SBIR-STTR Award

Real-time Multimodal Diffuse Reflectance and Polarization Imaging Based Nerve Identification in Surgical Field of View
Award last edited on: 1/15/2024

Sponsored Program
STTR
Awarding Agency
NIH : NIBIB
Total Award Amount
$1,332,346
Award Phase
2
Solicitation Topic Code
286
Principal Investigator
Baba Justin

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: 1R41EB029888-01A1
Start Date: 9/21/2020    Completed: 9/20/2021
Phase I year
2020
Phase I Amount
$333,355
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 (

Public Health Relevance Statement:
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.

Project Terms:
absorption; Acoustic Neuroma; Address; algorithm development; Algorithms; Automation; Award; base; Biophotonics; Breast Cancer Treatment; Cessation of life; Characteristics; Chronic; chronic pain; chronic pain management; Clinical; Clinical Research; Collection; contrast enhanced; cost; Data; Data Analyses; Data Collection; data visualization; deafness; design; Detection; Development; Device Designs; Devices; Diffuse; diffuse reflectance spectroscopy; Employment; Epidemic; Excision; Face; Financial compensation; Financial cost; Goals; Health Care Costs; health care delivery; Health Personnel; Healthcare; Healthcare Industry; Hybrids; Iatrogenesis; Image; Image-Guided Surgery; imager; Impotence; in vivo; Income; Individual; inferior alveolar nerve; Injury; injury prevention; Intellectual Property; Label; Laryngeal Nerves; Legal patent; Lesion; Litigation; machine learning algorithm; Mastectomy; Mediation; Medical; Medical Care Costs; Medical Liabilities; men; Methods; Monitor; Morbidity - disease rate; Motor; multimodality; Nerve; nerve injury; Nerve Tissue; novel; Numbness; operation; Operative Surgical Procedures; Opioid; opioid use; Oral Surgical Procedures; Overdose; overdose death; pain outcome; Paraplegia; Patients; Performance; peroneal nerve; Pharmaceutical Preparations; Pharmacotherapy; Phase; Postoperative Pain; Postoperative Period; pre-clinical; Prevention; Process; prototype; Quality of life; Radical Prostatectomy; Rattus; relating to nervous system; Reporting; Rights; Risk; sciatic nerve; scoliosis; Secure; Societies; Source; spectroscopic imaging; Spinal; Structure; Structure of radial nerve; Surgeon; Survivors; System; Systems Development; Techniques; Technology; Testing; Thoracic Surgical Procedures; Thyroid Gland; Thyroidectomy; Time; Tissues; Trigeminal nerve structure; United States; Universities; Update; Ventral thoracic nerve structure

Phase II

Contract Number: 2R42EB029888-02
Start Date: 9/21/2020    Completed: 7/31/2025
Phase II year
2023
Phase II Amount
$998,991
We propose to develop a novel non-contact, label-free multimodality imager that provides real-time intraoperativeidentification 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 postsurgicalcomplications, e.g., chronic pain. In the United States chronic pain management is a major putative contributingfactor in the current opioid-related drug overdose epidemic. Annually, over 45 million surgical procedures areperformed in the United States and an estimated 10% to 50% of them result in patient chronic postoperative painoutcomes. Though not all the at least 4.5 million are definitively ascribable to iatrogenic nerve injury, itnonetheless represents a significant recurring annual healthcare problem. Relatedly, analysis of large-scalenerve lesion treatment studies reveals that 25%, 60% and 94% respectively of sciatic, femoral and accessorynerve lesions addressed are caused by 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 2022, medicolegallitigation risk was a primary driver for a $1.5 billion global market for intraoperative nerve monitoring projected togrow at 5.1% annually through 2030. Our proposed solution targets filling both the deficiencies of currentlyavailable options and the growing demand by introducing an effective, commercially viable product.

Public Health Relevance Statement:
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 realtime intraoperative identification of nerves within the surgical field-of-view to facilitate the prevention of unintended nerve damage during surgical procedures.

Project Terms: