A Medical Device Daily
Aurora Imaging Technology (North Andover, Massachusetts) has established Aurora Asia , a wholly owned subsidiary, in Taipei, Taiwan.
The company manufactures the Aurora 1.5Tesla Dedicated Breast MRI System, which it said is "the most technologically advanced and only FDA-approved system specifically designed to fight breast cancer."
Aurora said the decision to set up the Taiwanese subsidiary was a direct response to the growing need for advanced breast imaging among Asian women. It said breast cancer is now the leading cause of cancer death in women in Asia.
Data from the Chinese Anti-Cancer Association , the Chinese equivalent of the American Cancer Society , shows that both incidence and death rates of breast cancer in China's major cities rose by nearly 40% over the last decade.
"Asian women are in dire need of access to the most effective breast imaging technology, such as MRI. By making our Aurora Dedicated Breast MRI System available, we increase the potential to detect cancer at its earliest, most treatable stage. Clinical trials have shown that earlier detection saves lives," said Olivia Ho Cheng, president/CEO of Aurora
Aurora's Asian presence began in 2006 with the receipt from the State Food and Drug Administration of China of a Registration Certificate for the Aurora 1.5T Dedicated Breast MRI System. The company said that approval "opened the door for Aurora to move into one of the world's fastest-growing economies, with a medical device market estimated at close to $3.5 billion."
Aurora Asia's president is Dr. Pai-Jung (PJ) Huang. Who the company said "brings not only a profound clinical understanding, but also a deep appreciation of the importance and technical challenges to visually present this disease using the MRI imaging technology.
Prior to being named president of the new subsidiary, Huang was Aurora's international clinical director. "It is timely for Aurora to aggressively expand our business throughout Asia, thus allowing us to respond more effectively to the growing demand," Huang said.
Canadian device license for BioSTAR
NMT Medical (Boston) reported receiving a medical device license in Canada for its BioSTAR bioabsorbable septal repair implant technology and Rapid Transport delivery system. The approval was required in order to begin commercialization in Canada.
BioStar incorporates a purified acellular collagen matrix delivered on the company's StarFlex alloy framework and uses NMT's latest Rapid Transport delivery system. The BioStar implant will be offered in three sizes: 23 mm, 28 mm and 32 mm.
President and CEO John Ahern said the approval "provides us with an opportunity to be the first company to have a commercially available bioabsorbable implant in North America for closure of patent foramen ovale (PFO) and other septal defects."
He said the company anticipates initiating its market launch in Canada early in 3Q07.
BioStar is designed to provide biological closure of atrial level defects using the patient's natural healing response. Between 90% and 95% of the implant is absorbed over time and replaced with healthy native tissue.
Data from the prospective multi-center BEST (BioSTAR Evaluation STudy) trial, published in the October 2006 edition of the journal Circulation, demonstrated that BioSTAR provides a more rapid and complete closure of atrial septal defects, with a 92% closure rate at 30 days and 96% at six months, NMT said.
Ahern said the anticipated launch in Canada "gives us another reason for increased optimism as we await CE-mark approval for BioStar."
NMT previously reported receiving conditional approval from the FDA for inclusion of BioStar in the MIST II PFO/migraine headache trial currently under way in the U.S.
Philips to acquire Brazilian firm
Royal Philips Electronics'Philips Medical Systems (Best, the Netherlands) unit said that it plans to acquire imaging diagnostic company VMI-Sistemas Medicos (VMI; (Minas Gerais, Brazil). The transaction is subject to regulatory approval, and is expected to close before the end of the second quarter.
No financial details were disclosed.
VMI-Sistemas Medicos was founded in 1985 and has production facilities in Lagoa Santa. It has a presence in the analogical and digital X-ray market, as well as in the cath lab, mammography and ultrasound markets.
"By acquiring VMI, Philips can offer customers in Brazil and across Latin America a more complete medical diagnostic imaging product portfolio," said Steve Rusckowski, CEO of Philips Medical Systems.
"This is our first acquisition of a healthcare company in a developing economy," he said, "and it endorses the company's global strategy of focusing on healthcare and investing in emerging markets, looking for solutions especially developed to address local needs."
Philips said that between 2003 and 2006, growth in the Brazilian market for medical diagnostic imaging and monitoring equipment expanded at close to 20% per year, compared to annual growth rates in the global market of between 4% and 5%.
The Dutch company already holds what was characterized as a "prominent" position in the market for most types of medical imaging equipment. With the VMI acquisition, Philips will become a leader in general X-ray in Brazil.
Philips said it believes the move will further boost growth by capitalizing on VMI's extensive distribution network. "Through this deal, we can build on VMI's extensive sales and services channels in Brazil to further increase [our] access to local customers and provide a benefit to hospitals through a wider product portfolio," said Daurio Speranzini, head of Philips Medical Systems in Latin America.
Philips said that the acquisition will give it the opportunity of producing both analogical and digital X-ray equipment in Brazil, offering "more affordable solutions" to the local market. Philips plans to boost VMI's Brazilian exports to other countries in Latin America, which at the moment represent approximately 5% of VMI's business.