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Karmanos Cancer Institute First to Prescribe FDA-Approved Device for Advanced Liver Cancer

FDA-approved TheraBionic P1 device, (Image courtesy of Karmanos Cancer Institute)

The Barbara Ann Karmanos Cancer Institute, Michigan’s largest cancer care and research provider, has become the first institution globally to prescribe the newly FDA-approved TheraBionic P1 device for at-home treatment of advanced liver cancer. This cutting-edge technology, now available through Karmanos Cancer Center, offers a groundbreaking approach to care as part of its partnership with McLaren Health Care.

The TheraBionic P1 device is an innovative, portable handheld device that generates low levels of 27.12 MHz radiofrequency electromagnetic fields. These fields are amplitude-modulated at frequencies specific to tumors. During treatment, a spoon-shaped antenna is placed on the patient’s tongue, and the therapy consists of three one-hour sessions each day. The device delivers low levels of radiofrequency electromagnetic fields throughout the patient’s body, effectively blocking the growth of tumor cells while leaving healthy tissue unharmed.

The P1 device received FDA approval in September 2023 for the treatment of advanced hepatocellular carcinoma (HCC), which is the most common type of liver cancer. This treatment is available to patients aged 18 and older who have not responded to first- and second-line therapies. The TheraBionic P1 device is the first FDA-approved systemic therapy that utilizes radiofrequency electromagnetic fields to treat cancer.

Boris Pasche, M.D., Ph.D., FACP, president and CEO of Karmanos, chair of the Department of Oncology at Wayne State University, and co-inventor of the TheraBionic P1 device, highlighted that this new treatment offers additional hope, extended life, and minimal side effects to patients with incurable cancer.

“Having this treatment finally come to market makes a meaningful difference in how we treat this disease and help our patients continue their lives,” Pasche said.

Dr. Pasche is a respected medical oncologist who specializes in treating gastrointestinal cancers and hereditary cancer syndromes. His research is centered on cancer susceptibility and the development of new therapies.

With the Therabionic P1 device, liver cancer frequencies are recognized by receptors on the liver cancer cells, transforming these frequency signals into growth arrest, making them solely effective in treating liver cancer. However, these same frequencies would not work for breast cancer tumors, and the reverse is also true. The radiofrequency levels delivered during treatment are lower than those generated by cellular phones when held close to the body.

HCC accounts for approximately 90% of all liver cancers, with average survival rates between 6 and 20 months. Patients with advanced hepatocellular carcinoma who fail first- and second-line therapies often have severely impaired liver function, with many patients needing to enter hospice care, so additional treatment options were previously limited or nonexistent. Multiple studies over two decades have shown using the TheraBionic P1 device resulted in tumor shrinkage, blocked new cancer cell growth, and increased overall survival rates.

According to TheraBionic, Inc., patients undergoing treatment in these studies did not experience debilitating side effects associated with other cancer-fighting therapies, including loss of appetite, diarrhea, and irritation of the palms and soles.

Robert Perrier’s case highlights the benefits of TheraBionic P1 therapy in treating HCC. Diagnosed in January 2011, he experienced recurrence after surgery and subsequent failed treatments. Perrier began using the P1 device in September 2011 alongside oral chemotherapy, which his physician discontinued two years later due to side effects. From then until he died in 2017, he only received treatments from the P1 device, living nearly six years post-diagnosis. He passed away from kidney failure after declining dialysis following complications from a hip fracture.

His wife attributes her husband’s additional years to using the device.

“…the TheraBionic device has provided my husband several additional years of life,” said Eveline Perrier. “I hope that other patients will be able to benefit from the device in the future.”

Anthony Shields, M.D., Ph.D., is a medical oncologist and a member of the Gastrointestinal and Neuroendocrine Oncology Multidisciplinary Team (MDT) at Karmanos, highlighted often that patients in the past who would have benefited from having more time with their loved ones if this device was available.

“As oncologists who treat gastrointestinal cancers, we often face some of the most incurable diseases. Our team is excited to be able to offer our patients another option in the fight, which is why patients come to Karmanos,” Sheilds said.

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