Cancer treatment systems maker BSD Medical Corp (BSDM) has secured a certification which establishes that its recently approved MicroThermX Microwave Ablation System (MTX-180) for soft tissue ablation (destruction) is compliant with the “IEC 60601-1” safety standard.
 
IEC 60601-1 is an international standard for safety of medical devices and is a vital tool for demonstrating compliance with regulatory requirements globally, including the requirements for CE Marking and the U.S. Food and Drug Administration (FDA) approval.
 
The safety certification, which is crucial for marketing MTX-180 in the U.S. and internationally, represents a major achievement for BSD Medical. It will enable the company to add the TUV safety mark to the state-of-the-art device as most hospitals and clinics in the U.S. require a safety mark on devices before purchase.
 
The TUV mark is a safety certification mark of Germany-based TUV Rheinland, a global provider of technical, safety and certification services. The addition of the mark to MTX-180 will validate that the device has fulfilled the essential safety requirements.
 
BSD Medical received 510 (k) approval from the FDA for MTX-180 on August 18, 2010, sending its shares up as much as 163% following the news. The MTX-180, one of the company’s leading pipeline candidates, leverages its 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. As such, it can be used by both surgeons and interventional radiologists.
 
Soft tissues are tissues that 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). 
 
Currently, radiofrequency (RF) energy is most commonly used to deliver ablation therapy in the interventional oncology market. The MTX-180 system offers several key advantages over the legacy RF-based systems including delivery of wider ablation zones in less time employing microwave energy. 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.
 
 
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