Medical Device Daily Contributing Writer
And MDDs

The dark days may be over for Medicrea (Lyon, France), the manufacturer of an advanced line of spinal implants.

The company went public a year ago on the Alternext exchange in Paris, raising EUR 11.6 million ($15.6 million), but then disappointed the market by posting an enormous loss for the year.

Medicrea reported in early May that it lost 12.1 million ($2.8 million) before taxes on sales of 15.7 million ($7.7 million). Sales revenue was down 24% from the previous year.

The annual report was delayed nearly three months as the company sorted out the impact of bringing sales and distribution for the French market back in-house.

On an upbeat note, Medicrea said sales for the second half were up 35% from the year-earlier period at EUR 3.3 million ($4.4 million) and that the company had absorbed one-time expenses that are now behind it, including what it called significant expenses related to winning approval from the FDA for a new product line.

"Finally we have a product authorized for the United States that represents a major break from traditional technologies for cervical fusion," said CEO Denys Sournac.

He said Medicrea will capture within three years "a major share" of what he estimated is a $480 million market for cervical plates in the U.S.

The new product, C-Jaws, reduces by up to 90% the time surgeons need for a spinal implant procedure and offers the possibility to operate on the cervical column with "considerably reduced" incisions, he said.

Sournac cited preliminary results from the first 100 patients participating in a clinical study in France where bone fusions have been accelerated with the C-Jaw components and post-operation pain has been significantly reduced.

The company also is encouraged by the early European marketing for its Pass 2 spinal implants that represent not an upgrade, but "a new generation," according to Sournac. The Pass 2 line is expected to be introduced in the U.S. in October.

CE mark for Cardiocom

Cardiocom (Minneapolis), a developer of remote patient monitoring equipment and disease management software, said it has obtained CE-marking and launched its products in the Europe.

The company said it has formed several distribution relationships in the UK, where the government is providing "significant funding" for telehealth solutions to meet the needs of an aging population.

Daniel Cosentino, president of Cardiocom, said, "We have found the right partnerships to bring our innovative technology to patients who will benefit from being connected every day to their healthcare team to manage their chronic disease and improve compliance."

The company said it has developed "flexible intervention and management processes that are more efficient and more effective. [Our] telehealth products and services operate as an integrated system for each specific disease state, offering clients maximum ability for complete management of patients with high-risk conditions."

The company will provide its partners with the Commander, Commander Cellular and AutoLink monitoring and alert products. The company's GlucoCom division will supply blood glucose monitoring supplies for diabetic patients.

Cardiocom said its UK partners will provide nurse call center services for daily monitoring of patient biometric data, health status and compliance using the company's web-based OmniVisor Pro patient management software system.

CBI acquiring Tripos's UK business

Commonwealth Biotechnologies (CBI; Richmond, Virginia) and Tripos (St. Louis) said they have entered into an agreement providing for the acquisition by CBI of all of the outstanding capital stock of Tripos Discovery Research (TDR).

The transaction is structured with an up-front payment of $350,000, followed by payments of up to $1.8 million from TDR receivables and billings.

In March, Tripos sold its discovery informatics business and its stockholders approved a plan of dissolution and liquidation for the company, with of the sale of the discovery research business an integral part of the deal.

CBI said it will continue to operate TDR from its present location in Bude, UK, which provides it with a strategic base of operations to enter the European market.

With this transaction, TDR is entering into a sale-leaseback transaction with the Southwest England Regional Development Authority, under which TDR will net about $4.16 million, enter into a 12-year lease in Bude, and be released from grant repayment obligations with SWERDA and with the UK Department of Trade and Industry.

The transactions are expected to close late this month or early June.

CBI specializes in life sciences R&D outsourcing and offers expertise and an array of synthetic and analytical technologies in the areas of biodefense, laboratory support and contract research.

Expanded approval for ablation catheter

St. Jude Medical (St. Paul, Minnesota) reported expanded European CE-mark approval to include the Therapy Cool Path irrigated ablation catheter with bi-directional steering for use in ablation procedures to treat abnormal heart rhythms.

The company said the catheter is the first open-irrigated ablation catheter to provide bi-directional steering, a feature designed to help physicians maneuver the catheter in difficult areas of the heart and perform complex ablations more efficiently.

"The main advantage of the bi-directional catheter is its ease of use in reaching difficult anatomical locations," said Carlo Pappone, MD, PhD, director of the Arrhythmology Department at San Raffaele University Hospital (Milan, Italy). "Because the catheter requires less manipulation and provides for greater simplicity of navigation, my procedural time was improved by about 20%."

The catheter is produced by St. Jude's Irvine Biomedical (Irvine, California), a business of St. Jude Medical (St. Paul, Minnesota).

Q-Med receives final payment from MedicisWith the FDA approval of Perlane, Q-Med AB (Uppsala, Sweden) said it has received $29.1 million (SEK197.4 million) from Medicis (Scottsdale, Arizona), the last additional purchase sum from an agreement that was entered into with that company in 2003.