analytics clinical decision support tools to improve sepsis care in hospitals. Prenosis’s ImmunoMatch technology partners with physicians to treat patients with confidence by enabling a precision medicine approach to sepsis that utilizes the proprietary NOSIS dataset, machine learning algorithms, and a point-of-care device. For more information, please visit www.prenosis.com or contact us at info@prenosis.com

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 for 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 is 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 device that 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 with 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 from 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 them know they’re sick before they 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 illness related to chemical, biological, radiological, or nuclear disasters.

Innovative technologies like the EnLiSense platform have the potential to 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.

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 2,000 words.
Submit a cost proposal of no more than 2,000 words.
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