Maui Imaging Raises $14 Million

MAUI Imaging is better capitalized, having raised $14 million in a Series D financing round (including equity funding) led by Acertara Acoustic Laboratories. The money will be used to support the production, sales, and marketing of the company’s Computed Echo Tomography-based imaging technology.

“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,” MAUI Imaging CEO/Co-Founder David Specht said. “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 is currently delivering devices to initial users. Acertara is leading pre-orders with an exclusive U.S. distributorship for hospitals outside of those MAUI Imaging serves directly.

“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,” Acertara Acoustic Labs President/CEO Levi Moore commented. “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.”

MAUI Imaging emerged from stealth last August with a $4 million U.S. Department of Defense (U.S. Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military. The Defense Department tapped MAUI Imaging’s technology to accelerate diagnosis and interventional care in high volume or mass casualty events and resource limited environments.

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, a major trauma center where the military trains trauma surgeons and other related healthcare providers.

A committee of independent expert physicians claimed MAUI represents a categoric change in ultrasound imaging for potentially improving patient management in emergent settings, regardless of the availability of other imaging modalities. In certain cases, like cranial and spinal imaging in adults, where traditional ultrasound has not been traditionally 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.

The MAUI K3900 device received U.S. Food and Drug Administration 510(k) in October 2023. 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; musculoskeletal conventional and superficial; urology (including prostate); and intraoperative (abdominal, thoracic and vascular).

MAUI Imaging has created a novel and effective approach to diagnostic imaging resultant in a cross between ultrasound and computed tomography (CT) without the need for dangerous ionizing radiation (X-rays). MAUI’s CET “pings” the designated part of the human body, uniquely visualizing anatomy beyond what other ultrasound systems can produce, according to the company. MAUI then uses proprietary patented algorithms to accommodate the reflected energy from various flight paths and sums 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 performing clinical studies with the military and elsewhere to fully demonstrate these capabilities.

MAUI’s core patents deal with solving speed-of-sound aberration issues in tissue, enabling views of a variety of tissue types, including lung and cranium, previously thought to be unobtainable. MAUI’s portfolio includes more than 160 granted patents and dozens more pending in and outside the United States.

MAUI uses a concave probe that fires pulses (pings) into the tissue from many different angles.  The MAUI probe’s concave shape sends and receives energy from multiple angles, one of the reasons that MAUI can see through and around traditional barriers. This ability reportedly is unknown to other ultrasound-based systems. MAUI probe apertures can also be much larger than traditional probes as they do not need to navigate between barriers, such as the ribs, making it more easily positioned over regions of interest. While a highly trained sonographer technician or physician is typically required to acquire images around the ribs in order to aim at what they want to visualize, with MAUI, the user can see beyond barriers without requiring more invasive imaging approaches.

The MAUI approach requires trillions of calculations per second and would not have been possible in a portable, cost-effective solution without chip advances often described as Moore’s Law. MAUI’s approach also creates a significantly larger data set that can be sliced into as many images as necessary, more like CT than traditional ultrasound. The datasets that MAUI produces can be used for deeper analytics, providing more insight about the anatomy it scans. MAUI’s volumetric imaging has the potential to significantly expand the role of ultrasound in AI-driven diagnostics.

MAUI Imaging’s Computed Echo Tomography (CET), uses ultrasound to insonify tissues 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 enabling novel insights that can assist in rapid and effective diagnosis and interventions. MAUI Imaging has multiple clinical sites and studies in process in trauma, neurosurgery, and interventional radiology. 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.