Ithaca startup aims to free diabetes patients from daily burden

The Center for Life Science Venturers (CLSV) has admitted a promising biotech startup company with deep roots at Cornell.

Persista Bio is pushing toward a goal that has tantalized scientists for decades: treating Type 1 diabetes - which affects 9 million people worldwide - without daily injections, pumps or immune-suppressing medicines.

If Persista's technology works in humans, the implications would be profound: an implant that restores insulin production without triggering immune rejection or requiring immunosuppressant drugs. That could dramatically reduce the risk of side effects, improve normal quality of life and lower costs over time, the researchers said.

Persista Bio was co-founded by Linda Tempelman, Ph.D. '93 and Minglin Ma, professor of biological and environmental engineering in the College of Agriculture and Life Sciences, whose lab developed the foundational encapsulation technology. Dr. Tempelman and her team at Giner Life Sciences developed the enabling oxygenation technology. The two teams got together in 2021 to combine the technologies and have published the resulting work.

Founded in 2023, Persista Bio is still in the preclinical stage, but it has already made strides that suggest it could be one of the most important players in encapsulated cell therapy, according to Ying Yang, the CLSV's director. Its lead technology, the O2Line™ platform, combines two powerful ideas: protected encapsulation of insulin-producing cells and continuous oxygenation to keep those cells alive and functional for the long term.

"This really has a potential to be a breakthrough therapy," Yang said. "With other technologies, maybe the cells are functional but the delivery system isn't - that's the bottleneck. Persista has an encapsulation system which doesn't require immune suppression, but allows full interaction with the body's systems. The technology has the potential to really make a difference."

Type 1 diabetes patients currently must rely on insulin injections or pump systems and constantly monitor blood sugar. Even with those tools, long-term complications - kidney disease, vision loss, cardiovascular damage - remain a serious risk.

According to Tempelman, the core challenge in cell therapy for diseases like type 1 diabetes is that while scientists can establish insulin-secreting cells in the lab from stem cells, keeping them alive once implanted is difficult. The encapsulation that protects them from immune rejection also deprives them of oxygenation; the wrong capsule material tends to cause scar tissue. Both responses degrade the cells' function.

Persista's O2Line system addresses both. It uses a nanofibrous capsule designed to protect the implanted cells from immune rejection while allowing nutrients and insulin to cross the capsule barrier freely. The system also includes an implantable electrochemical oxygen generator licensed from Giner, Inc., which supplies oxygen directly to densely packed cells. In a study published in August in Nature Communications, the Persista team reported that their system reversed diabetes in rats without requiring immunosuppression.

"What we're doing is encapsulating the cells with a membrane that has special properties so the body doesn't reject the cells," Tempelman said. "This means you won't need immune suppression-that is a huge advantage over the approaches taken by other companies. That opens up this treatment to the vast majority of people with T1D. In our system, these oxygenated stem cells sense glucose and put out the right amount of insulin acting like a normal pancreas."

Persista Bio is licensing its technology from Cornell and Giner Labs. Tempelman previously commercialized a transdermal sensor technology at Giner and holds eight U.S. patents. Ma has spent over a decade studying cell encapsulation. Another co-founder, James Flanders, emeritus associate professor at the College of Veterinary Medicine, brings experience in large-animal studies relevant to how devices behave in living bodies.

Persista Bio recently secured two grants from the National Institutes of Health (NIH). One of them, a $2.1 million Direct-to-Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases, will support scale-up to large animal models, validation of the device in minipigs and work on manufacturing under good manufacturing practices (GMP) standards.

"The Direct-to-Phase II grant is to prove proof of concept in large animals," Tempelman said. "As part of the incubator, the team will be onsite in Ithaca, and we will perform preclinical testing at the College of Veterinary Medicine. That's a prime opportunity. With the other grant, Persista will move toward commercial manufacturing of the capsule with a specialized grant that includes Ying Yang as a mentor to new entrepreneurs and principal investigator Beum Jun Kim Ph.D. '04, vice president of engineering at Persista."

According to Tempelman, the O2Line platform could apply to other diseases where cell therapies are constrained by oxygen or fibrosis, such as metabolic disorders, enzyme deficiencies, inflammatory diseases or chronic pain.

Over the next two years, Persista Bio aims to complete large-animal model studies, build its human system prototype and move toward clinical trials. Successful trials would not only validate the technology but could also help the company partner with larger biopharma or device companies, potentially licensing the system or collaborating to bring it to market in diabetes treatment and beyond.