Xhale Completes Spin-Off of Assurance Biosense

New wholly owned subsidiary, Assurance Biosense, Inc., will focus on PPG related products in rapidly evolving patient monitoring segment.

Gainesville, FL — Xhale, Inc. announced today the completion of the spin-off of Assurance Biosense, Inc., a wholly owned subsidiary of Xhale, Inc. The company is located in Glastonbury Connecticut, and is focused on the commercialization of an extensive IP portfolio centered on pulse oximetry and photoplethysmography (PPG). The first product being developed is a novel pulse oximetry sensor that is positioned on the side of the nose.

Richard Allen, CEO of Xhale, commented, “We are excited to see the launch of our new subsidiary, Assurance Biosense, Inc. We believe this to be an important milestone on the path to the rapid commercialization of this product line. We are pleased to have the group lead by Andrew Kersey and David Rich, both of whom have extensive experience in all aspects of pulse oximetry design, development and commercialization.”

The Assurance™ pulse oximetry sensor is innovative on several counts. It provides monitoring from a convenient single-point-of-contact sensor on the fleshy portion of the nostril, or the nasal ala. It is designed to stay in place with no patient discomfort. Its placement on the nose, and the resulting central signal source, provide more convenient, robust and dependable measurement of oxygenation, with fewer false alarms. And the underlying technology can provide critically needed cardiorespiratory parameters that are not currently available from any other non-invasive monitoring technologies.

“We are confident that the Assurance™ sensor will move us into the future of patient monitoring by more reliably tracking a broader range of physiologic parameters, while providing greater comfort for the patient at a lower cost,” says Andrew Kersey, President of Assurance Biosense, Inc. “The false alarms associated with conventional finger pulse oximetry, many of which are due to placement of the sensor on the finger, and related issues of sympathetic tone and patient movement, are significantly reduced with the Assurance™ sensor, which directly monitors the blood supply to the brain.” Assurance Biosense intends to file for 510(k) clearance later this year with commercialization planned for next year.

About Assurance Biosense

Assurance Biosense, a wholly owned subsidiary of Xhale, Inc. is committed to providing clinicians with easy to use, cost effective diagnostic solutions that improve patient safety and reduce false alarms. Its Assurance™ line of PPG/oximetry sensors monitors central blood flow to the brain through placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries. The unique physiology of the site provides a much stronger signal than that from a fingertip or extremity, delivering more robust pulse oximetry signals, while simultaneously enabling the monitoring of a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

About Xhale

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its two current product lines under development include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.
(Note: Certain applications described above have not been reviewed by the FDA, and are therefore labeled for investigational use only).

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Download PDF: 2012-10-5- Assurance Biosense Spin Off

Xhale Awarded National Institute of Drug Abuse (NIDA) Grant for Further Development of Innovative Breath-Based SMART® Adherence Tool.

GAINESVILLE, FL – August 22, 2012

Xhale, Inc. announced today it has been awarded a $1.7 million Small Business Innovation Research (SBIR) Phase II grant by the NIH National Institute of Mental Health (NIMH) to continue the development of SMART® (Self Monitoring and Reporting Therapeutics), a breath-based medication adherence system for HIV/AIDS therapies.

In 2007, NIH / NIMH awarded Xhale an SBIR Phase I grant to test the technical merit of SMART®. SBIR Phase II grants enable SBIR Phase I grantees to further develop their technology and prepare it for commercialization. Xhale will use the Phase II grant to develop and test additional functionality, accuracy and system usability. The result will be a commercial version of the system which will have multiple benefits to patients, doctors, researchers and pharmaceutical companies.

As with the Phase I SBIR, Dr. Richard Melker, CTO of Xhale, will be the principal investigator for the project. “Medication adherence has tremendous impact on patient health,” said Dr. Melker. “This is particularly true with HIV/AIDS patients where just a 10% change in adherence is associated with doubling of viral load and a 21% increase in the risk of developing full blown AIDS. NIHM was particularly interested since non-adherence to antibiotic or antiviral regimens also pose a serious threat to public health through the emergence of resistant organisms.”

“Building on our Phase I achievements, we will design and deploy a handheld, breath-based medication adherence device,” reports Dr. Donn Dennis, project Co-investigator and CSO for Xhale. “The system will first remind the patient to take their medication. After ingesting their medication, the patient will blow into the device which will detect and document that the appropriate medication was taken at the proper time. This technology should improve adherence rates, especially in high-risk populations, and provide pharmaceutical companies and the FDA with a higher quality data set for evaluating drug safety and efficacy in clinical trials.”

The New England Healthcare Institute (NEHI) in its August 2009 report noted that poor medication adherence costs the U.S. as much as $290 billion annually (13% of total health care expenditures),and affects virtually every aspect of the health care system. Besides an estimated $47 billion each year for drug-related hospitalizations, not taking medications as prescribed has been associated with as many as 40% of admissions to nursing homes and with an additional $2,000 a year per patient in medical costs for visits to physicians’ offices.

This is the third time in two years that Xhale has been awarded an SBIR grant. Previous awards were SBIR Phase I awards from the National Institute of Mental Health and the National Institute on Alcohol Abuse and Alcoholism.

There is a great need for a method to improve drug compliance which provides simple monitoring of medication dosing which is non-invasive, intuitive, and sanitary. Non-compliance of patients to drug regimens prescribed by their physicians results in excessive healthcare costs estimated to be around $100 billion per year through lost work days, increased cost of medical care, higher compliance rates, as well as drug wastage. Non-compliance refers to the failure to take the prescribed dosage at the prescribed time which results in under medication or overmedication. Non-compliance of patients with communicable diseases costs the public health authorities millions of dollars annually and increases the likelihood of drug-resistance, with potential for widespread dissemination of drug-resistant pathogens resulting in epidemics.

This method determines whether a patient has taken a medication, by providing a patient a medication comprising a combination of a least one active therapeutic agent and an odorous compound or olfactory marker, which is then detectable in gaseous exhaled breath. The patient then blows into an electronic SMART™ device which analyzes the patient’s exhaled breath for detection, or absence, of the odorous compound or olfactory marker to determine compliance. Presence of the markers indicates the patient has taken the medication at the prescribed time and in the prescribed dosage. The system is also expected to be an important tool for use in pharmaceutical clinical trials as part of drug development.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2011-08-01 Xhale NIH Naltrexone Grant

Xhale Completes NIH-Funded Study on SMART™ Adherence Monitoring System

Xhale, Inc. announced today the successful completion of an NIH-funded study of usability on its SMART™ Medication Adherence Monitoring System.

Gainesville, FL July 26, 2012 — Xhale, Inc. announced today the successful completion of a study sponsored by the National Institutes of Health (NIH) to assess the usability of the SMART™ Medication Adherence System.

SMART™ is being launched as a clinical trials tool and a service platform for the pharmaceutical industry, to address the very significant problem of noncompliance of participants in drug trials. Studies and reports have estimated that between 25% and 50% of study participants are either not taking the study drug per protocol, or not taking it at all. The result of noncompliance and unknown compliance rates in drug trials is flawed data and, ultimately, failed studies and failure to gain approval for important drugs. SMART™ definitively monitors who is taking the medication and who is not, in real-time, allowing intervention within a short period of time after a dose has been missed, driving compliance rates higher and generating superior data sets.

The NIH sponsored study was designed to assess the usability of SMART™ technology by subjects with disease (HIV/AIDS) in real-world environments (home). In the SMART™ system, a subject swallows a capsule containing FDA-designated direct food additives, termed adherence-enabling markers (AEMs). After being absorbed in the upper GI tract including the stomach, the AEMs rapidly generate volatile breath compounds, termed exhaled drug ingestion markers (EDIMs), which can be detected in the breath. The subject exhales directly into a small handheld SMART™ device, and the breath sample is analyzed for the presence of EDIMs. SMART™ devices in development will transmit data to a central repository in a HIPAA-compliant manner. The presence of EDIMs in exhaled breath coupled to a positive biometric authentication (i.e., facial recognition) indicates “definitive” subject adherence to the medication on a dose-by-dose, time-stamped basis without the expense and burden of directly observed therapy (DOT).

In response to interview questions, 100% of study participants generally liked the idea of a system documenting adherence, and 92% indicated that they would be willing to use the SMART™ device again in a clinical study if asked. Overall, subjects were willing to use the SMART™ Adherence System and generally satisfied with its operation. Subjects effectively used the SMART™ Adherence System during the observed initial interactions with the device and throughout the 10-day study period. Future SMART™ devices are expected to increase usability even further.

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its two current product lines under development include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2012-7-26 Xhale Completes NIH SMART Study

Xhale Issued U.S Patent for Breath-Based Closed-Loop Propofol Monitoring

Xhale, Inc. announced today the issuance of U.S. patent 8,211,035, disclosing a non-invasive method of monitoring and controlling propofol and other IV-administered agents utilizing a breath detection system.

Gainesville, FL July 3, 2012

Xhale, Inc. announced today the issuance of U.S. Patent 8,211,035, disclosing methods and apparatuses for the detection, quantitation, and trending of intravenous (IV) and/or inhalational delivered drug concentration(s) utilizing a breath detection system. This non-invasive system enables the monitoring of the intravenous anesthetic propofol via exhaled breath, controlling the delivery of the desired dose of propofol or other drugs to a patient. The system comprises a breath analyzer for analyzing the patient’s breath for concentration of the agents, and a control mechanism that delivers propofol or other drugs based on the concentrations in exhaled breath.

A major impediment to the wider use of the IV anesthetic propofol, has been the inability to precisely determine the quantity required to provide a sufficient anesthesia without accumulating an excessive amount. Medications are ineffective if blood concentration levels are too low, and can be toxic when concentrations are too high. Currently, there is no technology to measure the concentration of propofol in blood in real-time. Xhale’s newly patented system would provide the correlation to blood levels effectively in real-time.

“This provides a more predictive method to monitor blood propofol concentration ,” explained Dr. Richard J. Melker, M.D., Ph.D., Xhale’s Chief Technology Officer. “The system enables the user to immediately and continuously monitor the blood concentration of propofol, inhalation anesthetics and other medications routinely delivered to eliminate pain”.

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor in exhaled breath and is focused on novel patient-centric monitoring solutions. Among its product lines under development are SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2012-07-03 US Patent – Closed-Loop Propofol

Xhale Issued European Patent for Novel Nasal Pulse Oximeter Sensor Configuration

European patent EP1706025 discloses methods and probes for monitoring PPG and pulse oximetry signals across the nasal septum, optionally configured with a cannula to supply oxygen and/or a carbon dioxide sensor.

GAINESVILLE, FL – May 9, 2012

Xhale, Inc., a leading innovator in patient safety solutions, announced today the issuance of European Patent EP1706025, which includes claims to novel probes and methods for monitoring PPG and pulse oximetry at the nasal septum. Such probes may optionally include a cannula for supplying oxygen and/or a sensor for analyzing exhaled gases for carbon dioxide content. The novel probes described in EP 1706025 include features designed to provide improved patient comfort and strong PPG signals, and such features may allow for accurate, reliable detection of both pulse oximetry and respiratory parameters in a single, easy to use probe for spontaneously breathing patients.

The European patent provides additional protection of the Assurance™ sensor line, which is being commercialized by Xhale’s Assurance Biosense division. Richard Allen, CEO of Xhale, commented, “We are pleased to add this European patent to its US counterpart, US 7,024,235, further building our patent portfolio as we bring this technology to the market.”

“There is growing awareness of the great need for a reliable method to monitor ventilation and oxygenation in spontaneously breathing patients,” said Dr. Richard J. Melker, Chief Technology Officer of Xhale. “Opioid analgesics rank among the drugs most frequently associated with adverse drug events, and may cause respiratory depression in post-surgical patients, who often receive them for pain management. The Assurance™ technology protected by EP1706025 and US 7,024,235 can provide a unique solution, capable of monitoring both ventilation and oxygenation.”

About Xhale

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its two current product lines under development include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

(Note: Certain applications described above have not been reviewed by the FDA, and are therefore labeled for investigational use only).

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Download PDF: 2012-05-09 Xhale Issued European Patent for Novel Nasal Pulse Oximeter Sensor Configuration

Xhale Completes Spin Off of SMART Biotechnologies

GAINESVILLE, FL – Oct. 1, 2012 – Xhale, Inc.

Xhale, Inc. announced today the completion of the spin off of SMART Biotechnologies, a wholly owned subsidiary of Xhale, Inc. The company is located at the Xhale headquarters in Gainesville, Florida, and is focused on the development of a breakthrough technology for measuring, monitoring, reporting and improving adherence to prescribed medication regimens, including clinical trials.

The SMART™ Adherence system is the only technology currently available that definitively verifies that the right person took the right dose of the right medication at the right time. “This technology is crucial for the treatment of patients taking prescription medication, as well as the success of clinical drug trials,” states Susan Baumgartner, Pharm. D., MBA, Vice President of Business Development at SMART™ Biotechnologies.

This new technology uses a unique breath-based medical drug adherence monitoring system, which involves packaging safe food additives as adherence enabling markers (AEMs), together with the medication into a “smart” drug formulation. Once the patient ingests the SMART™ drug, the AEMs are absorbed in the stomach and rapidly metabolized into a taggant, or marker. The markers can then be detected in the breath using the non-invasive SMART™ device that collects and analyzes the breath to verify oral ingestion of the medication. The information is wirelessly transmitted to a HIPAA-compliant server and distributed to key stakeholders, such as health care providers who provide basic care to the patients, or clinical study coordinators. For the first time, stakeholders can access real-time information on medication adherence and receive alerts of non-adherence in order to investigate and intervene.

Richard Allen, CEO of Xhale commented, “We are excited to see the launch of our newest subsidiary, SMART™ Biotechnologies and look forward to the expansion of their innovative technology”. The group is lead by Dr. Donn Dennis. M.D., F.A.H.A, and Susan Baumgartner, Pharm. D., MBA, who both have extensive experience in the pharmaceutical industry. Mr. Allen adds, “We believe that the SMART™ Adherence System will become the gold standard for monitoring and improving medication adherence in clinical trials and in disease management and prevention.”

About SMART Biotechnologies

SMART Biotechnologies, a subsidiary of Xhale, has developed the SMART™ Adherence System for the pharmaceutical industry, where it is being launched as a clinical trials tool for use in drug development. The breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. The SMART™ system is the only technology
available that definitively verifies that the right person took the right dose of the right medication at the right time. The system is patient-centric and noninvasive. Utilizing exhaled breath, the SMART™ system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose.
SMART™ technology is expected to have a direct impact on the success of drug approval, and help provide safer, more effective drug development.

About Xhale, Inc.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2012-10-01 SMART Biotechnologies Spinoff

Xhale Issued Japanese Patent for Monitoring Drug Compliance

Xhale, Inc. announced today the issuance of Japanese patent 4773019, disclosing a method for monitoring drug compliance by detecting markers, such as odors, upon breath exhalation after medication is taken.

Gainesville, FL July 1, 2011

Xhale, Inc. announced today the issuance of Japanese Patent 4773019, disclosing methods and apparatuses for monitoring drug compliance by detecting markers, such as odors, upon exhalation by a patient after medication has been taken. These markers result either directly from the medication or from an additive combined with the medication. It utilizes electronic sensor technology to non-invasively monitor compliance, and a reporting system to then track and send any necessary alerts. The system which Xhale is developing to commercialize this technology is branded SMART™ (Self Monitoring and Reporting Therapeutics).

There is a great need for a method to improve drug compliance which provides simple monitoring of medication dosing which is non-invasive, intuitive, and sanitary. Non-compliance of patients to drug regimens prescribed by their physicians results in excessive healthcare costs estimated to be around $100 billion per year through lost work days, increased cost of medical care, higher compliance rates, as well as drug wastage. Non-compliance refers to the failure to take the prescribed dosage at the prescribed time which results in under medication or overmedication. Non-compliance of patients with communicable diseases costs the public health authorities millions of dollars annually and increases the likelihood of drug-resistance, with potential for widespread dissemination of drug-resistant pathogens resulting in epidemics.

This method determines whether a patient has taken a medication, by providing a patient a medication comprising a combination of a least one active therapeutic agent and an odorous compound or olfactory marker, which is then detectable in gaseous exhaled breath. The patient then blows into an electronic SMART™ device which analyzes the patient’s exhaled breath for detection, or absence, of the odorous compound or olfactory marker to determine compliance. Presence of the markers indicates the patient has taken the medication at the prescribed time and in the prescribed dosage. The system is also expected to be an important tool for use in pharmaceutical clinical trials as part of drug development.

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its two current product lines under development include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2011-07-01 Japanese Patent – Monitoring Drug Compliance

 

Xhale Issued U.S. Patent for Non-invasive Monitoring of Blood Glucose Using Exhaled Breath

Xhale, Inc. announced today the issuance of U.S. patent 7,914,460, disclosing a system and method for non-invasive monitoring of glucose concentrations in blood through the analysis of exhaled breath condensate.

Gainesville, FL (PRWEB) May 31, 2011 — Xhale, Inc. announced today the issuance of U.S. patent 7,914,460, disclosing a system and method for noninvasive monitoring of glucose concentrations in blood through the analysis of exhaled breath condensate. Such a system, when successfully commercialized and approved, would allow noninvasive blood glucose monitoring via the breath, using a small handheld device to accurately and conveniently measure blood glucose levels by simply exhaling into the device.

According to the U.S. Centers for Disease Control, diabetes affects more than 25 million Americans and is the seventh leading cause of death in the United States. Regularly checking blood glucose levels is one of the most important steps that patients with diabetes can take to successfully manage diabetes and prevent the significant complications of this devastating disease, including kidney failure, amputations, blindness, heart disease, stroke and death.

The most widely used devices to monitor blood glucose levels rely on blood samples that are obtained from the finger or other body site using a small needle. The pain, discomfort and inconvenience of obtaining and testing blood samples using these devices prevent many patients with diabetes from measuring blood glucose levels as often as recommended and as often as needed to successfully manage their health. The availability of a breath-based glucose meter could increase the frequency of blood glucose monitoring, with the potential to positively impact the lives of patients with diabetes by making it easier and more convenient for them to successfully monitor their blood glucose and manage their diabetes.

According to Richard Melker, M.D. Ph.D, Chief Technology Officer and co-founder of Xhale, “The great value of this technology lies in its ability to provide important information to patients and healthcare providers that can be used to make better healthcare decisions, reduce healthcare costs, and improve health outcomes. We hope that continued research will result in this breakthrough technology being available to patients, caregivers, healthcare providers and payers, all of whom would benefit from a more user-friendly glucose monitor.”

Additional research and development will be required to bring this innovation to patients who need it. Xhale, a research-driven medical device company, is a world leader in the use of sensors that analyze vapor and exhaled breath. The company, established in 2005, is dedicated to improving lives through innovation and technology, creating solutions that address unmet medical needs and advancing novel technologies for personalized medicine, point-of-need health monitoring, and diagnostics. Xhale is developing cost-effective, noninvasive technologies that provide critical information in real time about patient care and medication use. Xhale currently has 12 issued U.S. and European patents and 70 U.S. and foreign equivalent patent applications.

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Download PDF: Xhale Issued U.S. Patent for Non-invasive Monitoring of Blood Glucose Using Exhaled Breath

References:

1 http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf