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TABA Supplement for Hemophilia Point-of-Care Device

Award Number: R44HL151147
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2020
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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TABA Supplement for Hemophilia Point-of-Care Device - ABSTRACT Hemophilia A results from a deficiency of FVIII-activity and can result in severe bleeding. Head bleeds can be debilitating and joint-bleeds require major medical intervention. In this TABA Supplement to our Phase IIB effort, we will augment our commercialization efforts by obtaining the necessary outsourced compliance testing and intellectual property for our hemophilia point-of-care device. Our hemophilia solution is focused on measuring FVIII and emicizumab with a 15-minute turnaround time. Hemophilia A is an X-linked recessive genetic disorder with an incidence of 1 in 5000 live male births. For patients with hemophilia A, lifelong treatment is required to provide adequate and therapeutic FVIII or emicizumab FVIII-like levels. FVIII replacement monitoring is essential to maintaining optimal dosing. Acute bleeding and surgeries require knowledge of FVIII and/or FVIII-like levels for proper management. There are currently no approaches at the point-of-care for FVIII or FVIII-like measurements, resulting in challenges to implementation and access. This TABA Supplement will assist us in obtaining FDA clearance for our hemophilia tests. The two outsourced activities are to be performed by external vendors with the requisite expertise. Compliance testing for in vitro diagnostic (IVD) devices is on the critical path to device approvals. This requires testing for Electromagnetic Interference (EMI), Electromagnetic Compatibility (EMC), and Product Safety per EN 61010. These test lab activities require a vendor with dedicated expertise and equipment. Similarly, we will leverage outside intellectual property counsel to further solidify our patent protection. The success of developing a hemophilia POC diagnostic will allow a precision medicine approach for the management of hemophilia A. Home use will allow for more frequent measurement of FVIII levels to ensure therapeutic levels prior to engaging in physical activity and to assess correct dosage administration, including potential missed doses. The approach can be utilized to create FVIII activity trends which can be translated into immediate pK data, which can alert care providers to test for inhibitors. It will allow newer therapies, including emicizumab, extended half-life PEGylated FVIII, and gene therapies to be monitored. The results of our efforts will be a human-centered, hemophilia monitoring device and app that will provide accurate and easy-to-use tests with the goals of decreasing risk of unexpected bleeding and increasing patient care in all settings.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,050,000 )
2026	2026	THE DNA MEDICINE INSTITUTE, INC.	1 OAK PARK DR	BEDFORD	MA	01730	MIDDLESEX	USA	Blood Diseases and Resources Research	000	5	7/6/2026	NON-COMPETING CONTINUATION	$1,000,000
2026	2026	THE DNA MEDICINE INSTITUTE, INC.	1 OAK PARK DR	BEDFORD	MA	01730	MIDDLESEX	USA	Cardiovascular Diseases Research	001	5	7/16/2026	SUPPLEMENT FOR EXPANSION	$50,000
														Subtotal = $1,050,000

Issue Date FY: 2025 ( Subtotal = $1,000,000 )
2025	2025	THE DNA MEDICINE INSTITUTE, INC.	1 OAK PARK DR	BEDFORD	MA	01730	MIDDLESEX	USA	Blood Diseases and Resources Research	000	4	7/4/2025	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2024 ( Subtotal = $999,888 )
2024	2024	THE DNA MEDICINE INSTITUTE, INC.	1 OAK PARK DR	BEDFORD	MA	01730	MIDDLESEX	USA	Blood Diseases and Resources Research	000	3	2/28/2024	COMPETING CONTINUATION	$999,888
														Subtotal = $999,888

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	THE DNA MEDICINE INSTITUTE, INC.	1 OAK PARK DR	BEDFORD	MA	01730	MIDDLESEX	USA	Blood Diseases and Resources Research	000	2	9/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $724,677 )
2021	2021	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	001	2	6/8/2021	NON-COMPETING CONTINUATION	$724,677
2021	2020	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	1	11/6/2020	NEW	$0
														Subtotal = $724,677

Issue Date FY: 2020 ( Subtotal = $749,250 )
2020	2020	DNA MEDICINE INSTITUTE, INC., THE	727 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Blood Diseases and Resources Research	000	1	9/11/2020	NEW	$749,250
														Subtotal = $749,250

Grand Total All Awards = $4,523,815

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TABA Supplement for Hemophilia Point-of-Care Device

Award Number: R44HL151147

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/10/2020

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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