Will Modulim End the Amputation Epidemic?
Using light projections to see beneath the skin, Modulim’s device detects subtle changes in a diabetic patient’s microvascular circulation
Dec. 17, 2024 - By reducing the need for diabetes-related amputations, Modulim is poised to achieve the biotech trifecta: improve patient outcomes, deliver cost-savings to insurance companies, and streamline physicians’ workload.
David Cuccia will never forget sitting in Professor Bruce Tromberg‘s office with a group of faculty when the conversation shifted to the future of their research. A company had recently approached UC Irvine to license their technology and Cuccia, then a graduate student, turned to the faculty to ask what they planned to do about the offer.
“David, we’re faculty,” they said. “The question is, what are you going to do about it?’”
Cuccia realized he wasn’t interested in licensing the technology to someone else. Instead, he logged on to Legal Zoom to set up his own company for $250 that night.
That company was Modulated Imaging Inc., now known as Modulim, a medical device startup focused on preserving human limbs with medical imaging technology. With Cuccia as chief technology officer, Modulim is set to bring transformative changes to the field of diabetes care.
Curiosity Meets Innovation
Cuccia first arrived at UC Irvine as a freshman and lived at The Shire in the Middle Earth dorms. Initially, he saw himself becoming a doctor. Since he liked science and helping people, he assumed this would be his path. But after witnessing his first surgery, Cuccia knew medicine wasn’t for him. He switched to physics and joined Tromberg’s lab. The undergraduate research he conducted there eventually grew into Modulim, a venture that would come to define his career.
As Cuccia began planning for life after graduation, Professor Anthony Durkin suggested that writing a few more papers could allow him to quickly earn a Ph.D. Taking this advice, Cuccia decided to stay on and pursue his doctorate. Durkin was right about the timeframe. The average time to complete a Ph.D. in biomedical engineering is five to six years. Cuccia earned his in three and a half.
At the time, researchers at the Beckman Laser Institute had spotted a fascinating new trend. Combining near-infrared light and digital projectors, the researchers were able to capture extensive information about tissue in a novel manner. Cuccia and his colleagues invented Spatial Frequency Domain Imaging (SFDI), a non-invasive light-based imaging technique that can capture data on oxygen levels and hemoglobin concentrations in the skin. Instead of a single data point, SFDI captures whole images and examines tissue up to five millimeters deep. Moreover, it’s much quicker than other assessment methods, delivering widefield results in seconds without exposing patients to harmful radiation.
While a graduate student, Cuccia successfully applied for Small Business Innovative Research (SBIR) grants. By the time he graduated, he was able to transition from a Ph.D. student to a principal investigator with his own company. He also discovered that other researchers wanted to buy devices like the one he had built in the lab.
As Cuccia transitioned from graduate student to founder of a startup, Amaan Mazhar arrived at UC Irvine to start his Ph.D. in biomedical engineering. This turned out to be serendipitous. Not only was Mazhar interested in Cuccia’s work, but he was passionate about solving real-world problems.
“The growth of knowledge and technology development was fueled by Amaan. He was director of research, building the devices, and in charge of clinical collaborations. He’s been my partner in crime from the beginning,” says Cuccia. Mazhar now serves as Modulim’s CEO.
In his pitch to the first round of investors, Cuccia introduced a versatile platform with a diverse range of potential applications. Because the technology provided a lens into the properties of tissue and materials, potential applications included improving outcomes of surgical procedures, advancing wound care, and even streamlining fruit inspection. Out of the gate, Cuccia and Mazhar wanted to make sure they helped the most people and made the biggest impact. Their challenge lay in figuring out where to focus their attention first.
“Sometimes you don’t realize the wonderful ecosystem you’re in until you talk to other people. I think UCI is very progressive in how they think about translation and industry.”
– Amaan Mazhar, CEO, Modulim
Revolutionizing Diabetic Foot Care
Through their clinical collaborations, Cuccia and Mazhar learned more about the scale of the amputation epidemic. Every 20 seconds a person with diabetes undergoes a lower-limb amputation. Poor circulation in diabetes patients starves tissue of nutrients and leads to a breakdown of the skin, which results in chronic ulcers. Nerve damage, a common complication of diabetes, often masks the symptoms of these ulcers. As a result, patients may not even know they have an issue until a chronic ulcer has formed, leading to infection, gangrene, and hospitalizations. In severe cases, this can lead to the need for amputation.
In addition to the personal trauma of losing part of a lower limb, amputations come with significant financial costs. In total, the treatment of diabetic limb-related complications costs about $17 billion in the United States, which is more than the top five most costly cancers.
In a healthcare system that prioritizes treating acute conditions over preventative care, busy physicians often lack the resources to perform foot assessments on all diabetes patients. While it’s possible to train other healthcare personnel to conduct these exams, the current approach still isn’t ideal, since it is highly subjective and dependent on level of skill and interpretation. To effectively address this healthcare gap, Modulim plans to take the subjectivity and guesswork out of diabetic foot exams and make them widely available.
While light is ubiquitous in wearable devices like Fitbits and Apple watches, Modulim’s device uses light projections to see beneath the skin, detecting subtle changes in a patient’s microvascular circulation. Cuccia’s team is developing a handheld version of the technology that is about the size and shape of a smartphone, where a technician with minimal training could operate it in community settings. The device would be compact enough for healthcare personnel to carry in their bags, allowing them to bring it on home visits or to nursing homes.
Integrating a Multidisciplinary Problem
Besides subjectivity, accessibility, and cost, Modulim’s technology tackles another critical aspect of the amputation crisis. Diabetic foot care is a complex, multidisciplinary problem involving physicians from various specialties. A patient with diabetes could potentially see a primary care physician, an endocrinologist, a nephrologist, a vascular medicine specialist, and a podiatrist. Their provision of care often remains fragmented, with no single discipline taking lead.
“We can bridge these specialties by introducing an objective and quantifiable assessment that everyone can use,” says Mazhar.
To complement the device, Modulim has developed cloud-based software to help clinicians in care-management, to help track patients, monitor their microvascular changes, and to share insights within an organization. The device, combined with the algorithm and cloud-based software, has the potential to greatly enhance front-line diabetic care.
Collaborative Roots
The first office space Modulim used was, in fact, a converted printer closet. To help get the startup off the ground, UC Irvine faculty rearranged their postdocs so Cuccia and Mazhar could have a small space. Humble as it was, they were grateful for the “office,” especially since it was in UC Irvine’s Beckman Laser Institute, where groundbreaking work like theirs was taking place.
“Maybe they helped with the space out of pity, but I’m thankful for it,” says Cuccia. “I felt like we had a hundred percent support from everyone all of the time. They wanted to make this happen for us.”
In moving the invention from a university research discovery into a product in the private sector, Cuccia appreciates the freedom and fairness of the deals he’s made with UC Irvine through UCI Beall Applied Innovation.
“They gave us a long leash in terms of the initial fund repayment timeline. They understood that our need for cash was critical. This gave us a solid foundation to find the right fit,” he says.
As a licensing officer for UCI Beall Applied Innovation, Alvin Viray ensured that Cuccia had the support and resources he needed to protect and commercialize his Ph.D. research.
“It has been incredibly rewarding to see his ideas grow into a venture that has real potential to impact the health industry and patients,” Viray says.
These resources and support have generated a lot of loyalty from Cuccia and Mazhar. Even for a UC Irvine-born and incubated startup, their connection and loyalty to the university is deep. They take part in round tables and advisory boards. Their workforce includes a significant number of UC Irvine alumni. They work closely with UC Irvine Beall Applied Innovation by mentoring other startups and by speaking at events. Cuccia serves on the Campuswide Honors Collegium advisory board and Mazhar reviews Proof of Product (PoP) grants in his spare time. Both Mazhar and Cuccia even met their spouses while students at UC Irvine.
“UCI remains supportive of us, and we do our best to contribute in return,” Cuccia says.
A Bold Vision for Healthcare and Beyond
Modulim has attracted over ten million dollars in grants and private investment. Their solution has been rolled out with multiple partners, including Fresenius dialysis clinics, University of Arizona, University of Southern California, and Kaiser Permanente, to study patient populations with a heightened risk of amputation.
And diabetic foot care is only the beginning. With a $2.5 million dollar contract from the Department of Defense, Modulim has partnered with Anthony Durkin in UCI’s biomedical engineering department to build a tool for digital assessment of burns using their technology. Durkin’s lab has already demonstrated the ability of machine learning to map the area and severity of burns using Modulim’s proprietary outputs.
Moreover, the startup can tackle much more than just healthcare. Its technology has been used by research collaborators to understand skincare products, characterize produce quality, and visualize inks in tattoos and old manuscripts. The technology can also be applied in augmented reality by rendering a person’s appearance under different lighting conditions, utilizing a deeper understanding of how light interacts with skin.
But these projects are awhile away. Cuccia jokes that maybe when he’s retired, he’ll be able to work on these broader applications. For now, Modulim is focused on bringing their newest handheld version of their system to market. Understanding that collaborating with major payers and providers is crucial for commercial success, Modulim’s strategy aligns with the healthcare shift toward value-based care models, which focus on reducing costs and improving patient outcomes.
“If there’s a way that technology can help even the playing field and get patients earlier and better access to care,” says Mazhar, “it’s an opportunity for us to contribute to improving our health system.”
Learn more at: https://modulim.com/
- Jill Kato
