Medical Device Dailys

Neovacs (Paris) and Biomedical Diagnostics (BMD; Marne La Vallee, France) have won financing of €7.9 million ($11 million) for the Tracker theranostics program tharanostics meaning a pairing of a diagnostic test with a therapeutics in this case for treatment of rheumatoid arthritis.

The funding, from OSEO Innovation (Maisons-Alfort, France), combines a grant of €2.5 million ($3.5 million) with a loan of €5.4 million ($7.5 million) to validate the diagnostics tools developed by BMD and to test a therapeutic solution developed by Neovacs based on anti tumor necrosis factor (TNF) monoclonal antibodies.

The prevalent therapeutic used to treat rheumatoid arthritis, anti-TNF monoclonal antibodies progressively is neutralized by the antibodies it induces, leading to resistance or intolerance to the treatment, which renders it ineffective over time and in some cases toxic.

A recent study in the UK found that more than one-fourth of patients abandon this class of medication within 15 months.

More than 5 million people in Europe and the U.S. are diagnosed with rheumatoid arthritis which advances to become a disabling condition for 30% of this patient population within 10 years of diagnosis.

The two partners will use the OSEO funding to evaluate the neutralizing antibodies using BMD tests and determine a treatment strategy using a range of therapeutics from Neovacs involving active anti-TNF immunization.

Spun off from the Pierre and Marie Curie University (Paris) in 1993 by one of France's most eminent immunologists and AIDS experts, Professor Daniel Zagury, Neovacs holds a patent portfolio of therapeutic vaccines for the treatment of AIDS, cancer and auto-immune and allergic diseases.

In July, 2007 Neovacs received a €13 million ($18.3 million) investment from the Novartis Venture Fund and a second investment from Truffle Capital of €4 million ($5.6 million), an investor and majority shareholder since 2003.

BMD specializes in the production and marketing of in vitro diagnostics based on technology from Luminex (Oosterhout, the Netherlands), a multiplex platform that combines flow cytometry, microspheres, lasers, and digital signal processing.

BMD is targeting the emerging theranostics market, with the aim of personalizing medications by identifying appropriate biomarkers to indicate the progression, or regression under treatment, of a disease.

BMD said this market totaled $5.4 billion in 2005 and is expected to grow to $21.2 billion by 2012.

SprayShield Barrier on market in Europe

Covidien (Mansfield, Massachusetts) said its Surgical Devices (North Haven, Connecticut) business unit has introduced the SprayShield Adhesion Barrier System throughout Europe.

The SprayShield Adhesion Barrier System offers surgeons a synthetic, sprayable hydrogel that provides a barrier between tissue and organ planes that helps reduce the development of post-surgical adhesions. The CE-marked system is indicated for use in both open and laparoscopic abdominopelvic surgical procedures.

Scott Flora, president of Surgical Devices, said that the SprayShield Adhesion Barrier System "gives surgeons a new solution to help address an unmet clinical need."

A long-term study of women who had prior pelvic surgery showed that about 35% were re-admitted an average of 1.9 times over a 10-year period, due to adhesion-related complications. Covidien said that even during routine surgical procedures, the need to remove adhesions extends operating room time and can lead to increased blood loss and other complications.

The SprayShield Barrier, which can be stored at room temperature and prepared in less than two minutes, polymerizes within seconds when sprayed, enabling site-specific application, and is blue in color, enabling the surgeon to see the coverage and thickness of the material upon application.

Post-operatively, the SprayShield Barrier continues to separate tissue and organ planes as healing progresses under the gel, according to Covidien. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.

SprayShield Adhesion Barrier is available in certain Middle East markets and South Africa, in addition to Europe, but is not yet available in the U.S.

Lotus Valve System in second study phase

Sadra Medical (Campbell, California) reported the enrollment and treatment of four new patients in the second phase of the European feasibility study of the Sadra Lotus Valve System.

The system is designed to enable physicians to replace a diseased aortic valve using a less-invasive approach, navigating the valve through the patient's arteries using a catheter, thus eliminating the need for an open-chest surgical procedure.

Each one of the four patients presented with severe aortic stenosis and none was a candidate for surgical therapy. All were treated by Drs. Eberhard Grube and Ralf Müller at Heart Center Siegburg (Siegburg, Germany).

The surgeons said that the Lotus Valve deployment time averaged 16 minutes and that post-implantation valve function was good, with no perivalvular leakage observed.

"The percutaneous aortic valve replacement [PAVR] procedure using the Sadra Lotus Valve is enhanced by the ease of placement and the ability to safely reposition or retrieve the valve," said Grube, principal investigator for the Sadra Lotus Valve European feasibility study. "Based upon the one-year follow-up from the first patient and my experience involved in treating this latest set of patients, I am very encouraged about the Lotus Valve's potential to improve the PAVR procedure."

The company also reported that Fred Khosravi, company co-founder and board member, has accepted the role of chairman of the board.

"I am very pleased to have Fred playing a larger role at Sadra," said President/CEO Ken Martin. "[His] experience and insight will play a critical role in supporting Sadra's rapid evolution as the leading second-generation percutaneous aortic valve company."

Khosravi is managing director of Incept LLC and has co-founded eight companies, including EndoTex and Embolic Protection, both acquired by Boston Scientific, and Confluent Surgical, acquired by Tyco Healthcare.

He is currently president/CEO of another Incept company, AccessClosure.