A Medical Device Daily

Symmetry Medical (Warsaw, Indiana), a provider of products to the global orthopedics industry and other medical markets, said the audit committee of its board has initiated an independent review of “apparent irregularities” with respect to the company’s accounting policies and practices at its operating unit located in Sheffield, UK.

Based on information reported by company management last week, certain transactions at issue appear to have resulted in the overstatement of revenues by that unit dating back to 1999, well prior to Symmetry’s acquisition of the Sheffield operations in June 2003. From its initial review, management estimates that the overstatement of revenue and income before taxes for the entire nine-year period amounts to between $12 million and $16 million.

Symmetry said the employees at the UK unit believed to be primarily involved in the accounting activity in question, including its senior VP for Europe, are either no longer with the company or have been suspended, pending the completion of the review.

The audit committee said it believes that it may be necessary for the company to restate its financial statements for the periods subsequent to the date of the Sheffield acquisition.

Symmetry is a provider of implants and related instruments and cases to the orthopedic device industry and also produces such products for companies in other segments, including the arthroscopy, dental, laparoscopy, osteobiologic and endoscopy sectors. It also provides limited specialized products and services to non-healthcare markets, such as the aerospace market.

J&J fund to spur UK diabetes research

Johnson & Johnson (J&J; New Brunswick, New Jersey) has launched a £500,000 fund available to life science companies in England’s South East region to accelerate research into the diagnosis and management of diabetes and related illnesses.

J&J said the funding is aimed at stimulating R&D of diabetes diagnosis and management.

The South East region has the highest concentration of medical technology companies in the UK, with about 600 firms. Taken together, they provide one-third of the life science sector’s jobs nationwide.

The fund is being financed by J&J’s Ortho-Clinical Diagnostics (Raritan, New Jersey) unit and the corporate Office of Science and Technology in conjunction with the South East Health Technologies Alliance, Finance South East and the South East England Development Agency.

The deadline for proposals is Nov. 17. The fund is likely to offer two awards of £125,000, two of £75,000 and four of £10,000.

The fund is only open to companies in Kent, Surrey, Sussex, Hampshire, Berkshire, Buckinghamshire, Oxfordshire and Milton Keynes, though academic institutions from elsewhere will be able to apply.

European unit formed by MedeFinance

MedeFinance (Emeryville, California), a provider of business performance analytics for healthcare companies, reported that it has further expanded its operations in Europe with the formation of Mede International (London) and the appointment of Jon Horrocks as general manager to lead its European operations.

The company said Mede International will serve as a base of operations for sales, marketing and business development activities throughout Europe, “and will immediately allow Mede to meet the growing demand of its UK client base of NHS [National Health Service] Trusts and Foundation Trusts.”

MedeFinance said its decision to make “a substantial investment in the UK market” is a result of “the growing need in NHS Trusts to improve performance in activity, costing, income, operational efficiencies and clinical performance.”

The company said it already has gained a “substantial market presence” since beginning its sales efforts in the UK last year, and currently provides its solutions and services to more than a dozen UK healthcare organizations.

“We are committed to offering our business analytics solutions to the UK market to help provide NHS Trusts with comprehensive solutions to realize improvements in the relationship between resource allocation and patient care,” said Jim Quist, executive chairman.

Distribution accord for CryoLife

CryoLife (Kennesaw, Georgia), a biomaterials, device and tissue-processing company, said it has signed a distribution agreement allowing Proxy Biomedical Limited (Galway, Ireland) to include its BioGlue Surgical Adhesive in a hernia repair kit.

In addition to BioGlue, the kit includes a surgical mesh from Proxy Biomedical’s line of synthetic polymer surgical meshes. Initially, Proxy Biomedical will distribute the kits in Ireland, the UK and Germany, the company said.

CryoLife’s BioGlue is a two-component adhesive designed to create a flexible, mechanical seal, independent of the body’s clotting mechanism, within 20 to 30 seconds, and to reach its maximum bonding strength in two to three minutes.

BioGlue is FDA-approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels, and is CE-marked in Europe. BioGlue also is approved in Canada for use in soft tissue repair and in Australia for use in vascular and pulmonary sealing and repair, the company noted.

Proxy’s surgical mesh products include MotifMesh, VitaMesh, MotifMesh MIDS, and VitaMesh MIDS, which are CE-marked and FDA-approved.