Medical Device Daily Contributing Writer
And MDDs

Mölnlycke Health Care (Stockholm, Sweden), a major provider of single-use surgical and wound care products, comes under Swedish ownership again after being acquired last week for 12.85 billion ($3.6 billion) by Investor AB (also Stockholm) and Morgan Stanley Principal Investments (MSPI).

“Mölnlycke’s market-leading positions across a range of wound care and surgical products represent a strong platform for continued international growth, both organically as well as via acquisitions,” said Lennart Johansson, head of business development at Investor, in a statement.

Investor, an investment company with a market value of $16 billion, was founded in 1916 and is controlled by the Wallenberg family.

Mölnlycke reported 2006 sales of 1760 million and has almost 6,000 employees. The company was formed in August 2005 by private equity firm Apax Partners (London) with the consolidation of three businesses: the surgical glove maker Regent Medical, the wound care activities of SSL International (later re-named Medlock Medical) and Mölnlycke. Investor and MSPI will equally control ownership, with Mölnlycke’s management as minority shareholders.

Investor holds strong cash reserves and was nearly debt-free before the acquisition, which it says will be financed through external debt arranged by HSBC Bank, Morgan Stanley Bank International and SEB Merchant Banking.

In 2006, Investor purchased Gambro (also Stockholm), a major provider of renal care products and services. Recent MSPI healthcare investments include Grifols (Madrid, Spain), a supplier of plasma products, diagnostic reagents, automated analyzers and dosing machines, as well as US Oncology (Houston), specializing in oncology pharmaceutical services, with 85 outpatient clinics.

Uroplasy to close Endhoven site

Uroplasty (Minneapolis) reported that it plans to close its Eindhoven, the Netherlands, manufacturing facility and transfer those activities to its Minnetonka, Minnesota, site.

It said the move will reduce costs, increase productivity and streamline its manufacturing. It said it plans to complete the transition to, and obtain the necessary regulatory approvals for, its manufacturing facility in Minnetonka in the second half of 2007.

The restructuring will result in the termination of employment of three employees and the lease of the Eindhoven facility. It said it anticipates incurring $315,000 to $445,000 for exit charges during 2007, including $10,000 to $15,000 of non-cash charges for asset impairment.

David Kaysen, Uroplasty’s president/CEO, said, “We expect this action to save us about $400,000 in annual on-going costs after the transition period, and also allow us to be more efficient and better serve our customers.”

Uroplasty, with subsidiaries in the UK, manufactures and markets products for the treatment of voiding dysfunctions such as urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.

Ciphergen gets EU patent

Ciphergen Biosystems (Fremont, California) said the European Patient Office (EPO) has issued it Patent No. 1 224 466, titled “Prostate Cancer Marker Proteins,” for aiding in prostate cancer diagnosis. The patent describes a method that measures certain protein biomarkers present in the blood of patients with prostate cancer vs. patients who do not have prostate cancer.

“Our intellectual property portfolio is growing in size and strength,” said CEO Gail Page. “We continue to generate promising data for biomarkers that may be useful for prostate cancer diagnosis, disease monitoring, or prediction of recurrence.”

Ciphergen’s diagnostic program in prostate cancer includes the evaluation of a panel of biomarkers that may serve as potential tests for prostate cancer diagnosis, progression and recurrence.

In May 2006, Ciphergen and Johns Hopkins University (Baltimore) reported the discovery of two biomarkers that, when combined with prostate-specific antigen (PSA), were highly predictive of likelihood of recurrence of prostate cancer.

The data came from two studies, one examining more than 400 men with prostate cancer and the other examining 50 pairs of men followed for five years with prostate cancer matched for age, cancer stage and other clinical parameters.

Ciphergen said results suggest the potential for a test to aid in the diagnosis of prostate cancer; aid in the stratification of risk of highly aggressive prostate cancer, independent of other clinical variables; reduce over-treatment of prostate cancer in cases not likely to be lethal; and shift treatment to those cases that are particularly likely to be lethal.

Cerus cites platelet-treatment OK in Germany

Cerus (Concord, California) said that the Paul-Ehrlich-Institut (PEI), the agency that regulates blood components in Germany, has approved the sale of platelets treated with the Intercept Blood System by a German blood center located in the University Hospital Schleswig-Holstein’s L beck campus.

Applications are in progress for other German blood centers for similar marketing approvals.

“This first approval is significant in providing a blueprint for other blood centers seeking PEI marketing approval,” said Claes Glassell, president and CEO of Cerus. “The dossier submitted to PEI by the L beck blood center contained data on the Intercept Blood System that can be used as a common element in submissions by other blood centers in Germany.”

He cited the action as “a very important step for Cerus in commercializing the Intercept blood system in Germany, the largest national market in Europe.”

Peter Schlenke, MD, head of the blood donation center at the Institute of Immunology and Transfusion Medicine, University of L beck School of Medicine, said, “Bacterial contamination is the most significant infectious risk facing platelet transfusion recipients today. I believe patients will benefit from the higher level of protection offered by the Intercept system, and I’m pleased that L beck can now supply them to our local hospitals.”

The Intercept Blood System is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria, and parasites that may be present in donated blood intended for transfusion. The system inactivates plasma and platelets using the same illumination device, process and active compound.