MAUI Imaging has announced it raised $14 million in a Series D funding round led by Acertara Acoustic Laboratories.
Currently, MAUI Imaging is delivering devices to initial users, with Acertara as the exclusive U.S. distributor for other hospitals.
In August 2024, MAUI Imaging unveiled a $4 million contract with the U.S. Department of Defense to enhance trauma medicine across four military branches, aiming for faster diagnosis and care in mass-casualty situations and resource-limited environments.
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, one of the major trauma centers where the military trains trauma surgeons and other healthcare providers.
A committee of independent expert physicians reported that MAUI represents a categorical change in ultrasound imaging, offering the potential for significantly improving patient management in emergent settings, regardless of the availability of other imaging modalities.
In some instances, 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.
MAUI’s 510 (k) FDA clearance: In October 2023, the MAUI K3900 device received its 510(k) FDA clearance, making it available for commercial use.
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).
MAUI’s Patented Computed Echo Tomography (CET): MAUI Imaging has developed a novel and practical approach to diagnostic imaging, combining the benefits of ultrasound and CT without the need for ionizing radiation (x-rays). MAUI’s CET “pings” the designated part of the human body, uniquely visualizing anatomy that other ultrasound systems cannot produce. MAUI then utilizes proprietary, patented algorithms to account for the reflected energy from various flight paths.
It combines the data to create a reliable image of all the structures below the probe. Barriers such as bone, gas, fat, instruments, implants, etc., become part of the image instead of obstacles to image formation. MAUI is currently conducting clinical studies with the military and elsewhere to demonstrate these capabilities fully.
MAUI’s core patents address the issue of speed-of-sound aberrations in tissue, enabling views of various tissue types, including the lung and cranium, that were previously thought to be unobtainable. MAUI’s portfolio includes more than 160 granted patents and dozens more pending in the U.S. and abroad.
MAUI uses a concave probe that fires pulses (pings) into the tissue from many different angles. The MAUI probe’s concave shape allows it to send and receive energy from multiple angles, one of the reasons it can see through and around traditional barriers.
This ability is unknown to other ultrasound-based systems. MAUI probe apertures can also be significantly larger than conventional probes, as they do not need to navigate between barriers, such as ribs, making them easier to position over regions of interest. While a highly trained sonographer or physician is typically required to acquire images around the ribs to visualize what they want, with MAUI, the user can see beyond barriers without requiring more invasive imaging approaches.
The MAUI approach requires trillions of calculations per second, made feasible by advances in chip technology, often referred to as Moore’s Law. It generates larger datasets that can be divided into multiple images, resembling CT scans rather than traditional ultrasound. These datasets allow for deeper analysis and greater insights into scanned anatomy, significantly expanding the role of ultrasound in AI-driven diagnostics.
How the funding will be used: The funds will support the production, sales, and marketing of its unique Computed Echo Tomography-based imaging technology.
KEY QUOTES:
“With this support and our work with the U.S. military we are able to address the clear need for a new ultrasound-based technology to image all types of tissues. That need is most pronounced in trauma medicine, which is a major focus for us. MAUI will also be able to supply the volumetric imaging data for increasingly accessible and advanced AI tools that stand to transform medicine.”
MAUI Imaging CEO and co-founder David Specht
“The MAUI ultrasound system represents a major advancement in medical imaging. By reducing the complexity of image acquisition and offering an intuitive approach, it expands ultrasound’s reach to new users and clinical settings. We’re working closely with MAUI to accelerate adoption in hospitals nationwide, where this technology has the potential to save lives and significantly improve patient outcomes.”
Levi Moore, President and CEO of Acertara Acoustic Labs
