A Medical Device Daily

UltraShape (Yokneam, Israel/San Ramon, California) reported that Health Canada has granted it a medical device license to sell the UltraShape Contour I system for non-invasive fat emulsification for the purpose of aesthetic body contouring.

According to UltraShape, Contour I is the first clinically proven, non-invasive solution for body contouring based on focused ultrasound technology. It said the system has been demonstrated to deliver "durable and measurable circumference and fat thickness reduction in a single treatment and incremental reduction with multiple treatments."

Rodger Stewart, company president/CEO, termed the authorization "a key milestone as we establish ourselves as the leader in the non-invasive body contouring market in North America. With the exclusive distribution agreement [in place] with Coherent-AMT, we expect rapid adoption of the procedure in the Canadian marketplace, consistent with the clinical and commercial success we have experienced in 45 countries around the world."

Coherent-AMT is a leader in providing aesthetic solutions for the Canadian marketplace, representing a variety of aesthetic technologies and products. UltraShape said that the agreement with Coherent "gives [us] access to the largest direct sales, service and support system in Canada."

Dan Webb, CEO of Coherent-AMT, said, "We see significant demand for a non-invasive body contouring procedure that gives patients the option of undergoing a painless treatment for the reduction of localized fat deposits with no downtime and no required maintenance."

The Contour I system, based on focused ultrasound technology, is designed to target and disrupt fat, leaving surrounding skin, blood vessels and nerves intact. The procedure is guided by real-time tracking and guidance software to deliver uniform body-contouring results.

The procedure is performed in an office-based environment, requires no anesthesia or sedation, and the majority of patients report no pain or discomfort, UltraShape said. After treatment, patients immediately resume their daily routines and maintenance treatments are not needed.

FDA okays stem-cell trial

Mesoblast (Melbourne, Australia), an adult stem-cell company, reported FDA clearance of its Investigational New Drug (IND) submission of its U.S.-based sister company, Angioblast Systems, to commence a Phase II clinical trial of its allogeneic, or off-the-shelf adult stem cells for patients with heart attacks.

"FDA clearance is a significant step toward commercializing our stem-cell products in the U.S., the world's largest market for cardiovascular diseases," said Professor Silviu Itescu, Mesoblast's founder and chief scientific advisor.

The trial will be based at the Texas Heart Institute (Houston) and follow a similar protocol as that used by the same investigators in pre-clinical studies for the IND submission. These showed that implantation of the allogeneic stem cells by catheter into damaged heart muscle resulted in "significant improvement" in heart function and reduction in congestive heart failure, the company said.

The Phase II trial will be the first to test an allogeneic stem cell product injected by catheter into heart muscle damaged by a recent heart attack. It will use the latest-generation catheters provided through Angioblast's ongoing relationship with the Cordis (Miami Lakes, Florida) and Biosense Webster (Diamond Bar, California), both Johnson & Johnson (New Brunswick, New Jersey) companies.

The commercial strategy for Mesoblast and Angioblast is to generate high-margin stem cell products obtained from a single donor, expanded, frozen and then used in thousands of unrelated, or allogeneic, recipients as needed.

Madagascar selects OraQuick HIV test

OraSure Technologies (Bethlehem, Pennsylvania), a major participant in the oral fluid diagnostics sector, reported being selected by the government of Madagascar and its National AIDS Control Program to be the exclusive first-line provider of rapid HIV screening tests for the country's outreach program over the next five years.

The government intends to test more than 400,000 individuals in 2007 with the OraQuick Rapid HIV 1/2 Antibody Test. A major component of the AIDS control program is an outreach effort that includes teams of individuals traveling to highly populated areas and offering HIV tests in convenient locations, including individuals' homes.

"The rate of prevalence for HIV/AIDS [in Madagascar] is low, and we want to keep it that way," said Fenosoa Ratsimanetrimanana, executive secretariat of the National AIDS Committee. "Last year we saw a significant increase in HIV testing because we launched a rapid oral fluid HIV test during the second half of the year. This year, we anticipate more than tripling the number of HIV tests administered vs. the prior year."

OraSure said that due to the immediate impact of the OraQuick test when it was introduced in the latter part of last year, the Ministry of Health, Family Planning and Social Protection has elected to use the test on a preferred basis.

New Zealand presence at BIO 2007

More than 35 New Zealand life science companies and institutions will attend the BIO 2007 conference that started Sunday and running through Wednesday in Boston as part of a delegation led by Trevor Mallard, Minister of Economic Development, and Roy Ferguson, the country's ambassador to the U.S.

New Zealand is reaching out at the annual meeting of the Biotechnology Industry Organization (BIO; Washington) to partner with U.S. and international companies and research institutions.

"New Zealand policymakers recognize the importance of life science research and biotechnology for delivering better outcomes for health, the environment and for industrial, agricultural and energy production," said Dr. Chris Boalch, director of biotechnology for New Zealand Trade and Enterprise. "New Zealand is committed to biotechnology as a high-growth sector with increasing importance to the country's economy."

In addition to having a pavilion in the BIO exhibition hall, various representatives of New Zealand will participate in a variety of programs during the four-day conference.