Two Orange County healthcare companies are basking in overseas approvals of their key products.
Irvine-based Edwards Lifesciences Corp. started the festivities when it recently announced the Japanese Ministry of Health, Labor and Welfare cleared its less-invasive Edwards Sapien XT replacement heart valve for use in that country.
The decision makes Sapien XT, which is inserted via catheter, the first commercially available transcatheter heart valve in Japan, according to Edwards.
The device is used to treat severe aortic stenosis, or a narrowing of the body’s main artery, in patients too ill for traditional open-heart valve surgery.
“We are pleased that Japanese regulators took a progressive approach to the approval of Sapien XT, focusing their review process on the valve that is the market leader in Europe, rather than on our previous generation transcatheter valve,” said Larry Wood, Edwards’ corporate vice president, transcatheter valve replacement.
The company and other local device makers have criticized Japan’s medical-device reviews in the past and complained of having to retain outdated products in their lineups sold in that country.
Sapien XT does not yet have U.S. approval.
The device maker expects to obtain reimbursement for Sapien XT from the Japanese agency by the end of the year and plans to start selling immediately thereafter.
Chicago-based Zacks Investment Research called the Japanese approval of Sapien XT “a material upside for Edwards after a flurry of setbacks.”
Edwards reported disappointing first-quarter results in April and has faced several challenges, such as lower procedure growth, declining southern Europe sales, low usage rates and inventory problems in China.
Aliso Viejo-based drug maker Avanir Pharmaceuticals Inc. said the European Commission approved its Nuedexta drug for treating pseudobulbar affect a day after Edwards received word of the approval. The decision brought the 27 member states of the European Union into Avanir’s market, plus Iceland and Norway.
Pseudobulbar affect is marked by uncontrollable outbursts of crying or laughing.
Quality Systems News
Irvine-based Quality Systems Inc., a healthcare software maker, won 12 awards in the American Business Awards competition. Quality got two gold awards, four silver and six bronze.
It won the awards in a variety of categories, including the management and company category, as well as marketing and communications.
In other Quality Systems news, the company said NextGen will be the healthcare information technology provider for Chinese Hospital in San Francisco, a 54-bed, community-owned nonprofit offering a range of medical, surgical and specialty programs.
Chinese Hospital’s website said it has “a long and rich history of providing access to culturally competent healthcare services for the Chinese community” in San Francisco.
NY OKs Miscarriage Test
CombiMatrix Corp., an Irvine molecular diagnostic company, got a boost late last month when the New York state Department of Health granted it conditional approval to market a test.
CombiMatrix offers DNA-based testing services to the prenatal, pediatric and oncology markets.
It will market a chromosomal microarray test for miscarriage analysis. The health department’s decision will allow CombiMatrix to perform the test on patient samples from New York residents.
The company said its miscarriage analysis test is the fastest-growing in terms of volume.
CombiMatrix “will now begin to sell directly to customers and to seek distribution partnerships to leverage our internal sales force,” Chief Executive Mark McDonough said.
Company shares rose as high as 62% on June 25, when it announced the health department’s decision.
The stock, which trades on the Nasdaq Capital Market exchange, often experiences volatile price swings. CombiMatrix’ shares shot up more than 200% in December after it said two studies published in the New England Journal validated its test offerings. It has been down 38% since the start of the year, with a recent market value of $11.7 million.
Bits and Pieces
Ormco Corp., an Orange-based maker of orthodontic devices, said its Insignia Advanced Smile Design received a 2013 American Technology award from the Washington, D.C.-based TechAmerica Foundation. Insignia uses 3-D diagnostic technology and interactive treatment planning to fabricate patient-specific orthodontic treatment devices. … Numecent, an Irvine-based provider of “cloudpaging” services, said it is working with Edgewater, Md.-based TAI Software to deploy cloudpaging for HIPAA-compliant delivery of healthcare and human services software. Cloudpaging services take software from personal computers to clouds and deliver it back. … Amada Senior Care, a Laguna Woods-based company, said it expects to have 20 franchised offices by the end of the year. Amada was founded in 2007 by Tafa Jefferson, a former offensive tackle for the NFL’s Chicago Bears.
