Southmead Hospital of England to Treat Prostate Cancer Patients With Sonablate(R) 500 on Fee-Per-Use Basis; Misonix Reports Significant Increase in Number of Medical Sites Offering Treatment
Posted on: Wednesday, 28 June 2006, 09:00 CDT
Misonix, Inc. (Nasdaq: MSON), a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, today announced that North Bristol NHS Trust's Southmead Hospital has joined the growing list of hospitals and medical centers using the Sonablate(R) 500 for high intensity focused ultrasound ("HIFU") treatment of prostate cancer on a fee-per-use basis. The Sonablate 500 is a medical device developed by Focus Surgery, Inc. and manufactured and distributed in Europe by Misonix. In the United Kingdom (UK), the device is marketed through Misonix subsidiary UK-HIFU Limited. The fee-per-use program for the Sonablate 500 was launched in early 2006 and is available in forty sites. Previously, the Sonablate 500 had only been available in the UK for capital equipment purchases.
Southmead Hospital's use of the Sonablate 500 is considered by the respected government-controlled medical institution as a new, advanced technology for the treatment of prostate cancer. The hospital's Bristol Urology Unit will use the HIFU device for non-invasive treatment of prostate cancer. Many doctors are showing interest in the device because of its ability to deliver highly targeted treatment which generally do not require a second procedure for transurethral resection of the prostate, a surgical process in which tissue is cut from the prostate using a resectoscope. A different HIFU device available in the UK requires a separate initial procedure because of its limited ability to treat the size of the average prostate gland. Therefore, the patient must undergo two separate procedures which combine for what is estimated to be a lengthier treatment cycle than the single procedure with the Sonablate 500.
The Bristol community has embraced Southmead Hospital's use of the Sonablate 500. According to a newspaper story in The Bristol Evening Post, Paul Williams, aged 58, was one of the first people to benefit from the HIFU treatment. "When I first heard I had prostate cancer I was really worried that it would be a long painful treatment," he said. "But the HIFU treatment was no trouble at all...I was also concerned that it would make me impotent, but everything seems to be A-OK in that department. After I had the treatment I was back playing golf by the end of the week."
"We believe health care providers using the Sonablate 500 have selected our device among the other alternatives because of its efficacy and its single-procedure treatment that is both sensitive to the patient's lifestyle as well as ongoing efforts by regulators, insurers and medical practitioners to control the cost of health care," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "Our device has the ability to destroy the cancerous tissue and at the same time preserve the vital structures around the gland. Using the Sonablate 500's unique visually directed HIFU process, more precise targeting of cancer cells enable the physician to avoid damaging the neurovascular bundle and other delicate surroundings. As a result, patients enjoy relatively normal post-procedure body functions. Results to date indicate that 90% of men treated with the Sonablate 500 are retaining the same level of erectile function post-treatment as their pre-treatment levels and there have been no cases of urinary incontinence lasting more than six months."
"The Sonablate has led to very positive outcomes for the treatment of more than 100 men with prostate cancer in the UK during the last 12 months alone. In recent months, we have been successful in bringing the device to significantly more medical facilities on a fee-per-use basis, thus enabling the treatment of many more men diagnosed with prostate cancer. There are now a total of forty sites in the UK where HIFU prostate cancer treatment with the Sonablate 500 is available on a fee-per-use basis, which is an increase of approximately 20% during the past two months."
With the Sonablate 500, the health care professional using the device is able to tailor the treatment to the patient, providing the right level of ultrasound to destroy the cancerous tissue while minimizing damage elsewhere. This occurs in one procedure on an outpatient basis, and generally results in the patient being discharged just a few hours after treatment. A normal lifestyle can be resumed in as early two days after treatment. According to those familiar with Southmead Hospital and other medical professionals who have chosen the Sonablate 500, they also appreciate that, unlike other treatment modalities, the HIFU process does not involve an incision, which means the avoidance of complications associated with surgery, and does not expose the patient to ionizing radiation.
UK-HIFU was founded in 2004 to bring the benefits of HIFU technology to cancer sufferers and their families in the UK. Prostate cancer is the first cancer to be treated with HIFU technology in the UK using the Sonablate 500. In April 2006, Misonix announced that it had taken a majority interest in UK-HIFU as a part of Misonix's strategic commitment to expand its HIFU operations in Europe. A key initiative in the UK is close collaboration with leading healthcare providers, principally through the development of relationships with various trusts within the National Health Service ("NHS") system.
The NHS is the publicly funded health care system of the UK. NHS administers an estimated 90% of the healthcare coverage provided in the UK through regional health trusts. Healthcare coverage for the nearly all of the remaining population is provided through private insurance plans. NHS services are predominantly free at the point of delivery and paid for by taxes. The NHS budget for 2005/06 is over $145 billion. Employing well over one million people, the NHS is one of the largest employers in the world.
North Bristol NHS Trust is the largest health trust in the South West Region of England and one of the largest in the country. The Trust provides services for people in the cities of Avon, Gloucestershire, Somerset, Wiltshire and other local areas. In addition to Southmead Hospital, the Trust also provides services from Frenchay Hospital, Blackberry Hill Hospital, Cossham Hospital and Thornbury Hospital. In 2005, the Trust cared for over 100,000 inpatients and day case patients and saw over 300,000 outpatients. Southmead Hospital, a large hospital situated in the northern suburbs of Bristol, England, is now one of forty locations in the UK using the Sonablate 500 on a fee-per-use basis.
The Sonablate 500 has been approved by the UK's National Institute for Clinical Excellence ("NICE"). NICE issued a full guidance report to the NHS in England, Scotland and Wales on HIFU for prostate cancer treatment in mid-2005. UK-HIFU has been working with regulators to secure health insurance reimbursement for prostate cancer treatments using the Sonablate 500. To date, reimbursement for prostate cancer treatment using HIFU medical devices is provided in the UK by certain trusts within the NHS Trust system and by all medical insurance plans with certain conditions.
About Misonix:
Misonix 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 $4 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. In particular, the Company may not be successful in its efforts with respect to strategic opportunities for its Laboratory and Scientific Division and the affect this activity may have on the other businesses within the Company. 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, 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.
Source: Business Wire
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