MONTREAL, June 13, 2022 /PRNewswire/ - MY01 Inc. today announced that initial data from an ongoing, prospective multi-center study was presented at the Canadian Orthopaedic Association's Annual Meeting. The data represents the first 30 of 100 patients to be enrolled in MY01's inaugural post-market study, which is intended to assess functionality of the use of the MY01 continuous pressure monitor.
The presentation, entitled "Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients with an Upper or Lower Extremity Fracture at Risk for Acute Compartment Syndrome" reported that 88% of surgeons rated the device very good or excellent with regards to their confidence in the function of the device and its ability to monitor pressure continuously. 90% of users rated the device as very easy to deploy.
Ross Leighton, MD, who presented the results, commented, "As surgeons, we are seeking objective data to support our clinical judgement. MY01 is safe, easy to use, and a very useful tool as an adjunct to clinical examination. It may lessen overall risk and improve outcomes by balancing the significant clinical and medicolegal consequences of a missed compartment syndrome and the possible risk of overtreatment."
"The data presented is encouraging, and align with the overall positive feedback from surgeons who are already using the MY01 device across North America and Europe." said Charles Allan, CEO of MY01, Inc. "We are committed to providing a strong base of clinical research supporting the effective use of our product and its positive impact on patient outcomes."
The data presented included the first 30 patients from a prospective study with six sites and plans to enroll 100 patients.
About MY01, Inc. MY01, Inc. is on a mission to empower healthcare professionals with the objective data to aid in the diagnosis of compartment syndrome, thereby improving patient outcomes. MY01 believes that adding actionable, quantitative data at the bedside can augment clinical assessments to provide more effective care. Headquartered in Montreal, Quebec since 2019, MY01, Inc. leverages its expertise in microsensing technology to provide innovative diagnostic solutions.