Maui Imaging Emerges from Stealth Mode with $4M Military Contract
The company is developing an imaging technology for potential use in trauma diagnosis and triage.
August 27, 2024
At busy trauma centers, it can take up to 45 minutes to get a patient from the door to the CT machine, and it’s a bit of a guessing game to figure out which patients can afford to wait that long, and which cannot. That need for better ways to triage trauma patients was the inspiration behind Maui Imaging’s ultrasound-based technology designed to image all types of tissues.
“That need is most pronounced in trauma medicine, which is a major focus of Maui’s collaborative development efforts,” said David Specht, CEO and co-founder of the company. “Going forward, Maui will be able to supply the volumetric imaging data for AI tools that predominately come from CT and MRI.”
Maui recently emerged from Stealth mode with the announcement of a $4 million contract from the U.S. Department of Defense’s Army Medical Reseach and Development Command (MDRC) to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care in high volume (mass casualty) or resource-limited environments.
The MRDC-enabled program is being implemented at the University of Maryland Shock Trauma Center in Baltimore, which is one of the major trauma centers where the military trains trauma surgeons and other related healthcare providers. Additional collaborative efforts at other trauma centers affiliated with the military are also being planned, the company noted.
The program is designed to demonstrate that Maui can improve time-to-care in trauma patients, ultimately improving outcomes as patients receive lifesaving treatments faster and more effectively, particularly in austere environments such as in the field, naval vessels, and evacuation aircraft. MAUI enables an approach to providing diagnostic imaging usually reserved for CT and MRI, which are not typically available in these settings.
The MRDC project is divided into three Phases. In Phase 0, initiated in September 2023 and completed in June 2024, the company documented the baseline imaging performance of the system for more than 60 discreet anatomic regions, including intracranial and spinal imaging, needed for whole body trauma evaluations. Phase 1 of the MRDC project will be focused on developing the procedures and techniques for using Maui to image these 60 anatomic regions in a standardized fashion. Phase 2 will be focused on comparative imaging of actual trauma pathology in the Emergency Department.
Traditional ultrasound cannot image intracranially without a significant “window” into the skull involving large fractures or surgically removed bone, Maui noted. As a result, patients require CT or MRI scans which are not always available. Maui’s technology is designed to change this and aims to decrease time to diagnosis and treatment.
“Maui could be game changing in a mass casualty setting, underdeveloped countries, and on the battlefield,” said Rosemary Kozar, MD, PhD, professor of surgery, co-director of Shock Trauma Anesthesia Research (STAR) Center, University of Maryland School of Medicine.
The Maui K3900 ultrasound imaging system received 510(k) clearance from FDA in October 2023 and is available for commercial use.
The company says its system provides views that look like a cross between ultrasound and CT without the need for ionizing radiation. Maui’s computed echo tomography pings the designated part of the human body, uniquely seeing anatomy beyond what other ultrasound systems can see, the company noted. The system then uses algorithms to accommodate the reflected energy from various flight paths and sums up the data to create a reliable image of all the structures below the probe. Barriers such as bone, gas, fat, instruments, implants, etc. are intended to become part of the image instead of obstacles to image formation.
The imaging system uses a concave probe designed to fire pulses into the tissue from many different angles, allowing it to see through and around barriers.
MD+DI sat down with Specht to learn more about Maui Imaging and the company.
From space telescopes to medical imaging
MD+DI: What was the genesis of Maui Imaging?
Specht: My dad had been working on space telescopes and was working on the generation to replace Hubble and had to solve a variety of signal problems coming back to the telescope. Then, when Lockheed didn't get the contract, he said, “Well what else could we do with this” We had relationships with some of our early engineers who had been in sonar and in radar and we realized there was a better way to do signal processing for ultrasound, which he had been in previously in his career, and why don't we take advantage of that?
The original goal was to just like a wider telescope pick up more signal and get higher resolution, originally of the heart. But in solving that problem we realized that we had to accommodate the different tissues, as you might expect. ... When we started to solve the problems with the different types of tissues, we realized we were seeing more than conventional ultrasound could see.
Clinical need becomes inspiration
MD+DI: What is the clinical need you’re trying to solve?
Specht: We were presenting recently to a room full of about 15 trauma surgeons at a fairly sizeable hospital and they were telling us that in their state every single traumatic brain injury patient goes to that hospital and when they hit the door it's 30 minutes to 45 minutes to get them to the CT, and they don't know which of the [patients] are the critically injured where they need to take action right away. They were almost kind of giggling when they were imaging inside the skull because now, they were able to see enough of the anatomy and—I'm using their words here—as soon as that patient hits the door, they could now assess who was critically injured and expedite the process.
Eventually, everyone will likely get the CT until there's a body of science around what we do but in the in the near term they were so pleased because they're guessing as to who's most critically injured.
MD+DI: That’s amazing, I can think of so many use cases for something like this. So, tell me more about the technology itself and how it works.
Specht: It’s basically a shoebox size, weighs about 22 lbs, and you can put it in the overhead compartment on an airplane and take it wherever you want to go. However, the development of it has taken years because we're doing about 20 trillion operations per second. So, we send out an unfocused pulse, it's counterintuitive in that it's unfocused, and then we accommodate all of the echoes coming back. It’s kind of like when a lens is open on a 3D camera, all the light comes back and you collect all of that data and then in the 3D camera you can slice and dice wherever you want to go, it operates more like that than conventional ultrasound, which sends phased pulses throughout the body and is looking for echoes at specific times and locations. So, we send an unfocused ping, collect all of the data coming back, and then run it through our beamformer.
When we when we present to physicians, they've let us know their limiting factor right now is the number of techs or sonographers that are in the field. As the need for ultrasound gets larger because of its portability and accessibility as long as you're doing 2D imaging you really need a sonographer to have the smarts, they're really like artists, they find where the slice is and then they can understand in 2D what they’re imaging and then they capture that for the physician. So, all of the physicians we talked to are really interested in 3D, which we believe that this box will do, we've built an initial prototype, we're building a second prototype, but as you can imagine if you don't have to worry about where obstacles are, namely the ribs and lungs etcetera, then you could just place the probe over there and collect a volumetric data set.
With all the AI tools that are coming on board the world, I think, needs a way for everyone to be able to get a volumetric image of the area of interest and then the AI tools can solve the workflow issues.
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