A Medical Device Daily Staff Report

Solta Medical (Hayward, California), a developer of aesthetic skin treatments, reported Health Canada approval of its Thermage CPT and Fraxel re:store Dual systems. These products are now available to physicians in Canada. In the fall of 2009, the company received FDA clearance to market and sell both the Thermage CPT and Fraxel re:store Dual systems.

“Thermage and Fraxel are key tools that I use in my practice to reverse the effects of aging and sun exposure,“ said Penny Cumberland, MD, with Cumberland Laser Clinic (London, Ontario). “The Thermage CPT offers patients the most advanced solution for skin tightening and body contouring. The Fraxel re:store Dual provides superior skin resurfacing and rejuvenation. The Fraxel Dual system delivers both fast clearance of pigmentation and a non-invasive treatment for wrinkles and acne scars.“

The Thermage CPT incorporates proprietary Comfort Pulse Technology and includes a new ergonomic, vibrating hand piece. In addition, the Thermage CPT features treatment tips that are designed to enhance efficacy and greatly improve overall patient comfort.

The new Fraxel re:store Dual system provides enhancements that are designed to enable physicians to better address pigmentation and other dyschromia on the entire body. Prior to the non-ablative Fraxel re:store Dual system, laser skin resurfacing procedures were largely limited to the face. The system's expanded versatility, with the addition of the new 1927 nm wavelength, increases the areas of the body that physicians can treat.

The Thermage CPT and Fraxel re:store Dual laser systems are licensed by Health Canada. Isolaz is the only system licensed by Health Canada indicated to treat pustular and comedonal acne as well as mild-to-moderate acne vulgaris.

EDAP uses exclusive Ablatherm HIFU distributor

EDAP TMS (Lyon, France), a developer of therapeutic ultrasound technology, reported that Maple Leaf HIFU, the exclusive distributor of Ablatherm HIFU in Canada, is installing an Ablatherm device at their new medical office located at Cleveland Clinic Canada (Toronto). Patients with localized prostate cancer are now able to benefit from this minimally invasive HIFU procedure.

Marc Oczachowski, EDAP's CEO said, “I am very pleased that Ablatherm HIFU technology is now available at this location. This move supports our commitment to offer the Ablatherm HIFU solution to a greater number of patients in North America.“

EDAP's Ablatherm high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU is currently undergoing evaluation in a multicenter U.S. phase II/III clinical trial under an investigational device exemption granted by the FDA, the ENLIGHT U.S. clinical study. The company also is developing this technology for the potential treatment of certain other types of tumors.

Chembio gets Brazilian okay for HIV test

Chembio Diagnostics (Medford, New York), a maker of point-of-care diagnostic tests, has been notified that Bio-Manguinhos, a division of the Oswaldo Cruz Foundation of Brazil (FIOCRUZ), has received regulatory approval from Brazil's National Health Surveillance Agency (Anvisa) to market Chembio's Dual Path Platform (DPP) HIV 1/2 rapid test for use with oral fluid, blood, serum or plasma samples. The approval triggers $400,000 in license revenues payable to Chembio within 120 days of the date of approval.

During 2008, Chembio signed four agreements with FIOCRUZ in Brazil relating to products based on the company's DPP technology, including this HIV test. FIOCRUZ, which is affiliated with the Brazilian Ministry of Health, is the ministry's largest supplier for therapeutics, vaccines and diagnostic tests.

Under the agreement, a technology transfer to FIOCRUZ for this product is anticipated to occur over a five-year period, with anticipated aggregate minimum sales by Chembio to FIOCRUZ of this product and related components of $10 million over the period. Thereafter, it is anticipated that the technology transfer process will be complete and a five-year royalty phase will occur, with royalties of 4% of net sales as defined. In 2004, Chembio and FIOCRUZ entered a similar agreement for Chembio's HIV 1/2 STAT-PAK and components from which Chembio has realized about $7.8 million of revenues from 2004-2009. Since 2009 royalty payments have averaged about $24,000 per quarter for that product.

Lawrence Siebert, Chembio's CEO, said, “This is the first product approval using our DPP technology, and it is appropriately the first product we developed with this platform, which offers significant benefits and features. I believe this screening test will help increase the reach and accessibility of HIV testing in Brazil, which is already a world leader in HIV prevention and treatment efforts, by means of a less invasive oral fluid test.“