BB&T European Editor and BB&T Staff Reports

PARIS – It may look like a financial report, but it actually reads like a playbook for the successful marketing of biomarker-based in vitro diagnostics (IVDs).

In its presentation of third quarter financials published Nov. 10, Epigenomics (Berlin) spells out the strategies it is pursuing on both sides of the Atlantic for targeting the massive market for colorectal cancer screening.

In an interview with BB&T, the VP for Corporate Development, Achim Plum, spelled out details of the company's novel approach to challenges of commercializing the blood test both in Europe and the U.S.

The financial profile of Epigenomics is familiar for a start up cresting the development phase and heading into commercialization.

The company continues to burn cash, reporting a loss of €7 million ($9.7 million) through the end 3Q10 as revenues from partners like Abbott Molecular Diagnostics (Des Plaines, Illinois), or clinical lab giant Quest Diagnostics (Madison, New Jersey) have only begun to trickle in.

“Sales growth is taking longer than expected due to slower initial uptake of our test and this is likely going to continue at a gradual pace during 2011,“ said Geert Nygaard, CEO of Epigenomics.

Started in 1998, the company had the good fortune to go public in 2004, and on the strength of clinical trial results for the Septin9 biomarker, was able to raise fresh capital of €33 million ($46 million) that analysts predict will provide a comfortable runway for the company to take off toward profitability.

Except for the operational loss, all other indicators are moving up, according to Nygaard.

“New partners and distributors on board are giving us access to new markets and countries with our test and technology,“ he said. “We are also seeing very positive clinical data which are reinforcing the independent view that blood-based colorectal cancer tests are going to become an essential method of screening for patients in the future.“

mtm laboratories expands its 'C' round to $63M

mtm laboratories (Heidelberg, Germany), a privately held diagnostics company developing in vitro diagnostics for cervical cancer early detection and diagnosis, reported the signing for an additional tranche of €7 million ($9.64 million) to its Series C funding. This addition is a formal expansion of the company's last Series C in October 2009, and increases the total for the round to €46 million ($63 million) in equity.

This completed Series C financing was led by three existing investors for mtm: HBM BioVentures, Wellington Partners, Gilde Healthcare Partners, with a consortium which included National Technology Enterprises Company, Heidelberg Innovation, and private investors.

“This additional tranche of financing supports the continued investment the company is making into clinical trials and commercialization. We plan to use a large component of the proceeds of this financing to fund our United States regulatory trial for CINtec PLUS Cytology that would support a PMA application,“ said CEO Bob Silverman.

mtm launched CINtec PLUS Cytology (dual staining for p16 and Ki-67) in Europe in March.

The basis of mtm's IVD products, the proprietary p16INK4a biomarker, is strongly over-expressed in pre-cancerous and cancerous cells of the cervix. Screening and diagnostic tools based on this biomarker are developed to improve the accuracy and efficiency for the screening and early diagnosis of cervical cancer.

Varian updates brachytherapy at French institute

One of Europe's leading institutes for cancer treatment has confirmed its faith in the power of brachytherapy replacing five older devices with three advanced computer-controlled units from Varian Medical Systems (Palo Alto, California).

The Institute Gustave-Roussy (IGR) outside Paris treats more than 450 patients each year using the long established technique where an encapsulated radioactive source is placed within or adjacent to a targeted tumor.

The new GammaMed PDR (pulsed dose rate) systems use short pulses of radiation, typically once an hour during twenty-four hours to simulate the overall effectiveness of low-dose rate treatments for a range of applications including treatment of gynecological, head and neck, anal canal and penile cancers, as well as pediatric tumors such as rhabdomyosarcoma.

The Varian therapy suite includes computer-controlled afterloader devices, which feed the radioactive source into the target tumor, as well as the BrachyVision treatment planning software that drives the intervention by the afterloader device.

According to Christine Haie-Meder, MD, head of brachytherapy at IGR, the new devices and software increases the capability to treat using an optimized 3D-based brachytherapy procedure, as well as the quality of treatment using the pulsed delivery to replace low-dose rate radiation delivery.

Haie-Meder said IGR has modernized brachytherapy treatments with volumetric imaging using CT or MRI for dosimetry and optimizing effectiveness of radiation delivery, and that the Varian system integrates this approach in the planning software.

German med-tech grew 5.5% in 2010

Medical technology continues to provide robust growth for Germany and is restrained only by an inability to fill job vacancies, according to the semi-annual survey conducted by the national industry association BVMed (Bundesverband Medizintechnologie, Berlin).

Sales growth in 2010 was placed at 5.5% among the 139 member companies participating in the association's survey up from 3% one year ago.

“Over 80% of the med-tech companies surveyed expect to see sales growth this year outperform 2009,“ said Meinrad Lugan, BVMed chairman.

“The profit situation has been diminished due to a substantial rise in the prices of raw materials and a higher rate of late payments,“ he reported, adding that companies are cautious but optimistic in their outlook for 2011 with 48% expecting better results than this year while 17% expect to see a decline in profitability.

Med-tech continues to be a driver for employment with half of companies reporting the creation of new jobs in 2010, though at the same time 96% of companies reported vacancies for posts.

The health sector in Germany represents 10% of the nation's gross domestic product and more than five million jobs.

bioMérieux, Biocartis to co-develop assays

bioMérieux (Marcy l'Etoile, France) and Biocartis (Lausanne, France) have entered into a strategic agreement to co-develop assays on Biocartis' fully integrated molecular diagnostics system, which the two companies will co-distribute starting in 2012.

bioMérieux will have worldwide exclusive rights to develop and commercialize microbiology assays on the platform. It will also have access to the platform for certain oncology and theranostics assays. bioMérieux has taken a €9 million ($12.63 million) equity stake in Biocartis.

Biocartis has continued to successfully develop its molecular diagnostics platform, which was acquired from Philips (Amsterdam, the Netherlands) earlier this year. The platform now fully integrates all the steps of a multiplexed molecular assay, from sample-in to data-out, in a sealed disposable cartridge, which avoids any contamination risk. Providing rapid results, the system is able to perform complex tests on a wide variety of samples, including oncology assays on tissue. The Biocartis platform does not require molecular biology experience or infrastructure with highly skilled technicians, and involves only one or two minutes hands-on time. Adapted to both small and large labs, the platform is fully scalable and allows random access use.

bioMérieux will enhance the Biocartis platform's menu with an exclusive line of tests for healthcare-associated infections and sepsis. bioMérieux also plans to develop oncology and theranostics assays on the system.

Biocartis will receive upfront and milestone payments as well as royalties on future sales.

Edwards gets CE mark for VolumeView sensor

Edwards Lifesciences (Irvine, California) reported receipt of the CE mark for its new VolumeView sensor-catheter set that measures a patient's volumetric hemodynamic parameters and provides more clarity for clinicians treating critically ill patients. The company also reported a CE mark for its new EV1000 clinical monitoring platform that integrates many of its sensors and catheters into one intuitive system. With a touch-screen monitor that displays a patient's physiologic status, as well as color-coded clinical targets and alerts, the EV1000 clinical platform is designed to simplify decision-making in the operating room and intensive care unit.

Miracor reports FIM outcome with PISO

Miracor Medical Systems (Vienna, Austria) reported the successful first-in-man clinical outcome for its pressure-controlled intermittent coronary sinus occlusion (PICSO) system, designed to improve acute coronary syndrome revascularization following primary percutaneous coronary intervention.

The PICSO procedure was performed in one patient by Jan Pie, MD, at the Academic Medical Center (Amsterdam, The Netherlands), as part of the projected 10-patient 'Prepare PISCO' study of stable angina patients. It is planned that Miracor will initiate the pivotal RAMSES study of PICSO upon the successful completion of the current study.

RepRegen raises $1.6M to further pipeline

RepRegen (London) said it has raised £1.03 million ($1.6 million). The financing was led by existing investor Imperial Innovations and included Longbow Capital and other investors. Proceeds will be used to further the product development pipeline: including regulatory approvals, commercialization programs and preparation for relevant post market clinical studies.

RepRegen is developing repair and regeneration technology in two platforms, designed to mend and regrow tissue in vivo. The first platform is focused on bone and other hard tissue, whereas the second platform is focused on muscle and other soft tissue.

Through the recent CE marking approval, RepRegen is now commercializing the first product of its hard tissue repair and regeneration platform – StronBone bone graft substitute bioactive glass with Strontium. StronBone is targeted for orthopaedic (trauma and spine) and craniomaxillofacial applications.

SI-Bone gets CE mark for iFuse

SI-Bone (San Jose, California), a device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint, reported getting a CE mark for its iFuse implant system.

The iFuse system is a MIS system comprised of titanium implants coated with a porous plasma spray that acts as an interference surface fit, which helps decrease implant motion. The iFuse has a substantial thickness and sophisticated metallurgy, which provides immediate post-operative fixation, accomplishing the goal of traditional open SI joint fusion through an MIS approach. Clinical publications have identified the SI joint as a pain generator for up to 22% of low back pain patients and that up to 75% of post-lumbar fusion patients develop SI joint degeneration within five years of surgery. These represent significant unmet clinical needs and, when conservative therapy fails, iFuse may provide an MIS option, according to SI-Bone.

Medtronic launches Europen-based web portal

Medtronic (Minneapolis) reported the launch of Medtronic Eureka, a European web-based portal for medical technology innovation designed to help physicians and medical technology inventors to bring their innovative ideas to life.

The Medtronic Eureka program (www.MedtronicEUreka.com) is designed to provide a streamlined, single entry point for idea submissions, to enable strong partnerships between Medtronic and European inventors to bring novel product concepts to market. It responds to the need of physicians for a clear, simple process to have the potential of their ideas evaluated by professionals.

By submitting a new idea via the Medtronic Eureka portal, inventors are assured a fair evaluation by a small team of trained experts. This streamlined process means a consistent approach to evaluating ideas from Europe so that the ideas can be reviewed in view of matching needs across all of Medtronic's therapeutic areas. Inventors are informed of Medtronic's initial decision regarding their idea within roughly three months of submission. If evaluation doesn't reveal a fit for Medtronic, inventors can consent to allow the same idea to be evaluated by MD Start, an independent medical device incubator based in Switzerland. This two-step approach is designed to ensure the best chance for the invention to be reconsidered.