Misonix Announces FDA Clinical Trial Enrollment Acceleration for Sonablate 500 HIFU Treatment of Prostate Cancer
Misonix, Inc. (NASDAQ: MSON), a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, today announced the acceleration of patient enrollment relating to the United States Food and Drug Administration (“FDA”) clinical trials for the SonablateÃ‚® 500 (“SB500″), a medical device using high intensity focused ultrasound (“HIFU”) for non-invasive treatment of prostate cancer. The SonablateÃ‚® 500 is approved by the FDA as an investigational device for clinical trials in the United States. The increased enrollment pace pertains to the ongoing FDA approved pivotal study for the treatment of prostate cancer. Over 16 patients in the pivotal study have been treated using the SB500 device at two clinical study sites. A third clinical study site will start treatments in June 2007.
The SB500 is a medical device developed by Focus Surgery, Inc. (www.focus-surgery.com) and manufactured by Misonix. Misonix also has the exclusive European distribution rights for the product. Misonix is an investor in privately-held Focus Surgery, one of the most prominent developers of HIFU in the world. Other investors in Focus include Takai Hospital Supply, Inc. (www.thsinternational.com), which has the exclusive distribution rights to market the SB500 in Asia, Australia, Japan and part of the middle east, and US HIFU, LLC, the exclusive distributor in the Americas region and South Africa. US HIFU and Focus Surgery are leading the FDA clinical trials and approval process.
With the SB500 being used in 6,000 treatments in over 100 clinics in six years, interest in and usage of the HIFU medical device for prostate cancer treatment is gaining momentum. Drs. Michael Alabaster and Walter Rayford recently released preliminary data from the first U.S. clinical trials for the treatment of de novo localized prostate cancer using the SB500. Based on their positive results, the doctors report that interest in participating in the FDA clinical trials has been extremely heavy, with calls received from all over the country requesting patient entrance into the trials.
Dr. Alabaster, managing partner with Southeast Urology Network (“SUN”) of Memphis, TN, had been performing HIFU procedures outside of the United States for approximately two years prior to his participation in the FDA clinical studies using the SB500. He stated that the demand for this procedure is great, with scores of American citizens going for HIFU treatment every month in Europe, Canada, Mexico, and the Dominican Republic where the SB500 is presently being used. HIFU treatment with the SB500 only became available in the U.S. as part of the next phase of FDA approval process which commenced in March 2007. With the approval of the trials by the FDA earlier this year, Dr. Alabaster stated, “I have been inundated with calls almost daily for three months.”
Dr. Rayford, an Urologic Oncologist with SUN, stated that the PSA data for their patients following treatment with the SB500 has been “astounding at six weeks status post-surgery.” He added, “These patients have probably not even reached their nadir yet, and at six weeks we are finding their PSAs typically almost undetectable…[Furthermore,] the side effect profile to date within our clinical trials, as well as previous offshore experience, definitely offers an advantage over the standard treatments presently approved in the United States.”
“There is long-term data out there to support the technology as being as effective, if not more so, than many forms of treatment that presently are being deployed in the United States,” noted Dr. Alabaster. “There is no doubt that this will be a heavily demanded procedure by patients, as they seek other treatments that are less invasive than presently available procedures and maintain a better quality of life.”
The Memphis clinical study site is currently enrolling patients with prostate gland sizes 40 grams or less, Gleason scores of 6 or less, and PSAs scores of 10 or less. Meeting these criteria, Stuart Boyd , a professional pilot from Florida, enrolled for treatment in May. Immediately following the procedure, he stated, ” I was feeling so good the next day, I went out to dinner that night. I found out about this technology from a fellow pilot who had gone to Canada for the same treatment. His result and quality of life was excellent and that led me to search the Internet. I found the trials being offered by Focus Surgery and SUN. I have returned to my normal baseline in several days and was using all bodily functions as they were designed to be used!”
Mr. Boyd offered Dr. Alabaster his thanks for performing the surgery and changing his life. Then, after a short pause, he added, “No, I mean thank you for NOT changing my life in terms of incontinence and impotence.”
Misonix, Inc. (NASDAQ: MSON) designs, develops, manufactures, and markets medical, scientific, and industrial ultrasonic equipment, laboratory safety equipment, and air pollution control products. Misonix’s ultrasonic platform is the basis for several innovative medical technologies. Misonix has a minority equity position in Focus Surgery, Inc. which uses high intensity focused ultrasound technology to destroy deep-seated cancerous tissues without affecting surrounding healthy tissue. 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, 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, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, 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.