Notice Number: NOT-HL-19-708

Key Dates
Release Date: July 11, 2019

PA-19-270 : PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Issued by
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This NOSI aims to support the development of bioelectronic sensors, intelligent chemical sensor array systems coupled with bio-receptors, capable of identifying the prodromes of an acute exacerbation in patients with a chronic cardiopulmonary disease.

Background

Alerting patients with a chronic cardiovascular or lung disease of an impending worsening of their condition could save lives and reduce medical care costs. Exacerbations for many chronic cardiovascular or pulmonary diseases are almost always accompanied by a worsening of symptoms derived from physiological and metabolic changes that are amenable to measurement with biosensors [e.g. O2/CO2 levels, cough frequency, airway pressure/volume, (for lung disorders) cardiac and renal biomarkers, metabolic function, electrical or immunomodulatory alterations in transplantation, ischemic metabolites, mitochondrial energetics (for cardiovascular disorders) and chemical signatures in exhaled breath, urine, or blood].

Objectives

It is anticipated that the funded applications will propose to develop and test in appropriate models/patients a prototype bioelectronic sensor technology that should include biological recognition components in combination with signal transducers and reader devices. These biosensor exacerbation detection devices will need to have high discriminatory and predictive value, should be based on strong associative data between the analyte(s) of interest and the disease indication, and would benefit from development through a partnership between cardiologists, pulmonologists and bioengineers.

Specific activities are expected to include production and immobilization of sensing elements onto a sensor surface, validation of the constructed sensors and their ability to transmit a detectable signal, development and refinement of reader software, and the testing of prototypes in disease-relevant models or other applications. The anticipated commercial product(s) would be detector(s) of low cost and relatively modest size that could readily be used by a patient with chronic cardiac or lung disease by testing her/his own exhaled breath, saliva, sweat, urine, skin, or other easily targetable biological sample. The anticipated activities performed during the award should lead to a prototype which represents a deliverable that we believe will have enormous commercialization potential and address an unmet need for patients at high risk for an exacerbation with diseases like COPD, CHF, and IPF.

Application and Submission Information:

This notice applies to due dates on or after September 5, 2019. The following funding opportunity announcements (FOAs) or their reissued equivalents must be used for submissions for this initiative

• PA-19-270: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

For funding consideration, applicants must include NOT-HL-19-708 in the Agency Routing Identifier field (Box 4.b) of the SF 424 (R&R) Form. Applications without this information in Box 4.b will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NHLBI program officer listed on this NOSI well in advance of the grant receipt date.

Inquiries

Please direct all inquiries to:

Antonello Punturieri
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0202
Email: punturieria@nhlbi.nih.gov

Patrice Desivigne-Nickens
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:301-435-0504
Email: desvignp@nhlbi.nih.gov

Matt Craig
National Heart, Lung, and Blood Institute (NHLBI)
Email: matt.craig@nih.gov
Telephone: 301-435-0222