Innovative, Patented, Advanced Sensor Technology for Healthcare

The Temperature and Pressure (TAP) Sensing Insole for Diagnosing Diabetic Foot Ulcerations (DFUs)

Finalize Development

The Insole API is completed and the software for the client dashboard is ready to be completed per the client needs.

Complete Useability

The CAD drawing and material requirements are complete. Final testing of the first 100 users is needed to verify all of the design and sustainability of the electronics in the insole. Two universities are planning to complete the testing.

Begin to Manufacture

The electronics will be imbedded into the insole by our US manufacturer of insoles. The electronics will be finished at our facility in Greenville SC. Testing and shipping will be handled by our company.

PRODUCT OVERVIEW

The TAP (Temperature and Pressure) Diabetic Insole incorporates flexible sensors in the insoles of Diabetic patient’s shoes who are experiencing peripheral neuropathy.

Real-Time alerts are sent to the patient, caregiver and physician, providing an earlier warning and possibly preventing an infection, amputation and extended hospital stays.

SIMPLE SUMMARY

By incorporating temperature and pressure sensors into the insoles of Diabetic patient’s shoes who are experiencing peripheral neuropathy, TAP Insole’s proposed technology can detect pre-ulcer conditions five weeks prior to ulcer formation. As you can see from the temperature and pressure schematics below, there is a predictable area of focus for ulceration.

The insole would also provide cushioning to reduce the pressure, adding support for the feet, and preventing further damage to patient’s health, as well as prevent extreme measures such as amputation of limbs. This gives the patient an earlier warning, and can prevent infections, amputations, and extended hospital stays. Further this is patient empowering.

PROBLEM

Internationally, over 250,000,000 adults currently have Diabetic Peripheral Neuropathy.

Diabetic foot complications affect 40,000,000 – 60,000,000 people annually.

Every 30 seconds a lower limb or part of a lower limb is amputated somewhere in the world resulting from diabetes.

In a recent study, it was found that only 6% of Diabetic patients practice proper foot care.

CHALLENGES

Eye problems, arthritis,  obesity, and age limit the patient’s ability to do visual inspection and further limits the ability to improve visual inspection rates.

Given both the complications of detecting and addressing foot ulcers, alternative approaches are needed to help Diabetes patients address this potentially life threatening and life altering condition.

UNIQUE INNOVATION

The TAP Sensing Insole measure both Temperature and Pressure, in order to diagnose an early DFU, as well as assist in offloading compliance. TAP Insole is fully enclosed in the insole of the shoe, Using WiFi, BLE4 and cellular for communication.

At the First sign of problem, an alert is sent to the Patient, Caregiver and Physician.

Research has shown that daily monitoring of the feet can reduce DFUs by up to 85%

Business Plan - Investors Summary
TAP Sensing Diabetic Insole

1. Overview

XtremedX is a medical device and technology company, focusing on creating diverse products in the the medical industry, that help to solve patient’s problems, and reduce overall health care cost.  The TAP (Temperature and Pressure) Sensing Insole will do both 

2. Problem/Opportunity

Internationally, 250,000,000 adults have Diabetic Peripheral Neuropathy. Every 0.1 seconds, someone is diagnosed with a Diabetic Foot Ulceration (DFU). Every year, DFUs affect over 7,000,000 adults in U.S., and cost the healthcare system over $16 B per year. The TAP Insole sends alerts to the patient, caregiver, and physician if a problem presents.

3. Unfair Advantages

  •  Patented technology
  • First product of its kind to market
  • Highly experlenced team
  • Expert knowledge of the medical market
  • Significant connections within the diabetic and podiatry communities

4. Demo

5. Sales & Marketing

Our first strategy will be direct to consumers,
focusing on national pharmacies, e-commerce, and big box department stores. We, also, plan on partnering with a major pharmaceutical/medical company to promote into their existing physician
customer base. Last, we will focus on the VA hospital and the international markets.

6. Market Potential

  • Retail: >$25,000,000
  • E-commerce: >$500,000
  • Physician: >$350,000,000
  • VA: >$50,000,000
  • International: >$500,000,000

7. Business Model

  1. Design, manufacture, and sell TAP Insoles into retail, Physician, and International locations.
  2. Continue the development of our other medical device products for future commercialization.

8. Forecast

Revenue (000)     Gross Profit      Mkt Share
2023       $4,500           50%                  <3%
2024       $15,000           55%                 <5%
2025       $30,000          60%                 <10%

9. Team

Dr. Andrew Clark, PhD – (CTO) PhD in Bio
Engineering from Clemson University with 5 US issued patents. Design more than 20 Products for Customers.

10. Status & Milestones

Founded, in 2019, XtremedX LLC is medical device and technology company, focusing on creating diverse products in the medical Industry. We leverage co owned IP, and have research relationships with Clemson University, The University of SC, and Duke University.
 
In 2021, XtremedX was named as a Top Blomechanics Solution Provider by MedTech Outlook.
 
In 2022, XtremedX’s TAP Insole won First Place at the international WearRAcon 22 convention In Scottsdale, AZ. for Best New Wearable Device- 2022.
 
XtremedX has a robust pipeline of new, medical, prototype products that we will soon begin further developing.

Temperature and Pressure will be compared at each location.

A 4-degree difference triggers an alert.

#1 on right foot compared to #1 on left foot. #2 compared to #2, etc.…

The GEN 1 will only incorporate temperature sensors as an alert.

Unlimited Possibilities

- National Pharmacy Chains
- Home Health
- E-Commerce
- International Markets

POTENTIAL MARKETS

The GEN 2 will incorporate temperature and pressure sensors as an alert.

Advanced Markets

- Custom Orthotic Manufactures
- VA Hospitals

THE PROCESS

First Place Winner!!!

XtremedX is honored to have just been named as the Top New Innovator for 2022 in the Wearable Robotic market. The Temperature and Pressure (TAP) Sensing Insole for early diagnosing Diabetic Foot Ulcerations won first place in this International Innovation Challenge atWearRAcon 22 (Wearable Robotics Association) competition in Scottsdale, AZ.