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 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