The device aims to add an extra layer of safety during sedation – Inside INdiana Business
Just weeks ago, a Texas jury awarded a family more than $21 million after routine surgery on their 27-year-old son left him in a vegetative state. The jury agreed that the tragic outcome was the result of starving his brain of oxygen when his airways were not adequately monitored during surgery. South Bend-based Aeris Surgical, Inc. is working to commercialize a simple add-on device that it says could be a critical safety net to prevent such “worst-case scenarios,” which the startup says occasionally they result because anesthesiologists are “flying blind.” ”
Aeris Surgical co-founder and CEO Hunter MacMillan says that general anesthesia, compared to IV sedation, is easier; the patient is intubated with an endotracheal tube that is extended into the trachea. Because it is a closed system, anesthesiologists can very accurately monitor the exchange of oxygen and carbon dioxide (called Co2). This method is generally used for surgeries that require an overnight stay in the hospital for further post-operative care.
“Real-time Co2 data is an essential vital sign in the OR; it allows you to respond to patient complications much faster,” says MacMillan, who earned his MBA from Notre Dame. “In [intubated surgical patients], you get a wonderful Co2 waveform; that’s what anesthesiologists are trained to understand.”
However, in ambulatory surgery centers, which are becoming more common, doctors use IV sedation; MacMillan says this is one of the fastest growing segments in anesthesia. The patient is sedated, but is breathing on his own. Doctors use an oropharyngeal airway (OPA) to prevent the tongue from blocking the airway while the patient’s muscles relax; the rigid plastic tube ends at the base of the tongue.
Unlike general anesthesia, IV sedation is an open system, making it more difficult to monitor a patient’s CO2 data in real time. To overcome this hurdle, the startup says anesthesiologists “equip” a nasal cannula, a lightweight tube that collects samples of the patient’s CO2 data through the nostrils. Standard practice is the “tube and tape” method: the tube is cut with scissors and taped to the OPA in the patient’s mouth.
“They are placing these tubes randomly; as a result, they get a very poor Co2 waveform, if any waveform at all,” says MacMillan. “Some anesthesiologists have [told me]’Where we’re supposed to be writing a [Co2 result]we’re just putting a plus or a minus, we’re just saying that the patient is breathing or not breathing’”.
Aeris Surgical has created a simple add-on device called the Adjunct Airway Monitoring Device (AAMD). Slightly larger than a postage stamp, the universal device pressure fits all OPAs (and nasopharyngeal airways worn in the nose) and securely connects oxygen and co2 lines, eliminating tape.
“The way we designed the device, you’ll get a high-fidelity Co2 waveform,” says MacMillan. “Basically, you go from flying blind to getting high-quality, real-time information about the patient’s breathing. It’s great for the patient, it’s another line of defense. It’s great for clinicians, in the sense that they get real-time data that they can respond to and avoid potential side effects.”
Aeris says the method offers CO2 capture similar to that of a closed system, providing the same high-quality reading used in general anesthesia in hospitals for IV sedation used in outpatient clinics.
Using the standard “tube and tape” method, MacMillan says oxygen and CO2 tubing often slips, especially if the patient needs to be moved. He believes that a second benefit of oxygen and CO2 lines connecting to the device is that the tubes will stay securely in place.
“These things don’t happen all the time; these are worst-case scenarios – the kind of things no one wants to think about when undergoing routine surgery,” says MacMillan. “All the more reason why, for a very low price, this device should be in every [IV sedation] Surgery as the last line of defense.
The device was conceptualized by the Aeris co-founders, who practice in Arizona; Cody Birch is a nurse anesthetist and Dr. Thomas Kotoske is a plastic surgeon who grew up in South Bend. Familiar with Notre Dame, Kotoske pitched his idea to the IDEA Center, which he invested in innovation through his Pit Road Fund. Aeris plans to close its $500,000 pre-seed round soon, which also includes Indianapolis-based Elevate Ventures.
Aeris will submit the device for FDA approval in the summer and plans to be on the market in 2024.
“The thing that excites us all…is really influencing the standard of care,” says MacMillan. “If there is something on the market that can be more reliable and make these routine procedures even safer, we think it’s a no-brainer.”
MacMillan says the startup is working with Parkview Health in Fort Wayne to conduct a qualitative clinical study of the device using high-fidelity mannequins.