|Cardio3 CEO Christian Homsy|
Cardio3 BioSciences pulled in €4 million ($5.5 million) in regional government funding to help support U.S. commercialization of its C-Cathez catheter for delivering stem cell treatments directly into the heart.
The intramyocardial catheter has several distinguishing characteristics that enable the delivery of delicate stem cells to treat heart failure and other conditions, Cardio3 CEO Christian Homsy told FierceDrugDelivery. First, the device has a curvature that anchors it to the tissue. This nitinol-based anchor, while keeping the needle in place, also has side holes that allow for high-volume delivery over a larger surface area in the heart. And importantly, the catheter's size reduces the pressure of the delivery to protect the stem cells on their way into the tissue. The device picked up a CE mark in 2012.
With the cash infusion, the Belgian company hopes to meet FDA requirements following a Phase III European trial. The Walloon regional government in Belgium granted Cardio3 about 60% of the non-dilutive funding up front, and the rest is to be paid before 2015, according to the company. It is intended to finance half of the costs for the first 60 patients in the study.
"After going public in July and two additional European research grants, the funding from the Walloon region is intended to finance the first patients in our European trial," Homsy said. "That data will help us support the funding of C-Cathez into Phase III."
Cardio3 suffered a few setbacks earlier this year after a Forbes blog report exposed "questionable" data surrounding the Phase II trial. The company fired back to explain inaccuracies in the report, but shares still slid down at the time.
The $5.5 million financing follows a $31 million IPO in July, as well as $6 million and $9 million grants from research organizations later in the year. The funding from the Walloon region continues a relationship the two have had since Phase II, Homsy said.
"It is essential for Wallonia to support expertise and the economic development of companies in the region," said the region's vice president, Jean-Marc Nollet, in a statement. "This funding … is crucial in this respect, especially as its expertise makes Cardio3 Biosciences a world leader in its field."
- here's the release