Three’s better than one, according to Ecom Medical Inc.
The San Juan Capistrano-based cardiac output monitoring device maker, which already has two Food and Drug Administration-cleared devices and is seeking approval for a third, isn’t planning to introduce its products on an individual basis.
Instead, Chief Executive Guy Lowery told the Business Journal it will fully launch next year with its portfolio of three devices.
“Most medical device companies make one device, then introduce the concept. We want to do it differently to eliminate barrier to adoption,” he said.
The rollout will come with a cost. The company’s seeking between $10 million to $12 million in a Series C fundraising round, according to Lowery.
Proceeds will support development and regulatory clearance of its third device, as well as U.S. commercialization.
It tapped New York-based boutique financial and advisory firm Andrew Garrett Inc. to help with the latest round of fundraising.
The 4-year-old company has raised $6 million to date from its Series B round that closed earlier this year. It employs about 10 and hasn’t announced any plans to ramp up staffing for the product launch.
‘Smart Devices’
Ecom, which stands for Endotracheal Cardiac Output Monitoring, develops minimally invasive devices inserted into the trachea that measure blood flow. The monitoring tubes are attached to a cardiac output monitor that displays the captured information. The monitor-and-tube systems are based upon products currently used by anesthesiologists and other practitioners in their daily management of patients.
What Ecom does differently is incorporate its proprietary technology, which prints electronic circuit on monitoring devices, to enable real-time continuous feedback.
“We turn them into what we term as smart devices … but without changing anything the clinician does,” Lowery said, noting that doctors don’t need to insert any new device or go through training.
“Our idea is to give them the ability to monitor patients without taking any extra time changing what they do or making things more complicated,” he said.
Cardiac output monitoring is particularly important in high-risk, critically ill surgical patients.
There are many ways to monitor the amount of blood the heart is pumping.
Currently the gold standard for monitoring cardiac output is thermodilution via a pulmonary artery catheter, according to Chief Financial Officer Daniel Wu. He pointed out that method is invasive.
Other methods, such as external pads and finger cuff monitors, are often less accurate and often not providing continuous monitoring.
Ecom’s devices sidestep those limitations by monitoring the patients “from what is called the body core,” Lowery said.
Endotracheal tubes go into the trachea, which is next to the ascending aorta, a portion of the largest artery in the body.
Based on the principle that electrical resistance of blood changes when it moves or fluctuates in volume, the monitor delivers an electrical current that the sensing electrodes can use to measure cardiac output and other hemodynamic information.
There are a total of 19 combinations of electrodes and if a signal is weak or lost, the company’s software will search for other signals so that no adjustment is needed to be made once the tube is inserted.
The company’s two FDA-cleared devices are an endotracheal tube and an endobronchial tube cardiac output monitoring system, which received clearance in 2013 and 2017, respectively.
Pricing for the devices hasn’t been disclosed.
The company has noted that 25-30% of patient undergoing major surgery have at least one post-surgical complication, which can cost the hospital $17,000 per complication.
Ecom believes its products can reduce these complications by an average of 50%.
Oldest Kid at School
Wu told the Business Journal the company’s “like a startup, but [one that] has been around a long time.”
The company’s technology came from Imagyn Medical Technologies Inc., a one-time Irvine-based firm that developed products for the urology, minimally invasive and general surgery and gynecology markets.
Imagyn was acquired by ConMed Corp. (Nasdaq: CNMD) in 2003.
Lowery said ConMed invested significantly in the technology that now makes up Ecom, but ConMed was unable to take the product to market. ConMed and Lowery founded Ecom in 2014; ConMed received an equity position in Ecom in exchange for parting with the technology.
While Ecom never formally raised a Series A, Lowery said the company “was fortunate to be in a situation to have private investors, and just be patient, keep a low profile and complete the development work.”
Lowery was previously a managing director of ConMed and prior to that senior vice president at Imagyn. Wu, who branded himself as “business advisor and entrepreneur,” according to his LinkedIn profile, is a principal of Corona del Mar-based Karpas Advisors, which provides business advisory, corporate accounting and finance consulting services to small and midsized companies.
