MAUI Imaging Emerges From Stealth With $4 Million Department of Defense Contract To Support Trauma Medicine

Novel FDA-cleared imaging technology reveals anatomy that traditional ultrasound devices cannot; initial focus on trauma as well as neurosurgery and interventional radiology

TUCSON, Ariz., Aug. 22, 2024 /PRNewswire/ -- MAUI Imaging, inventor of patented technology that sees anatomy other ultrasounds cannot, today emerged from stealth with the announcement of a $4 million U.S. Department of Defense (US Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care in high volume (mass casualty) and/or resource limited environments.

"With the U.S. military contract and our technology becoming more visible on a broader stage, we've decided it's time to come out of stealth and show what we have been working on," said MAUI Imaging CEO and co-founder David Specht. "The feedback we have received from physicians and technologists highlights the profound need for a new ultrasound-based technology that enables imaging of all types of tissues. That need is most pronounced in trauma medicine, which is a major focus of MAUI's collaborative development efforts. Going forward, MAUI will be able to supply the volumetric imaging data for AI tools that predominantly come from CT and MRI."

MAUI will present a poster describing their breakthrough imaging technology and its potential use in trauma diagnosis and triage at the Military Health System Research Symposium taking place August 26-29, 2024 in Florida. MAUI's Chief Medical Officer, John Cheronis, MD PhD will present imaging data from the initial studies funded by the MRDC. Additional imaging of trauma pathology is being developed in partnership with Dr. Rosemary Kozar, MD PhD from the University of Maryland Shock Trauma Center and Dr. Matt Bradley, CAPT USN, Uniform Services University of the Health Sciences, a part of the Walter Reed National Military Medical Center, as part of the USAMRDC project.

Department of Defense:

The USAMRDC-enabled program is sponsored by the Office of the Assistant Secretary of Defense for Health Affairs through the Combat Casualty Care Research Program under Award No. HT9425-23-3-0002. It 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 health care providers. Additional collaborative efforts at other trauma centers affiliated with the military are also being planned and will be announced when implemented.

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 available in these settings.

The USAMRDC project is divided into three Phases. In Phase 0, initiated in September 2023 and completed in June 2024, MAUI 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. No other ultrasound system is capable of imaging all of these regions. Phase 1 of the USAMRDC 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.

A committee of independent expert physicians reported that MAUI can image comparably, or better than traditional ultrasound in areas where traditional ultrasound is used. In certain cases, like cranial and spinal imaging in adults, where traditional ultrasound has not been employed, MAUI has been reported to provide clinically meaningful images needed by physicians to diagnose, triage, and treat serious injuries.

Traditional ultrasound cannot image intracranially without a significant "window" into the skull involving large fractures or surgically removed bone. As a result, patients require CT or MRI scans which are often unavailable. MAUI is designed to change this and aims to decrease time to diagnosis and treatment.

"Trauma remains a major cause of death for individuals of all ages, both in civilian and military settings," said Rosemary Kozar MD, PhD, Professor of Surgery, Co-Director of Shock Trauma Anesthesia Research (STAR) Center, University of Maryland School of Medicine. "The ability to rapidly evaluate trauma without the need for immediate access to X-ray, CT and MRI facilities would be of tremendous value to trauma victims worldwide who have sustained significant injury. MAUI could be game changing in a mass casualty setting, underdeveloped countries and on the battlefield."

"The MAUI ultrasound technology and the K3900 offer a potentially significant advance in the triage, diagnosis and management of trauma in austere environments, i.e., on the battlefield, on naval vessels, on evacuation aircraft, in field hospitals, and more," Eric Elster, MD, FACS, FRCSEng (Hon.), CAPT, MC, USN (Ret.). "This technology could provide for the rapid evaluation of injured war fighters and civilians in conflict zones by first responders (medics and corpsmen), nurses, technicians, and physicians with minimal training, thereby improving clinical outcomes in resource-restricted environments. We look forward to the results of this research funded by the US Army Medical Research and Development Command."

MAUI's 510K FDA clearance:

In October 2023, MAUI K3900 received its 510K FDA Clearance and is now available for commercial use. Because MAUI's technology differs from existing imaging ultrasound technologies, MAUI was required to conduct comparative image testing proving it can effectively image with a simple probe. No other recently cleared ultrasound systems have been required to do this, thus demonstrating the unique and powerful potential for this patented imaging technology.

The MAUI K3900 Ultrasound Imaging System is intended for use by qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Examples of differentiating images for use in trauma, neurosurgery and interventional radiology can be found at mauiimaging.com/solutions.

MAUI's Patented Computed Echo Tomography (CET):

MAUI Imaging has created a novel and effective approach to medical imaging that provides views that look like a cross between ultrasound and CT without the need for dangerous ionizing radiation (x-rays). MAUI's CET pings the designated part of the human body, uniquely seeing anatomy beyond what other ultrasound systems can see. MAUI then uses proprietary patented 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. MAUI is performing clinical studies with the military and elsewhere to fully demonstrate these capabilities.

MAUI's core patents deal with solving for speed-of-sound issues in tissue, enabling views of a variety of tissue types, including lung and cranium, previously thought to be unobtainable. MAUI's portfolio is believed to be one of the strongest imaging patent portfolios with more than 160 granted patents and dozens more pending in and outside the U.S.

MAUI uses a concave probe that fires pulses into the tissue from many different angles. The MAUI probe's concave shape sends and receives energy from multiple angles, one of the reasons allowing MAUI to see through and around barriers. This is something no other known ultrasound-based system can accomplish. MAUI's probe can also be much larger as it does not need to navigate between barriers, such as the ribs, making it more easily positioned over regions of interest. In addition to enabling clinicians to see beyond barriers without requiring more invasive imaging approaches, typically, a highly trained sonographer technician or physician is required to get images around the ribs and aim at what they want. With MAUI, the user doesn't have to worry about the ribs or perfect placement of the probe making medical imaging ubiquitous.

The MAUI approach requires trillions of calculations per second which necessitated MAUI's requirement for Moore's law to catch-up to deliver a portable cost-effective solution. MAUI's approach also creates a significantly larger data set that can be sliced into an infinite number of images more like CT than traditional ultrasound. The dataset that MAUI produces can be used for deeper analytics, providing more insight about the anatomy it scans. Currently traditional ultrasound represents <10% of AI in medical imaging, MAUI's volumetric imaging should dramatically change this.

About MAUI

MAUI Imaging's Computed Echo Tomography (CET), uses ultrasound to insonify through and beyond barriers for rapid and effective imaging of the human body and is protected by more than 160 patents. MAUI's FDA Cleared system produces a large-scale dataset and novel insights that can assist in rapid and effective diagnosis and treatment. MAUI Imaging has multiple clinical sites and studies in process in trauma, pediatric neurosurgery, and interventional radiology departments. MAUI's CET system enables rapid imaging of the brain, and other internal organs and structures, in real time by existing clinical personnel without additional training. For more information visit mauiimaging.com.

Media Contact: Chris Gale ([email protected])

SOURCE MAUI

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