SBIR-STTR Award

Ambulatory cryocooling therapy device
Award last edited on: 2/4/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIAMS
Total Award Amount
$961,320
Award Phase
2
Solicitation Topic Code
846
Principal Investigator
Steve M Savoy

Company Information

Nanohmics Inc (AKA: Nanohmics LLC)

6201 East Oltorf Street Suite 400
Austin, TX 78741
   (512) 389-9990
   info@nanohmics.com
   www.nanohmics.com
Location: Single
Congr. District: 35
County: Travis

Phase I

Contract Number: 1R44AR081321-01A1
Start Date: 9/23/2022    Completed: 7/31/2023
Phase I year
2022
Phase I Amount
$258,500
Tissue protection following injury begins with shutting down vasodilation and limitingsubsequent swelling through the application of cold. In many cases, the cold comes in the formof bags of ice or frozen cold packs, or commercial cooling products such ice packs or ice packholding limb wraps. In others it may be via a chilled water circulator device, for example thePolar Care Kodiak Cold Therapy where ice water is sent from the "holding box" through ¾"tubing into a cooling pad applied to the skin. The drawback with ice and frozen packs is the riskof skin burn and soft tissue damage stemming from skin contact with such a low temperature.With as little as 20-30 minutes of an icepack lying against the skin, damage may occur.However, studies have shown that 20 minutes of cooling one time is not enough to change thecourse of treatment and decrease the swelling. Longer term cooling is needed to make adifference. However, the patient's functional mobility and compliance is limited due the bulk ofthe apparatus, and this discourages longer term use and increases risks associated with deepvein thrombosis which combine decrease patient outcome. Ideally, the device could be worn"hands-free" for extended periods providing a long-term (full day) programmable therapeuticregimen which includes periods of anti-inflammation (T ~ 10 °C) followed by brief periods ofelevated temperature (T ~ 20 °C) to prevent skin damage.An alternative electrical-to-thermal cooling device that could be applied directly to the injurysite would increase patient adoption and improve patient therapy benefit. Nanohmics' directelectric-to-thermal approach to address this shortcoming will provide programmabletemperature control over the entire contact region in a low-profile, low-power consumptiondevice that will enable the patient full ambulatory freedom during the therapeutic regimen afterinjury (e.g. ankle/wrist sprain) or surgery (e.g. knee arthroscopy). No ice means there are noissues with melting and replacement, and the temperature can be programmed for cold (anti-inflammatory) and heat (cellular debris clearing, thrombosis) which may lead to benefits indecreased pain medicine consumption, post-injury range of motion, and decreased pain scoreand risks associated with deep vein thrombosis.

Public Health Relevance Statement:
PI: Savoy Project Narrative Development of a conformable thermoelectric cooling/heating device would solve issues of traditional thermal and cold therapy by eliminating the need for dedicated refrigeration systems, coolers or chilled liquid circulators, gels, or ice. The inability to produce large-area flexible thermoelectric devices is a significant shortcoming that has kept these highly effective devices from being adapted into the form factor required for a low-profile solid-state cryotherapy device. Modern water/ice cooling methods can sometimes damage tissue by over-cooling and if continuously fed, require pumps, tanks and tubes that can be prone to leaks. The benefits in patient mobility, lower risk of deep vein thrombosis, and hands-free utility of a therapeutic regimen by conforming to a specific region of the body (i.e. "wearable") and uniformly extract heat energy with power requirements commensurate with wearable batteries are numerous.

Project Terms:

Phase II

Contract Number: 4R44AR081321-02
Start Date: 9/23/2022    Completed: 7/31/2025
Phase II year
2023
Phase II Amount
$702,820
Tissue protection following injury begins with shutting down vasodilation and limitingsubsequent swelling through the application of cold. In many cases, the cold comes in the formof bags of ice or frozen cold packs, or commercial cooling products such ice packs or ice packholding limb wraps. In others it may be via a chilled water circulator device, for example thePolar Care Kodiak Cold Therapy where ice water is sent from the "holding box" through ¾"tubing into a cooling pad applied to the skin. The drawback with ice and frozen packs is the riskof skin burn and soft tissue damage stemming from skin contact with such a low temperature.With as little as 20-30 minutes of an icepack lying against the skin, damage may occur.However, studies have shown that 20 minutes of cooling one time is not enough to change thecourse of treatment and decrease the swelling. Longer term cooling is needed to make adifference. However, the patient's functional mobility and compliance is limited due the bulk ofthe apparatus, and this discourages longer term use and increases risks associated with deepvein thrombosis which combine decrease patient outcome. Ideally, the device could be worn"hands-free" for extended periods providing a long-term (full day) programmable therapeuticregimen which includes periods of anti-inflammation (T ~ 10 °C) followed by brief periods ofelevated temperature (T ~ 20 °C) to prevent skin damage.An alternative electrical-to-thermal cooling device that could be applied directly to the injurysite would increase patient adoption and improve patient therapy benefit. Nanohmics' directelectric-to-thermal approach to address this shortcoming will provide programmabletemperature control over the entire contact region in a low-profile, low-power consumptiondevice that will enable the patient full ambulatory freedom during the therapeutic regimen afterinjury (e.g. ankle/wrist sprain) or surgery (e.g. knee arthroscopy). No ice means there are noissues with melting and replacement, and the temperature can be programmed for cold (anti-inflammatory) and heat (cellular debris clearing, thrombosis) which may lead to benefits indecreased pain medicine consumption, post-injury range of motion, and decreased pain scoreand risks associated with deep vein thrombosis.

Public Health Relevance Statement:
PI: Savoy Project Narrative Development of a conformable thermoelectric cooling/heating device would solve issues of traditional thermal and cold therapy by eliminating the need for dedicated refrigeration systems, coolers or chilled liquid circulators, gels, or ice. The inability to produce large-area flexible thermoelectric devices is a significant shortcoming that has kept these highly effective devices from being adapted into the form factor required for a low-profile solid-state cryotherapy device. Modern water/ice cooling methods can sometimes damage tissue by over-cooling and if continuously fed, require pumps, tanks and tubes that can be prone to leaks. The benefits in patient mobility, lower risk of deep vein thrombosis, and hands-free utility of a therapeutic regimen by conforming to a specific region of the body (i.e. "wearable") and uniformly extract heat energy with power requirements commensurate with wearable batteries are numerous.

Project Terms: