Funding and Clinical Trial Progress Position Company for PMA Submission
MINNEAPOLIS, June 22 /PRNewswire/ -- CoAxia, Inc. of Maple Grove, MN, announced today completion of a $21.5M Series D financing. The round was led by Sofinnova Partners with participation from all previous major investors including Affinity Capital Management, Baird Venture Partners, Canaan Ventures Partners, Johnson and Johnson Development Corporation, and Prism Ventureworks.
In addition, CoAxia reported strong, continued enrollment in its SENTIS pivotal trial of NeuroFlo(TM) technology for acute ischemic stroke. The company has now enrolled over 75% of its goal of approximately 500 patients, with enrollment expected to conclude in early 2010, and PMA submission later that year. Also, the company announced that it has recently completed two pilot studies of its NeuroFlo catheter in additional stroke patient populations; a) those treated as late as 24 hours after stroke onset, and b) those who received NeuroFlo treatment in conjunction with intravenous tPA - the only FDA approved stroke treatment. If the trials are successful, CoAxia believes that the NeuroFlo technology has the potential to become integrated into the standard of care for stroke treatment, and thus treat more than 500,000 ischemic stroke patients per year - resulting in a market in excess of $1B.
The purpose of the Series D financing is to provide sufficient funds for CoAxia to complete the SENTIS trial, and to submit results to the US FDA. In addition, the funds will allow further investigation of NeuroFlo in combination with a variety of stroke devices and drugs, and initiation of marketing.
CoAxia President & CEO Andrew M. Weiss stated, "We are excited to have attracted Sofinnova Partners to lead this round, and to have continued support from our current investors: Affinity, Baird, Canaan, JJDC & Prism. Despite the difficult financial environment, we are pleased to have raised a sizeable, and oversubscribed, financing round. These funds will provide the resources to finalize our pivotal trial and demonstrate safety and efficacy. Looking forward, with Sofinnova's experience in financing medical device companies developing breakthrough technologies to successful exits, we believe that we are now well positioned for trial completion, PMA submission and initiation of sales and marketing."
Antoine Papiernik, Managing Partner at Sofinnova Partners commented: "Sofinnova is pleased to have led the Series D round for CoAxia. We have long been interested in treatment opportunities in ischemic stroke, given the very large, global, untreated population. We had been following CoAxia's progress for many years and we felt it was the right time to get involved. We find the NeuroFlo technique very compelling, given its ease of use, excellent safety profile and impressive early clinical results. If the SENTIS trial is successful, we believe that NeuroFlo has the potential to become a standard of care. We are very impressed with the strength of CoAxia's operating team, and are convinced that they can continue to deliver on the NeuroFlo potential. I look forward to joining CoAxia's Board of Directors for this exciting period ahead."
CoAxia, Inc. is a venture-backed, privately held, clinical-stage company providing perfusion augmentation therapies to improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions. In addition to the SENTIS, Flo24 and FASTFlo trials for ischemic stroke, CoAxia's NeuroFlo(TM) & FloControl(TM) devices have been approved by the US FDA via Humanitarian Device Exemption for the treatment of cerebral vasospasm, have received US FDA 510(k) clearance, and have secured the CE Mark for cerebral perfusion augmentation.
Sofinnova Partners is an independent venture capital firm based in Paris, France that specializes in investments in early stage companies and corporate spin-offs in the technology and life sciences sectors. Since 1972, the firm has financed over 450 companies, many of which have gone public or have been acquired, and currently manages over euro 1 billion in assets. Sofinnova's experienced team and hands-on approach in nurturing and supporting portfolio companies from initial financing to successful exit have created market leaders and multiplied revenues. www.sofinnova.fr
|SOURCE CoAxia, Inc.|
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