CoAxia

CoAxia, Inc. was a medical device company established in 1999 and founded by Denise Barbut. The firm operated from Maple Grove, Minnesota, and concentrated on developing catheter-based treatments for cerebral ischemia, which can result from conditions like stroke and vasospasm. CoAxia's core business involved creating and manufacturing perfusion augmentation systems designed to improve patient outcomes by redistributing blood flow to the brain during acute ischemic events. The company was privately held and venture-backed, securing a total of $72.6 million in funding over four rounds from institutional investors such as Sofinnova Investments, Johnson & Johnson Innovation – JJDC, Baird Capital, and Canaan Partners.

The company's primary products were the NeuroFlo™ and FloControl™ catheters. The NeuroFlo catheter system was designed to be placed in the descending aorta, where its dual balloons would inflate to temporarily reduce blood flow to the lower body. This action aimed to divert a greater volume of blood toward the upper torso and brain, increasing cerebral perfusion by a reported 35-50%. This technique was intended to support brain function and potentially limit neurological damage in patients experiencing an ischemic stroke. The FloControl catheter was designed for selectively stopping or controlling blood flow in the peripheral vasculature. The devices received FDA 510(k) clearance, a Humanitarian Device Exemption for treating cerebral vasospasm, and CE Marking in the European Union.

CoAxia conducted several clinical trials, most notably the SENTIS trial, to evaluate the safety and efficacy of the NeuroFlo technology for treating acute ischemic stroke patients within 14 hours of symptom onset. While the trial met its primary safety endpoints, it did not achieve statistically significant levels of efficacy for its primary outcome. In 2013, CoAxia was acquired by Zoll, a subsidiary of the Asahi Kasei Group.

Keywords: medical devices, cerebral ischemia, catheter-based treatment, perfusion augmentation, neurovascular, stroke therapy, vasospasm, NeuroFlo catheter, FloControl catheter, interventional neurology, medical technology, surgical devices, blood flow diversion, SENTIS trial, humanitarian device exemption, CE Mark, FDA clearance, Zoll acquisition, Asahi Kasei Group, Denise Barbut