Making Sense of Inflammation

Approach

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Making Inflammation a New Vital Sign

Mission

Utilize the real time measurement of inflammation to impact the lives of individuals, treatment and care from physicians and the overall patient care from medical institutions.

Tag Line

Making Sense of Inflammation

Business Model

Kypha is in the business to develop inflammation-monitoring diagnostic tests that are intended to change the way medicine is practiced.  The business thesis is based on the premise that there is huge untapped clinical and commercial potential of measuring and assessing complement in human health and disease. Complement is central to inflammation and innate immunity, and is associated with a wide range of diseases. The plan is to address a major unmet clinical need: objective, real-time measurement of inflammation and immune status.  Kypha’s solution could have broad clinical utility and significantly improve care and outcome measures for a large number of patients, clinicians and caregivers across many disease specialties.

Several challenges related to accuracy, speed, complexity and cost have limited the clinical utility of existing inflammation diagnostics, and especially complement tests. With the right combination of technology, clinical protocol and complement markers, Kypha’s COMP ACT™ is designed to surmount many of the current obstacles. Roughly the size of a stick of gum, and tests require only a drop of sample to a small handheld reader that delivers quantitative results in 20 minutes or less. Roughly the size of a stick of gum, tests require only a drop of blood/sample and a small handheld reader delivers quantitative results in 20 minutes or less. To maximize impact, COMP ACT had to be versatile and robust.  As such, it shares several features with finger stick-based glucose testing. It is designed as portable, easy to use, rapid, with quantitative results. Intended as a point-of-care test, the Comp ACT platform is designed to accommodate lab, office, field or home use, and intended to support additional biomarkers. The product will be clearly differentiated and uniquely positioned in the market as a rapid point-of-care test to quantitatively measure inflammation and immune activity in near-real time.

Kypha’s clinical partners comprise the flagship of our commercialization strategy and team. Working closely with collaborators at several top-tier institutions to help validate clinical utility, these sites are likely the source of early adoption of COMP ACT. Multiple studies are underway in lupus, stroke, traumatic brain injury, preeclampsia, infection, aHUS and TTP, nephrology, kidney disease and transplant rejection. Earliest adoption is expected in lupus and certain other diseases where complement is most strongly associated or when complement testing is already performed.

Clinical Studies

We are currently collaborating with physicians and thought leaders from several renowned medical centers and research institutions.

Clinical-Studies-Organizations