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Tool_power

05/14/19 10:10 AM

#5669 RE: tchalla #5668

Hi Gonzilee,

As I’m somewhat new here, what is the next big news that’s expected?
Seems to me that they have their commercial manufacturing ready to go and FDA Approvals on the product.

Are they working on creating Sales and Markets channels now? Perhaps looking to partner (or be merged) with a larger company that already has these Sales/Marketing channels in place?

TIA.
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Werbe

05/14/19 11:38 AM

#5684 RE: tchalla #5668

The device is not fda approved. FDA approval would be given to the manufacturing facility.

How it is portrayed in filings, the call house system is fda cleared to be used with fda approved devices.

BioDatix HealthBand

Our BioDatix Health Band requires our Remote Patient Monitoring (RPM) solution that speaks to our FDA cleared Electronic House Call system. The BioDatix Health Band passively collects heart rate, blood pressure, blood oxygen every 15 minutes. It calculates sleep and steps and sends to our BioDatix iOS/Android app and then to our RPM solution.



BioDatix Remote Patient Monitoring

In addition to our BioDatix HealthBand, our RPM solution accepts data from multiple FDA approved devices on a patient’s health status, ie. blood pressure, weight, glucose levels, etc. It’s a product that is primarily for home bound patients that need remote monitoring vs. placement in a rehab center after hospital discharge. The information in our RPM solution can then be accessed by the physician/staff to determine the health status of the patient and whether or not a critical situation is at hand for the patient to go to the hospital, come in for a visit, or receive a nursing staff visit.