The most desirable form of vascular access for most hemodialysis patients is an arteriovenous fistula (AVF). Flow Forward believes it can expand the AVF prevalence rate to 90% with its Arteriovenous Fistula Eligibility (AFE) System, a temporary external blood pump that rapidly dilates peripheral veins prior to AVF surgery.

With a projected worldwide market of over three million hemodialysis patients by 2020, TVA Medical Inc. sees a potential $1 billion+ annual market opportunity with everlinQ, a minimally invasive, catheter-based system that allows physicians to use an endovascular approach to create an arteriovenous fistula (AVF) for vascular access in chronic kidney patients who require ongoing hemodialysis.

CMS pays 33% of its budget for patients with end stage kidney disease, a group that, in terms of patient numbers, accounts for less than 1% of the Medicare population. For all this money spent, mortality rates remain high--the one year mortality rate for patients on hemodialysis stands at 24%, a survival rate that's worse than that of metastatic cancer. In an industry traditionally resistant to change, however, changes are coming, brought about by reimbursement changes and a delivery model that can't scale-up to meet a growing population, making room for new start-ups in the space.

If there's one word that ought to sum up the goal of cell therapy today, it's sustainability. Certainly that's the hope of using living cells to restore health and function to diseased tissues so that they perform as the body intended them to. But more to the point, in today's tough financing environment for venture-capital-backed start-ups, sustainability is the watchword for companies facing 15- to 20-year development curves. Tissue-engineered three-dimensional organs are complex, decades-long projects. Embryonic stem cells are much simpler in concept but are far from a commercial reality. Between those two extremes of tissue-engineering, however, there exist some well-defined opportunities, notably in the treatment of blood vessel disease. Start-ups Pervasis and Cytograft are gaining clinical validation in those areas.