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Concept to Commercialization: the Artificial Pancreas Technology

Living with Type 1 diabetes (T1D) requires constant management – a delicate balance between eating, exercise, and daily activity with measuring blood-sugar levels and insulin intake. Though patients can effectively manage T1D with insulin therapy, young children living with T1D and their families must make complicated medical decisions every day to avoid the life-threatening nature of the disease.

Finger sticks gave way to continuous blood glucose monitors, and standard injections gave way to insulin pumps. But the dosing decisions remained an art, not systemized or controlled other than by the patient.

Creating the closed-loop system was considered impossible, an unsolvable control algorithm that would connect glucose monitoring systems with insulin pumps to automate the delicate balance of blood sugar levels with eating, exercise, and administering insulin. The impossible became a reality when a collaborative team of mathematicians, engineers, physiologists, clinicians, alumni, and a software startup from the University of Virginia (UVA) made it happen.

In August 2018, DexCom, Inc., the leader in continuous glucose monitoring for people with diabetes, acquired TypeZero Technologies, Inc., uniting the groundbreaking artificial pancreas technology with an industry giant capable of bringing TypeZero’s innovative solutions to the commercial market. The success of this deal illustrates how UVA’s collaborative research faculty, engaged alumni network, and the business expertise of the Licensing & Ventures Group (LVG) working in lockstep can advance knowledge toward life-changing impact.

While the concept can be traced back to more than 50 years, the quest for the artificial pancreas accelerated in 2006 when the Juvenile Diabetes Research Foundation (JDRF) initiated the Artificial Pancreas Project and funded a consortium of centers to carry out closed-loop control research. Among the funding recipients was a group of interdisciplinary researchers from the UVA Schools of Medicine and Engineering and the University of Padova in Italy, including Boris Kovatchev, Ph.D., Stephen Patek, Ph.D., Patrick Keith-Hynes, Ph.D., Marc Breton, Ph.D., and Stacey Anderson, M.D.

Researchers who had been working for years to understand the physiology of the disease and exploring mathematical theories were now well funded and connected with engineers capable of translating the ideas into a practical application. During the pursuit of an algorithm-based software platform that would connect Continuous Glucose Monitoring (CGM) systems with insulin pumps, the team created a simulator that digitally replicated the human metabolic system. The UVA-Padova team submitted the use of this software to the FDA for preclinical trails. The FDA accepted it as a substitute for animal trials, which advanced the work of the UVA team and the entire JDRF Artificial Pancreas Project.

The team went on to secure funding from the NIH along with many other sources*, while LVG leveraged its relationship with the UVA translational research fund, LaunchPad, for further support. Additional funding allowed the team to continue technology development of the closed-loop system, execute subsequent clinical trials, and establish the UVA Center for Diabetes Technology.

By 2011, the team had converted their once bulky computer system, which connected sensors and pumps, into a wireless smartphone device that patients could take home and integrate into their care routines as participants of clinical trials. The staggering success of the trials brought a wave of new hope to patients living with diabetes.

In the same year, UVA transformed its Patent Foundation into the UVA Licensing & Ventures Group, which adopted a new business model to align with a singular new objective: impact. For the artificial pancreas to impact the lives of diabetes patients the way that the researchers, philanthropic supporters, and clinical trial patients knew that it could, the technology would need to move from the lab to a commercial entity.

Recognizing this need, LVG established connections within the UVA community, building one of LVG’s most significant assets to date – its network. As the organization that sits at the physical intersection of Grounds and the city of Charlottesville, LVG stewards research ideas from concepts into marketable solutions for its industry partners. The artificial pancreas stood out from others in the portfolio due to its advanced stage of development and was primed to advance toward commercialization. Accordingly, LVG worked to find a licensing partner for the technology among the industry organizations sponsoring research conducted by the UVA-Padova team, including DexCom. However, the portfolio was substantial enough to warrant the creation of a new venture.

LVG tapped UVA alumnus Chad Rogers (McIntire ’97), a local entrepreneur who had returned to Charlottesville after 15 years in the startup technology and investment industries in San Francisco and Boston. LVG first engaged with Rogers when he took a management role as interim CEO of another UVA startup, HemoSonics. A local alumnus and entrepreneur with experience in technology development was the perfect match for the diabetes research portfolio.

In September 2013, Rogers and his co-founder, Jeff Keller, the current Chief Innovation Officer of the UVA Health System, partnered with LVG to license the artificial pancreas technology and launch TypeZero Technologies, Inc. As has become its practice, and to encourage its commercial success, LVG allowed significant flexibility in the license agreement and worked closely with the Company as it navigated relationships with academic inventors and raised capital to reach its development milestones.

Several members of the research team joined the Company, including Patrick Keith-Hynes, Benton Mize, and Antoine Robert, who created the first software systems to instantiate the artificial pancreas. As the company got off the ground, the researchers continued the ongoing clinical trials at UVA supporting TypeZero, pursued complementary diabetes technology research, and steadily gained credibility in the field, putting the UVA Center for Diabetes Technology firmly on the map.

Concurrently, in 2015, with support from University leadership and the UVA Health System, LVG launched the $10 million LVG Seed Fund and closed its first investment with TypeZero as part of the Company’s larger funding round. Establishing the fund and supporting early-stage UVA startups at the seed stage is yet another example of how LVG worked to strengthen UVA’s ability to advance ideas to impact. A technology as promising as the artificial pancreas needed funding, credibility, and a route to industry-level production. Now it had all three.

Among its several product offerings, TypeZero’s “inControl Diabetes Management Platform” uses a series of mathematical algorithms and prediction tools, embedded in a mobile application to allow the CGM systems and insulin pumps to operate as a single closed-loop system intelligently. The system reduces the need for individual action by automatically monitoring blood glucose levels and regulating them through customized, calculated insulin dosages based on future predictions. The most extraordinary component of the platform is that it operates agnostic to any particular CGM or insulin pump allowing patients to continue to choose the devices and tools that work best for them.

When DexCom came to the table with an offer, TypeZero held the single largest patent portfolio ever licensed from UVA through LVG, which leveraged more than 30 clinical trials with more than 500 patients at 12 sites, including one at UVA. The acquisition marked the first exit for the LVG Seed Fund, and the artificial pancreas reached a coveted commercialization status rarely achieved by university technologies.

“This story is representative of what is possible when we harness the full capacity of this institution to support innovation,” said Michael Straightiff, LVG Executive Director. “Our interdisciplinary team of researchers leveraged federal funds, the financial generosity of our alumni, and our sophisticated translational research infrastructure to engineer technologies to relieve the heavy decision-making burden from patients living with diabetes. Then, in partnership with our research team, LVG once again leveraged the time and talent of our alumni to build, invest in, and sell a company that productized these early technologies. The story, though not yet over, has culminated in local economic development, return on investment, and, most importantly, lives enriched and improved by the University of Virginia.”

TypeZero will remain headquartered in Charlottesville and will work toward the introduction of the inControl platform to the commercial market by DexCom. In early 2020, the Company will relocate from its space in the IX Art Park to the new Dairy Building on Preston Ave down the road from LVG.

*Philanthropic supporters of the artificial pancreas research at the University of Virginia and the University of Padova include the Juvenile Diabetes Research Foundation, the National Institutes of Health, the Manning Family Foundation, the Helmsley Charitable Trust, the National Institute of Diabetes and Digestive Kidney Diseases, and the Wallace H. Coulter Translational Research Partnership.