We are pleased to announce the MDL from Health Canada to market the LIPOSONIX system in Canada, said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis Pharmaceutical Corporation. We believe the LIPOSONIX body contouring technology will position Medicis Aesthetics Canada for continued leadership in the popular Canadian aesthetics market by providing an effective and non-invasive procedure for the reduction of subcutaneous abdominal fat. We believe many adults wanting to reduce their waistlines by several centimeters could be potential candidates for the LIPOSONIX treatment.
The LIPOSONIX system is designed to focus high intensity ultrasound to cause permanent disruption, or ablation, of subcutaneous adipose tissue in the anterior abdomen without damaging the epidermis, dermis or underlying tissues and organs. A custom-designed ultrasound transducer delivers energy across the skin surface at a relatively low intensity, and brings this energy to a high intensity focus at precise depths in the targeted subcutaneous adipose tissue, causing thermal coagulation of the adipose tissue within the focal zone of the ultrasound beam.
Large white blood cells, or macrophage cells, are attracted to the treated area, engulfing and transporting the damaged tissue and lipids through the lymphatic system to the liver, where the lipids are processed by the body’s normal biochemical pathways. The damaged tissue in the treated area is resorbed over a period of several weeks, which can yield an aesthetic body contouring effect.
During clinical development, the LIPOSONIX technology has demonstrated effective, non-invasive contouring of the abdomen which:
•Results in little to no patient down time;
•Involves one treatment of approximately one hour; and
•May reduce waistline circumference by up to several centimeters.
In clinical studies to date, a single LIPOSONIX treatment of approximately one hour duration resulted in an average 2.8 cm reduction in waistline circumference. Results were typically seen in 8 to 12 weeks. Individual results may vary.
The LIPOSONIX technology was developed over a period of nine years by leading engineers, ultrasound experts and physicians with more than 200 years of combined experience in ultrasound technology. Medicis holds and has pending numerous patents in the US and worldwide related to the licensed LIPOSONIX system and technology. The LIPOSONIX system is in full compliance with both the European Union (EU) Electromagnetic Compatibility Directive and the EU Low Voltage Directive, CE marked accordingly and is currently marketed through distributors in member states of the EU.
The LIPOSONIX treatment is not intended as a replacement for liposuction, but as an alternative body contouring procedure that may appeal to a much broader audience due to its non-invasive nature. According to the most recent statistics available, liposuction ranks as the number one surgical procedure requested by Canadian men and women.
Medicis Aesthetics Canada anticipates launching the LIPOSONIX system in Canada in the second half of 2009, which is in line with the Company’s original expectations and most recent guidance.
The LIPOSONIX system is not for use in patients with a coagulation disorder or who are receiving anticoagulant therapy or who have an implanted electrical device.
The LIPOSONIX system is not for use on patients with a body mass index (BMI) greater than 30, in areas with less than 1 cm of adipose tissue beyond the selected focal depth or areas previously treated with injection lipolysis, liposuction, abdominoplasty or other surgery (open or laparoscopic) or where hernia, implanted material, sensory loss or dysesthesia is present.
The LIPOSONIX system is not for use on patients with cancer or systemic disease, who are taking prescription drugs for a chronic condition or who are pregnant, suspected to be pregnant or lactating.
During treatment as recommended, patients may experience cold, prickling, tingling, warmth, discomfort or pain. The most common post-treatment side effects include temporary erythema, mild ecchymosis, discomfort and edema.
