A Medical Device Daily

Arbios Systems (Waltham, Massachusetts), which focuses on developing medical devices and cell-based therapies for patients at risk for life-threatening episodes of liver failure, reported signing an exclusive supply agreement with Membrana (Wuppertal, Germany).

According to the U.S. firm, Membrana is the leading independent supplier worldwide of membranes and microporous materials for medical and technical applications. It is a wholly owned subsidiary of Polypore International (Charlotte, North Carolina), a global high-tech filtration company specializing in microporous membranes.

The agreement provides for future exclusive supply by Membrana, and exclusive sourcing by Arbios, of membranes suitable for use in Arbios’ SEPET therapeutic blood filtration products for the treatment of liver failure and sepsis.

Shawn Cain, interim president/CEO of Arbios, said, “Membrana’s poly-ether sulfone [PES] microporous membrane technology is currently utilized in FDA-approved blood filtration cartridges for renal dialysis/hemofiltration indications, and we believe that they have excellent PES technology for our proprietary liver dialysis application.”

He added, “We look forward to continuing to work with Membrana as we focus on bringing the SEPET product to market for the treatment of liver failure, and as we develop further generations of blood filtration products indicated for sepsis and potentially other critical-care disorders.”

The Arbios-Membrana supply agreement has a term of up to six years following Arbios’ first commercial sale of the SEPET Liver Assist Device.

The SEPET Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities such as hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration.

Those substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, and suppressing the function and regeneration of the liver.

SEPET is designed for use with standard blood dialysis systems available in hospital intensive care units.

In addition to the SEPET device, Arbios is developing the HepatAssist Cell-Based Liver Support System, a bioartificial liver that combines blood detoxification with liver cell therapy to replace liver function in patients with the most severe forms of liver failure.

KCI to establish plant in Ireland

Wound care and therapeutic surfaces firm Kinetic Concepts (KCI; San Antonio) said it plans to establish a global manufacturing operation at the Irish Development Agency Business & Technology Park in Athlone, Ireland.

The investment, supported by IDA Ireland, will create up to 250 new jobs over the next five years, KCI said. About 50 jobs will be created by the end of 4Q07, with another 200 jobs tied to future growth requirements of the business.

Catherine Burzik, president and CEO of te U.S. company, said “We are pleased with the opportunity to develop this new manufacturing capability in Athlone and with the support being provided by IDA Ireland. The new operation will play an integral role in the growth of our global business going forward.”

KCI has major positions in both the advanced wound care and therapeutic surfaces sectors, offering a wide range of products that it said “can improve clinical outcomes and ... help reduce the cost of patient care.”

Irish Minister for Enterprise, Trade and Employment Miche l Martin said “This is excellent news for Athlone and the whole of the Midlands, as it will bring new high-quality employment opportunities to the region and new benefits for local suppliers in areas such as plastics, electronics, logistics and packaging, as KCI plans to locally source a number of components.”

He added: “Ireland faced strong competition for the investment and the factors which influenced the decision in favor of Athlone included the availability of a workforce with experience in the medical technology industry and the Midlands’ record of success with companies in the industry.”

KCI said it already has recruited seven employees, including a number of senior managers, for the Athlone facility. The operation is to initially locate in a leased building at the IDA Business & Technology Park in Garrycastle.

The operation will manufacture KCI’s V.A.C. Therapy Units — for Vacuum Assisted Closure — and associated sterile products for global markets. It also will manage the supply chain for third-party manufacturers, global purchasing, supplier agreements and distribution of KCI’s products.

CE mark for three Keraplast products

In more news involving a San Antonio-based company, Keraplast Technologies and its New Zealand-based partner, Keratec Ltd., reported European Union approval of the first keratin-containing medical devices.

Through the CE-marking process, the EU medical device regulatory body has approved three wound dressings developed in a joint collaboration by the two companies.

“The Keraderm, Kerafoam and Keragel dressings are designed to target chronic wounds in a wide range of clinical settings,” said Tim Herring, chairman/CEO of Keraplast Technologies.

He added, “While these dressings will be of significant interest to consumers in the worldwide markets that recognize the CE mark, we also envision sizeable application of these products ultimately in the global theaters of war and human suffering.”

Plastic surgeon and inventor Robert Allen Smith, MD, of Jackson, Mississippi, said of the new Keraplast products, “This is a revolutionary medical platform technology that further encompasses not only the field of wound healing, but also has vast relevance in orthopedics, tissue engineering, drug delivery, medical device coatings and endosurgery.”

Smith, a member of the company’s board, added, “These three products will be directed toward full-thickness and partial-thickness injuries.”

Full-thickness injuries include surgically created wounds as well as the chronic ulcerations of bed sores, venous stasis ulcers and diabetic ulcerations of all types. Partial-thickness injuries include such wounds as burns, abrasions and donor sites for skin grafts.