Results from Misoniz show that the hemiablation procedures were successfully completed with positive ablation of cancerous tissue in the effected area of the prostate gland, and patients showed 100 per cent continence and potency in follow-up examinations. Misonix, Inc., a developer of ultrasonic medical device technology for the treatment of cancer and other chronic health conditions, has announced the results from the first hemiablation procedures for prostate cancer treatments in a United Kingdom-based study using the Sonablate 500 ("SB500"), a medical device using high intensity focused ultrasound ("HIFU") that is manufactured and distributed in Europe by Misonix.

According to Dr. Mark Emberton, a leading surgeon for the study and member of the Clinical Effectiveness Unit of the Royal College of Surgeons of England, London, UK, the results show that the hemiablation procedures were successfully completed with positive ablation of cancerous tissue in the effected area of the prostate gland, and patients showed 100 per cent continence and 100 per cent potency in follow-up examinations. Unlike many of the traditional prostate cancer surgeries which treat or remove the entire gland, HIFU hemiablation using the SB500 involves ablation of cancer in patients who have had biopsy-proven prostate cancer limited to one side of the prostate.

According to Nick Stevens, Managing Director at Misonix's UKHIFU subsidiary, "The hemiablation technique is very important and the study we are involved with represents the most comprehensive of its kind. This treatment process has significant implications in allowing non-invasive cancer therapy of the prostate while enabling substantial quality of life benefits and reducing patient risk and one-time as well as ongoing healthcare costs. It is with these benefits in view that we are pleased to have these studies partially funded by Cancer Research UK, the leading funder and largest charity of cancer research in the UK, and the approval by the UK National Cancer Research Network (NCRN), which is a UK government organization."

The study is being conducted at the University College London Hospitals NHS Trust (UCLH) to evaluate hemiablation therapy using HIFU in the treatment of localized adenocarcinoma of the prostate (prostate cancer). Dr. Hashim Uddin Ahmed, a clinical research fellow at the UCLH, presented the Hemiablation trial to the assembled clinicians at last week's Annual Misonix HIFU Society meeting. In explaining the necessity for the study, Dr. Uddin Ahmed noted that men diagnosed with localized prostate cancer (cancer that is confined to only the prostate) generally have had limited options of care: active surveillance or radical therapy.

Active surveillance involves ongoing diagnostic healthcare costs for intensive monitoring with PSA and repeat biopsy, until it is determined that the cancer risk has increased and treatment is necessary. Generally recommended radical treatment has involved the destruction or removal of the whole prostate gland; an alternative to radical surgery is radiotherapy or the radiation of the entire gland which has a side effect of radiating all/part of the patient's body. In his presentation Dr Ahmed quoted figures for radical prostatectomy showing erectile dysfunction of between 20-90 per cent, and incontinence of 20-30 per cent. These treatment options presented significant shortcomings for patients, until the new HIFU hemiablation technique was introduced.

The HIFU hemiablation research project challenges the assumption that all men need to have their whole gland and the surrounding structures treated irrespective of the amount and location of their prostate cancer. Men with prostate cancer only evident in one half of their prostate following MRI and extensive biopsy are candidates for this treatment. With HIFU hemiablation, the intent is to provide a form of focal therapy treating only the half of the prostate affected, leaving the other half intact and unaffected. According to surgeons familiar with this process, the concept is similar to that of 'lumpectomy' over mastectomy in breast cancer. The SB500 HIFU study seeks to cure or at least actively control the cancer and not cause any side effects.

"Medical technology companies such as Misonix are making great strides in the treatment of cancer," said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix. "The prevalence of prostate cancer has raised the need for early detection and there are now far more precise methods of diagnosing early stage prostate cancer. For many men with prostate cancer, the associated risks of traditional therapies are not easily accepted. As a result, new treatments and modalities have been sought to eliminate the cancer in its earlier stage before it becomes a greater risk -- as well as when the cancer spreads and becomes a substantial life threatening risk. HIFU with the Sonablate 500, which many are considering the most important trend for the treatment of prostate cancer in Europe as well as around the world, is proving to be the modality of choice for localized as well as broader cancer treatment of the prostate gland."

The SB500 is available in over 20 countries, with more to be added, and to date over 4,000 treatments using the medical device have been completed worldwide. In a study previously announced by Misonix, prostate cancer treatment using the SB500 showed successful outcomes that far exceeded published reports for other HIFU devices and rivaled that of traditional surgical treatment. Important advantages of the SB500 over traditional surgery include that it is a non-invasive procedure that is performed on an out-patient basis and offers significant quality of life advantages.


Source: Misonix, Inc.