2335289
Cooperative Agreement
Overview
Grant Description
SBIR Phase II: Productization, clinical validation, and quality & regulatory activities for in-home diabetic foot imaging bathroom scale system.
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel at-home scale to reduce severe diabetic foot ulcers in patients with diabetic neuropathy, often suffering from lost or impaired sensation.
Ulcers affect approximately one-fourth of diabetic patients over their lifetime significantly impacting their mobility and life expectancy.
Estimates for diabetic foot ulcer treatments are as high as $40B per year and up to one-third of all direct diabetic healthcare spending.
Long term effects include amputation of one or more extremities; accounting for a majority of non-traumatic lower extremity amputations each year.
The proposed solution provides a remote at-home monitor providing daily visual inspections for early signs of foot ulcers significantly improving current qualitative and often variable-inspection methods representing the current standard of care for detection.
This Small Business Innovation Research (SBIR) Phase II project will develop a novel in-home health monitoring product for diabetic foot complications within constraints required for commercialization.
The proposal builds on the company’s proprietary imaging and algorithmic method and prototype developed during the Phase I project with three concurrent objectives:
(I) Advance the design, engineering and manufacturing activities to ruggedize the product suitable for patient use;
(II) Complete a clinical study with a partner health system to demonstrate patient use adherence and provider usability with the images and data suitable for clinical adoption; and
(III) Perform quality assurance testing of the manufacturable product at scale.
The activities aim to complete a product suitable for commercialization for use at home as intended at cost, scale and quality.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.
Subawards are planned for this award.
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel at-home scale to reduce severe diabetic foot ulcers in patients with diabetic neuropathy, often suffering from lost or impaired sensation.
Ulcers affect approximately one-fourth of diabetic patients over their lifetime significantly impacting their mobility and life expectancy.
Estimates for diabetic foot ulcer treatments are as high as $40B per year and up to one-third of all direct diabetic healthcare spending.
Long term effects include amputation of one or more extremities; accounting for a majority of non-traumatic lower extremity amputations each year.
The proposed solution provides a remote at-home monitor providing daily visual inspections for early signs of foot ulcers significantly improving current qualitative and often variable-inspection methods representing the current standard of care for detection.
This Small Business Innovation Research (SBIR) Phase II project will develop a novel in-home health monitoring product for diabetic foot complications within constraints required for commercialization.
The proposal builds on the company’s proprietary imaging and algorithmic method and prototype developed during the Phase I project with three concurrent objectives:
(I) Advance the design, engineering and manufacturing activities to ruggedize the product suitable for patient use;
(II) Complete a clinical study with a partner health system to demonstrate patient use adherence and provider usability with the images and data suitable for clinical adoption; and
(III) Perform quality assurance testing of the manufacturable product at scale.
The activities aim to complete a product suitable for commercialization for use at home as intended at cost, scale and quality.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.
Subawards are planned for this award.
Awardee
Funding Goals
THE GOAL OF THIS FUNDING OPPORTUNITY, "NSF SMALL BUSINESS INNOVATION RESEARCH PHASE II (SBIR)/ SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS PHASE II", IS IDENTIFIED IN THE LINK: HTTPS://WWW.NSF.GOV/PUBLICATIONS/PUB_SUMM.JSP?ODS_KEY=NSF23516
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
San Bruno,
California
94066-2412
United States
Geographic Scope
Single Zip Code
Empo Health was awarded
Cooperative Agreement 2335289
worth $1,000,000
from National Science Foundation in August 2024 with work to be completed primarily in San Bruno California United States.
The grant
has a duration of 2 years and
was awarded through assistance program 47.084 NSF Technology, Innovation, and Partnerships.
The Cooperative Agreement was awarded through grant opportunity NSF Small Business Innovation Research / Small Business Technology Transfer Phase II Programs (SBIR/STTR Phase II).
SBIR Details
Research Type
SBIR Phase II
Title
SBIR Phase II: Productization, Clinical Validation, and Quality & Regulatory Activities for In-Home Diabetic Foot Imaging Bathroom Scale System
Abstract
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel at home scale to reduce severe diabetic foot ulcers in patients with diabetic neuropathy, often sufferring from lost or impaired sensation. Ulcers affect approximatey one-fourth of diabetic patients over their lifetime significantly impacting their mobility and life expectancy. Estimates for diabetic foot ulcer treatments are as high as $40B per year and up to one-third of all direct diabetic healthcare spending. Long term effects include amputation of one or more extremities; accounting for a majority of non-traumatic lower extremity amputations each year. The proposed solution provides a remote at home monitor providing daily visual inspections for early signs of foot ulcers significantly improving current qualitative and often variable- inspection methods representing the current standard of care for detection.
This Small Business Innovation Research (SBIR) Phase II project will develop a novel in-home health monitoring product for diabetic foot complications within constraints required for commercialization. The proposal builds on the company’s proprietary imaging and algorithmic method and prototype developed during the Phase I project with three concurrent objectives: (i) Advance the design, engineering and manufacturing activities to ruggedize the product suitable for patient use; (ii) Complete a clinical study with a partner health system to demonstrate patient use adherence and provider usability with the images and data suitable for clinical adoption; and (iii) Perform quality assurance testing of the manufacturable product at scale. The activities aim to complete a product suitable for commercialization for use at home as intended at cost, scale and quality.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
Topic Code
MD
Solicitation Number
NSF 23-516
Status
(Ongoing)
Last Modified 8/27/24
Period of Performance
8/15/24
Start Date
7/31/26
End Date
Funding Split
$1.0M
Federal Obligation
$0.0
Non-Federal Obligation
$1.0M
Total Obligated
Activity Timeline
Additional Detail
Award ID FAIN
2335289
SAI Number
None
Award ID URI
SAI EXEMPT
Awardee Classifications
Small Business
Awarding Office
491503 TRANSLATIONAL IMPACTS
Funding Office
491503 TRANSLATIONAL IMPACTS
Awardee UEI
GK2MFTYWFK26
Awardee CAGE
8VJB1
Performance District
CA-15
Senators
Dianne Feinstein
Alejandro Padilla
Alejandro Padilla
Modified: 8/27/24