A Medical Device Daily

ThermoGenesis (Rancho Cordova, California) reported that the European patent office has granted it a new patent entitled “Method & Apparatus for Cryogenic Storage of Thermolabile Products” covering the technology used in the BioArchive System, its automated cryogenic device used by cord blood stem cell banks in most of the industrialized countries to obtain precision cryogenic freezing and robotic storage and retrieval of cord blood stem cell units for transplant.

Philip Coelho, CEO and chairman of ThermoGenesis, said, “The BioArchive System has become the preferred platform at more than 80 cord blood stem cell banks in 29 countries, and we have built a formidable IP estate with 10 issued U.S., Japanese and European patents covering our BioArchive technology.”

The BioArchive System cryopreserves, archives and retrieves samples within liquid nitrogen without exposing the samples to detrimental transient warming events (TWEs), which can reduce cell viability. The system is a computer-driven robotic technology allowing users to cryopreserve and archive up to 3,623 units of blood components in -196 degrees C liquid nitrogen.

GE Healthcare (Chalfont St. Giles, UK) is the non-exclusive global distribution partner for the BioArchive System, as well as the exclusive distribution partner for ThermoGenesis’ AutoXpress System, which ThermoGenesis bills as the first fully closed, automated cord blood stem cell processing system that simplifies the traditional, labor-intensive manual process that often requires an expensive ‘clean room’.

ThermoGenesis develops automated blood processing systems and disposables that enable the manufacture, preservation and delivery of cell and tissue therapy products.

Cambrex sells sites in Ireland, Belgium

Cambrex (East Rutherford, New Jersey) reported signing an agreement to sell two non-strategic facilities within its Human Health segment – in Cork, Ireland, and Landen, Belgium — to a holding company controlled by International Chemical Investors II (ICIG; Luxembourg).

The facilities manufacture small-molecule active pharmaceutical ingredients (API) and advanced intermediates, with reported combined sales of $40.4 million and a loss of $29.8 million during FY05, including charges of $24.8 million for the impairment of goodwill and long-lived assets. Sales for the first six months of 2006 were $21.9 million, with an operating loss of $200,000.

“As part of our evaluation of strategic alternatives, we identified the divestiture of Cork and Landen as an initial step in our effort to streamline and strengthen the Human Health business,” said James Mack, president/CEO and chairman of Cambrex. “We believe that under ICIG’s leadership and experience in this industry bringing to bear synergies with their other activities, combined with the dedicated workforce at the sites, the new owners will achieve the full turnaround in the foreseeable future.”

With the sale, Cambrex expects to report a non-cash charge of about $30 million in the 4Q06. This transaction is expected to close within 30 days.”

The Human Health segment of Cambrex is a provider of products and services to the global life science industry.

ICIG is focused on mid-sized chemical businesses, preferably subsidiaries of large corporations considered non-core, with leading positions in niche markets.

Kensey Nash receives ThromCat CE mark

Kensey Nash (Exton, Pennsylvania) reported receiving CE-marking for its ThromCat Thrombectomy Catheter System, a mechanical thrombectomy catheter used to remove thrombus or blood clots from a patient, indicated for use in both the coronary and peripheral vasculature in Europe.

The ThromCat is a disposable catheter system that incorporates HeliFlex technology to flush, macerate and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal.

The company cited industry sources indicating that the current market for thrombectomy catheter systems is about $100 million worldwide, including the coronary market. The company says that the worldwide market could expand with the offering of a simple and effective device.

The device will be sold through the company’s Endovascular direct sales force in Germany and through a distribution network for the rest of Europe. It has had limited market release in the U.S. with an initial indication for use in AV grafts and fistulas, Kensey Nash said. The official U.S. launch is underway at the Transcatheter Therapeutics Conference this week in Washington.

Joseph Kaufmann, president/CEO of Kensey Nash, said, “Kensey Nash is now offering a full complement of simple to use, fully disposable products designed to remove dangerous clot and emboli from the arterial system in both the U.S. and Europe. We envision it as a device that will be useful for interventional cardiologists, interventional radiologists and also vascular surgeons to quickly and easily remove moderate to relatively heavy thrombus burdens.

“We believe it will be an important product within our endovascular portfolio and that it is a perfect complement to our recently launched QuickCat Extraction Catheter. In combination with our TriActiv ProGuard and TriActiv FX embolic protection systems, we will be able to offer our customers a broad platform of products for removing unwanted debris and thrombus from the vasculature.”

The ThromCat Thrombectomy Catheter System is complementary to the company’s QuickCat Extraction Catheter, recently cleared in the U.S. and Europe, for the removal of thrombus from the arterial system. The QuickCat is a disposable device, designed for soft thrombus burdens. The TriActiv ProGuard is available for sale in the European Union and the TriActiv FX is available for sale in the U.S.

Kensey Nash provides products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets.

EORTC/NCI/AACR symposium in November

The 18th EORTC – NCI – AACR Symposium, titled “Molecular Targets and Cancer Therapeutics” will be held Nov. 7-10 in Prague, Czech Republic, at the Prague Congress Centre. The symposium is joint program of the European Organisation for Research and Treatment of Cancer , the U.S. National Cancer Institute and American Association for Cancer Research . The symposium will provide information on new cancer drug R&D from experts in Europe, North America, Asia and Australia.