Summary: MY01 is a digital medical device that aids in the diagnosis of Acute Compartment Syndrome (ACS). ACS occurs when muscle swelling exceeds blood pressure in surrounding tissue and cuts off blood supply to affected muscles, usually following high-energy trauma incidents. ACS is rare but difficult to identify, and if affected muscles lack blood supply for too long, then patients risk suffering permanent muscle damage or even limb amputation. Currently ACS is diagnosed based on subjective and unreliable outcomes like pain, and existing compartmental pressure sensors are inaccurate and inefficient to use. MY01 solves an unmet clinical need because doctors lack a simple, reliable way to screen trauma patients for ACS. Its elegant, proprietary insertion mechanism allows easy, accurate placement of a small pressure sensor into muscle compartments. The sensor physically connects to an LCD screen, which continuously outputs highly accurate pressure values while resting on the
patient’s skin. MY01 is accompanied by a mobile app that wirelessly connects to the medical device via Bluetooth and transfers pressure data to hospital cloud systems, allowing remote data display. Thus, by providing timely monitoring of muscle pressure,
MY01 helps doctors to reliably diagnose ACS and take action before it is too late. MY01 is a simple solution to a dangerous problem.
Need: MY01 solves an unmet clinical need because doctors lack a simple, reliable way to screen trauma patients for ACS. Currently ACS is diagnosed based on subjective and unreliable outcomes like pain, and existing compartmental pressure sensors are inaccurate and inefficient to use. Thus, far too often, trauma patients tragically sustain long-term disabilities and limb amputations because of missed diagnoses. Even more often, doctors mitigate their uncertainty by performing unnecessary prophylactic fasciotomies, thus wasting valuable OR time and hospital resources, besides causing patients unneeded pain and discomfort (and risk of complications from surgery).
Value: MY01 offers unrivaled accuracy and usability. By utilizing MEMS-based pressure-sensing technology, MY01 improves accuracy and resolution by at least an order of magnitude when compared to existing compartment pressure sensing devices.
In terms of usability, the elegant, patent pending insertion mechanism allows easy, accurate placement of a small pressure sensor into muscle compartments. The single-use, self-contained device saves precious time usually spent searching for competitor device kits when they are needed most, and there are no complicated wires or accessories to manage. Embedded software and Bluetooth connectivity allows remote patient data display through a companion mobile app. MY01 brings ACS diagnosis into the digital age.