In December, Detroit-based Barbara Ann Karmanos Cancer Center became the first facility in the world to offer at-home liver cancer treatment with the TheraBionic P1, a device recently approved by the FDA.
Co-invented by Karmanos Cancer Institute President and CEO Boris Pasche, MD, PhD, the TheraBionic P1 uses radiofrequency electromagnetic fields at specific frequencies to target liver cancer tumors.
Dr. Pasche recently spoke to Becker's about the device and what it means for the future of cancer care.
Editor's note: Responses have been lightly edited for clarity and length.
Question: Can you briefly explain how the TheraBionic P1 works?
Dr. Boris Pasche: It is a small, portable device. The patient holds a spoon in their mouth. That's the treatment. Once the treatment starts, the patient receives it for one hour. The device emits 27 MHz radiofrequency electromagnetic fields that are amplitude-modulated at tumor-specific frequencies ranging from 380 Hz to 100 kHz, which have been identified to block the growth of tumor cells, shrink them and transform them into scar tissue in patients with liver cancer.
This treatment is delivered three times a day for one hour and the body itself becomes the antenna, allowing the signal emitted by the device to be dispersed and absorbed throughout the entire body. Additionally, we have found that these electromagnetic fields do not affect normal tissue. The frequencies are tumor-specific, meaning they selectively block the growth of tumor cells in the liver and its metastases. This makes it a systemic, targeted therapy for liver cancer, indicated for patients who have failed first-line and second-line therapy.
Multiple studies conducted over the past 20 years with this technology, which led to FDA approval of the device, showed an overall survival extension of approximately 34%. Tumor shrinkage was observed in about 10% to 15% of patients, and there were virtually no significant side effects that led to discontinuation of treatment.
Q: How has the device been integrated into care at Karmanos?
BP: In the big scheme of things, the TheraBionic technology offers a new addition to the cancer therapies we have and one that can be easily added to existing therapies. When you have a patient with liver cancer that has failed checkpoint inhibitors and progresses to receiving one of the three approved tyrosine kinase inhibitors, you're running short of options. Many of these patients are still in good physical condition yet frequently have very few options.
TheraBionic is the only FDA-approved therapy indicated in liver cancer patients that fail first-line and second-line therapy, so that's really the place it takes right now in 2025. Patients can receive the treatment if they are in the hospital, though the majority of patients will have most of their treatment delivered at home.
Q: How do oncologists manage patient care with an at-home device?
BP: The device also registers the length of time the device was in use. When a patient comes back to the physician, they bring the device. The physician will register the number of hours and minutes left and have an exact measurement of treatment compliance. So while there is some documentation, it's fairly easy for both the patient and the physician, and it's transparent. You can immediately see if the patient took the treatment properly. And if not, you can address it.
CMS issued a new CPT code for this technology and it is being integrated into the EMR as a novel treatment modality.
Question: How does the TheraBionic P1 device align with Karmanos’ long-term strategy? What lessons can other hospitals/health systems learn from your approach?
BP: The device and its potential for diseases align extremely well with the priorities of Karmanos and its core message: a world without cancer. There is potential to use these tumor-specific frequencies for other tumor types. Two studies will be opening very soon at Karmanos. One will be the post-approval study for liver cancer, and one will be for stage 4 pancreatic cancer. We also have several other protocols in preparation for breast cancer, colon cancer and ovarian cancer.