A Medical Device Daily

Orthovita (Malvern, Pennsylvania) reported that it has received the CE mark for its Vitoss Foam product line, which will permit products in that line to be sold in all of the countries of the European Union as well as in other countries, such as Switzerland and Australia, that have adopted the European Union’s regulatory standards.

This latest certification is in addition to three others received earlier by the orthopedic biomaterials developer.

It received the CE mark in July 2000 for the core Vitoss Bone Graft Substitute product line, in October 2001 for the use of Cortoss in securing the fixation of bone screws in patients with weak bone caused by osteoporosis, and in January 2003 for Cortoss for its use for vertebral augmentation of vertebral compression fractures, including compression fractures of the spine caused by osteoporosis and invasive tumors.

The Vitoss Foam product line was 510(k) cleared by the FDA at the end of 2003 and was a significant factor in Orthovita’s product sales growth during 2004. Additional product iterations are planned for this year.

“Seeing the impact that the Vitoss Foam product line made to U.S. sales during 2004, we are particularly pleased by the addition of the Vitoss Foam product line to the portfolio of products we have available for sale in Europe and in other territories,” said Doug Low, vice president of European operations.

Study shows tumor regression

pSivida Ltd. (Perth, Australia) said that study data on its lead cancer product, BrachySil, was presented at the European Society for Therapeutic and Radiation Oncology conference in Budapest, Hungary, earlier this month.

BrachySil is a micron-sized particle in which the isotope 32 phosphorus is immobilized. pSivida believes that the product is advantageous in that it demonstrates a high degree of isotope targeting and retention, “thus maximizing the therapeutic load on the tumor while reducing the risk of radioactivity affecting healthy hepatic tissue or entering the systemic circulation; a finding borne out by the data from this critical study.”

The Australian nanotechnology company said data on eight liver cancer patients has demonstrated “marked tumor regression” as determined by CT scanning – up to 100% in some smaller tumors. pSivida said the study represents the first step in the regulatory program leading to product approval and was specifically focused on the safety and tolerability of the treatment.

Importantly, the study has found that all patients tolerated study procedures and the investigational treatment well, with no significant product-related findings, with all patients discharged from the clinic the day following treatment.

PSivida, which said is planning to seek a sales and marketing partner for the product, reported in April that it would be commencing a Phase IIa human clinical trial using BrachySil later this year for pancreatic tumors as a second market for the product in addition to liver tumors.

The company has said that the BrachySil product is expected to be applicable to a range of other solid-tumor cancer markets.

PSivida’s strategic partner and largest shareholder is the QinetiQ group, the former UK government Defense Evaluation Research Agency, which it said was instrumental in discovering BioSilicon.

Protedyne opens office in UK

Laboratory automation supplier Protedyne (Windsor, Connecticut) has opened an office in the UK. Located in Essex, the new office houses the company’s European sales and support groups.

Ashley Gould, the company’s regional manager for Europe, will oversee the UK facility.

“Protedyne’s fast-growing European customer base, coupled with our strong focus on customer support, has provided us with a timely opportunity to expand our presence in Europe,” said Catherine Williams, vice president, sales, marketing & customer care. “Having a sales and support office located in the United Kingdom will enable us to rapidly respond to the needs of our European customers.”

Protedyne said its BioCube System platform brings advanced industrial automation capabilities into the life science laboratory.