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Ampio Pharmaceuticals, Inc. Message Board

  • billwilliams836 billwilliams836 Oct 9, 2013 11:22 AM Flag

    Latest 8K: Luoxis progress

    From latest 8-K re:Luoxis. Doesn't seem related to recent price decline, but revenue is a distant event.
    Importantly, we remain on track to achieve our goals of CE mark acceptance, FDA clearance, and near-term commercialization.

    • First, we have completed and analyzed two key clinical studies utilizing the company’s proprietary oxidation-reduction potential (ORP) diagnostic platform (which we have now named and trademarked RedoxSYS™). The first study..analyzed patients who suffered a hip fracture and found significant correlations between ORP values and various patient outcomes. ... The second study involved 645 patients with isolated traumatic brain injury (iTBI) and showed that oxidation-reduction potential closely correlated to numerous patient outcomes, including in-hospital mortality and discharge disposition.

    • Second, we are well on our way as a company to becoming ISO 13485: 2003 certified. ..Thus, we will have our second audit in November which could enable ISO certification within the next few months.

    • The company has solidified manufacturing relationships and quality agreements with two suppliers ... Both suppliers have begun to scale production in anticipation of commercial launches in 2014.

    • Importantly, we submitted our pre-submission to the US Food and Drug Administration in July and have received initial correspondence back..., we are pursuing classification of the ORP system as a 510(k) de novo device which would enable truncated review and relatively rapid clearance if classified as such. We will continue this regulatory filing process and still plan for submission in the near term.

    • We have established two research agreements with leading oxidative stress researchers outside the UUS. Our early outreach efforts have focused on gaining interest from prominent researchers in the field of oxidative stress and have these researchers begin integrating the RedoxSYS platform into their research activities.

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