Xhale Assurance to Showcase Alar Sensor at AANA2017

Xhale Assurance announced today that it will showcase its Nasal Alar SpO2 Sensor at the AANA2017 Nurse Anesthesia Annual Congress, hosted by the American Association of Nurse Anesthetists. The Congress will be taking place September 9 – 12, 2017 at the Washington State Convention Center, halls 4A and 4B in Seattle, WA.

Xhale Assurance will be demonstrating its Nasal Alar SpO2 Sensor at booth #1743.

Xhale submits Biomarker Qualification package to FDA for Medication Adherence Monitoring Tool

Xhale submits Biomarker Qualification package to FDA for Medication Adherence Monitoring Tool.

Gainesville, FL, September 21, 2015

Xhale, Inc. announced today that it has submitted to the Food and Drug Administration (FDA) the first Biomarker Qualification package for a Drug Development Tool for medication adherence monitoring.

 

The submittal to FDA marks an important step for the company’s patented SMART® Medication Adherence Monitoring system. The components of the system are a breath-based SMART® device and an adherence marker which is incorporated into a capsule with the medication. Within minutes after the medication is swallowed, the adherence marker is absorbed in the stomach and metabolized. The study participant then blows into the SMART® device, which takes a photo of the person’s face as they are providing the breath sample, and a metabolite of the marker is detected in the breath, proving that the medication was ingested by a specific individual. The SMART® device wirelessly transmits that information to cloud servers in real-time via a built in cellular connection.

 

SMART® is the culmination of more than 6 years of development, including support from the National Institutes of Health in funding the development of the system. The underlying technology was licensed from the University of Florida (UF), one of the nation’s premiere public research universities and an academic leader in technology transfer.

 

“One of the qualities that makes SMART® particularly unique is that it provides a definitive assessment of medication adherence,” said Dr. Donn Dennis, a co-inventor from UF and co-founder of Xhale. “In other words, because the SMART® device measures the metabolite created in the patient’s body and provides a key biometric parameter – the facial photograph – we know definitively that the medication was swallowed by the intended individual. It’s simple, elegant and definitive. Having a high degree of confidence in the quality of adherence data is a very important consideration in the assessment of clinical trial safety and efficacy data by pharmaceutical companies and regulatory authorities.”

 

The full Biomarker Qualification package was submitted to FDA based on their invitation after the agency had reviewed data and information on the SMART® system from earlier initial briefing packages.

 

Xhale has designed the SMART® system for use in pharmaceutical clinical trials. Pharmaceutical companies often spend more than $1 billion to obtain marketing approval for a new medication. “According to industry reports,” explained Richard R Allen, CEO of Xhale, “average nonadherence rates among patients in clinical trials receiving treatment for chronic conditions can be as high as 57%*. If a drug fails to achieve approval in part because participants aren’t taking the study medication, not only is it a terrible waste of money, but drugs that could be helpful to patients may never gain approval.”

 

Unlike systems that rely on ingestible chips, with SMART® the patient is only ingesting a food-grade marker with the medication, and no adhesive skin patch is required for monitoring. Furthermore, because SMART® includes metabolite detection in the breath and a photo of the person providing the breath sample, with SMART® there is no question who ingested the medication.

 

Contingent upon qualification, FDA plans to publish the qualification recommendation as an appendix to their guidance on the FDA Guidances (Drugs) website.

 

About Xhale

Xhale, Inc. is a medical technology company commercializing novel monitoring platforms for the healthcare industry. Through its subsidiary Xhale Smart, Inc. the company is commercializing it’s breath-based medication adherence monitoring system called SMART®. Through its subsidiary Xhale Assurance, Inc., Xhale is commercializing the Assurance® pulse oximetry sensor, a simple, highly-effective single-point-of-contact sensor that can reliably monitor critical cardiorespiratory parameters under challenging conditions for patients. Xhale was founded on technology licensed from the University of Florida. For more information, please visit www.xhale.com or contact the company at info@xhale.com.

 

*The New England Journal of Medicine in 2005 (Lars Osterberg, M.D. and Terrence Blaschke, M.D., “Drug Therapy: Adherence to Medication”)

Xhale Assurance Announces CE Mark for Nasal Alar SpO2 Sensor

Xhale Assurance announced today that it has received CE Mark approval for its Nasal Alar SpO2 Sensor which allows for nasal ala oximetry utilizing a highly dependable central site.

 

GAINESVILLE, FL August 21, 2015 – Xhale Assurance, Inc.

 

Xhale Assurance, Inc. today announced it has received CE Mark approval of its Nasal Alar SpO2 Sensor for clinical use in CE countries. A CE Mark verifies the Assurance® Nasal Alar SpO2™ Sensor has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland.

 

“In light of the tremendous market response the sensor has already experienced in the U.S., we are excited to bring the Assurance® Nasal Alar SpO2™ Sensor to CE countries,” said John Moscarillo, Vice President at Xhale Assurance. “We are dedicated to meeting the growing demand for accurate, real-time pulse oximetry. With high European demand for the product, and now with CE Mark approval, we can report the shipment of our product to new customers in Europe.”

 

Xhale Assurance will be presenting several webinars on the Assurance® Nasal Alar SpO2™ Sensor in the near future. If you are interested in attending a webinar, email info@xhale.com for an invitation to the event.

 

For ordering information or to receive additional product information, contact your local distributor or contact Xhale toll-free at (855) 743-4589 or info@xhale.com.

 

  1. Comparative Desaturation Study performed at Xhale Assurance, Inc. and University of Florida, 2012. Data on file at Xhale Assurance, Inc.
  2. Melker, RJ, et al. Usability/Acceptance Study Final Report Xhale Assurance Nasal Alar Sensor. Feb. 2015. Data on file at Xhale Assurance.
  3. Morey TE, et al. Feasibility and accuracy of nasal alar pulse oximetry. British Journal of Anesthesia. Advance Access published April 15, 2014.

 

 

About Xhale

 

Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Nasal Alar SpO2™ Sensor, received marketing clearance in the United States and has received CE Mark approval. The Assurance® Nasal Alar SpO2™ Sensor pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

 

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

 

For more information, please visit www.xhale.com/assurance or contact the company at info@xhale.com.

 

Xhale’s Assurance Nasal Alar SpO2 ™ Sensor to be Showcased at National Teaching Institute & Critical Care Exposition

Xhale’s Assurance Nasal Alar SpO2 ™ Sensor to be Showcased at National Teaching Institute & Critical Care Exposition

The Xhale Assurance Nasal Alar SpO2 ™ Sensor which detects SpO2 changes faster than a finger-applied sensor will be featured at The National Teaching Institute & Critical Care Exposition.

GAINESVILLE, FL   May 15, 2015 – Xhale Assurance, Inc.

Xhale Assurance, Inc., developer of the Nasal Alar SpO2™ Sensor, today announced that the company will demonstrate its SpO2 sensor at the NTI conference.

  •  May 17-21: National Teaching Institute & Critical Care Exposition Booth #3028, San Diego Convention Center, San Diego, CA, USA

Previous meetings of these professional groups have highlighted the widespread problem of current SpO2 technologies and Xhale Assurance will demonstrate the potential of the Nasal Alar SpO2™ Sensor to address the significant need for reliable SpO2 readings.

Assurance’s Nasal Alar SpO2™ sensor applied to the nasal ala detects SpO2 changes faster than a finger-applied sensor, an early response that can be critical for clinical intervention.

About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States. The Assurance® Alar One-Sense™ pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

 

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

 

For more information, please visit www.xhale.com/assurance or contact the company at info@xhale.com.

Xhale Assurance Announces FDA Approval of its Second Generation Nasal Alar SpO2 Sensor

Xhale Assurance, Inc., developer of the patented Assurance® Nasal AlarSpO2TM Sensor, today announced FDA clearance and the global launch of its second-generation pulse oximetry sensor.

The new Assurance® Nasal AlarSpO2TM Sensor is now compatible with the majority of pulse oximetry monitors in use in a wide variety of health care settings.

“The Assurance® Nasal AlarSpO2TM is a true innovation in pulse oximetry,” says John Moscarillo, Vice President of Xhale Assurance. “This sensor provides dependable monitoring3 in a wide variety of patient conditions and settings, early detection of oxygen saturations changes1, and in a recent study, the sensor was validated for 7-days of continuous use which can provide substantial cost savings for the health care system2.”

The Assurance® Nasal Alar SpO2 Sensor is easily removed and reapplied, eliminating the waste associated with trying multiple sensors to get a good signal. And because it can be repositioned the nasal alar sensor can eliminate pressure injuries; unlike forehead sensors which contribute to tissue necrosis with prolonged use4.

“Because the Assurance® Nasal Alar SpO2 Sensor is placed at the nasal ala, it is unaffected by many of the most common conditions that cause inaccurate pulse oximetry readings,” reports Dr. Richard Melker, Chief Technology Officer of Xhale Assurance. “In research studies, Nasal Alar Oximetry™ detected desaturations up to 30 seconds faster than finger-applied sensors”1,5

Xhale Assurance will be presenting several webinars on the Assurance® Nasal Alar SpO2™ Sensor in the near future. If you are interested in attending a webinar, email info@xhale.com for an invitation to the event.

For ordering information or to receive additional product information, contact your local distributor or contact Xhale at 855.743.4589 or XA.CustomerService@xhale.com.

 

 

 

  1. Comparative Desaturation Study performed at Xhale Assurance, Inc. and University of Florida, 2012. Data on file at Xhale Assurance, Inc.
  2. Melker, RJ, et al. Usability/Acceptance Study Final Report Xhale Assurance Nasal Alar Sensor. Feb. 2015. Data on file at Xhale Assurance.
  3. Morey TE, et al. Feasibility and accuracy of nasal alar pulse oximetry. British Journal of Anesthesia. Advance Access published April 15, 2014.
  4. Lee M, Eisenkraft JB, Forehead pulse oximeter-associated pressure injury, A A Case Rep. 2014 Jan 15;2(2):13-5. doi: 10.1097/ACC.0b013e3182a66b29.
  5. Melker, RJ, et al. Earlier Detection of Desaturation NADIR from the Nasal Ala. Presented at the Annual Meeting of the Society for Technology in Anesthesia, January 2013

 About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Nasal Alar SpO2TM pulse oximetry sensor, that received marketing clearance in the United States, is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

 

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

 

Xhale’s SMART® Adherence Technology Enabled Through Collaboration with Catalent

Xhale announces availability of first solution to enable integration of breath-detectable adherence markers into pharmaceutical products

Xhale, Inc., a commercial stage medical technology company focused on developing and selling patient-centric monitoring solutions for the healthcare industry, announced today the availability of SMART™ Softgels for clinical research use with the SMART® Adherence System. The breath-based SMART® Adherence System is being developed to verify, monitor, and report information about how and when study participants are taking study medications in clinical trials.

SMART™ Softgels are the first solution offered by Xhale to enable integration of breath-detectable adherence markers into a broad range of pharmaceutical products. SMART™ Softgels were designed, developed, and manufactured through a collaboration between Xhale and Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products.

Catalent and Xhale jointly presented scientific information about the development and performance of the SMART™ Softgels at the annual American Association of Pharmaceutical Scientists (AAPS) Meeting, the world’s largest gathering of pharmaceutical scientists. The SMART™ Softgels demonstrated stability, reliable release of the adherence marker, and favorable properties to support pharmaceutical use.

The SMART® Adherence System is designed to offer definitive and noninvasive monitoring of medication adherence, utilizing exhaled breath to confirm that medication has been taken by study participants as directed. Through near real-time reporting of reliable adherence information and a user-friendly breath analysis device, the SMART® Adherence System offers significant potential to optimize clinical trial management and outcomes.

Xhale chose to partner with Catalent because of its experience and track record of RP Scherer Softgel innovation, which spans more than 80 years. Working with Xhale, a Catalent RP Scherer Softgel product was developed to feature a thin shell to help overcome potential formulation challenges and prevent evaporative loss during and after manufacturing.

The SMART® Adherence System, including the SMART™ Softgels manufactured by Catalent, is now available for research use in the collection and reporting of definitive treatment adherence data in clinical studies. Xhale has filed a Type IV (Excipient) Drug Master File with the Food and Drug Administration (FDA) that contains comprehensive information supporting the use of SMART™ Softgels in clinical studies.

For more information about the SMART® Adherence System or SMART™ Softgels, please contact Xhale at info@xhale.com or 352-371-8488.

  

About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States. The Assurance® Alar One-Sense™ pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

For more information, please visit www.xhale.com or contact the company at info@xhale.com or 352-371-8488.

 

 About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

Xhale Assurance™ Appoints John Moscarillo as VP of Commercial Operations

Xhale Assurance announced today the appointment of John Moscarillo as VP of Commercial Operations.

Mr. Moscarillo joins Xhale Assurance™ with outstanding credentials and a proven track record in sales, management, channel partnerships and corporate alliances.  Mr. Moscarillo brings with him 17 years of valuable industry experience and has earned numerous awards and recognition in a variety of sales, sales training and sales management positions.  His first duties will be in the sales and marketing of the Assurance® Alar/Nasal SpO2 Sensor which offers faster reflection of oxygen saturation changes and a dependable signal that is less prone to drop out.

Mr. Moscarillo initially joined Xhale in December 2013 as the National Business Development Manager of Xhale SMART.  In November 2014, Mr. Moscarillo was promoted to Vice President of Commercial Operations for Xhale Assurance™ with responsibility for Sales, Business Development and Operations in both national and international markets.

Previously, while serving in progressive sales roles with Medtronic, Inc. and Phyiso Control, Inc., Mr. Moscarillo developed clinical experience in the hospital and pre-hospital markets with an emphasis on Cardiology, ICU, and Emergency Departments.  Prior to that, Mr. Moscarillo spent five years in the pharmaceutical sales industry.

Mr. Moscarillo received a Bachelor of Arts degree from Longwood University.

 

About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States. The Assurance® Alar One-Sense™ pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

For more information, please visit www.xhale.com or contact the company at info@xhale.com.

Nauman Toor Joins Xhale, Inc.’s Board of Directors

GAINESVILLE, August 1, 2014 – Xhale, Inc.

The Board of Directors of Xhale, Inc. today announced the appointment of Nauman (Nick) Toor as a board member of Xhale, Inc.

Mr. Toor is a Co-Founder and the Chief Investment Officer of Luzich Partners, a multi-strategy investment fund with a focus on both public and private equity investments. Previously, Mr. Toor was Founder and Chief Investment Officer of BlackRoot Capital, an investment fund focused on small-cap public equities and special situations.

Prior to BlackRoot Capital, Mr. Toor served as Managing Director of Jefferies & Company Inc., from April 2001 to December 2006. He also served as Head of Media Investment Banking at Jefferies, where he began working in 1994, and guided Jefferies’ growth and strategic direction as a member of the Investment Banking Management Group. Mr. Toor began his career in investment banking with Kidder Peabody & Co. in New York in 1990.

Mr. Toor holds a Bachelor of Arts degree in Economics from Ohio Wesleyan University and a Masters in Business Administration from Harvard Business School.

About Xhale

Xhale is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology that offers definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Xhale Smart is an emerging leader in patient-centric monitoring solutions for medication adherence. Through its Xhale Assurance subsidiary, Xhale is developing a patient monitoring technology – the Assurance® platform – designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States. The Assurance® Alar One-Sense™ pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

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Download PDF: 07312014 Nauman Toor Joins Xhale Final

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