A Richland company’s breakthrough radiation therapy that’s seen success in treating cancer in animals is closing in on FDA clearance.

Vivos Inc. has licensed and improved a proprietary hydrogel technology patented by Battelle to deliver powerful next-generation radiation therapy that the Food and Drug Administration has called a “breakthrough device.”

As Vivos President and CEO Mike Korenko explained, RadioGel for human use and IsoPet for animals is an injectable precision radionuclide therapy. It uses highly localized short-range beta radiation to destroy cancerous tumors by placing the radioactive isotope Yttrium-90 phosphate directly inside them.

The treatment is safer and less invasive as it treats from within the tumor compared to traditional external-beam radiation that zaps cancer cells from outside the body, potentially exposing healthy tissues.

The hydrogel is liquid at room temperature, then gels up inside the tumor, spreading to half a centimeter, for precise treatment that minimizes damage to surrounding healthy tissue.

Yttrium-90 features a short half-life of three days, delivering more than 90% of its radiation within 10 days, as opposed to six weeks or more of therapy using other treatment options.

Over a few months, the hydrogel dissolves into a sort of fine and inert sand that poses no harm to the body.

Most tumors tested are eradicated after one injection.

“If we can image it and reach it with a needle, we can kill it … 80% of cases have been resolved in one treatment, though large tumors sometimes have to be hit more than once and afterward the leftover tissue may need to be removed surgically,” Korenko said.

RadioGel typically requires one treatment versus six to eight, thanks to the higher therapeutic dose that can be administered to the targeted treatment area compared to other radiation therapies.

In short, “it’s an incredible technology … an elegantly simple tool,” Korenko said.

Because the FDA considers it a “breakthrough device,” the review priority is expedited for Vivos’ investigational device exemption submission seeking authorization to begin human clinical trials.

Partners at the Mayo Clinic are standing by for the green light.

Vivos has been in pursuit of FDA clearance for nine years.

“We are confident that thus far our submissions have provided 90% to 95% of the information they require,” Korenko said in a July 29 statement. He said the company plans to resubmit additional information within the next 45 days to address the FDA’s most recent round of feedback.

“We’re making history in Tri-Cities,” Korenko told the Tri-Cities Area Journal of Business.

First used in animals

Vivos’ RadioGel technology is not without precedent. The company has proved its own concept using its IsoPet product for animals.

The FDA doesn’t require pre-market approval for veterinary devices, so Vivos and its eight partner clinics across the U.S. have been able to make the treatment electively available to pet owners.

About 25 pets have been treated so far.

“We’re learning a lot from the animal therapies that will bear fruit for the human treatment,” Korenko said.

IsoPet was first tested on a cat with sarcoma at Washington State University in 2018, then on a dog’s soft tissue sarcoma at the University of Missouri in 2019.

Kennewick vet tests it out

Vista Veterinary Hospital at 5603 W. Canal Drive in Kennewick was the first private practice clinic in the nation to begin offering IsoPet injections.

Dr. Michelle Meyer recalled how one of her fellow Vista veterinarians had a connection to Korenko and requested a sit-down about the possibility of offering it.

“It skyrocketed from there,” she said.

Meyer flew to Missouri in 2019 to observe Vivos’ clinical trial at the University of Missouri.

Soon after she performed Vista’s first IsoPet treatment on an 11-year-old cat named Drake with spindle cell sarcoma near his nose. Drake’s owner, also a veterinarian, brought him from Alaska.

Maxximus, an 11-year-old dog, was one of the most recent patients, having received a single injection in February.

“Five, maybe six years ago, Maxximus developed a tumor in his left leg. We got chemo at WSU,” said his owner, Jason Hargrove. “Ever since, he’s had more bouts of spindle cell tumors.”

Then more tumors began to develop, including another in the same place on his leg, but bigger than before.

“The area was too big to heal and be removed properly; it would have been an amputation,” Meyer said. Amputations are common in animals when tumors develop on the limbs, Korenko said.

“At his age, that would have been almost life ending with his breed and possible hip problems,” Meyer said.

“IsoPet was a serious life changer; it was the best option to both save his leg and his life,” Hargrove said of the dog he brought home from the Benton-Franklin Humane Society as a tiny pup.

One IsoPet treatment later and the site is cancer-free, though the tumor mass remains as scar tissue.

“Before treatment, he was limping a lot and pulling up the leg but now he uses it like it’s no big deal,” Hargrove said.

“IsoPet works best on soft tissue sarcomas, but we have tried it on multiple types of tumors,” Meyer said. “Soft tissue sarcomas are interesting because there is a primary tumor, but it has fingerlike projections and it’s hard to get all of it with traditional therapy techniques.”

“Normally, (before IsoPet) we would have to refer patients to an oncologist at WSU or on the west side. Radiation therapy is usually not a one-time treatment and people can expect their pet to spend anywhere from one to three weeks at either the hospital or boarded in between treatments. Some people opt to stay in a hotel with their pet,” Meyer said.

Traditional radiation therapy can range from $2,500 to $7,500 and up depending on the number of treatments required. That doesn’t include the cost of travel, boarding and lodging for pet owners.

One injection of IsoPet costs $10,000 and pets can go home the same day.

Meyer stressed early detection and taking action being key to the success of the treatment. Waiting can lead to metastasis or larger tumors that are harder to treat.

The road ahead

This summer, the IsoPet team hit the road, canvassing the country to raise awareness about cancer in animals and provide education about IsoPet as a treatment option. It hopes to recruit more clinics to administer IsoPet and eventually expand its reach internationally.

Brad Weeks, business development manager at Vivos, said the company is working on breaking IsoPet into three targeted market segments: small household animals like dogs and cats, horses, and exotic animals.

He said that IsoPet presents a lot of value to zoos which put significant investments into their animals.

“Think of a bird that lives to be 70 – the options for a bird with a tumor on its wing would be to take the wing – but some animals don’t adapt well. (The other option is) to perform surgery, but smaller animals don’t do well in surgery,” Weeks said.

IsoPet also resolves the logistics of treating horses with cancerous tumors. Horses are often too big to be treated in clinics and can’t usually be boarded on site like household pets to undergo full treatment using other radiation methods.

Korenko noted the value proposition for million-dollar racehorses and pet horses alike that can live up to 30 years.

According to Global Market Insights, the global equine veterinary oncology market is projected to be valued at $1.7 billion by 2032, up from $923.5 million in 2023.

One partner veterinarian, Dr. Bill Bradley of New England Equine Practice in New York, also has seen success in treating caudal nerve heel pain in horses using IsoPet, making multiple targeted injections to kill the nerve. He’s now exploring treating other nerve-related issues in horses using IsoPet.

Potential uses

“There is a lot of potential here,” Korenko said, rattling off ways doctors and researchers have approached Vivos about testing in humans: cancer of the spine, brain, pancreas, lung, lymph node, thyroid, ocular melanoma, post-mastectomy cavity, in combination with autoimmune therapies and more.

Korenko said he’s taken some “sad calls” along the road to FDA clearance from desperate doctors facing difficult cases.

“In oncology, they never say ‘cure,’ they say ‘life extension.’ But I’m here to say that our goal is to cure it,” he said.

Go to: isopet.com, vivosinc.com