In 2017, the Center for Disease Control stated that 30.3 million Americans, or 9.4 percent, have diabetes. More than 1.4 million Americans are newly diagnosed with diabetes annually, according to American Diabetes Association (ADA). Over six million Americans with diabetes take insulin, according to the ADA. Of these, over 1.25 million have Type 1 diabetes, also known as juvenile diabetes, where the pancreas produces little or no insulin and patients must inject an insulin drug with every meal.
Instead of constant injections and the need to calculate the proper insulin dosage, diabetic patients could benefit from using an automated insulin delivery system that combines an insulin pump with a continuous glucose monitor. Insulin pumps provide a continuous stream of insulin and enable patients to adjust their dose to match requirements, which can change hourly with food and exercise.
Continuous glucose sensors also provide constant monitoring of blood sugar level, which helps to optimize the insulin dose. Clinical trials have shown that using these devices together lowers the chance of hypoglycemia, or dangerously low glucose levels, and helps keep glucose within the target range.
But existing insulin pumps are still difficult and uncomfortable to use, relying on an infusion cannula that must be inserted under the skin and changed every two to three days. These cannulas often kink upon insertion, sometimes causing them to fail unexpectedly, which requires emergency replacement. Only one in three people with Type 1 diabetes currently choose to use an infusion pump instead of injections.
Capillary Biomedical’s Solution
The Cove @ UCI startup Capillary Biomedical, Inc., a medical device company developing technologies for diabetes management, received funding from the Juvenile Diabetes Research Foundation (JDRF) to develop an improved infusion cannula that addresses this key barrier to insulin pump use. The Capillary Cannula is flexible and coil-reinforced, which prevents kinking while reducing bruising and scarring. The cannula also has holes along its shaft like a sprinkler hose, which distributes insulin throughout the tissue and prevents the insulin from pooling in one area and the cannula from getting clogged.
Together, the company expects these changes will help preserve infusion sites by minimizing tissue trauma, scar formation and discomfort; and also reduces the frequency of infusion set failure and unexpected hyperglycemia, or dangerously high glucose levels.
According to Capillary’s Chief Executive Officer Paul Strasma, MBA, an insulin pump user may not realize their device has failed to deliver the proper amount of insulin. It can take several hours before an alarm will sound to inform the user of a problem, and then even more time to determine that the cannula has malfunctioned and needs replacement. In the meantime, blood sugars are not being adequately controlled.
“Our infusion set should never fail in that fashion,” said Strasma. “It was designed not to kink. Preclinical studies show that our cannula does less damage and better distributes insulin throughout tissue.”
According to Strasma, in addition to the flexible cannula, the company has also created a novel self-insertion device. Experiments with this innovation started in the Cove @ UCI’s prototype lab, and were then supported by UCI’s on-campus RapidTech manufacturing facility.
Another Cove @ UCI company then referred them to a molding manufacturer for further product development.
How the Company Got Started
Capillary Biomedical was founded in 2014 by Strasma and Jeffrey I. Joseph, O.D., vice chairman and director of research of the Anesthesiology Department and director of the Artificial Pancreas Center at the Sidney Kimmel Medical College at Thomas Jefferson University.
Strasma and Dr. Joseph originally focused on creating an implantable glucose sensor to improve automated insulin delivery systems. They pitched the concept to JDRF, but learned that the poor reliability of infusion cannulas was a more immediate barrier to fully automating insulin delivery with these systems.
“We learned that the variability of insulin absorption was now a bigger hurdle than sensor performance for closing the loop,” Strasma recalled.
JDRF provided an initial academic innovation grant to Dr. Joseph at Thomas Jefferson University to understand how infusion sets were failing. Based on promising preliminary findings, Capillary Biomedical then received a larger industry award of $1.5 million to develop a more reliable, longer-lasting infusion set.
“After the JDRF award, we were eventually able to raise a $1.6 million in matching funds from private investors,” said Strasma. “Our next step will be to raise additional funding from organized angel groups, venture capital firms and strategic partners in the industry.”
Joining the Cove @ UCI Ecosystem
UCI Professor of biomedical engineering, Elliot Botvinick, Ph.D., reviewed the company’s grant application and thought it was compelling. JDRF offered to facilitate an introduction. Upon meeting with Strasma, the two realized there was an opportunity to collaborate and bring the company into the Cove @ UCI. Capillary Biomedical became a Cove @ UCI tenant where it rented two offices and bench space in the Cove @ UCI’s prototyping lab. Strasma and Dr. Joseph began to evaluate how UCI biomaterials might further improve the company’s designs.
“We realized there was an opportunity to spin Capillary into the Cove and obtain access to UCI resources including equipment, laboratory space, rapid prototyping, and knowledge,” Strasma recalled.
The initial draw was 3D printing at the Cove @ UCI’s rapid prototyping lab, which the Capillary engineers used to rapidly refine and test their design. Over time, the company hired UCI student interns and branched out to work with additional UCI faculty advisors while accessing specialized equipment in other labs. The company has submitted a pipeline of additional grant applications to both governmental and private grant agencies.
“A couple of years ago, I noticed that the Cove was becoming the center of gravity for entrepreneurial medical device innovation in Orange County,” said Strasma. “As tenants, we have benefited from being an active part of that ecosystem working side-by-side with early-stage startups and entrepreneurs. There are many opportunities to learn from mentors and peers and pay it forward to the next generation of entrepreneurs.”
Medical device innovation takes years, and Capillary Biomedical is just now planning its first clinical studies, which will support regulatory approval of its improved infusion set. Such studies require significant funding, which the company is busy raising to support commercialization to make its innovative product accessible to people with diabetes.