Claro Scientific, LLC
Company Overview
Claro Scientific is advancing its patented optics based diagnostic system, SpectraWave™, through a series of clinical studies. The company has been in operation since 2006 and employs ten people, primarily research and clinical scientists and engineers. Near term, Claro will complete additional clinical studies demonstrating that SpectraWave can identify the cause of bloodstream infections and assess drug resistance in real time without reagents. With additional funding, Claro will manufacture fully integrated systems for additional clinical studies and to place in medical laboratories. Analysis using the system will also be expanded from pathogen identification to characterizing whole blood samples to assess patient health and monitor markers of chronic diseases such as diabetes. At the same time, Claro is seeking to partner non-FDA regulated applications of Spe! ctraWave to monetize the technology without compromising the rights to commercialize medical diagnostic applications that are integral to its planned exit strategy.
Product / Service
Claro’s patented SpectraWave system has been developed to leverage core hardware and software components to answer the critical need for timely, accurate and actionable healthcare information. The same core system can also be used in other important commercial applications including protein and cellular analysis, environmental analysis and biodefense. Currently, systems that deliver robust, quantitative sample information are hospital laboratory based. They are complex to operate and require the use of reagents and highly trained laboratory personnel. Often tests are run on more than one system requiring healthcare professionals to reconcile disparate data from multiple platforms for decision making. As a result, the delivery of actionable information can require hours and sometimes days due to a combination of processing, confirmation and transport times. Claro has developed SpectraWave to be a disruptive system, redefining how optics can be applied to medical diagnostic and patient monitoring applications. Claro’s breakthrough is in delivering the powerful combination of unique and confirmatory information that requires several discrete optical analysis methods today. Combining these methods means a single set of proven, accurate and quantitative methods can be deployed with the levels of sensitivity and specificity and limits of detection required to meet today’s medical diagnostic requirements. Claro’s patented, fully integrated interpretation model and optical profile databases are at the core of this innovation. The Company has also developed a novel signal capture system that simultaneously collects transmission, scattering and fluorescence data from a sample. Through the addition of customized sample preparation modules, applications for the analysis of whole blood, blood culture, urine, as well as biological, chemical and environmental samples can be developed and commercialized. Depending on sample preparation requirements, the time to result ranges from a few seconds to less than five minutes. The SpectraWave system is portable and reagentless, meaning the same technology can be used in the laboratory, in the clinic and in the field. Whether focused on patients, products or processes, users will benefit from improved quality, better outcomes and cost savings.
Target Market
The U.S. infectious disease diagnostics market including molecular, immunoassay, and blood culture products totaled approximately $4 billion in 2005 with a CAGR of 7.7% . The introduction of new tests and innovative technologies is expanding the market. The market is also growing due to the increases in hospitalized patients, an aging and increasingly immune-compromised population, and the use of implant procedures putting patients at greater risk for bloodstream infections. This market is dominated by three global players, bioMerieux, Becton Dickinson and Trek Diagnostics. Claro sought a launch opportunity where its technology is differentiated from other approaches, is supplemental to current testing methodologies, faces limited competition, and delivers a positive impact on patient outcomes and hospital profitability. Rapid identification of MRSA and MSSA is highly warranted. Benefits include accurate targeting of treatments, improved patient outcomes, a reduction in length of hospital stay and cost of care, and an improvement in patient morbidity/mortality. Current estimates of this market alone range between $100 and $200 million . The targeted customer base is hospitals, clinics and physician offices in the EU. Claro will expand the number of tests to identify additional pathogens from the same sample. As a result, the assay revenue opportunity for each SpectraWave™ system increases each year. As hospitals adopt these new assays, the price per assay will be lowered to increase the value return from use of SpectraWave™. Claro can further increase revenues with FDA approval and licensing the system for use outside the U.S. and EU.
