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HOUSTON, TX, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 162.82K | Year: 2012

DESCRIPTION (provided by applicant): The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessmentof insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Insulin resistance, which frequently accompanies obesity, is known to be a key factor in the pathogenic development of type 2 diabetes. In fact, there are currently no clinical criteria by which an individual could be classified as being insulin sensitive or resistant or as having mild, moderate, or severe impairment of insulin secretion. Measurements of insulin sensitivity and secretion are currently done only for research purposes and are only comparable in individual studies. Furthermore, it is anticipated that the number of type 1 diabetics using insulin infusion pumps (currently approx. 200,000 users in the US or approx. 5%) will grow in the near future. Significant progress in developing a reliable closed loop system (insulin pump + glucose monitor) should accelerate the widespread use of insulin pumps further. However, current pump technologies do not provide any means to quantify the amount of insulin entering the blood stream. This can pose major risk to the health of the users in cases where the insertion needle may not deliver insulin due to improper placement, or scar tissue. In both cases, a much smaller amount, or no insulin at all may enter the body, causing the blood sugar to increase far above normal values. Even worse, a sudden increase of insulin infusion rate due to pump-malfunction could lead to a lethal overdose of insulin entering the body. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor'soffice, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) in blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care). PUBLIC HEALTH RELEVANCE: The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessment of insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor's office, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) i blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care).


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 248.89K | Year: 2012

DESCRIPTION (provided by applicant): Project Summary The goal of this NIH-SBIR Phase I proposal is to develop a new point-of-care (POC) detection platform and methodology for assessment of human exposure to hazardous environmental compounds in the bloodstream. Because the mechanisms of transport of such chemicals into the body, their differing stabilities, and elimination are difficult to model, if possible, it is much more straightforward to assay for these compounds in the body rather than in the environment. The primary innovations in our approach are that a novel optical micro- to nano-fluidic device will be used along with unique aptamers and Raman reporter molecules to simultaneously measure several classes of compounds in a multiplexed fashion. The opto-fluidic device is an extremely sensitive surface enhanced Raman spectroscopy (SERS) nanochannel cartridge that was invented at Texas AandM University by professors Jun Kameoka and Gerard Cot . The aptamer functionalization chemistry as well as the overall integrated product will be developed at BioTex, Inc. The device being developed provides signal enhancements equal to or exceeding 1014 at the entrance to the nanochannel, enabling rapid quantification of femtomolar or smaller levels of targets in fluids. This SERS-based nanofluidic platform has been demonstrated through several publications and so the key question that need to be addressed by the company are can the aptamer chemistry perform as intended in progressively complex media including whole blood with this platform and can the platform be optimized for this application. Thus, the specific aims of this research are to develop the aptamer assay for specifically detecting model polychlorinated biphenyls (PCBs), bisphenol-A (BPA), and model phthalates. The resonant-SERS reporting and nanofluidic concentrator employed have the potential to provide orders-of-magnitude improved sensitivity over standard fluorescence and without the complicated multistep tasks of ELISA or full analytical chemistry analysis such as chromatography and mass spectrometry. PUBLIC HEALTH RELEVANCE: Project Narrative The goal of this research is to develop a new point-of-care (POC) detection platform and methodology for assessment of biological exposure to harmful chemical compounds. With the potential to greatly improve the sensitivity and ease of such measurements, the end-product of this research is expected to have considerable impact allowing toxicologists, environmental health professionals, and clinicians the ability to correlate the effects of toxic chemicals to disease states.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 160.92K | Year: 2012

DESCRIPTION (provided by applicant): The goal of this Phase I SBIR application is to develop a new minimally invasive therapy for laser ablation of epileptogenic seizure foci. There is a large unmet need for better treatment options for the nearly one million epilepsy patients in the U.S. that are refractory to current medical treatments. While surgical removal of the epileptogenic foci offers relief in 70 percent of the well selected cases, most patients decide against this option due to the highly invasive nature of the procedure. We hypothesize that precise, image-guided laser thermal ablation of epilepsy foci would provide results approaching surgical resection in terms of seizure relief, and could be carried out with a far lower risk of surgical morbidity to the patient. In Phase I we will use our FDA-cleared technology (Visualase Thermal Therapy System), which is currently used for cancerous tumor ablation applications, to perform a pilot feasibility study in adult epilepsy patients who are refractory to medical therapy and have an identifiable lesion deemed responsible for their seizures. We will also develop hardware and software enhancements which will optimize the system for this application. In Phase II, we will perform expanded multi-center clinical studies on patients with broader inclusion criteria, including treatment of mesial temporal lobe epilepsies. Finally, we will construct a data registry with the goal of gathering clinical data necessary for the design of a successful definitive FDA trialin Phase III in which we will seek specific indications for the treatment of Epilepsy. PUBLIC HEALTH RELEVANCE: RELEVANCE Current medical therapy leaves 30 percent of Epilepsy patients without adequate control of their seizures. Developmentof a minimally invasive surgical option for thermally destroying the tissue in the brain responsible for seizures would have a significant impact on epilepsy patients and their families. This project will develop precise methods using MRI-guided laser technology, which if successful, has potential to be that minimally invasive option.


Patent
Biotex, Inc. | Date: 2012-06-06

The present invention is directed to a system, device and method for measuring the concentration of an analyte in a fluid or matrix. A thermodynamically stabilized analyte binding ligand for use in the system, device and method is disclosed. The thermodynamically stabilized analyte binding ligand is resistant to degradation at physiological temperatures and its use within the device provides a minimally invasive sensor for monitoring the concentration of an analyte in a fluid or matrix as are present in the body of an animal.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 714.23K | Year: 2016

DESCRIPTION provided by applicant The goal of this NIH SBIR Phase II effort is to develop a new point of care POC detection platform and methodology for assessment of human exposure to hazardous environmental compounds in the bloodstream Because the mechanisms of transport of such chemicals into the body their differing stabilities and elimination are difficult to model it is much more straightforward to assay for these compounds in the body rather than in the environment The primary innovations in our approach are that a novel optical micro to nano fluidic device will be used along with unique aptamers and Raman reporter molecules to simultaneously measure several classes of compounds in a multiplexed fashion The opto fluidic device is an extremely sensitive surface enhanced Raman spectroscopy SERS nanochannel cartridge that was invented at Texas Aandamp M University by professors Jun Kameoka and Gerard Cot The aptamer functionalization chemistry as well as the overall integrated product will be developed at BioTex Inc with aptamers discovered at sister company Base Pair Biotechnologies The device being developed provides signal enhancements equal to or exceeding at the entrance to the nanochannel enabling rapid quantitation of femtomolar or smaller levels of targets in fluids As demonstrated in Phase I the individual components of the system have been thoroughly tested and the Phase II study will therefore focus on the engineering integration and demonstration of overall system performance The resonant SERS reporting and nanofluidic concentrator employed have the potential to provide orders of magnitude improved sensitivity over standard fluorescence and without the complicated multistep tasks of ELISA or full analytical chemistry analysis such as chromatography and mass spectrometry Using aptamers to virtually any environmental compound of concern the fully developed platform will be able to provide quantitative andquot point of careandquot or field results in a matter of minutes PUBLIC HEALTH RELEVANCE The goal of this research is to develop a new point of care POC detection platform and methodology for assessment of biological exposure to harmful chemical compounds In contrast to most prior approaches which attempt to measure the amount of such compounds in the environment the technology developed here will have the sensitivity and specificity to detect toxic agents in human blood samples directly and thereby determine the toxicological andquot loadandquot within the patient The end product of this research is expected to have considerable impact allowing toxicologists environmental health professionals and clinicians the ability to correlate the effects of toxic chemicals to disease states

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