Case Study:

Modulated Imaging, Inc.

Dr. David Cuccia is the CEO and CTO of Modulated Imaging, a startup based in Irvine, CA that is focused on employing a UCI-patented optical imaging technology, spatial frequency domain imaging (SFDI), toward helping diabetic patients avoid complications, such as ulcers and amputations.

2002 - 2006:
The seeds for Modulated Imaging were planted in 2002, when David, then an undergraduate in Physics at UC Irvine, began exploring new light-based ways to more accurately image and measure the health of tissue. With the help of his mentors, Dr. Bruce Tromberg and Dr. Anthony Durkin at the Beckman Laser Institute, David developed a new imaging technique and Spatial Frequency Domain Imaging (SFDI) was born.

David was excited about the potential of SFDI and made it the subject of his doctoral dissertation in Biomedical Engineering from 2002-2006. The facilities of the Beckman Laser Institute and resources of the UCI IRB review committee were both significant contributors to David’s success in building and medically validating SFDI technology. As a UCI graduate student, David was able to build prototypes in Professor Tromberg’s and Durkin’s lab, and upon IRB approval, could then wheel them next door to the Beckman Laser Institute Medical Clinic to evaluate the devices’ clinical feasibility and utility. In such a way, early market research concepts could be tested quickly and efficiently, with rapid feedback from clinicians and academicians. Convinced of the value SFDI could bring to the research and medical communities, David worked independently to develop SFDI, and with guidance by his BLI mentors, he pursued the next steps to form a startup company. During this period David also communicated regularly with the UCI Invention Transfer Group and indicated his interest in licensing the SFDI intellectual property that had been developed.

2006 - 2012:
In 2008 after receiving his Ph.D., David began to build the Modulated Imaging startup team and product development of his SFDI technology. The Modulated Imaging startup was originally housed within the Photonic Incubator at the Beckman Laser Institute at UC Irvine.

Once Modulated Imaging was incorporated, David and all the UCI affiliated personnel with financial interests in Modulated Imaging worked closely with the Conflict of Interest (COI) team to address the conflict of interest concerns. By working with the COI team, a plan to address COI concerns (including those related to data collection, analysis, and reporting) was developed which allowed the UCI research to continue.  The COI Plan has continued to be updated and modified as the company has developed over the years.

David credits UCI for much of Modulated Imaging’s early funding success; most importantly, through UCI’s Small Business Innovative Research Program. David and Modulated Imaging applied for and were awarded SBIR grants totaling over $7 million that helped fund his research technology development.

In 2010, Modulated Imaging introduced it’s first generation Ox-Imager™ device, and made it available to a select group of customers within the research community, including researchers from the Beckman Laser Institute and Dartmouth College. Modulated Imaging also entered into a Letter Agreement with UCI for three patents that were the basis for their technology. The next year an additional patent was added to the Agreement and the Agreement was extended to 2012.

2012 - Today:
Through continued and expanded research collaborations and funding from SBIR/STTR awards, over $11M to date, Modulated Imaging made advancements from the initial product. The SBIR/STTR funding also required refining the conflict of interest mitigation plan as some of the funding was subcontracted to UCI. In 2012, Modulated Imaging released their second-generation research product, Reflect RS. The current version of the Modulated Imaging research platform is a true “turnkey” research instrument and is now found in corporate research laboratories, as well as in many internationally recognized universities.

After several years of successful SBIR/STTR funding, Modulated Imaging moved out of the BLI Photonics Incubator space in 2014 and signed a license with UCI for the 4 technologies in the Letter Agreement as well as three additional patents. The company expanded to its first commercial space in San Juan Capistrano, and quickly outgrew this location.

Today, Modulated Imaging company has grown and operates in a 6,000-sq. ft. building in Irvine, California, that includes office space, and separate areas dedicated to lab research and device production. In August 2016, Modulated Imaging secured their first round of private financing, jointly backed by the Cove Fund and Hamamatsu Corporation. In December 2016, Modulated Imaging received FDA clearance for their first medical device, Ox-Imager CS. Finally, in August 2017, the company secured Series A financing to help with the planned clinical studies, point-of-care device development, FDA submissions and market/customer development.