A Medical Device Daily

CoAxia (Maple Grove, Minnesota) reported the completion of a $21.5 million 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 & Johnson Development Corp., and Prism Ventureworks.

CoAxia also reported strong, continued enrollment in its SENTIS pivotal trial of NeuroFlo technology for acute ischemic stroke. The company said it has now enrolled more than 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.

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 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.

"These funds will provide the resources to finalize our pivotal trial and demonstrate safety and efficacy,'" said CoAxia president/CEO Andrew Weiss. "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."

In addition to the SENTIS, Flo24 and FASTFlo trials for ischemic stroke, CoAxia's NeuroFlo and FloControl devices have been approved by the FDA via humanitarian device exemption for the treatment of cerebral vasospasm, have received FDA 510(k) clearance, and have secured the CE mark for cerebral perfusion augmentation.

In other financing news, Axis Three (Boston), a developer of surgical simulation tools for the cosmetic surgery industry, reported that it has closed a round of financing, led by Crescent Capital and existing investors Clarendon Fund Managers and Siemens, a strategic partner. With this round, the company now has secured more than $8 million in funding, which will be used to support the company's continued expansion into global markets.

"Axis Three is poised to become the standard in surgical simulation software for the plastic surgery industry," said John Knapton, investment manager, Crescent Capital. "Axis Three's powerful combination of innovative products, smart leadership, and a robust market opportunity has made it a company to watch in 2009 and beyond, and we are excited to participate in the company's next stage of growth."

"This latest round of funding is a strategic milestone for us, providing us with the resources to expand our sales and operational footprint in the U.S. market and overseas markets," said Steve Crummey, CEO, Axis Three. "This financing gives us the ability to penetrate further into the U.S. and overseas markets for board-certified plastic surgeons, while also allowing us to continue to innovate and deliver the key product offerings our surgeons need and their patients want."

The company's Tissue Behavior Simulation (TBS) technology allows surgeons to combine a patient's individual body attributes with specific implants from manufacturer's catalogues, for more accurate visualizations of results prior to surgery. Through an exclusive licensing agreement, Axis Three has integrated patented image-capture technology developed by Siemens with its own proprietary software to create a powerful, flexible and intuitive platform that can be tailored to a variety of surgical needs.