SBIR-STTR Award

In-flight certified device for pain relief : AEROrelief
Award last edited on: 11/14/2023

Sponsored Program
SBIR
Awarding Agency
DOD : DHA
Total Award Amount
$1,099,979
Award Phase
2
Solicitation Topic Code
DHA224-D002
Principal Investigator
Abhishek Datta

Company Information

Soterix Medical Inc (AKA: SMI)

Aspen Corporate Park 1480 US Highway 9 North 204
Woodbridge, NJ 07095
   (888) 990-8327
   contact@soterixmedical.com
   www.soterixmedical.com
Location: Single
Congr. District: 06
County: Middlesx

Phase I

Contract Number: N/A
Start Date: 9/16/2022    Completed: 1/15/2025
Phase I year
2022
Phase I Amount
$1
Direct to Phase II

Phase II

Contract Number: W81XWH-22-C-0111
Start Date: 9/16/2022    Completed: 1/15/2025
Phase II year
2022
Phase II Amount
$1,099,978
Problem: Neck/back pain causes extensive losses in time and resources for the US and international allies. Back and neck pain compromise performance of aircrew and resource management in the cabin resulting in exhaustion or pain-related human error mishaps. Medical grounding has severe impact on crew operation and results in expensive medical procedures and loss of the aircrewman to disability-related early retirement. This issue affects aircrew personnel serving in the Navy, Army, Air Force, Marine Corps, and Coast Guard. Likewise, officers and sailors involved in surface and submarine warfare and manning watch-stations and consoles experience neck/back pain. This burden necessitates novel approaches through the form of a device that can treat neck/back pain during military operations, especially in-flight. Currently, treatments for neck/back pain within the DoD include rest, pharmacological treatment, seat cushions/material solutions, muscle exercises, physical therapy (PT) and surgery. Resting is often impossible while on-duty; pharmacological treatment and cushion solutions are only partially effective; muscle exercises are not possible in the confined space of an aircraft cabin while wearing flight gear and restricted in a seat; and PT and surgery are both time consuming and fiscally expensive. Additionally, PT for neck/back pain drains valuable personnel time and resources from other, more severe injuries. Furthermore, these treatment/mitigation modalities are unavailable when resources are used up by injuries, combat or trauma. This results in potentially preventable injuries going untreated, becoming more severe and/or permanent. Objective: We intend to develop a TENS+Heat device for use by aircrew and other military personnel.The design will be iterated by performing a range of human factors experiments - in a simulator, grounded plane and under long-haul condition. It will be ruggedized, made waterproof and optimally designed for use in a cockpit or marine environment, by requiring very minimal user interaction and no upper body movement. Additionally, it will be FDA cleared for OTC marketing and certified to relevant military standards. Effort: We currently provide an OTC TENS device. We will upgrade the device into a ruggedized form, certified to military standards. We will add a heating component, make it waterproof and operated by a non-lithium battery and simplify its functionality to require very minimal user interaction. We will perform feasibility testing in a simulated environment followed by additional testing in a grounded aircraft.

Anticipated Results:
We expect our efforts to result in a validated device optimal for use by USN and non-military personnel (heavy machinery operators, commercial pilots, etc.)-i.e. a TENS+heat device for back/neck pain. Future work (Phase III) will involve testing in an operationally relevant environment (i.e during actual flying) in preparation for adoption by the US DoD and allied forces.