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Noninvasive multiphoton imaging of subcellular structures with color contrast for rapid detection of skin cancers

Award Number: R44CA221591
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/25/2017
PERIOD OF PERFORMANCE END DATE: 03/31/2024

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Noninvasive multiphoton imaging of subcellular structures with color contrast for rapid detection of skin cancers - Nonmelanoma skin cancer (NMSC) represents the most common form of cancer in the human body. The method for diagnosing and treating NMSCs requires a skin biopsy that is processed and stained for analysis on a standard optical microscope. This process is painful for patients, and the invasiveness of biopsy introduces a delay into NMSC detection, which contributes to patient morbidity and adds substantial cost to the healthcare system. EnSpectra Health, Inc (Enspectra) aims to address the unmet clinical need for a better method to detect NMSCs earlier. This Phase IIB application builds on the progress of awarded Phase I and Phase II projects (NCI, 2R44CA221591-02A1). In Phase I of this grant, EnSpectra demonstrated the feasibility of a portable, skin-imaging microscope for human clinical studies (Aim 1), developed software for data acquisition, image processing, and improved user interface (Aim 2), and demonstrated in 5 human subjects with basal cell carcinoma (BCC) the ability to detect pathologic features of BCC (Aim 3). EnSpectra has created the first fiber coupled multiphoton microscopy (MPM) system for in vivo imaging of skin cellular anatomy. In Phase II of this grant, EnSpectra advanced the development of its portable, skin-imaging microscope (Aim 1), developed a library of slide images of targeted skin diseases comparing MPM to traditional histology (Aim 2), and is on track to complete in vivo human performance testing (Aim 3) prior to the Phase II end date. The completion of the Phase II aims will enable EnSpectra to build clinical evidence in to support a 510(k) submission for United States Food & Drug Administration (FDA) clearance. In this Phase IIB proposal EnSpectra will accomplish two aims: Aim 1) Develop and manufacture 8 portable, skin-imaging microscopes for commercial readiness (12 months), Aim 2) Conduct clinical trial to support reimbursement body of literature (24 months).


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: 2024 ( Subtotal = $0 )
2024	2023	ENSPECTRA HEALTH, INC.	2495 HOSPITAL DR	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Treatment Research	000	5	6/26/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $815,870 )
2023	2023	ENSPECTRA HEALTH INC	2495 HOSPITAL DR	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Treatment Research	000	5	2/10/2023	NON-COMPETING CONTINUATION	$815,870
														Subtotal = $815,870

Issue Date FY: 2022 ( Subtotal = $1,212,820 )
2022	2022	ENSPECTRA HEALTH, INC.	2495 HOSPITAL DR STE 300	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Treatment Research	000	4	3/11/2022	NON-COMPETING CONTINUATION	$1,212,820
														Subtotal = $1,212,820

Issue Date FY: 2021 ( Subtotal = $1,968,512 )
2021	2021	ENSPECTRA HEALTH, INC.	2495 HOSPITAL DR STE 300	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Treatment Research	001	3	4/14/2021	COMPETING CONTINUATION	$1,968,512
2021	2020	ENSPECTRA HEALTH, INC.	2495 HOSPITAL DR STE 300	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Detection and Diagnosis Research	000	2	3/31/2021	COMPETING CONTINUATION	$0
														Subtotal = $1,968,512

Issue Date FY: 2020 ( Subtotal = $1,944,985 )
2020	2020	ENSPECTRA HEALTH, INC.	2490 HOSPITAL DR STE 310	MOUNTAIN VIEW	CA	94040	SANTA CLARA	USA	Cancer Detection and Diagnosis Research	000	2	1/6/2020	COMPETING CONTINUATION	$1,944,985
														Subtotal = $1,944,985

Grand Total All Awards = $5,942,187

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Noninvasive multiphoton imaging of subcellular structures with color contrast for rapid detection of skin cancers

Award Number: R44CA221591

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/25/2017

PERIOD OF PERFORMANCE END DATE: 03/31/2024

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