DuoTherm

A wearable thermal vibrating device.

Multi-modal compression comfort with eight noninvasive neuromodulation therapy cycles, acupressure, and soothing heat or anti-inflammatory cold.

Regulatory Path to Market

NCT04494841 - FDA NIH Pilot N=20 Milestone >50% reduction in pain intensity

FDA NIH Pivotal Trial with Active control LG 8-Channel TENS in moderate to severe LBP: NCT04491175 - Reduce Opioid prescribing 30% and Use past 7 days in the opioid naive.

NCT04494698 - Significantly reduce acute pain intensity and restore function for chronic pain using PROMIS Pain Interference.

DuoTherm Product Timeline

2018

NIH Funded NIDA HEAL Help End Addiction Long Term

2019

FDA Issues NSR for Pivotal Trial

2020

R&D Harmonic Device

2022

Pivotal Trial Results Completed, Phase 2 Milestone Go

2023

DuoThem Received SGS Certification as Type BF Medical Device

2024

  • FDA NIH Pivotal Trial N=159: Data Collection Complete (July 6, 2024)

2025

Preparing to submit the FDA De Novo

  • FDA NIH Pivotal Trial N=159: Opioid Milestone Paper Submitted (January 2025)
  • FDA NIH Pivotal Trial N=159: Acute and Chronic Pain Submission (February 2025)
  • De Novo FDA Submission (Q1)

Features

Testimonials

It has been the capstone to my 30 year healing journey while struggling with chronic back pain. Once I started using my DuoTherm, I quickly noticed my morning pain and stiffness reduced. After any hard physical exercise, I am able to snap myself out of the “pain cycle” that I would typically fall into once I stopped moving.
— Roger
I used Duotherm for pain management after my abdominal surgery. It was exactly what I needed to get me through the time in between ibuprofen doses and helped me fall asleep on rougher days. I was able to limit my at-home opioid usage to only three doses and relied on over-the-counter options for the rest of my multi-month recovery.
— Sarah