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A novel instrument for continuous blood pressure monitoring

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AG082574-01
Agency Tracking Number: R43AG082574
Amount: $309,746.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PA22-176
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-06-01
Award End Date (Contract End Date): 2024-05-31
Small Business Information
1410 Sachem Place
Charlottesville, VA 22901-2496
United States
DUNS: 120839477
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 BRIAN CLARK
 (434) 973-1215
 clark1n@bainet.com
Business Contact
 B PARKER
Phone: (434) 973-1215
Email: barron@bainet.com
Research Institution
N/A
Abstract

Project Summary/Abstract
Problem High blood pressure (BP) is a substantial public health problem that affects 45% of adults (75% of
individuals over age 65) and is a leading cause of excess cardiovascular morbidity and mortality. BP monitoring
has high diagnostic and prognostic value as an important marker of cardiovascular disease. Static BP snapshots,
which are typically obtained via sphygmomanometry during doctor’s office visits, have documented reliability
issues, including “white-coat” hypertension and poor technique. Auscultatory or oscillometric cuff-based ambu-
latory BP monitors (ABPMs) that can be worn in home settings and provide regular automated measurements
over 24-hour periods have seen widespread adoption. However, these devices also suffer from poor reliability
because measurements are seldom performed according to the specified guidelines even with training (e.g.,
seated, feet not crossed, arm cuff maintained at heart level, etc.). They also yield only intermittent measure-
ments (potentially missing important BP events), worsen sleep quality due to their intrusiveness, confound BP
measurements due to autonomic response to cuff inflations, and are obtrusive and uncomfortable.
Solution The proposed Blood Pressure Sage (BP-SAGE ) system will be a novel, reliable, easy-to-use, and
comfortable (non-cuff-based) continuous ABPM (cABPM) that can operate 24/7, even during activities of
daily living (ADL) and sleep without disturbing or requiring any action from the wearer, and without imposing
stringent measurement guidelines.This new class of BP monitor will be an important addition to clinical practice, accurately and unobtrusively
assessing individuals with established or suspected hypertension, even during movement and without uncom-
fortable cuff inflations. BP-SAGE will provide accurate BP estimates without restricting users’ mobility, body
postures, or arm elevations. The beat-to-beat BP estimates may be used directly or averaged over arbitrary
intervals (e.g., to reproduce conventional ABPM results).The Phase I effort will demonstrate proof-of-concept and feasibility for the BP-SAGE methodology via rigorous
evaluation in both healthy and hypertensive subjects. In particular, BP-SAGE systolic, diastolic, and mean arterial
BP estimates will be obtained during rest and at different BP levels and compared to criterion BP measurements
obtained using a laboratory-grade continuous noninvasive BP (cNIBP) monitor. As a true pulse transit time
(PTT)-based technique, and based on the proposed novel modeling approach that also accounts for variations in
vasomotor tone, BP-SAGE will obviate the need for repeated calibrations associated with traditional pulse arrival
time (PAT)-based methods. BP-SAGE software will automatically generate clear, interpretive reports that meet
international standards and include summary data to simplify interpretation by clinicians. BP-SAGE will fulfill
the need for an ergonomic, accurate, reliable, and low-cost continuous BP monitoring for use in healthcare and
clinical research.

* Information listed above is at the time of submission. *

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