SBIR-STTR Award

Label-free, Multimodality Diffuse Reflectance and Polarization-Based Proximity Probe for Iatrogenic Nerve Injury Prevention During Surgical Procedures
Award last edited on: 3/14/2023

Sponsored Program
STTR
Awarding Agency
NIH : NIBIB
Total Award Amount
$328,433
Award Phase
1
Solicitation Topic Code
286
Principal Investigator
Justin Baba

Company Information

Yaya Scientific LLC

2525 West End Avenue Suite 950
Nashville, TN 37203
   (865) 776-6336
   N/A
   N/A

Research Institution

Vanderbilt University

Phase I

Contract Number: 1R41EB032747-01A1
Start Date: 7/1/2022    Completed: 6/30/2023
Phase I year
2022
Phase I Amount
$328,433
We propose to develop a novel contact, label-free multimodality-based sensing probe that provides real-timeintraoperative identification of nerves within the thermal damage threshold range of a surgical tool. The tool willfacilitate prevention of direct/indirect 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 painmanagement is a major complicit factor in the ongoing opioid-related drug overdose epidemic. Annually, over 45million surgical procedures are performed in the United States and an estimated 10% to 50% of them result inchronic postoperative pain patient outcomes. Though not every one of the at least 4.5 million chronic pain casesare definitively ascribable to iatrogenic nerve injury, it nonetheless represents a significant recurrent annualhealthcare problem. Relatedly, analysis of large-scale nerve lesion treatment studies ascribes 25%, 60% and94% respectively of sciatic, femoral and accessory nerve lesions addressed to iatrogenic nerve injury.Additionally, iatrogenic nerve injury features prominently in post-surgical quality of life issues that range fromloss of sensation and motor function, to the aforementioned chronic pain, and morbidity. Reportedly, 2-3 yearspost 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 significantlyreduces their quality of life, and injury to the intercostobrachial nerve is the primary cause. Even in surgeries withminimal neural damage risk like acoustic neuroma removal (<1%), spinal scoliosis surgery (<0.6%), andthyroidectomy (<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 healthcareindustry as nerve damage is a common source of litigation with compensation being awarded in 82% of casesof spinal accessory nerve injury, for an example. The exposure of healthcare personnel and providers tomedicolegal liability is extensive as Iatrogenic nerve injuries are commonly reported on the laryngeal nerveduring thyroid operations, trigeminal nerve and inferior alveolar nerve during facial and oral surgeries, intercostalnerves during thoracic surgeries, and on the spinal accessory nerves, common peroneal nerve, superficial radialnerve, and genitofemoral nerve branches during various other surgeries. Consequently, as of 2015, medicolegallitigation risk was a primary driver for a $2.2 billion global market for intraoperative nerve monitoring projected togrow annually at 4.79% until 2025. Our proposed solution targets filling both the deficiencies of currently availableoptions and the growing demand by introducing an effective, commercially viable product. Our proof-of-conceptstudy targets highly consequential surgical cancer treatment thyroidectomy procedures.

Public Health Relevance Statement:
PROJECT NARRATIVE Proliferation in the use of minimal-blood-loss thermal-based surgical incision devices, such as surgical lasers electro-surgery tools or ultrasonic scalpels, have made the related collateral thermal damage to adjacent and surrounding tissues and structures a significant problem. In particular, the unintended damage to unidentified proximally embedded nerves during surgical procedures are a significant and costly public healthcare delivery problem in urgent need of a solution as the current methods are inadequate in preventing surgical-tool-use related collateral damage. The consequences of increased healthcare costs linked to medical-liability issues and the significant erosion in quality-of-life issues that include the escalation in chronic pain management opioid-use- related drug overdose epidemic, make addressing this highly impactful to society.

Project Terms:

Phase II

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