BORNHEIM, Germany - Cardion AG, the trans-Atlantic merger of former Cardiogene AG, of Erkrath, Germany, and Intracardia Inc., of Cincinnati, covers a technology that allows controlling a potential future safety standard in stem cell-derived grafting, the company's CEO said.

CEO Michael Ruhl said Intracardia has contributed the Loren Field technology, which can be used to avoid unwanted contaminations such as tumors and teratomes during stem cell transfer.

"This is the technology you can make stem cell technology absolutely safe with for clinical use," he said. "This is of value for all kind of stem cells." According to Ruhl, Cardion owns the patent for this technology, and "developing alternative approaches should be very difficult for competitors."

The main source of Cardion's revenues for the future will be product sales, Ruhl said. "We expect first sales in 2004," the Cardion CEO told BioWorld International. The company's lead product is NOStentin. "This nonviral gene therapy product for prevention of restenosis is an in-house development of Cardiogene," he said. "We'll start Phase I clinical trials as soon as we have approvals by the authorities." The trial is expected to take place in Germany and the U.S. and include 40 patients.

"The other product we can talk about at the moment is Cardioprotectin by Intracardia," Ruhl said. "It shall make regeneration of heart muscle by stem cell-derived grafting possible." But it would take another few years having it clear for clinical trials, he added. "Safety issues, e.g. electrophysiological coupling of newly transplanted cardiomyocytes, have to be dealt very thoroughly."

At the moment, there are no agreements of cooperation with other companies, although Ruhl said those would be considered. The privately held company intends to go public next year, he said.