MSON moving on this:
Misonix Announces FDA Grants Investigational Device Exemption -IDE-
for Focus Surgery to Begin Localized Prostate Cancer Trials
Misonix to Manufacture Sonablate(TM) - 500 Systems for Trial
FARMINGDALE, N.Y.--(BW HealthWire)--Dec. 14, 2000-- Misonix, Inc. (NASDAQ NM: MSON, today announced that the Food and Drug Administration
(FDA) has granted approval for commencement of the Focus Surgery's study of High Intensity Ultrasound (HIFU) using the Sonablate(TM) - 500 System for the
treatment of prostate cancer. Misonix owns 20% of Focus Surgery, and is the manufacturer of the Sonablate(TM) - 500 System. Enrollment of a total of 40 patients
is expected to begin immediately under an Investigational Device Exemption (IDE) granted by the FDA. Misonix plans to manufacture and ship the systems for use in
the pivotal studies during the first quarter of 2001.
Under the IDE, Focus will utilize two separate protocols. The first will treat 20 patients electing HIFU as their first defense against prostate cancer. The second will
study 20 patients whose localized prostate cancer has recurred following an earlier, unsuccessful treatment modality. Studies will be conducted initially at two sites in
the U.S.
These treatment protocols were based on the consensus of an international panel of leading urologists recently assembled at Indiana University Medial Center, and
the results obtained by Dr. Toyoaki Uchida of Kitasato University in Tokyo, Japan, who has been treating patients with the Sonablate for localized prostate cancer
for the last two years. The goal of these two protocols is to restore the prostate specific antigen (PSA) to normal levels, or less than 0.5ng/ml.
Dr. Michael Koch, Urology Department Chairman of Indiana University Medical Center said, ``As a pioneering center for the development and advancement of
HIFU, we look forward to beginning the prostate cancer treatment at Indiana University.'' Another principle investigator in the trials, Dr. Martin Resnick, M.D.,
Urology Department Chairman at Case Western Reserve University/University Hospitals Cleveland said, ``Based on our success with the treatment of Benign
Prostate Hyperplasia (BPH) with the Sonablate(TM), and the significant results by Dr. Uchida, we believe the use of ultrasound for prostate cancer represents a
significant advance in the treatment of prostate disease. We at Case Western look forward to working with Focus Surgery on this important program.''
Results of Dr. Uchida's testing show that HIFU is effective in dramatically reducing the PSA levels, without blood loss, or complications, and, unlike most other
prostate treatments, is retreatable.
President and CEO of Focus Surgery, Narendra Sanghvi said, ``We are extremely pleased with the FDA (IDE) approval to let us start treatment of the prostate
cancer with the Sonablate(TM). This will enhance the Sonablate(TM) applications for benign and malignant tumors, making it a truly multifunctional HIFU platform.''
President and CEO of Misonix, Michael McManus said, ``We are very pleased with the progress of Focus Surgery in the management of prostate diseases. Our
partnership has now finished design of a new Sonablate(TM)-500 System. Misonix is ready to manufacture Sonablate(TM)-500 and plans to start shipment of these
new devices in the first quarter of 2001.''
The HIFU technology is capable of destroying deep-seated tissue by rapidly elevating the temperature in a precise focal zone, without affecting the intervening tissue,
and without ionization effects. The Sonablate(TM) system is currently in Phase III PMA trials at five sites in the U.S. for the treatment Benign Prostate Hyperplasia
(BPH). Patients participating the study have generally been able to resume normal physical activities within forty-eight hours of treatment. The treatment is quick,
bloodless and has minimal complications.
Focus Surgery is the leader in the development and commercialization of minimally invasive surgical devices using HIFU for the treatment of various diseases
including Benign Prostate Hyperplasia (BPH) and prostate cancer.
Misonix, Inc. develops, manufactures and/or markets medical, scientific, and industrial ultrasonic and air pollution systems, and maintains a minority equity position in
Focus Surgery as its exclusive manufacture of the Sonablate(TM) system
Forward Looking Statement: Statements in this news release looking forward in time are made pursuant to the Safe Harbor Provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties, including general economic conditions, delays
and risks associated with the performance of contracts, uncertainties as a result of research and development, potential acquisitions, consumer and industry
acceptance, litigation and/or court proceedings, and regulatory risks including approval of pending and/or contemplated 510(k) filings.
Contact:
Misonix, Inc., Farmingdale
Michael McManus, Jr., 631/694-9555
President and CEO
www.misonix.com
- or -
Investor Relations:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212/838-3777
kim@lhai.com
Bruce Voss, 310/575-4848
bruce@lhai.com
www.lhai.com |
