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Real-time Multimodal Diffuse Reflectance and Polarization Imaging Based Nerve Identification in Surgical Field of View

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EB029888-01A1
Agency Tracking Number: R41EB029888
Amount: $333,355.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIBIB
Solicitation Number: PA19-270
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-21
Award End Date (Contract End Date): 2021-09-20
Small Business Information
Knoxville, TN 37934-0933
United States
DUNS: 117020871
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (865) 776-6336
Business Contact
Phone: (865) 776-6336
Research Institution
110 21 ST. AVE. SOUTH
United States

 Nonprofit College or University

We propose to develop a novel non-contact, label-free multimodality imager that provides real-time intraoperative
identification of nerves within the surgical field-of-view to facilitate the prevention of unintended nerve damage
(termed iatrogenic nerve injury) during surgical procedures, as they are a major source of postsurgical
complications, e.g., chronic pain. In the United States chronic pain management is a major putative contributing
factor in the current opioid-related drug overdose epidemic. Annually, over 45 million surgical procedures are
performed in the United States and an estimated 10% to 50% of them result in patient chronic postoperative pain
outcomes. Though not all the at least 4.5 million are definitively ascribable to iatrogenic nerve injury, it
nonetheless represents a significant recurring annual healthcare problem. Relatedly, analysis of large-scale
nerve lesion treatment studies reveals that 25%, 60% and 94% respectively of sciatic, femoral and accessory
nerve lesions addressed are caused by iatrogenic nerve injury.
Additionally, iatrogenic nerve injury features prominently in post-surgical quality of life issues that range from
loss of sensation and motor function, to the aforementioned chronic pain, and morbidity. Reportedly, 2-3 years
post radical prostatectomy ~60% of men are still impotent as a result of damaged cavernous nerves. Likewise,
20% - 60% of mastectomy breast cancer treatment survivors suffer chronic post-surgical pain that significantly
reduces their quality of life, and injury to the intercostobrachial nerve is the primary cause. Even in surgeries with
minimal neural damage risk like acoustic neuroma removal (andlt;1%), spinal scoliosis surgery (andlt;0.6%), and
thyroidectomy (andlt;2-3.8%) the consequences of nerve damage can be severe: leading to deafness, paraplegia,
and even death respectively. The associated financial implications of iatrogenic nerve damage are significant.
There are direct financial costs to the individual due to loss of employment and/or income, and to the healthcare
industry as nerve damage is a common source of litigation with compensation being awarded in 82% of cases
of spinal accessory nerve injury, for an example. The exposure of healthcare personnel and providers to
medicolegal liability is extensive as Iatrogenic nerve injuries are commonly reported on the laryngeal nerve
during thyroid operations, trigeminal nerve and inferior alveolar nerve during facial and oral surgeries, intercostal
nerves during thoracic surgeries, and on the spinal accessory nerves, common peroneal nerve, superficial radial
nerve, and genitofemoral nerve branches during various other surgeries. Consequently, as of 2015, medicolegal
litigation risk was a primary driver for a $2.2 billion global market for intraoperative nerve monitoring projected to
grow annually at 4.79% until 2025. Our proposed solution targets filling both the deficiencies of currently available
options and the growing demand by introducing an effective, commercially viable product.PROJECT NARRATIVE
Unintended nerve damage during surgical procedures is a significant and costly public healthcare delivery
problem and current methods for injury prevention via intraoperative nerve monitoring leave substantial room
for improvement. The ramifications of increased healthcare costs due to associated medical-liability issues and
the significant reductions in quality of life issues, including the burgeoning chronic pain management related
opioid-related drug overdose epidemic, make addressing this very impactful to society. The proposed
development will yield an effective, commercially viable, non-contact multimodality imager that provides real-
time intraoperative identification of nerves within the surgical field-of-view to facilitate the prevention of
unintended nerve damage during surgical procedures.

* Information listed above is at the time of submission. *

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