Skilled Healthcare to restate financials

Skilled Healthcare Group (Foothill Ranch, California) said that, based on a preliminary review by management, the company expects to restate its consolidated financial statements for the quarterly and annual periods from Jan. 1, 2006, through March 31, 2009. As a result, the audit committee of the board has concluded that investors should no longer rely on the company's historical financial statements nor on the reports of Ernst & Young LLP, the company's independent registered public accounting firm, for those affected periods.

The expected restatement relates to understated reserves for accounts receivables in each of the affected quarters. Based on the company's preliminary analysis, it expects that the correction of the understatement is likely to require cumulative charges against after-tax earnings in the aggregate amount of between $8 million and $9 million over the affected periods. The actual amounts of the adjustments to be made in each of the affected periods are being determined by management.

Sonic Innovations changes name to Otix Global

Sonic Innovations' (Salt Lake City) shareholders approved the renaming of Sonic Innovations to Otix Global. The company has filed the appropriate paperwork, with the name and ticker symbol change scheduled to take effect on June 15.

"The move is designed to create a holding company that will allow the Sonic Innovations brand and Sonic's other brands to operate independently from each other," said Sonic CEO/Chairman Sam Westover. "Sonic Innovations will continue as a company and brand developing and distributing leading hearing instruments and services, and Otix Global Inc. will serve as the parent company of Sonic Innovations Inc. and Sonic's other legal entities."

Westover assured that the company renaming will not have an impact on Sonic Innovations, Inc. stock issued prior to the name and ticker symbol change, which will remain under the Sonic name, but stock purchases made after June 15 will be issued under the name Otix Global. All stock will then be traded in the market under the OTIX ticker symbol on Nasdaq.

Strategic Diagnostics gains ISO certification

Strategic Diagnostics (Newark, Delaware) said that it gained an ISO 9001:2000 certification for all five of the company's facilities.

"This certification demonstrates our commitment to excellence in product and service quality, and a continued focus on improving the customer experience," said Francis DiNuzzo, president/CEO of Strategic Diagnostics. "SDI continues to expand its competencies with a strong focus on quality and innovation. As a result we are building a leadership position in the Life Science market with a full suite of custom immunosolutions based on our antibody expertise and in the food safety marketplace with a growing portfolio of rapid pathogen detection solutions."

Prix Galien award adds medical device award

Prix Galien USA (New York), considered by some the highest industry accolade for pharmaceutical research and development, has added a new recognition category to its 2009 program Best Medical Device. Online nominations for the 2009 Prix Galien USA are now being accepted at through July 1.

The Prix Galien USA will be awarded in three categories that offer broad implications for future biomedical research: Best Pharmaceutical Agent, Best Biotechnology Product and Best Medical Device. All pharmaceutical and biological drugs or devices approved by the FDA for first or new indications between 1999 and 2008 are eligible for nomination in 2009. The new, decade-long eligibility period will permit the judges to determine both the immediate and the long-term impact these pharmaceuticals, biotechnology products and devices have had on human health and disease.

CLIA-certified lab opened by Perlegen

Perlegen Sciences (Mountain View, California), a developer of genetic tests that correlate genetic variation to disease risk and drug response, said it has opened the Perlegen Clinical Laboratory Services facility at its Mountain View location, following a successful inspection for CLIA (Clinical Laboratory Improvement Amendments) licensure by the California Department of Public Health's Laboratory Field Services.

MammaPLUS is a novel genetic test panel that will examine individual patients' blood samples to detect the absence or presence of validated and replicated common genetic variations associated with an increased risk for non-familial breast cancer. MammaPLUS is designed to help physicians assess aggregate breast cancer risk from these genetic markers, plus factors from a standard clinical assessment based on a patient's family and personal history, thus giving a clearer picture of an individual woman's risk of developing breast cancer.

Coloplast opens doors in Minneapolis

Coloplast (Humlebaek, Denmark) celebrated the grand opening of its U.S. headquarters in Minneapolis with employees, global leadership from Denmark, business partners, neighbors and city officials, including Mayor R.T. Rybak. Coloplast makes intimate healthcare products and services to make life easier for people with deeply personal and private medical concerns, such as stomas, erectile dysfunction, incontinence, severe skin conditions and chronic wounds.

Coloplast's 192,000-square-foot campus houses nearly 400 employees in research and development, production, sales, marketing and administration. Additionally, the office serves as a meeting place for many of its end users, nurses and doctors who work with Coloplast on a regular basis.