Medical Device Dailys

Mauna Kea Technologies (Paris) closed a $30 million financing round led by U.S.-based Psilos Group to expand commercialization of its Cellvizio endomicroscope, primarily in the American market. The news was first reported on last week in Medical Device Daily (Medical Device Daily, Jan 24, 2007).

The funding from Psilos, which specializes in medical technology with over $500 million in investments, inspired the French-based investment fund Seventure and the original investor in Mauna Kea, Creadev, to also up their stakes in this third financing round for the company.

Cellvizio was launched commercially in the U.S. market during Digestive Disease Week in May 2007 and Mauna Kea founder and CEO Sacha Loiseau told Medical Device Daily the privately held company will report €3 million ($4.5 million) in sales for the past year.

Approved for gastroenterological and pulmonary procedures, the Cellvizio GI and Cellvizio-Lung provide cellular level images of potentially cancerous tissue in real time through a one millimeter probe inserted in the working channel of any endoscope.

The microscopic view of cells is displayed on a screen in the operating theater adjacent to the endoscope’s macro view allowing a clinician to perform what is called an “optical biopsy” of suspect tissue; thereby significantly reducing the number of tissue samples extracted for lab analysis from an average of 24 to half a dozen.

During the U.S. funding road show in 2007, Cellvizio was the subject of studies published in the November issues of both Clinical Gastroenterology and Hepatology and Gastrointestinal Endoscopy.

In an editorial covering two of the studies, Dr. Kenneth Wang of the Mayo Clinic (Rochester Minnesota) said as the wave of diagnostic endoscopy wanes, micro-endoscopy announces the “dawning of the age of the endoluminal gastroenterologic surgeon.”

One of the studies led by Thomas Wang, MD, PhD, of Stanford University (Stanford, California) concluded “confocal imaging using Cellvizio GI (gastrointestinal) can be performed in vivo to assess the functional behavior of tissue in real time for providing pathologic interpretation, representing a new method for histologic evaluation.”

A second study led by Alexander Meining, MD, from Klinikum rechts der Isar (Munich, Germany) tested the accuracy of Cellvizio GI images with traditional biopsy results, comparing tissue analysis with 119 video sequences of both normal and neoplastic areas.

The pathologist and gastroenterologist found 92% agreement for accuracy, sensitivity and specificity for the real-time optical biopsy versus the delayed lab results.

Mauna Kea has renamed its U.S. operations Cellvizio Inc., and will move from Boston to Philadelphia in 1Q08.

The company expects to maintain direct distribution of its two approved products in the U.S., as well as in the larger European markets of France, Germany, Spain and the UK. Mauna Kea has a distributor in Italy and Loiseau told MDD that distributors will likely be sought for smaller European markets and Asian markets.

A tabletop version of Cellvizio for research labs is sold by Leica Microsystems (Wetzlar, Germany) in the U.S., Japanese and European markets (MDD, Nov. 8, 2007).

Loiseau said the third funding round also will enable Mauna Kea to expand clinical trials to reinforce the patient benefits of optical biopsy, and will allow exploration of new clinical applications.

The competing commercially available confocal endomicroscope is from Pentax (Tokyo) based on technology developed by Optiscan Imaging (Victoria, Australia).

Loiseau said Cellvizio holds a competitive advantage with a probe independent of a specific endoscopy line and a miniaturization that allows penetration to areas where clinicians have never seen cellular activity in vivo, including alveoli in the lungs and exploration of mucosa of the small bile duct.

Mauna Kea’s market lead could stretch to six years, said Loiseau, noting that is how long it required for the company to move from start-up to approval of its technology by the FDA.

ART leases space for stent manufacturing

Arterial Remodeling Technologies (ART; Paris) said it has leased a 20,000-square-foot manufacturing facility as a result of mastering its proprietary polymer-based manufacturing technology to produce bioresorbable stents.

The company said those bioresorbable stents are designed to dismantle in vivo over an optimized time horizon, “thus allowing the body’s natural arterial remodeling process to occur, which is normally restricted by the deployment of permanent metallic stents.”

ART reported in November that it had closed on a new venture financing round of €5.5 million ($7.8 million) from investors Matignon Technologies and SGAM Alternative Investments.

“Our approach is to achieve temporary stenting of the traumatized angioplasty site,” said Patrick Sabaria, founder and CEO of ART and a former vice president, Europe, for Johnson & Hohnson Interventional Systems.

“Bioresorbability is not an end by itself,” Sabaria said. “Our stent is designed to provide the requisite initial mechanical scaffolding to resist acute recoil, but as it dismantles over time due to bioresorbability, the possibility of arterial remodeling returns to the artery.”

ART is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Its technology is based on intellectual property originating from the Cleveland Clinic; the French national research institute, Centre National de Recherche Scientifique (Montpellier); and Necker University (Paris).

To date, the company has raised a total of €10 million ($14.2 million) in venture capital from Matignon and SGAM.

CE mark for RhinoChill System

BeneChill (San Diego) said it has received the CE mark, allowing for the commercial sale of its RhinoChill System in the European Union member. The company said the RhinoChill System is a battery-operated, non-invasive, portable and easy-to-use medical device for rapid therapeutic patient cooling.

“This is an important step for BeneChill,” said Denise Barbut, MD, founder and CEO. “This market clearance ... will provide medical personnel within the European Union with a user-friendly tool to cool patients rapidly and non-invasively.”

The RhinoChill System uses a nasal catheter to deliver an inert coolant to the nasal cavity to reduce patient temperature. The company noted that therapeutic hypothermia — reducing patient temperature to about 33 degrees C or 91 degrees F — has been shown to improve survival and neurologic outcome after cardiac arrest.

The battery-operated RhinoChill System does not require a refrigeration unit — a drawback associated with other existing hypothermia devices.