How is it October already? Soon it’ll be November and time to VOTE (don’t forget!)
Every year since we started the AcKnowledge RS blog, we’ve dedicated a month to medical devices that have not yet received FDA approval. It’s an easy way to see what cool things people are inventing, and maybe give you a small glimpse into the future. Who knows, you might be able to “ask your doctor whether Device XYZ is right for you” in the next few years!
The next device in our series is called VectRx™, a Thermal Treatment (TTx) system being developed as an adjunct therapy for solid tumors. This device comes from Kansas-based device maker, NeoTherma Oncology, and has been granted FDA breakthrough device designation for treatment of pancreatic cancer. The company prides itself in providing a “more effective and more humane solution for treating cancer.”
From the www.neothermaoncology.com website:
“Our technology is based on applying a safe, non-invasive, nonionizing electromagnetic field to produce local ‘fever-range’ temperatures in tumor tissue, intended to increase the effectiveness of anticancer radiotherapy, chemotherapy and immunotherapy. The energy emitted by our TTx device increases blood perfusion in tumor micro-environment, reversing the treatment-resistant hypoxia, and promoting a therapeutic immune response.”
Hold up…let’s back up a minute and talk about cancer…chances are, you or someone you know has been directly affected by this disease. According to the American Cancer Society’s recent report, in 2018 alone there will be an estimated 1,735,350 new cancer cases diagnosed and 609,640 cancer deaths in the United States. This disease is defined as the uncontrolled division of cells in the body. Many cancers form solid tumors, which are abnormal masses of tissue, and can either be benign (non-cancerous) or malignant (cancerous). Solid tumors are named for the type of cells that form them, and include sarcomas, carcinomas, and lymphomas. Treatment for solid tumors is generally a combination of surgery, chemotherapy and radiation therapy.
Pancreatic cancer — statistically known as the deadliest of the solid tumors — is the fourth leading cause of cancer-related death in both men and women. The NIH based National Cancer Institute estimates that 55,440 new cases of pancreatic cancer will be diagnosed and 44,330 deaths will be associated with the disease this year. Last year there was an estimated 43,090 deaths caused by this type of cancer and researchers place the 5-year relative survival rate at a meager 8.5%. Radiation therapy and chemotherapy are currently the main treatment options for pancreatic cancer. Unfortunately, less than 20% of patients are candidates for surgery because pancreatic cancer is often detected well after it has spread beyond the pancreas. Enhancing the efficacy of existing therapies is one crucial way that scientists and doctors can improve treatments for this deadly cancer. With all these stats in mind, it’s not hard to see why FDA designated this product as a Breakthrough Device. It clearly meets the first criterion that states it “provide a more effective treatment for a life-threatening or irreversibly debilitating human disease” [emphasis added].
As mentioned above, the VectRx device provides a radio frequency thermal treatment to raise the temperature around the tumor from 37°C to ~42°C. This localized increase in temperature at the tumor site can support the chemotherapy treatment by increasing the blood flow around the tumor (thus enabling the drugs to penetrate the tumor at lower doses). Warming up the tumor site also likely provokes a therapeutic immune response by increasing the tumor cell surface proteins. Helping make the chemotherapy drugs more efficacious while making you feel less cruddy, along with triggering the body’s natural defense system to attack the tumor, equates to a serious ‘one-two punch’ combination in this fight against cancer! It’s exciting to know that VectRx works at increasing the efficiency of the available treatments, while simultaneously minimizing the harsh effects that those treatments have. The device is being developed for treatment of a wide range of cancers, but the lead target for the company right now is pancreatic adenocarcinoma.
Although surgery, radiation therapy, and standard chemotherapy will continue to play an important role in treating cancer, the emergence of novel adjunct therapies like VectRx will expand the treatment options available to cancer patients. We’re excited to see how FDA and NeoTherma Oncology work together to bring this potentially game-changing treatment to the US market.