ECOM Medical Inc. in San Juan Capistrano plans to raise $5 million series B preferred to grow sales of its Endotracheal Cardiac Output Monitor, or ECOM, a system that provides real-time blood-flow information used in post-surgery critical care monitoring. It includes a monitor and a tube that’s inserted through the trachea.
“The gold standard for monitoring cardiac output is thermal dilution using a pulmonary artery catheter,” said Wu, explaining that the method threads a catheter through the heart into the pulmonary artery to measure indicators such as pulmonary artery pressure and cardiac output. “Our technology is less invasive.”
The device received Food and Drug Administration clearance in 2013.
ECOM uses an endotracheal tube with multiple electrodes to measure cardiac output, or the amount of blood pumped by the heart per minute, plus other parameters, such as cardiac index and the volume of blood pumped per beat.
The company has raised over $3.8 million and will close the round this month, according to Chief Financial Officer Daniel Wu. Proceeds will be put toward building out sales and marketing, including hires, and developing new monitors and other disposable products.
Its most current FDA-cleared device is the ECOM Double Lumen Endobronchial Tube, which is the first minimally invasive blood-flow monitoring device designed specifically for thoracic cases, such as lung transplants, lobectomies and thoracic aortic aneurysms, according to Wu.
He said the company hopes to get FDA clearance to launch two new products next year.
The company currently has nine employees.
Oxygenation
Surgery outcome measurements, including mortality, complication rates, length of hospital stay and readmission rates, directly affect payment, leading to changes in patient management. An approach known as goal-directed therapy says patients undergoing major surgeries experience better outcomes if their fluid is monitored and acted on in real time to make sure oxygen delivery meets oxygen need, according to the company’s website.
The measurement has traditionally been done through a thermal dilution catheter, though risks are associated with the method, inducing hypervolemia, a condition in which the liquid portion of the blood is too high. Other devices that rely on arterial pulse analysis have less sensitivity and accuracy.
Those limitations make monitoring bloodflow something “nice to have, as opposed to must-have, for most surgeries,” said Wu, who added that ECOM surgeons have the tools to monitor crucial information, such as ensuring adequate oxygen circulation. He said the device is also easy to place and use, and provides continuous real-time data.
ECOM has entered into agreements with three additional distributors. Combined with an existing relationship with distribution partner Armamentarium Inc. in Texas, it will have sales coverage in 40 states. Its product is available nationwide.
Spinout
ECOM started operations in January 2014 after being spun out of ConMed Corp. in Utica, N.Y., into a new company. ConMed, which was in a tough proxy battle with investors, was “unable to absorb the negative impact to quarterly earnings per share pressure if they had committed the amount of money necessary to commercially launch the ECOM product,” Wu said.
Guy Lowery, who was a managing director at ConMed and developed the ECOM technology, took the helm as ECOM president and chief executive.
ConMed has a minority ownership in ECOM that at the time of the spinoff was 19.9%, according to Wu. Lowery paid $30,000 for the majority share of the company, or 80.1%. Ownership for both parties has been diluted since the spinoff due to additional financing.
Wu said ECOM grew faster than a ground-up startup because ConMed contributed all assets, including inventory, intellectual property and customer lists, at the time of the spinout. The company also benefitted from owning an FDA-cleared asset that it could sell commercially at its inception.
Wu declined to provide sales but said the company hasn’t reached positive cash flow.
