From laboratory innovation to cancer care, USF-born technology offering pet owners hope

By John Dudley, University Communications and Marketing

A Tampa Bay-based innovation backed by more than three decades of federally funded university research is poised to change how cancer drugs are delivered - using electricity and gentle heat instead of invasive procedures or high-dose chemotherapy. The technology is now in veterinary cancer trials, the final step before planned human clinical testing.

LifePulse Bioscience, a biotech startup spun out of the University of South Florida, has developed a device that enables precise, localized delivery of cancer drugs through short bursts of electric pulses. The work is supported by approximately $35 million in federal grants, including from the National Institutes of Health, and led by longtime USF biomedical researcher Richard Heller, a pioneer in the field of electroporation.

"This started as a fundamental question about how to get medicine inside a cell," Heller said. "By using electric fields, we can open temporary pathways in cell membranes so that drugs or genes can get inside and do their job."

Heller began exploring electric-field drug delivery in the early 1990s and was soon joined by then-graduate student Mark Jaroszeski, now a professor of medical engineering at USF. They conducted the first U.S. clinical trials delivering chemotherapy to solid tumors. From there they worked together to establish USF as a leader in gene electrotransfer research, conducting the first clinical trial in the world using electric fields to deliver DNA-based treatments.

A breakthrough came in 2019, when Heller met Gary Strange, an investor struggling to commercialize a European technology in the same space.

"After about 10 months beating my head against a wall with that, I met Dr. Heller," Strange said. "And that's when everything changed."

Heller and Jaroszeski had already optimized the electrical parameters and electrodes, but a key discovery - adding mild heat and monitoring tissue impedance - made the process far more efficient. Tissue impedance is the amount of resistance that skin and other tissues have to electrical current.

"We found that gently warming tissue to about 43 degrees Celsius (109.4 degrees Fahrenheit) before pulsing, and using real-time electrical feedback to guide the process, increased delivery success rates by roughly tenfold, Jaroszeski said. "That was the breakthrough that made it commercializable."

Built in Tampa Bay, tested by Florida veterinarians

LifePulse Bioscience applies a short series of low-energy electrical pulses directly to tumors, temporarily opening pores in cancer cells so drugs can enter and attack the disease at its source. The localized treatment reduces the need for high systemic doses and minimizes the widespread side effects of treatments such as chemotherapy.

The devices are designed and built by Clearwater-based medical equipment manufacturer Concise Engineering, led by USF MBA graduate Justin Bushko.

Bushko helped refine the system's hardware for reliability and consistency in clinical use, and he is delighted to see his company play a role in its commercialization.

The company's next-generation modular electrode design allows adaption for different tumor sizes and sites - potentially extending applications from veterinary cancers to human skin and internal tumors.

"Patients don't get sick from this procedure," said Dr. Erin Roof of Florida-based Animal Cancer Care Clinic, one of several veterinarians now participating in early clinical use. "The whole process takes about an hour, usually just one or two treatments. Side effects are minimal - maybe some redness or flakiness around the site - and most patients go home and feel fantastic."

Roof said her practice adopted the therapy to give owners access to a less strenuous, more affordable cancer treatment option.

"The results are night and day," said Strange, who recently finalized an international distribution agreement for the United States, Canada and the United Kingdom with Patterson Veterinary, a $4.1 billion global vet distribution company.

He hopes the deal sets the stage for additional investment and rapid growth.

From grant funding to real-world impact

LifePulse Bioscience's progress underscores the value of sustained federal research investment, most recently being awarded a $2 million NIH Small Business Innovation Research grant to bridge the gap between academic discovery and market-ready technology.

"That $35 million wasn't venture capital," Jaroszeski said. "It was public funding that let us build a strong scientific foundation. Now investors are coming because the science is already de-risked."

The ongoing veterinary trials are considered translational, providing data to inform FDA submissions for human use. If outcomes continue to show promise, Heller believes the first human clinical trials could begin within the next year.

"We already have clinicians talking with us who want to use this technology in human studies," he said. "Our next steps are completing the veterinary data, building more systems and moving through the FDA process."

While LifePulse Bioscience is beginning in veterinary oncology, its platform could one day deliver a broad range of treatments precisely without systemic toxicity. Strange and Heller hope its impact will ultimately be measured by effective, milder, more affordable cancer treatments.

"How many good drugs that could be game changers for people have failed efficacy because they had no delivery mechanism to get them there?" Strange said. "For these scientists and for me, it's got nothing to do with the money. Will it be worth a lot of money? I'm sure it will. But it's about getting this technology into the clinic to help people who need it."