Medical Device Daily And MDDs

Intelligent Medical Implants (IMI; Zug, Switzerland), a privately-held neurostimulation company, reported raising EUR15 million in a Series B financing led by Global Life Science Ventures and Abingworth Management. Existing investors, including the Series A lead investor PolyTechnos, and a new investor, Quantum Technology Partners, also participated.

Stephen McCormack of GLSV has become chairman of IMI, and Timothy Haines, a partner at Abingworth, has joined the company's board.

IMI, with an R&D subsidiary IIP-Technologies (IIP; Bonn, Germany), is developing the Intelligent Retinal Implant System (IRIS), which provides some visual perception to blind people.

The company says that the technology is best suited for patients with degenerative diseases such as retinitis pigmentosa and macular degeneration.

Speaking from Germany yesterday, Hans-Jürgen Tiedtke, CEO of parent company IIP, told Medical Device Daily that the funding will initially support launch of a 30-person clinical trial in Europe to support pursuit of CE marking.

The endpoint of the trial is visual "resolution" by the subjects, sought with the use of "a standardized visual acuity test, applicable to low-vision people, who can almost see nothing."

This test will involve the trial subject, after implantation, looking at a circle on a wall, about 4 feet in diameter, with the circle containing black bars in horizontal and vertical arrangements. They will be asked to determine whether the bars are horizontal or vertical to help establish the amount of resolution achieved. Additional circles contain additional bars in different patterns.

Tiedtke said that the plan is to use the European trial results to move on to FDA approval, and that IMI already has had "good discussions" with the agency. The European trial will take from 12 to 18 months, including a six-month follow-up, he said, and the company will then have more detailed discussions with the FDA to see what it will want in terms of "different requirements."

"For sure, we will approach the FDA most likely in the second quarter or first quarter next year, depending on results on Europe," Tiedtke told MDD.

Start-up firms always have an appetite for more funds, but Tiedtke projected that the EUR15 million funding would take it at least through the European trial phase.

The company's device consists of a retinal stimulator implanted in the eye, a set of glasses the person wears — containing a mini-camera — and a transmitter that acts as an interfacing component intended to provide what it has termed "intelligent information."

The company has moved from its prototype instrument, which enabled the observation of light in 19 of 20 individuals, to one in which a camera will be used to provide "information from the outside world," Tiedtke said. The company also is working to move from the prototype, which used 49 electrodes, to a third-generation device that will contain 231 electrodes, to produce greater resolution.

"We have no clear idea how much the brain can get out of the information provided," Tiedtke acknowledged.

While there are a handful of other companies working on systems to provide some sight to blind patients, Tiedtke said that he thought only one, Second Sight , is in the same category as IMI in terms of clinical trial progress.

But Second Sight has provided little information concerning its system and so their relative positions and potential regulatory outcomes are unknown.

Eyegate now has U.S. operations

Another company working in the area of reduced sight is EyeGate Pharma (Paris), a company using iontophoresis technology to deliver therapeutics non-invasively to the anterior and posterior chambers of the eye.

The company has reported the launch of its U.S. operations in Waltham, Massachusetts, in 12,200 square feet of combined office and lab space.

The company also introduced its President/CEO, Stephen From, a former CFO and life science investment banker, as well as other members of its management team.

Thomas Finneran, president of the Massachusetts Biotechnology Council (Boston), said, "EyeGate is the latest in a growing number of companies coming from the Continent to Massachusetts. The scientific talent pool our area offers is unmatched by any region and this is evidenced by the pace and quality of the new hires EyeGate has recruited in a very short time."

Michael Mullen, EyeGate's chairman and managing director and founder of Tarvos Capital, said, "Starting U.S. operations in the Boston area is an important step for EyeGate because of the region's deep roots in biotechnology."

From was formerly a senior executive and CFO at Centelion , a 100-person independent biotech company with a Phase II biological drug for the treatment of peripheral vascular disease. In early 2006, Sanofi Aventis (Paris) acquired 100% ownership of that company.

EyeGate says it is the first company to demonstrate clinical significance utilizing iontophoresis for the local treatment of ocular disease. The company is developing products for severe uveitis and glaucoma and says it will will seek to partner indications that address other sizeable opportunities that treat ocular disease.

Oridis to use NIH TMA technology

Oridis Biomed (Graz, Austria) reported that it has entered into a license agreement with the U.S. National Institutes of Health for the worldwide commercial use of NIH's proprietary Tissue Micro-Array (TMA) technology.

Georg Casari, PhD, head of Oridis Tissomics business. "This license agreement further strengthens our Tissomics business for the life-science industry worldwide, where we offer our clients the ability to validate their research, such as biomarker and target verification programs."

Tissue Micro-Arrays are a research tool within Oridis's Tissomics platform that enables the rapid and simultaneous study of several hundred tissue samples, using standardized high-throughput analysis by in-house pathologists. Oridis commercializes its Tissomics platform in collaborations with industrial partners, as well as its own R&D programs.

Oridis develops therapeutics, diagnostics and biomarkers for liver diseases. Therapeutic programs include primary liver cancer (hepatocellular carcinoma, HCC), and metabolic liver diseases, such as alcoholic steatohepatitis (ASH) and non-alcoholic steatohepatitis (NASH), where incidence rates are rapidly increasing due to modern life-styles, while treatment options are limited, expensive, and often ineffective.