Massachusetts-based Asahi Kasei (TYO:3407) subsidiary Zoll Medical announced today that it purchased the assets of CoAxia Inc., an early revenue stage medtech company behind the NeuroFlo and FloControl devices, which divert blood flow in the brain for patients suffering cerebral ischemia as a result of stroke, vasospasm, or other conditions.
Zoll acquired CoAxia’s intellectual property, including "several key patents on cerebral perfusion augmentation as well as numerous other patents relevant to other various vascular procedures," according to a press statement. The companies did not disclose the terms of the deal.
"NeuroFlo technology has the potential to address a large portion of the population who suffer cerebral ischemia, offering a significant benefit to patients and the healthcare system," Zoll president James Palazzolo said in prepared remarks. "Our task is to continue to develop the significant body of clinical evidence started by CoAxia demonstrating the safety and efficacy of the NeuroFlo catheter and, in the end, do what is necessary for it to be a standard treatment option for hundreds of thousands of stroke patients worldwide."
The acquisition complements Zoll’s critical care portfolio, the company said, and both the NeuroFlo and FloControl devices and regulatory clearances and reimbursement in the U.S. NeuroFlo is cleared under a humanitarian device exemption approval for treating patients with vasospasm following subarachnoid hemorrhage, Zoll reported. FloControl has 510(k) clearance for "stopping and controlling blood flow in the peripheral vasculature."
Zoll said that it plans in the "near future" to follow-up on CoAxia’s prior ischemic stroke studies to evaluate NeuroFlo’s safety and efficacy in increasing cerebral blood flow in order to minimize brain damage caused by ischemic stroke. CoAxia’s SENTIS (Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke) trial failed to achieve statistical significance in efficacy, but met safety endpoints and showed "numerous positive signals for both safety and efficacy using the NeuroFlo technology," Zoll said.
In 2005 CoAxia won FDA HDE approval for the NeuroFlo system in patients who had failed "maximal medical management," allowing physicians to use the device to stop or control blood flow in the peripheral blood vessels. CoAxia has previously said that the NeuroFlo device demonstrates 35-50% improvement in cerebral perfusion and can be placed in 10-15 minutes via the abdominal aorta.