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Advanced Intraoperative Imager for Nerve Identification

Award Number: R44DE029631
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2019
PERIOD OF PERFORMANCE END DATE: 03/31/2024

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Advanced Intraoperative Imager for Nerve Identification - Project Summary/Abstract In this R&D program, Physical Sciences Inc. (PSI), in collaboration with Dartmouth Hitchcock Medical Center (DHMC), proposes to demonstrate and commercialize an advanced intraoperative fluorescence imager that can efficiently highlight nerve presence in the surgical bed and thus eliminate risk for nerve damage. Unintended nerve injury is a major cause of morbidity for many surgeries, especially in soft tissue orthopedic, otolaryngology, craniofacial, and genitourinary operations. Distinctive visualization of nerves from adjacent connective and fat tissues is challenging, and therefore nerve injury remains a major surgical complication. Fluorescence guided surgery (FGS) based on nerve-labelling agents has the potential to improve nerve identification. An outstanding problem in FGS is the negative impact of the strong ambient light, which interferes the weak fluorescence signal. Currently, this problem is mitigated by turning off the light in the operating room (OR) during the fluorescence imaging procedure. However, this causes unwanted interruption to the surgical workflow and thus dampens the enthusiasm of the surgeons and diminishes the potential for clinical adoption of FGS technologies. PSI and DHMC will develop a fluorescence imager that overcomes most of the issues of the current FGS systems. The proposed technology uses a novel tempo-spatially modulated (TSM) illumination scheme, which significantly reduces the negative impact of the ambient light background. During the Phase I effort, we successfully demonstrated a robust imager that is cable of suppressing the ambient light background by a factor of >16,000. The high rate of background rejection enabled the collection of high-contrast nerve- highlighting images under the regular high-brightness OR light. During the Phase II program, we propose to further optimize and mature this technology and demonstrate its suitability and readiness for clinical use. The Phase II effort will focus on: 1) improving the technical performance by incorporating simultaneous dual-wavelength fluoresce and reflection white-light imaging; 2) demonstrating the benefits of the technology through extensive in vivo animal studies; 3) evaluating the clinical suitability and readiness of the imager; and 4) performing instrument demonstrations to key opinion leaders and outreach to potential customers. This R&D project will lead to a reliable solution for intraoperative fluorescence imaging in the presence of standard OR lighting conditions, avoiding the interruption to the normal surgical workflow by turning off the room light. This will promote intraoperative fluorescence imaging procedures to be seamlessly integrated into current clinical workflows for optimal patient outcome.


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: 2023 ( Subtotal = $870,860 )
2023	2023	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Oral Diseases and Disorders Research	001	3	3/7/2023	NON-COMPETING CONTINUATION	$870,860
2023	2022	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Oral Diseases and Disorders Research	000	2	10/19/2022	COMPETING CONTINUATION	$0
														Subtotal = $870,860

Issue Date FY: 2022 ( Subtotal = $891,162 )
2022	2022	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Oral Diseases and Disorders Research	000	2	3/18/2022	COMPETING CONTINUATION	$890,324
2022	2022	PHYSICAL SCIENCES INC.	20 NEW ENGLAND BUSINESS CTR DR	ANDOVER	MA	01810	ESSEX	USA	Oral Diseases and Disorders Research	001	2	5/25/2022	COMPETING CONTINUATION	$838
														Subtotal = $891,162

Grand Total All Awards = $1,762,022

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Advanced Intraoperative Imager for Nerve Identification

Award Number: R44DE029631

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/16/2019

PERIOD OF PERFORMANCE END DATE: 03/31/2024

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