Thank you for taking the time to read our submission and your valuable feedback. We have answered the following below:
1) This is a great point. Our objective is to test physical properties of the device with higher precision for the tensile strength and elasticity at a pre-clinical trial phase. Then we would test the product for safety, comfort, and retention on normal subjects and those with varying degrees of osteoporosis symptoms such as bone hypodensity in a safe laboratory environment. We would then evaluate the product further with a larger population comparing it to existing and comparable devices on the market for side effects and efficacy on a larger scale. Finally we will commit to a post-market surveillance program similar to a drug to collect information about long-term effects for users.
2) Our product’s properties are in the material and in the body sensor network that we are using as well as the design to maximize comfort and aesthetics. We are able to manipulate the dimensions of the product in order to fit different joints and over time we hope to customize our product further to cover more joints. Your point is very rational and we will launch our product addressing one or two joints initially.
- The moral hazard analogy you make is interesting and this is something we will have to keep in the backs of our minds. We take very seriously the idea of misleading advertising and would be prudent to make claims that have not been verified by outcome measures with independent parties (i.e. external clinics). We will also abide by the regulatory requirements including proper labeling. Educating our distributors and ultimately our patient users about what our product is, what it intends on doing, what it has shown to do, and how we recommend they use HaloJoint for the betterment of their lives is just as important as the research and development. Thanks for sharing and mentioning the bike riding scenario for the wrist application. These are exactly the scenarios that we need to consider during our trial testing of HaloJoint and we appreciate the input!