MONTREAL — A Montreal company backed by a Quebec medtech investment consortium has received approval from the Food and Drug Administration to bring its flagship product, a device that can diagnose a potentially fatal orthopedic condition, to the U.S. market. 

Founded in 2015, My01 makes a device that can detect acute compartment syndrome (ACS), a condition where swelling causes the fascia—the membrane covering a group of muscles and nerves—to constrict the muscle, restricting blood flow. Often resulting from bone fractures, ACS can lead to muscle necrosis and even death if left untreated. Golfer Tiger Woods notably suffered from ACS as a result of his February car crash. 

ACS is labour-intensive to monitor and often results in missed diagnosis and unnecessary surgery. My01’s single-use device is inserted into the affected muscle by way of a needle. Once in place, the device’s sensor provides real-time data about muscle swelling, thereby “objectifying” the diagnosis, said My01 CEO Charles Allan. The device, which can remain in place for up to 18 hours, delivers results through My01’s app.

Medteq Invest, the investment arm of the Quebec medical-technology consortium Medteq, invested an undisclosed amount in the company in 2019. Private investment from “high-net-worth individuals” constitutes the bulk of My01’s funding, according to Allan. The company expects to be cash-flow neutral this year, said My01 chief medical officer Dr. Edward Harvey. Quebec’s life-sciences and medtech sector employs over 56,000 and provides $5.6 billion to the provincial GDP, according to a report from Medtech Canada.

Because it can diagnose ACS with far greater accuracy, Allan said the My01 device will reduce the number of fasciotomies, an invasive surgery that relieves pressure, and which is performed often as a precaution. 

The company has sold the device in Canada since receiving Health Canada certification in February 2020. In the U.S, the device will retail for US$3,200, and sales will begin in earnest with the FDA approval. Among its first American clients is Dr. Charles Moon, the director of orthopedic trauma at Cedars-Sinai Medical Center, who treated Woods after his transfer from Harbor-UCLA Medical Center. 

“Those are patients that you worry about,” Moon told The Logic of Woods. “If he hadn’t gotten a fasciotomy in his index procedure—which he did, yeah—Woods would be somebody that you would be monitoring and be very worried about, because it’s a high-energy, segmental tibia fracture. If anyone can get compartment syndrome, it’s somebody with that injury.”

Diagnosing and treating ACS is a fraught process requiring hours of monitoring and a reliance on a patient’s inherently subjective description of pain levels. “In the U.S. medical system, ACS is actually the No. 1 cause of lost lawsuits against orthopedic surgeons,” Moon said, adding his department would purchase “about 10” My01 devices. (Moon has no stake in the company, nor has he received any promotional considerations.)

“It’s basically a disposable, reliable catheter monitor that you can put in the affected muscle compartment? It’s no more invasive than an IV, you know. And it gives you data over time. We can’t wait to get our hands on it, to be honest,” Moon said.

Editor’s note: This story has been updated to clarify the pricing of the device.