VISTA'S INITIAL PRODUCT MARKETS

Vista’s functionalized nanowire (NW) system will facilitate significant improvements in the measurement of blood and urinary biomarkers because it allows frequent, inexpensive, label-free, multiplexed detection at great sensitivity. In addition, the results are available in minutes, not hours or days. After spending a great deal of time and energy speaking with potential customers about their needs, we have refined our system design around a single, universal nanowire sensing device that will be immediately applicable to several related markets without further customization. The markets for our NanoBioSensor™ have been identified as follows:

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 Pharmacokinetic and toxicokinetic studies in animals. The most informative biomarkers for acute toxicity, injury or illness have rapid induction and resolution profiles lasting only minutes to hours. For drug candidates intended to treat acute disorders, or that induce acute toxicity, the time-rates-of-change of these biomarkers is the most valuable information they provide. Current ELISA-based assays are ill-suited for conducting kinetic analysis because they are expensive, time consuming, insensitive and the turn-around time for results is measured in hours. These limitations impose dollar costs and animal suffering that could be significantly reduced using Vista’s Nanobiosensor.
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 Tissue culture applications. Differential expression of protein or gene transcripts is widely employed with in vitro safety assays. Release of markers into the culture medium can be assessed continuously by Vista’s technology, or aliquots of cells can be lysed and their contents assessed periodically (this is especially well suited to non-adherent cell types).
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 Assessment of urinary markers. It has been well-established that several types of kidney and liver damage can be accurately assessed by measuring specific proteins in the urine. Vista’s technology is perfectly suited to both periodic and continuous analysis in humans or test animals because of its low volume requirements.
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 Optimization of Kidney Dialysis: The typical hemodialysis patient is dialyzed 3 to 5 hours, 3 times/wk. At present, the ‘adequacy’ of each session is defined grossly as a urea reduction (predialysis BUN - postdialysis BUN) and patients suffer from treatment-limiting side effects with enormous variability. Nephrologists agree that if tools were available to continuously monitor biomarkers of adequacy and toxicity on a real-time basis, this would represent a critical advancement in patient care. Vista’s technology is ideal for monitoring biomarkers of efficacy and toxicity during dialysis.
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 Assessment and Monitoring of Acutely Ill/Injured Patients: Death following ICU admission is most sensitive to treatment received during the first 24 hours. The hourly rates of change of serum biomarkers of organ damage are highest during the first 24 hours of admission for both survivors and non-survivors. Kinetic analysis of biomarkers throughout this crucial period is significantly more informative than the once-daily method currently employed. Vista’s technology facilitates kinetic analysis because it reports results within minutes of sample collection and requires only microliters of sample.
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 Optimization of Treatment with Highly Toxic Drugs: Because of population and health-status variability of patients, conservative dosing limits are established for the use of toxic drugs such as anti-tumorogenic agents and antibiotics. For such drugs the maximum benefit is achieved when administered at the highest dose that a given patient can tolerate. This can only be determined empirically on a patient-by-patient basis. If physicians could monitor organ toxicity continuously and contemporaneously with drug treatment, such treatment could be adjusted…during dosing…to match the patient’s response(s).

Animal and tissue culture assays require no regulatory approval. Application of Vista’s Nanobiosensors to clinical research likewise requires no regulatory approval so long as no treatment decisions are based upon results obtained. Vista will approach the non-regulated markets first. Over a longer-term time horizon, Vista will seek regulatory approval for all appropriate applications of its technology. As discussed in detail in the next section, the universality of Vista’s design and its ease of use of Vista’s means that end-users will find additional applications.