Thermedical, a medical device manufacturer based in Waltham, Massachusetts, received clearance from the Food and Drug Administration for its flagship product, a specialized cancer treatment tool. The product is the first FDA-approval for the 15-year-old company.
Thermedical’s SERF ablation system can be used to kill malignant soft tissue in the body with a targeted beam of radiation. This can be beneficial when treating cancers found in the liver and other parts of the body with soft tissue.
The company behind this device has only seven employees as of now. Since the company was founded (originally under the name of EP Limited), it has provided support for itself by contracting research projects with other medical device companies. According to Michael Curley, the current president of Thermedical, the Saline-Enhanced Radio Frequency (SERF) tissue ablation system has been in development since the company’s inception. The company has also been able to receive grants from a variety of Small Business Innovation Research groups.
The FDA clearance gives Thermedical the ability to sell its SERF system on the market. However, the company does not have the right to make efficacy claims as of yet. According to Curley, the company will hold off on selling this product until its efficacy has been tested on liver cancer. He estimates that clinical tests for the product should begin in 2013. Clinical results and potential efficacy reports should be available within 12 months.
Liver cancer is fatal and very fast-acting. While the market for liver cancer treatment products is over $2 billion, most products currently on the market only increase mean survival times by around a month.