Healthcare Industry News:  kidney cancer 

Devices Oncology

 News Release - March 12, 2008

Misonix CEO Announces HIFU Strategy Targeting Cancer Therapy

FARMINGDALE, N.Y.--(HSMN NewsFeed)--Misonix, Inc. (Nasdaq: MSON), a developer of minimally invasive ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, issued today the first formal statement from its Chief Executive Officer Michael A. McManus, Jr. regarding the Company’s High Intensity Focused Ultrasound (“HIFU”) strategy. HIFU is a minimally invasive novel medical technology through which intersecting, precision focused ultrasound waves raise the temperature of the target tissue to 80-90 degrees Celsius in two to three seconds, effectively destroying the targeted cancerous tissues.

As a backdrop for the formal HIFU strategy statement, last week Misonix announced that it had entered into an agreement pursuant to which Misonix agreed to sell its equity position in Focus Surgery, Inc. Focus Surgery is a developer of HIFU technology and the Sonablate® 500 (“SB500”) for the HIFU treatment of prostate cancer. Although agreeing to the sale of its equity position in Focus Surgery, Misonix maintained the following: its exclusive rights as the global manufacturer of the SB500 for Focus Surgery; the right to distribute the SB500 in the European Union and Eastern Europe; and the rights to use Focus Surgery’s HIFU technology for Misonix to develop, manufacture and market medical devices for HIFU treatment of cancer in the kidney, liver and breast.

Mr. McManus stated: “The intent of the Focus Surgery equity sale was to extract value by monetizing this asset which was carried on our balance sheet at $0 as it had previously been written down. As a result of our agreement to sell our equity interest in Focus Surgery, we now anticipate the receipt of approximately $2.15 million plus an amount for reversing a tax reserve for a total consideration of approximately 10% of our publicly traded market value, which will serve as a means of further strengthening our balance sheet. Meanwhile, we maintain all of the same rights for manufacturing and product development pertaining to Focus Surgery’s HIFU technology, and we are positioned to pursue other HIFU initiatives.”

Misonix: The World’s Most Advanced and Extensive Platform of Therapeutic Ultrasound Medical Devices

“Misonix is proud of its position as the world’s leading provider of therapeutic ultrasound medical devices and a HIFU platform for multiple indications,” Mr. McManus continued. “As a company focused on the use of ultrasound for the development of unique medical devices, we believe there is no more important and powerful technological platform than that of HIFU. We believe HIFU is undeniably the basis for innovative “next generation” medical devices that will be used around the world and taught in medical schools as a new standard of care. Ultrasound -- and HIFU in particular -- are gaining global prominence, with companies in the United States, Europe and China at the forefront of development of medical devices based on this technology.

HIFU – Prostate Cancer

“Our initial exposure to the many benefits of HIFU began with the creation of the SB500 for prostate cancer treatment as part of our original investment in Focus Surgery. Around the world approximately 550,000 men a year are diagnosed with prostate cancer, which has an estimated annual market value for treatment of $750 million. Misonix is the sole manufacturer of the SB500 for Focus Surgery and we distribute it in the European Union and Eastern Europe. On a global basis, the SB500 has now been used in more than 6,000 treatments in over 100 clinics over the past six years.

“With regard to our distribution of the SB500, we presently have agreements to market the product in 11 European countries. The priority for Misonix with its first commercial HIFU medical device, the SB500, is to focus on broadening the use of the product on a fee-per-use basis. This business model, which is intended to deliver a longer life span of revenues for each practitioner using the device, will allow us to place more units in the field and foster greater awareness of the many benefits of HIFU in the medical community.

“There are many important benefits of HIFU. The process is less invasive than other procedures and does not require potentially harmful radiation; treatments are patient-friendly with limited surgical side effects; it is a repeatable procedure; it typically requires a shorter procedure time; and it appeals to the medical industry’s desire for innovative and advanced practices that ultimately improve healthcare and reduce costs.

HIFU – kidney cancer

“Leveraging our work with the SB500, Misonix has for the past few years invested in research and development toward the completion of the Sonatherm, a medical device for HIFU ablation of soft, cancerous tissue. With this medical device, we are targeting kidney tissue as our first indication. Misonix is the first company to receive 510(k) approval for a minimally invasive procedure using HIFU in the United States, which we are applying toward the treatment of kidney tissue.

“We have designed and improved HIFU probes internally at Misonix for improved treatment of kidney tissue. We have reported successful procedures using this technology in the kidney at Oxford University in the United Kingdom and at the University of Vienna in Austria. These are Phase 1 studies that are being conducted at two sites; we will be starting a third study in the near term. Our clinical work and the satisfaction of regulatory requirements will enable us to participate in the market of approximately 200,000 cases of kidney cancer that are diagnosed around the world each year. The annual market value for treatment of kidney cancer is estimated at $150 million.

HIFU – Liver Cancer

“Based on the technology of the Sonatherm device, we will be applying our expertise for HIFU treatment to other cancer indications, including liver and breast tissue. The incidence of liver cancer is more prominent in Asian countries. Nearly 95% of the estimated 500,000 diagnoses of liver cancer per year are made outside of the United States. The total market for treatment of liver cancer is estimated to be $700 million annually.

“Misonix will be developing a medical device for the laparoscopic HIFU ablation of tissue to treat liver cancer. We believe our HIFU modality is superior to other commonly used treatments in that our process will not require puncturing of the organ or cutting off the blood supply, bleeding is reduced, is less invasive, and should be favorably received by patients and doctors given the high mortality rates of surgical resection. Throughout 2008, Misonix will be working on the development of a new probe and other equipment leading toward the completion of a HIFU product to treat liver tissue. We plan to commence clinical studies, including procedures on the human kidney, in 2009.

HIFU – Breast Cancer

“Around the world approximately 1.1 million women a year are diagnosed with breast cancer, which has an estimated annual market value for treatment of $600 million. Following our efforts in the kidney and liver, we will leverage our existing technologies to accelerate development of a HIFU product to treat breast tissue.

“It is our intent to continue to strengthen our intellectual property through the addition of patents as well as bringing new products, processes and technologies to market. Misonix has received 45 patents with an additional 19 patents pending (published and non-published) with regard to therapeutic ultrasound products. We will continue to work with the FDA on new integrated imaging features and motion control for wider surface treatment of tissue for the probes used with our HIFU medical devices.

“Misonix continues to make progress with its unique medical devices used for large and important therapeutic markets. We continue to insulate our business from competition while working toward differentiating our medical devices as superior to conventional surgeries and other non-ultrasound technologies. The barriers to entry we are creating include years of ultrasound research and significant investment in HIFU and other technologies. Our expert Research & Development staff will continue to work internally to develop the expertise to improve our current HIFU technology and to apply this knowledge to potential, new applications using HIFU. With the proceeds from the sale of our equity stake in Focus Surgery and the improved operating performance of Misonix’s other business lines, we are better positioned with improved financial resources to accelerate the development and sale of our HIFU products.”

About Misonix:

Misonix, Inc. (NASDAQ: MSON ) designs, develops, manufactures, and markets, therapeutic ultrasonic medical devices, and laboratory equipment. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $3 billion annually, Misonix’s proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company's Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.


Source: Misonix

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