Cancer treatment systems maker BSD Medical Corp (BSDM) has secured 510 (k) approval from the U.S. Food and Drug Administration (FDA) for its MicroThermX Microwave Ablation System (MTX-180) for soft tissue ablation (destruction). With this approval, the company can now commercialize the innovative device in the U.S. BSD Medical’s shares jumped $1.84 (or 162.8%) following the news closing at $2.97 on August 18.
The MTX-180, one of BSD Medical’s lead pipeline candidates, leverages the company’s proprietary synchronous phased array technology to deliver precision-guided microwave energy to ablate soft tissues using a single-patient-use disposable antenna. The minimally-invasive device has been developed to provide treatments as a stand-alone therapy and has applications in open surgical and percutaneous (via needle-puncture of the skin) ablation procedures. It can be used by both surgeons and interventional radiologists.
Soft tissues connect, support or surround non-skeletal structures and include muscle, ligament, tendon, fascia, blood vessels, nerves and fat. Ablation therapies are widely used in cancers of soft issues (soft tissue sarcoma).
The global market potential for soft tissue ablation has been estimated to exceed $2 billion, a significant revenue opportunity for a micro-cap company like BSD Medical. The MTX-180 has been specifically targeted at the growing interventional oncology market with worldwide revenues in excess of $200 million in 2009. This market has been projected to grow to nearly $500 million by 2015.
Currently, radiofrequency (RF) energy is most commonly used to deliver ablation therapy in the interventional oncology market. Based on published results from various studies, the state-of-the-art MTX-180 system delivers wider ablation zones in less time, employing microwave energy.
MTX-180 will thus offer physicians a user-friendly and optimized microwave ablation therapy having several key advantages over the legacy RF-based systems. BSD Medical expects to receive the CE mark for the device in the near future, which will enable it to launch the therapy system in Europe.
