2010 was a big year for regulatory approvals. The company announced in Q3 that it had received European and Canadian Regulatory approval, and in December, the company was granted a Class II FDA 510(k) clearance to allow us to market our device in the US as well. The difficult regulatory environment was a hot topic in the medical device industry in 2010 and this represents a major milestone…
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Building on our innovation award from the European Association of Cardiothoracic Surgeons award in 2009, the company received additions awards in 2010. PleuraFlow® was awarded an international industrial design distinction award from I.D. Magazine. In addition, PleuraFlow® was awarded a manufacturing excellence award as the top innovation of the year from Fenner, a $1B international manufacturing giant that bought our manufacturing partner, MRI, in 2010.
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The company continues to have a strong R & D effort to support the commercial roll out of the PleuraFlow® product. Two of our pre clinical studies were published in internationally recognized peer reviewed journals. In a head to head comparison with a same sized conventional chest tube in the setting of heavy bleeding, the PleuraFlow® drained far more, and significantly prevented residual hemothorax. This article, entitled, “Improved…
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Our lead product, the PleuraFlow® Active Tube Clearance® System is now available for marketing in the US, Canada and Europe. The board has worked with the executive team to lay out a strategy for the commercial roll out in 2011. The interest level by the surgeons and nurses is strong. The interest level by prospective distribution partners has been large and our global director of sales and marketing…
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In October, 2010, the company announced it closed an equity financing round with total proceeds of $1.2 million. The financing was led by the Oregon Angel Fund (OAF), joined by additional Oregon based angel investors. The financing will support the clinical launch of the company’s lead product, the PleuraFlow® Active Tube Clearance® System and continued technology development.
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Financing was led by the Oregon Angel Fund (OAF), joined by additional Oregon based angel investors, and will support the clinical launch of the companyʼs lead product.
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and European Launch of the PleuraFlow Active Tube Clearance System
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Demonstrating Improved Drainage with the PleuraFlow Active Tube Clearance System
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