Update on U.S. Clinical Trial Activities and Positive User/Patient
FARMINGDALE, N.Y.--(BUSINESS WIRE)--June 5, 2007--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 Sonablate(R) 500 ("SB500"), a medical device using high intensity
focused ultrasound ("HIFU") for non-invasive treatment of prostate
cancer. The Sonablate(R) 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
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.
CONTACT: Misonix Contact:
Richard Zaremba, 631-694-9555
Chief Financial Officer
Investor Relations Contact:
Darrow Associates, Inc.
Jordan M. Darrow, 631-367-1866
SOURCE: Misonix, Inc.