Market Overview

Modulated Imaging Receives FDA Clearance for its New Clarifi Imaging System


, the leader in optical imaging solutions powered by Spatial
Frequency Domain Imaging (SFDI) for noninvasive assessment of tissue
health, announced today that it has received FDA 510(k) clearance for
its new medical device, the ClarifiImaging System.

Clarifi is the first and only commercialized diagnostic medical device
to use SFDI, a patented technology based on structured light, that helps
clinicians assess tissue function and compromised circulation by
measuring oxygenation and hemoglobin levels in superficial tissue. This
essential information can be used in the assessment, management and
treatment of several challenging conditions, including peripheral
vascular diseases, diabetic foot ulcers, burns, skin flaps, and chronic

Clarifi is a non-contact noninvasive system that measures tissue oxygen
saturation (StO2), oxyhemoglobin (HbO2), and
deoxyhemoglobin (HbR). In addition, it is the first noninvasive
diagnostic technology to quantitatively display total hemoglobin levels
in superficial (0-1mm) and subsurface (1.5-3 mm) layers—HbT1
and HbT2, respectively. Clarifi's exclusive capabilities
gives clinicians greater understanding of tissue perfusion, oxygen
supply, and utilization. This critical information can be used for
earlier identification of patients who are at risk for developing
wounds, and to guide clinical interventions to prevent their onset or

Optimized for seamless integration into a variety of care delivery
environments, Clarifi is designed to address shortcomings of existing
spectral imaging systems (multispectral and hyperspectral) by
incorporating structured light into the process. Clarifi is smaller,
faster, and lighter than its predecessor, Ox-Imager CS®, and it offers
the largest optical imaging field available—approximately 225 mm x 300
mm—and can image the entire plantar aspect of a foot. The system
displays color-coded images of each biomarker to help clinicians assess
oxygenation and hemoglobin delivery to superficial and subsurface tissue
in any region of interest, with clarity and confidence.

"The ability to separately quantify and display in total hemoglobin and
distribution in superficial and subsurface layers of tissue is a
significant advancement," said Anand S. Patel, MD, Chief of
Interventional Radiology at Providence Little Company of Mary Medical
Center. "Modulated Imaging's technology should enable us to better
diagnose and treat patients with compromised circulation who may be at
risk for lower limb diabetic complications, peripheral arterial disease,
or similar conditions."

"With much of our daily practice dedicated to limb salvage, this
technology is so exciting because I know it will provide information
that will allow us to prevent ulcers before they occur, heal them more
efficiently when they do occur, and ultimately limit amputations," said
Jeffrey Lehrman, DPM, Medical Director at the Crozer Wound
Healing Center in Pennsylvania.

"Clarifi is a powerful example of how cutting edge optical imaging and
computational technologies can be combined to create new, accessible
tools for Precision Medicine," said Bruce Tromberg, PhD, Director of the
Beckman Laser Institute and Medical Clinic at UC Irvine. "Clarifi
delivers more insight into oxygen delivery, availability, and
utilization at the microvascular level than any other diagnostic
technology. Unlike other optical imaging devices used for assessing
tissue, Clarifi quantifies and displays hemoglobin concentration and
distribution in the superficial and subsurface. Every person is
different, and this new information reveals individual biomarkers that
clinicians can use to optimize health and clinical outcome for each

"We're proud to be able to provide meaningful information that advances
patients' health and wellness. FDA clearance is a major milestone for
our company, and for the patients and physicians within the vascular
treatment communities," said David Cuccia, PhD, Modulated Imaging's CEO
and CTO. "Clarifi can lead to significant preventive care actions as
well as over $6 billion per year in savings to the US healthcare system."

The Clarifi imaging system demonstrates Modulated Imaging's continuing
mission to deliver technology that provides clinically actionable
information for early intervention, enabling caregivers to prevent the
onset or escalation of conditions related to circulatory compromise.

The company is currently ramping up production of the Clarifi imaging
system and expects to start fulfilling orders by the end of Q4.

About Modulated Imaging: Modulated Imaging leverages medical
photonics and informatics to help clinicians assess tissue health.
Powered by Spatial Frequency Domain Imaging (SFDI), the company's
disruptive technology identifies compromised circulation and perfusion
by measuring microvascular tissue oxygenation and hemoglobin
concentration and distribution. As a result, the company's optical
imaging system can identify patients with tissue health problems early
enough for clinicians to intervene. With widespread adoption, this
approach could save thousands of limbs and lives, not to mention
billions of dollars in treatment costs.

Spatial Frequency Domain Imaging was invented by researchers at UC
Irvine's Beckman Laser Institute, including Dr. David Cuccia, CEO/CTO of
Modulated Imaging. Dr. Cuccia and Dr. Amaan Mazhar, VP Research &
Development, are internationally-recognized experts in medical photonics.

Clarifi and Ox-Imager are trademarks of Modulated Imaging.

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