WEST PALM BEACH, FL, United States
WEST PALM BEACH, FL, United States

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Patent
Isense, Llc | Date: 2013-09-11

A device and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin. Such a device allows a sensor to penetrate mammalian skin without the use of an introducer device such as a needle. A device in accordance with embodiments of the present disclosure includes a housing for attachment to mammalian skin including an exit port for receiving the distal end of a biosensor and an injection activation device including a mechanism for forcing the sensing device from a first position within the housing, through the exit port to a second position, with sufficiently high velocity to partially penetrate the mammalian skin.


Patent
Isense, Llc | Date: 2014-11-06

A urine test for diagnosing lung cancer has been developed that uses an artificial nose such as a colorimetric sensor arrays to identify metabolic profiles in urine headspace gas. Cancer cells excrete unique compounds that are a byproduct of their metabolism. The compounds are excreted through a patients endocrine system by filtration through the kidneys and other organs and are ultimately excreted through the urine. Some of these cancer cell by-products excrete in the urine are small volatile organic compounds (VOCs). Once the urine has exited the body, these VOCs may be outgassed to the environment. Experimental research has determined that a colorimetric sensor array as disclosed is capable of reliably identifying patients with lung cancer based after exposure to the VOCs of the urine headspace gas.


Embodiments of the present invention provide a device and method for treating animal skin to produce tautness in the skin during the insertion of an analyte sensor. A device in accordance with embodiments of the present invention includes a housing that partially encloses a cavity and is adapted for mounting onto animal skin and a sensor insertion module adapted to insert an analyte sensor through animal skin.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 300.00K | Year: 2012

DESCRIPTION (provided by applicant): Sepsis is a common and frequently fatal condition with a mortality rate that ranges from 20% to 50% for severely affected patients. It is the second leading cause of death in the U.S. among patients in non-coronary intensive care units and the 10th leading cause of death overall. It is a rapidly increasing health concern, especially for elderly, immune-compromised, or critically ill patients. Blood culturing with automated liquid culture systems is the standard test foridentifying the pathogenic bacteria involved in sepsis, but it is slow and insufficiently sensitive for slow- growing bacteria or in patients pretreated wih antibiotics. iSense, LLC has a novel sensor technology that can simultaneously detect and identifythe causative bacteria by sensing metabolic volatiles, and do so after only four hours of blood culture incubation: a substantial improvement in time to diagnosis. In collaboration with the Stanford School of Medicine, iSense has evaluated the new nanoporous pigment-based colorimetric sensor array's ability to detect and identify 33 different microorganisms cultured in Petri dishes and drawn from reference strains and clinical isolates from 14 clinically relevant pathogen species. Over 400 experiments wereperformed on solid media in Petri dish, yielding 99% accuracy for species identification. We propose to adapt this sensor matrix to develop a prototype system that can be used to detect and identify causative bacteria in blood culture bottles. If successful, iSense technology could revolutionize the sepsis diagnostic method, dramatically improving the quality of health care while reducing its cost. PUBLIC HEALTH RELEVANCE: The proposed research effort will develop and test a novel high-dimensionalcolorimetric sensor array technology for the detection and identification of bacteria responsible for sepsis. The proposed effort, if successful, will yield a rapid diagnostic tool for sepsis, allowing prompt delivery of appropriate antibiotic treatment and reduced health care costs.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 998.51K | Year: 2016

Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing more than $ billion annually More than million blood culture bottles are produced annually with a market size greater than $ B in the US and EU alone The two year phase II period spanned February to February R AI The developments funded in part by this grant have created a new paradigm to diagnose blood stream infection causing sepsis The work of this grant has assisted in creating the SpecID blood culture system which the company is now commercializing The SpecID solution replaces the present step process for characterization of blood samples currently divided into detection of infection an obligatory Gram stain for all positive cultures performed on the bench by trained technician and then species ID by MALDI TOF again requiring skilled sample preparation The SpecID solution combines faster detection more accurate Gram status determination than the benchtop stain and ID more accurate than MALDI in a single fully automated step which reduces the time to ID streamlines lab workflow and saves significant cost The result is improved patient outcomes and improved lab operating performance The objectives of this Commercialization Readiness Pilot CRP Program proposal reflect the key goals not supported by the Phase II or Phase IIB programs but required to achieve commercial market entry of the SpecID blood culture system including development of blood culture media manufacturing processes development of quality control and documentation systems FDA strategy to achieve k approval and development of the SpecID blood culture instrument and blood culture bottle sensor attachment Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing for than $ billion annually Rapid identification of the infection is critical for effective treatment The ultimate goal of this project is to bring hospitals a new technology solution that reduces the time to identification in a single automated instrument The result is improved patient outcomes and importantly in today s cost critical healthcare system the solution is less expensive than current practice


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 1.12M | Year: 2011

The sensitivity of iSense Medical Corp (IMC) sensor system for the detection of a lung cancer signature from breath will be enhanced and demonstrated, a new breath collection device completed and a modification of the Cleveland Clinic Foundation (CCF) protocol for the ELDDA study of 8000 lung cancer patients and controls will be completed. The first generation of this non-invasive, inexpensice and rapid assay for the presence of lunf cancer has already been tested at CCF wwith specificity and selectivity ofdetection in the 80s. The next generation of this sensor array,comprising optical indicators embedded in a nanoporous sol-gel matrix is now>100x more sensitive to a range of lung cancer breath markers, enhancing sensitivty for a breast sensor technology already proven effective in lung cancer detection. The approved CCF protocol will be refined to assess the specific claim that following an indeterminate lung CT witht he IMC breath test reduces lung cancer diagnosis false positives over 200%. Further, as lung cancer breath signature arises from active tumor metabolism, the protocol will be adapted to test the hypothesis that the IMC breath rest represents a rapid and low-cost assessment for the efficacy of chemotherapy.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1000.00K | Year: 2016

DESCRIPTION provided by applicant Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing more than $ billion annually More than million blood culture bottles are produced annually with a market size greater than $ B in the US and EU alone The two year phase II period spanned February to February R AI The developments funded in part by this grant have created a new paradigm to diagnose blood stream infection causing sepsis The work of this grant has assisted in creating the SpecID blood culture system which the company is now commercializing The SpecID solution replaces the present step process for characterization of blood samples currently divided into detection of infection an obligatory Gram stain for all positive cultures performed on the bench by trained technician and then species ID by MALDI TOF again requiring skilled sample preparation The SpecID solution combines faster detection more accurate Gram status determination than the benchtop stain and ID more accurate than MALDI in a single fully automated step which reduces the time to ID streamlines lab workflow and saves significant cost The result is improved patient outcomes and improved lab operating performance Phase IIB aims address application to clinical human specimens along with development of instruments and media appropriate for commercial use The objectives of this proposal reflect the major goals required to achieve commercial entry of the SpecID smart culture system into commercial high volume laboratories including development of the SpecID blood culture instrument blood culture bottle sensor attachment and the clinical and analytical studies to prove performance gain regulatory approval and make first sales PUBLIC HEALTH RELEVANCE Sepsis is the leading cause of deaths in US hospitals contributing to or causing of all US hospital deaths and is the most expensive condition treated in US hospitals costing for than $ billion annually Rapid identification of the infectio is critical for effective treatment The ultimate goal of this project is to bring hospitals a new technology solution that reduces the time to identification in a single automated instrument The result is improved patient outcomes and importantly in todayandapos s cost critical healthcare system the solution is less expensive than current practice


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 149.90K | Year: 2014

DESCRIPTION (provided by applicant): In the U.S., prostate cancer is the second leading cause of cancer death in men, and one in six men will eventually develop prostate cancer during his lifetime. Currently, the prostate specific antigen test and digitalrectal examination are the most predominant used tools for prostate cancer detection, but both methods have low specificity and poorly predict the presence of aggressive prostate cancer. To that end, researchers and clinicians have worked to discover novel biomarkers that would give an early indication of the disease with high accuracy. iSense Medical Corp. has developed a sensor platform that enables the identification of cancer from metabolomic biomarkers in urine headspace. The cancer cell metabolism produces unique volatile organic compounds that partitions to blood and then excretes into urine, which can be measured in the urine headspace using our colorimetric sensor array technology. In this work, we propose the detection of prostate cancer from


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 149.74K | Year: 2013

DESCRIPTION (provided by applicant): Acute pesticide poisoning remains a vast health problem in the developed and developing world. Domestically, a 2004 study estimates that 18 of every 100,000 US agricultural workers suffer from acute pesticide poisoningand a 2002 study of California air found dangerous levels of three pesticides in urban areas. Since pesticides are primarily applied by sprayers or aerially from planes, where spray drift can translate pesticides far from their targeted areas, widespread monitoring of pesticide concentration at the site of their use and in surrounding areas is required to protect the public from dangerous levels of exposure. However, current monitoring strategies are too slow and costly to do this on a widespread scale. iSense, LLC has developed a novel sensor technology that can detect various toxic industrial chemicals (TICs) across multiple chemical moieties below their permissible exposure (PEL) limit. The technology is rapid, inexpensive and capable of distinguishing between TICS as well as complex mixtures of compounds. We propose to test, improve and optimize this technology toward the detection and identification of organophosphate pesticides, the leading type of pesticide identified in US pesticide poisoning. If successful, iSense technology could drastically reduce unhealthy pesticide exposure and improve medical treatment by simultaneously identifying the pesticides responsible for pesticide poisoning. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Theproposed research will develop and test a novel array based sensor technology for the detection and identification of organophosphate pesticides. If successful, the proposed effort will yield technology to rapidly detect and identify pesticides, drastically reducing unhealthy pesticide exposure and allowing for the prompt administration of appropriate medical treatment when unhealthy exposure persists.


Patent
Isense, Llc | Date: 2013-03-06

A method of creating an analyte sensor. The method starts with the step of providing an electrochemically active surface. Then, at least one nub made of dielectric material and extending transversely outwardly from the electrochemically active surface is created. A curable liquid is applied to the electrochemically active surface and the nub and is then cured. In this process, the nub, which could be one of several nubs, serves to support the liquid before and during the curing.

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