Medical Device Daily

PARIS – French artificial heart maker Carmat (Paris) raised €29.3 million ($43.3 million) in a second-round stock offering to existing shareholders.

Proceeds from this new offering will finance the company's final development and launch of a fully implantable mechanical heart that it expects to bring to market in 2013 (Medical Device Daily, July 13, 2011).

Despite turbulent market conditions, the Carmat offering of 240,617 shares was oversubscribed by 27%, triggering an opportunity for the company's board to extend the offering to 306,488 shares.

The value of the shares purchased by preferred subscribers was estimated to be €105 last week when Carmat was trading on the NYSE-Euronext exchange at €87.

The share price increased in trading this week to €99.

The initial offering for Carmat in July, 2010 was €18.75 and one year later the shares soared to €185.

As confidence in the public markets was shaken, Carmat saw its share price slide during July, settling into the €90 range just ahead of issuing the new shares in August.

“Exceptional companies like Carmat can raise capital even during very difficult markets,“ triumphed Philippe Pouletty with Truffle Capital (Paris), which underwrote this latest offering and has backed the company since its start-up.

“Clearly if clinical trials fulfill our hopes, Carmat will be in a great position to grow fast, supported by the stock market,“ he wrote in an e-mail reply to Medical Device Daily.

In a statement the company said “Carmat is now one of the best capitalized European companies in the medical devices sector and can plan its strategic and industrial development with confidence.“

“Given the progress made in our project, we are confident we will meet the goal of a first implant of the heart before the end of 2011,“ said Marcello Conviti, CEO of Carmat.

He said the company remains on track for a commercial release in 2013.

Clinical trials will be conducted on the first patients to receive the heart device.

The company also will fund the industrialization of the device that includes quality processes necessary for assembly line production of the artificial heart itself and accelerated development of a portable, external system of batteries, connectivity and monitoring.

Beyond the funding for the initial launch, Pouletty said Carmat “now has a very strong balance sheet and multiple options to grow and further build shareholder value.“

He said that beyond public markets, Carmat can tap the interests of “large med-tech companies to make partnerships and pharma companies [that] will increasingly behave as healthcare companies and enter the medtech field.“

BD launches MAX Open System in Europe

BD Diagnostics (Franklin Lakes, New Jersey), a segment of BD (Becton, Dickinson and Company), reported the European launch of the BD MAX Open System for molecular testing, which will enable laboratories to run both laboratory and BD-developed assays and offer enhanced testing services that elevate the standards of care at their institutions.

“In a world with ever-evolving pathogens, laboratories need to provide clinicians with fast, accurate and actionable diagnostic information that will save patient lives,“ said Tom Polen, president of BD Diagnostics - Diagnostic Systems. “The new completely open, state-of-the-art BD MAX System empowers laboratories to automate their unique internally developed molecular assays, while accessing a rich and growing menu of world-class assays from BD and our leading assay development partners.“

BD MAX is a fully automated, open, bench-top molecular testing workstation able to perform both IVD/CE and laboratory-developed tests. The system gives clinical laboratory professionals new ability to help their institutions respond to emerging threats, such as new strains of deadly drug-resistant bacteria or respiratory illnesses.

“BD's strategy is to make BD MAX the laboratory equivalent of a smartphone,“ said Polen. “We are working with leading assay development companies from around the world to develop a constantly growing, content-rich menu of tests that deliver critical information to caregivers faster and more accurately than current methods. Our plan is to make the BD MAX System an indispensible tool that no laboratory professional will want to live without.“

According to Polen, BD intends a steady stream of announcements regarding agreements with best-in-class IVD assay developers to bring new assays to the BD MAX System for a broad range of disease categories.

The BD MAX System's content-rich menu, open capability, full automation and standardized workflow will enable laboratories to consolidate and standardize a broad range of molecular tests to build programs that meet both their current and future clinical needs, the company said.

Neurologica receives CE mark for inSPira HD

NeuroLogica (Danvers, Massachusetts) reported that it received CE mark approval for its inSPira HD. As a result, the portable, high-resolution single photon emission computed tomography (SPECT) camera will now be made available within the European Union and other select markets.

Designed primarily for brain imaging, the battery-powered inSPira HD can provide high-quality SPECT images in any venue, including epilepsy clinics, ICUs and private practice neurological imaging centers. The high-resolution camera is capable of imaging any radioisotope energies between 80-200 keV for clinical applications such as epilepsy, Parkinson's disease, neuropsychology, stroke and brain perfusion as well as Alzheimer's disease and dementia.

“Features such as high spatial resolution, convenience, portability and versatility set the inSPira HD apart from other brain SPECT imaging systems currently on the American and European markets,“ said Dr. Colin Timothy McDonald, NeuroLogica's chief medical officer. “The technologies in traditional systems haven't really changed since the 1960s so they continue to suffer from poor spatial and contrast resolution, in short, 'fuzzy imaging.'“ The inSPira HD presents a new method of SPECT detection, acquisition and reconstruction, which is designed to approach a spatial resolution of 3 mm, rivaling that of PET imaging.

“Images obtained with the inSPira HD SPECT camera provide a much higher spatial resolution than with any other SPECT camera on the market,“ said Dr. Jean-Paul Soucy, director of the PET unit at the Montreal Neurological Institute (Montreal, Quebec). “Since inSPira HD has reconstructed spatial resolution to 3 mm and true attenuation correction, it will give physicians more detailed clinical information of brain activity by allowing them to better evaluate cerebral blood flow distribution patterns at a resolution higher than anything ever achieved in that field before.“