Medical Device Dailys

On the strength of a 45% growth for 2007 in its molecular diagnostics division, Tepnel Life Sciences (Manchester, UK/Stamford, Connecticut) reported strong profitability for 2007 and CEO Ben Matzilevich told Medical Device Daily the company is "very comfortable" with analysts' targets for 2008.

The UK-based company bought the molecular diagnostics assets of Orchid BioSciences (Princeton, New Jersey) in 2004 (MDD, Jan. 23, 2004), which have since "become the cornerstone of our diagnostic line," according to Matzilevich, providing organic growth of more than 20% each year.

Branded as Tepnel LifeMatch, the rapid analysis products detect and measure HLA (human leukocyte antigen) markers using the the xMAP platform from Luminex (Austin, Texas).

Claiming the industry lead for reagent sales in the field of transplant immunology and genetic disease predisposition, Matzilevich told MDD that Tepnel will launch in 4Q08 a line of blood bank screening tests for the Luminex platform.

The new test screens for pathogens for transfusion-related acute lung injury (TRALI) and Matzilevich said that if a majority of blood banks follow the recommendations from the American Association of Blood Banks (Bethesda, Maryland), he expects the market for TRALI diagnostics will double from current spending of between $75 million and $100 million for this subset of the overall $40 billion blood bank market.

This month, Tepnel also reported an exclusive licensing agreement with the University of Manchester for a bioactive liposome technology that detects and identifies living pathogenic micro-organisms and simultaneously generates a profile of their antibiotic resistance.

The agreement is the most recent of seven licensing deals in line with Tepnel's strategic push to expand its product pipeline and entering into new markets.

The University of Manchester technology offers simpler and more rapid, targeted antimicrobial treatment than current microbiological methods and does not give false positive reactions.

"The primary interest is for the diagnostics division to determine if there are viable pathogens in an organ to be donated," Matzilevich said. "The costs of organs for transplant are rising, the number of available organs is falling, and the number of recipients waiting for a specific organ is growing."

He said the new test will help assure the best match possible and contribute to more cost-effective treatment.

Other applications of the licensed technology will be exploited by Tepnel's Research Products and Services division for life sciences research, which in 2007 reported growth slowing to 4% from 24% the previous year.

"The patent platform is of interest in biotechnology and pharmaceutical applications for its potential use as a drug delivery or drug-amplification system," Matzilevich said.

In May, the company said AstraZeneca (London) had extended a preferred supplier agreement.

Commenting on the recently released results for 2007, he told MDD the company turned the corner toward profitability in 2006 and showed its ability to sustain this growth in 2007.

Despite punishing exchange rates for the British pound against the U.S. dollar, Tepnel reported operating profit from continuing operations at £1.4 million ($2.75 million) compared to £50,000 ($98,500) for 2006.

Guidance for 2008 is for £2.5 million EBIT ($4.92 million) on sales of £21.3 million ($41.9 million).

CE mark for UniCAP knee-resurfacing system

Arthrosurface (Franklin, Massachusetts), a developer of less-invasive joint resurfacing systems, said it has received the CE mark for its UniCAP Unicondylar resurfacing system.

The company said that with this approval, it is poised to move into the fast-growing European market of partial knee replacements.

"We have taken our clinical experiences from the HemiCAP focal knee resurfacing product in Europe, in part, to create a larger-sized Unicondylar knee system that is joint-preserving while having the fit of a device similar to a ... custom implant," said COO Steve Ek.

"What makes the UniCAP system unique is that it is the only unicondylar knee system on the market that allows for the preservation of the soft tissues about the knee, including the meniscus, and preserves the healthy tissues and bone in the knee," said Anthony Miniaci, MD, of the Cleveland Clinic. "The ability to perform the procedure as an arthroscopically assisted surgery will benefit the patient, especially for those that continue an active lifestyle."

The company said it believes that its product lines address a gap in existing treatments, specifically between biological options, which tend to be viable for the young, and joint replacement, for those who are much older or less active.

1,000 installations for Vital Images

Vital Images (Minneapolis), a leader in the field of enterprise-wide advanced visualization and analysis solutions, said it has surpassed the milestone of 1,000 installations of its advanced visualization software solutions in the European market.

Marc Lamont, managing director of Vital Images Europe (The Hague, the Netherlands), said, "We have invested in the European market by establishing our headquarters in The Hague, and developing a sales force with a dedicated service team to provide service excellence to our large and growing European customer base."

He added, "Our presence in the European market also has helped to strengthen our relationships with strategic partners such as Toshiba Medical Systems Europe, who has been a partner for over eight years in Europe and has been critical to our establishment in this market, as well as Sectra, which is a newly established and strategic partner that we expect to help us penetrate the enterprise market."

"We are using the fully integrated ViTAL solution with our Sectra PACS [picture archive and communication system] and it is available on 40 PACS workstations within our hospital," said Leiden University Medical Center in the Netherlands. It also was one of the first worldwide users of Vitrea fX software, developed by Vital Images in cooperation with Toshiba for the new Aquilion ONE.