In recent years, a number of ablation (removal or excision) procedures have found their way into the armamentarium of surgeons and interventional radiologists. RFA (Radiofrequency ablation), LITT (laser interstitial tumor therapy), cryotherapy and microwave therapy are a few to name.
The most frequently used in the interventional oncology ablation market is radiofrequency. However, with microwave energy proving to be more advantageous over radiofrequency, medical experts regard microwave as the future of soft tissue ablation therapy.
The soft tissues include, muscle, tendons, ligaments, synovial tissue, and other structures such as nerves, blood vessels and fat. If these soft tissues become diseased or develop cancers, ablation, which is an alternative to surgery, is used to achieve cell death in the soft tissue.
The surgical ablation of soft tissues is expected to see significant growth in the next few years, and a number of companies are developing and marketing ablation products. The soft tissue ablation world market potential is estimated to exceed $2 billion.
Now, one more new device has been added to the ablation lineup, following the marketing clearance of BSD Medical Corp.'s (BSDM) MicroThermX Microwave Ablation System (MTX-180) on Wednesday. The news sent the company's shares soaring as much as 124% in intraday trading to $3.60, before it settled down at $2.97.
BSD is focused on developing hyperthermia cancer treatment systems and microwave ablation systems. The company's hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy, while its microwave ablation system has been developed as a stand-alone therapy to ablate and destroy soft tissue.
The MTX-180 provides minimally invasive access to the target tissue and can be used in open surgical as well as in percutaneous ablation procedures, which will allow the MTX-180 to be used by both surgeons and interventional radiologists.
The MTX-180, a phase II ablation system, is a compact, mobile system that includes a state-of-the-art computer, a microwave generator, single-patient-use disposable applicators and a proprietary thermistor-based temperature monitoring system. The device uses precision-guided microwave energy to ablate (destroy or vaporize) soft tissue.
In September 2008, the FDA granted marketing clearance for the company's phase I ablation system - MicroThermX Microwave Ablation System (MTX-100) for ablation of soft tissue. The newly cleared phase II ablation system MTX-180 is expected to provide a wider range of clinical application.
The company has thus far been deriving revenue from sales of hyperthermia cancer treatment systems like BSD-500 and BSD-2000. The BSD-500 is a hyperthermia cancer treatment system approved by the FDA for use alone or in conjunction with radiation therapy to treat certain tumors. Yet another hyperthermia cancer treatment system is BSD-2000, which includes the BSD-2000, the BSD-2000/3D and the BSD-2000/3D/MR.
The BSD-2000 system has not yet received pre-market approval from the FDA for commercial marketing in the United States, but has obtained an investigational device exemption, or IDE, for placement in the United States for research purposes only. BSD-2000 has won regulatory approval in China and been sold there since 2005.
Since inception through May 31, 2010, BSD has generated an accumulated deficit of $22.93 million.
In early February, the company entered into securities purchase agreement with two institutional investors for the sale of 1,176,471 shares of its common stock in a registered direct offering at $1.70 per share. The completion of the offering was closed on February 17, 2010. The warrants, which are exercisable beginning yesterday (August 18), expire 5 years after becoming exercisable and have an exercise price of $2.04 per share.
Now that MTX-180 has been cleared in the U.S. for marketing, BSD expects MTX-180 to represent a major part of its business plan moving forward and provide additional revenue streams. The company is optimistic of CE Marking approval for the MTX-180 System, which will allow for the initiation of a European market launch.
BSDM has been trading in the range of $0.86 to $4.77 over the past twelve months. The stock closed Wednesday's trading at $2.97, up 163% on a volume of 27.68 million shares. In after-hours, the stock further gained 8.75% to reach $3.23.
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