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Enhancing the Commercialization Readiness of a Noninvasive Total Hemoglobin Monitor

Award Number: SB1HL106860
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2011
PERIOD OF PERFORMANCE END DATE: 12/21/2021

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Enhancing the Commercialization Readiness of a Noninvasive Total Hemoglobin Monitor - Abstract It is a rare event when new and useful medical parameters can be added to the suite of monitoring and diagnostic tests available in a clinical setting. Of particular importance is the ability to measure crucial physiological parameters or analytes in a continuous and noninvasive manner—evidenced by the importance of noninvasive vital signs monitoring—because it reduces expense, eliminates delays in diagnosis, and removes the potential for exposure to blood-borne pathogens. This SBIR Commercialization Readiness Pilot (CRP) program proposal is being submitted to further the regulatory plan, intellectual property strategy, manufacturing readiness, and market launch plan for a new patient monitor capable of accurate, noninvasive, and continuous measurements of total hemoglobin (tHb) and oxygen saturation (SpO2). The measurement of total hemoglobin is a crucial and frequently performed blood test used in nearly all areas of healthcare. The accurate measurement of this parameter is particularly important for patients potentially requiring a transfusion, receiving rapid administration of fluids, undergoing a surgical procedure, or having experienced trauma that has resulted in significant blood loss. Total hemoglobin must also be measured for anemia screening prior to blood donation. The new monitor will look much like a conventional pulse oximeter, the ubiquitous vital-signs monitor that has been in widespread clinical use since the 1980s and which uses a clothespin-like sensor to “shine” red and infrared light through the finger and report a measure of the oxygen level in the arterial blood. The product realized from the current research will not only provide a noninvasive and continuous measurement of total hemoglobin but also noninvasively measure oxygen saturation with unprecedented precision and accuracy. Successful completion of the proposed work will improve the commercial readiness of a pulse oximeter capable of total hemoglobin and oxygen saturation measurements. It is the culmination of the Company's efforts to prove that the high measurement precision provided by the use of narrow- band lasers can make possible accurate noninvasive measurement of tHb on human subjects over the full clinically-relevant tHb range. Availability of a noninvasive total hemoglobin monitor will help diagnose anemic patients sooner and contribute to the judicious use of blood transfusions, all with less pain or risk of infection while reducing the time burden on caregivers and costs to the healthcare system. It could also eliminate the need for the painful fingersticks associated with blood donation.


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: 2022 ( Subtotal = -$88,891 )
2022	2021	KESTREL LABS INC	3133 INDIAN RD SUITE K	BOULDER	CO	80301	BOULDER	USA	Blood Diseases and Resources Research	001	5	2/3/2022	NON-COMPETING CONTINUATION	-$88,891
2022	2021	KESTREL LABS INC	3133 INDIAN RD SUITE K	BOULDER	CO	80301	BOULDER	USA	Blood Diseases and Resources Research	000	5	1/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = -$88,891

Issue Date FY: 2021 ( Subtotal = $170,172 )
2021	2021	KESTREL LABS INC	3133 INDIAN RD SUITE K	BOULDER	CO	80301	BOULDER	USA	Blood Diseases and Resources Research	000	5	6/22/2021	NON-COMPETING CONTINUATION	$170,172
														Subtotal = $170,172

Issue Date FY: 2020 ( Subtotal = $329,470 )
2020	2020	KESTREL LABS INC	3133 INDIAN RD SUITE K	BOULDER	CO	80301	BOULDER	USA	Blood Diseases and Resources Research	000	4	7/10/2020	COMPETING CONTINUATION	$329,470
														Subtotal = $329,470

Grand Total All Awards = $410,751

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Enhancing the Commercialization Readiness of a Noninvasive Total Hemoglobin Monitor

Award Number: SB1HL106860

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/22/2011

PERIOD OF PERFORMANCE END DATE: 12/21/2021

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