A Medical Device Daily

ICON (Dublin, Ireland) reported filing a shelf registration statement with the U.S. Securities and Exchange Commission covering the offer of up to $125 million of its American Depositary Shares (ADSs), representing ordinary shares, EUR 0.06 per share. The ADSs will be sold at various times and prices by ICON, certain selling shareholders identified in the registration statement or a combination of both.

ICON is a contract research organization providing clinical research and development services on a global basis to the pharmaceutical, biotech and medical device industries. As of December 31, 2005, ICON had about 3,050 employees and operations in 41 locations in 27 countries, including the U.S. and major markets in Europe and the rest of the world.

Euro HIT initiatives bring restructuring

Government initiatives to improve efficiency levels across the healthcare continuum in eastern Europe are resulting in widespread restructuring and the integration of disparate healthcare IT (HIT) systems. This process will be facilitated by accession to the European Union and associated increases in infrastructure funding flows, according to a new report from Frost & Sullivan (F&S; London). However, the report says that centralized purchasing “will hamper the rapid expansion“ of these emerging HIT markets.

“Accession to the European Union will motivate government-backed initiatives to develop information infrastructure and expand functionality through various eGovernment schemes in healthcare,“ says Deepa Vaideswaran, F&S research associate. “At the same time, structural funds to member states for the improvement of public infrastructure – including the provision of healthcare – will facilitate the implementation of requisite healthcare IT solutions.“

F&S projects the “embryonic“ east European market to grow at a steeper rate than its more mature western counterpart. However, political instability is likely to negatively impact healthcare provision.

At the same time, it says that with most funding for HIT contracts being tilted in favor of the public sector, opportunities for private sector participants have been limited. The resultant lack of competition has done little to encourage the public sector to ensure greater cost-effectiveness and has, in turn, dampened public sector investments into more advanced IT solutions.

“The predominance of individual solutions catering to niche healthcare segments and the lack of standardized regulations across geographic regions is impeding global participants from penetrating these emerging markets,“ says Vaideswaran. “With increasing concerns about cost, quality, interoperability and patient safety, vendors keen on venturing into the emerging Eastern European healthcare IT market must focus on developing economical solutions that can be easily customized and integrated.“

ThermoGenesis in Euro distribution pacts

ThermoGenesis (Rancho Cordova, California) reported signing exclusive agreements with distributors in the UK and Hungary for its CE-marked CryoSeal FS System, which produces fibrin surgical sealant from a patient's own blood in about an hour, and the TPD which produces activated thrombin in less than 30 minutes.

BVM Medical , a UK-based device distributor focusing on interventional congenital cardiology, interventional radiology, cardiothoracic and vascular surgery, will distribute the CryoSeal FS System and TPD in England, Scotland, Wales and Ireland; Neurotrade, a unit of Switzerland-based Medivent Medizintechnik , will distribute these products throughout Hungary. Neurotrade markets products for the surgical, dental and plastic surgery markets.

ThermoGenesis said the agreements allow it to advance its strategy of penetrating the European fibrin sealant market and the platelet gel market. Both markets have been limited due to the past reliance on the high cost of conventional fibrin sealants and Factor V antibody risks associated with the use of bovine thrombin for platelet gels.

Rudy Huylebroeck, director of Global Sales and Marketing Hospital/Wound Care Division, said the agreements with BVM and Neurotrade “will allow ThermoGenesis to further expand its CryoSeal and TPD business in Europe. With excellent relationships with surgeons and hospitals, these distributors are already promoting our products successfully and receiving favorable reactions from potential customers who have discovered CryoSeal Fibrin Sealant is a cost-effective alternative to conventional fibrin sealants, sourced from pooled human blood and bovine lung tissue.“

ThermoGenesis manufactures automated blood processing systems and disposables that enable the manufacture, preservation and delivery of cell and tissue therapy products.

Rockwell wins Euro dialysate patent

Rockwell Medical Technologies (Wixom, Michigan), a manufacturer of hemodialysis products, reported that the European Patent and Trademark Office has issued a patent for its proprietary iron-delivery product SFP, covering the “Method and Pharmaceutical Composition for Iron Delivery in Hemodialysis and Peritoneal Dialysis Patients.“

Rockwell's SFP product is designed to provide physiological iron replacement in ESRD patients by delivering iron via dialysate during hemodialysis and peritoneal dialysis treatment. Rockwell has licensed the exclusive rights to the SFP patent and is in the process of seeking FDA approval to market the product.

“This European patent issuance was expected based on the allowance we had previously received,“ said Robert Chioini, president, CEO and chairman of Rockwell. “It is a significant step for Rockwell as it enables us to protect our proprietary technology in a major market. Currently, we are making solid progress in our FDA development process and we expect to achieve several more significant milestones as we work towards market approval.“

The countries the patent grant will affect are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK.

The company said that compared to intravenous (IV) iron administration, results based on an FDA-approved Phase II Study have shown that delivering iron via dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs.

Rockwell estimates the U.S. dialysis market for IV iron delivery represents $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets.

Brussels hospital gets Fusion install

Carefx (Scottsdale, Arizona) reported that Saint-Luc UCL hospital, the academic hospital for Catholic University Louvain (Brussels, Belgium), has implemented Carefx's Fusion system to deliver secure access to aggregated patient data. Fusion from Carefx enables Saint-Luc's physicians and staff to view vital patient information in a single view from any workstation at any time throughout the hospital.

Saint-Luc UCL hospital had a proliferation of clinical applications housing critical patient data but these applications were not integrated. Needed were unique user IDs, passwords and patient searches within each individual application in order to get a complete view of a patient's clinical record.

“Before Carefx, we had a portfolio of applications that did not interoperate, making the process of accessing all the patient data required to make fully informed clinical decisions both difficult and time-consuming,“ said Dominique Gonze, MD, of Saint-Luc UCL hospital. “After exploring several options for linking our clinical applications, we found that Carefx provided better service, the ability to aggregate patient information both in web and client application environments, as well as utilized industry standards within an open, flexible and scalable architecture.“

Carefx reports more than 200 hospitals in the U.S. and internationally using Fusion from Carefx.