Medical Device Daily

PARIS — An established in vitro diagnostics (IVD) company that, according to a majority shareholder, "had lost its way in recent years," announced it had received a €3 million ($4.5 million) injection of led by two Paris-based funds specializing in life sciences.

The investment makes Truffle Capital and AGF Private Equity majority shareholders of Biomedical Diagnostics (BMD; Paris).

Philippe Pouletty MD, the General Partner of Truffle Capital told Medical Device Daily he has been serving as the acting CEO of BMD since September, 2009 and that a new chief executive will be brought on board before the first of the year.

"BMD now has a renewed and driven management and a far more operational board," said Pouletty.

BMD was founded in 1986 as a spin-off from Abbott Diagnostic (Rungis, France) and Luminex (Austin, Texas) to develop, produce and market innovative auto-immunity and infectious disease diagnostics.

In 2003 BMD launched the FIDIS System based on the Luminex xMAP technology, and the next year launched the CARIS system, which is considered the standard in immunofluorescence automated testing.

BMD derives 25% of revenues from in-house production while the remaining 75% of sales come from distributing other manufacturer's products.

While BMD has built a sales network in Europe, Australia, and Latin America, France and Belgium remain its strongest markets, and the company leads in autoimmunity disease diagnostics in France with a 40% market share.

The company reported sales of €15.7 million ($20.5 million) in 2006 but has seen a steady decline in revenues, reporting €12.2 million ($17.2 million) at the end of 2008. Dollar values are based on historic exchange rates.

Acknowledging the decline in sales, Pouletty said that since becoming the acting CEO in September BMD has greatly improved its gross margin, decreased headcount and has streamlined its portfolio to eliminate costly products and refocus on core strengths in auto-immune diagnostics.

Explaining the takeover of a majority position with an investment representing less than one-fourth of sales, Pouletty said, "When a company urgently needs cash, the key is who can make decisions and act quickly."

"Those who cannot see their shares diluted," he said.

Moving forward, Pouletty has renewed the commercial strategy and sharpened the focus for research and development.

On the commercial level, BMD is actively seeking alliances with IVD companies, primarily those based in the U.S., to introduce new products into its European distribution network, and potentially to secure manufacturing rights.

While requiring the company to burn cash, Pouletty said the R&D push comes at a "reasonable cost and in a very interesting area of diagnostics for monoclonal antibodies."

"The drawback of these therapeutics is that after a few weeks patients develop a resistance to the drug, making them ineffective," he explained.

"BMD is currently developing monitoring kits to test patient resistance, and even earlier on, to stratify patients who are likely to develop a resistance," he said.

"While it is in the class of companion diagnostics, these kits are independent of any pharmaceutical company," he added.

In 2008, the French innovation funding agency OSEO awarded €7.9 million ($12 million) in financial support for the Tracker project to develop diagnostic monitoring kits a rheumatoid arthritis therapy.

BMD shares in this research funding with Neovacs, a start-up transferring a technology platform from the Pierre & Marie Curie University (Paris) for a drug discovery and development program around cytokine targets.

In the Tracker project, BMD is developing a therapy-specific diagnostic as part of an overall patient management strategy, validating its tools for detecting drug-neutralizing antibodies in conjunction with Neovacs' active anti-TNF (tumor necrosis factor) immunization approach to treatment of rheumatoid arthritis patients.

Truffle Capital is an investor in Neovacs and Pouletty is a member of the company's board.

Agilent names 1st SureSelect Euro CSP

Agilent Technologies (Santa Clara, California) reported that Fasteris (Geneva) has been named the first European Certified-Service Provider (CSP) for Agilent's SureSelect Target Enrichment System for next-generation sequencing.

SureSelect, introduced in February 2009, has been shown to greatly increase the speed and cost-efficiency of next-generation sequencing workflows used in life science research by enabling experiments to focus on genomic regions of interest rather than sequencing the entire genome.

Fasteris achieved CSP status for the SureSelect system after demonstrating a high level of proficiency using the SureSelect system with the Illumina (San Diego) Genome Analyzer.

"Fasteris is a pioneer in next-gen sequencing, and we're delighted that they'll be combining the efficiencies of SureSelect with their expertise on the Illumina Genome Analyzer," said Fred Ernani, PhD, Agilent senior product manager for Emerging Genomics Applications. "Having Fasteris as an Agilent-certified service provider promises to deliver real value to the genomics community."

TheSureSelect system is based on an in-solution design, making it automation-friendly and easily scalable from ten reactions through thousands.

Users can design their own custom SureSelect kits using Agilent's eArray online design tool, which contains many key genomes and also lets users upload their own sequences. Because sample requirement is 3 micrograms or less of gDNA, researchers can perform highly targeted next-generation sequencing on very precious samples.

Agilent and Illumina have a non-exclusive co-marketing agreement to support the SureSelect Target Enrichment System optimized for the Illumina Genome Analyzer.

Sorin reports 1st patient in Clepsydra trial

Sorin Group (Paris) reported the first inclusion of a patient in the Clepsydra clinical trial. The study will investigate the sensitivity to changes in heart failure status of PhD, a unique diagnostic feature using the dual sensor technology of minute ventilation and accelerometer to monitor patient's breathing and activity levels every day.

The algorithm aims to provide physicians with both trends and indicators in order to highlight sustained changes in overall health status that could relate to heart failure (HF) evolution.

PhD is available in the Paradym family of ICDs in Europe and under clinical evaluation in Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-D) in Europe and U.S.

As the severity of HF can fluctuate and drug therapies adjusted to improve the patient's condition, it is important to monitor recognized indicators of disease progression to prevent the patient being hospitalized. PhD measures activity workload and ventilation at rest and exercise, which are two key measurements to indicate that a patient's heart failure condition is progressing. The Clepsydra study will test the PhD algorithm that is designed to give advance notice of sustained deterioration. Advanced warning at follow-up could give physicians time to intervene in the patient's treatment to avoid the costs and patient burden associated with hospitalization.

The Clepsydra study, will evaluate PhD in 550 patients to be enrolled in the U.S. and Europe. Patients will be closely monitored over a minimum of 13 months by hospital visits and by telephone checks.

The first implant was performed by Andrew Kaplan, MD, cardiac electrophysiologist with CVAM, CardioVascular Associates of Mesa, at Mountain Vista Medical Center (Mesa, Arizona).

"Tracking and managing heart failure progression in our patients is complex and time consuming. The Clepsydra study should help us better predict and intervene earlier in the heart failure process through evaluation of the data collected by the PhD sensor-based function. The implantation in our first patient was smooth and the device performed well," said Kaplan.