Xhale’s SMART Technology Showcased at Drug Development, Medication Adherence, and Innovation Meetings

SMART® solution which enables the management of medication adherence and clinical trial outcomes highlighted at ASCP Annual Meeting, International HIV Adherence Conference, and the Catalent Institute Innovation Symposium

GAINESVILLE, FL June 10, 2014 – Xhale Smart, Inc.

Xhale Smart, Inc., developer of the SMART® Medication Adherence System, today announced that the company has been invited to present the SMART® System at three key meetings during the month of June. The SMART® presentations include:

  • “Usability Evaluation of SMART® Adherence System in HIV/AIDS Patients” Poster, 9th International Conference on HIV Treatment and Prevention Adherence, Miami, FL, June 8 – 10, 2014
  • “SMART®: A Breath-Based Technology to Definitively Document Adherence to Medications” Presentation, Innovation Showcase: Advanced Drug Delivery Approaches for Small and Large Molecules, Catalent Applied Drug Delivery Institute, St. Paul, MN, June 12, 2014
  • “Definitive Verification and Monitoring of Oral Medication Adherence Using Breath Analysis” Poster, American Society of Clinical Psychopharmacology (ASCP) 54th Annual Meeting, Hollywood, FL, June 16 – 19, 2014, Nominated for Best Poster

Previous meetings of these professional groups have highlighted the widespread problem of study participants not taking study medications as directed and its adverse impact on clinical trials and drug development programs. Xhale’s presentations demonstrate the potential of the SMART® System to address the significant need for a reliable adherence tracking tool that can verify, monitor, and report medication adherence.

The SMART® Medication 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® System offers significant potential to improve clinical trial execution and outcomes.

About Xhale, Inc., Xhale Smart, Inc. and Xhale Assurance, Inc.

Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale, Inc. is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale, Inc. is developing a medication adherence monitoring technology 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, Inc. subsidiary, Xhale, Inc. is developing a patient monitoring technology 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, Inc.’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: SMARTShowcased

Xhale Awarded NIH/NIMH SBIR Grant for Monitoring Microbicide Gel Use

GAINESVILLE, FL April 16, 2014 – Xhale SMART, Inc.

Xhale, Inc. has been awarded a 2-year Complex Technologies Phase 1 National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant in the amount of $622,000 by the National Institute of Mental Health (NIMH). This is the seventh SBIR grant awarded to Xhale.

The grant, entitled “SMART: A Breath-based Adherence Technology to Monitor HIV Microbicide Gel Use,” will be used to apply Xhale’s breath-based SMART® (Self Monitoring and Reporting Therapeutics) technology to seek to develop an alternative, breath-based, adherence monitoring tool for investigators studying microbicide administration. The SBIR program is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and move innovative products towards commercialization.

This grant will bring together researchers from Xhale, Inc., RTI International, and the University of California – San Francisco, and will be led by Donn Dennis, M.D., F.A.H.A., the Chief Scientific Officer of Xhale, Inc. In addition to his work with Xhale, Dr. Dennis is a professor in the Departments of Anesthesiology, Psychiatry and Pharmacology & Experimental Therapeutics in the College of Medicine at the University of Florida.

About Xhale, Inc., Xhale SMART, Inc. and Xhale Assurance, Inc.

Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale, Inc. is focused on developing two broad technology platforms. Through its Xhale SMART, Inc. subsidiary, Xhale, Inc. is developing a medication adherence monitoring technology which focuses on monitoring patient adherence to medication regimens established in protocols for investigation drugs in clinical trials. Through its Xhale Assurance, Inc. subsidiary, Xhale, Inc. is developing a patient monitoring technology 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, Inc.’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States in April 2013. 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: Xhale Awarded SBIR Grant for Monitoring Microbicide Gel Use

Xhale Assurance Receives ISO 13485 Certification

GAINESVILLE, FL – April 1, 2014 – Xhale Assurance, Inc.

Xhale Assurance, Inc., developer of the Assurance® Alar One-Sense™ pulse oximetry sensor, today announced it has received ISO 13485 certification, an internationally recognized quality standard for the establishment of Quality Management Systems for manufacturers of medical devices.

The scope of Xhale’s ISO 13485 certification covers the design, development, manufacture, servicing and distribution of monitors and sensors for pulse oximetry and respiratory rate.

ISO (the International Organization for Standardization) is the world’s largest developer and publisher of International Standards. ISO 13485 registration is a step for medical device companies to take in order to meet global quality system requirements. Although implementing ISO 13485 is voluntary, applying this standard demonstrates compliance with the continually changing customer and regulatory requirements within the medical device industry.

About Xhale, Inc., Xhale Assurance, Inc. and Xhale SMART, Inc.
Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale, Inc. is focused on developing two broad technology platforms. Through its Xhale Assurance, Inc. subsidiary, Xhale, Inc. is developing a patient monitoring technology 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, Inc.’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States in April 2013. 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. Through its Xhale SMART, Inc. subsidiary, Xhale, Inc. is developing a medication adherence monitoring technology which focuses on monitoring patient adherence to medication regimens established in protocols for investigation drugs in clinical trials.

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Download PDF: Assurance ISO Press Release

Assurance® Alar One-SenseTM Pulse Oximetry Sensor to be Presented in Two Clinical Abstracts and an Educational Session at Society for Technology in Anesthesiology Meeting

Research shows faster response time and the ability to identify abnormal breathing patterns

GLASTONBURY, CT (January 17, 2014) – Xhale Assurance, Inc., developer of the unique Assurance® Alar One-SenseTM Pulse Oximetry Sensor, today announced that its new Alar One-SenseTM Sensor is being highlighted in two clinical research presentations and an educational session on “Cutting Edge Clinical Technology” at the Society for Technology in Anesthesia (STA) Meeting in Orlando, FL, January 15- 17, 2014. The STA is dedicated to improving the quality of patient care by innovation in the use of technology and its application. The meeting is attended by physicians and other practitioners in the field of anesthesia from around the world.

Xhale Assurance, Inc. is showcasing its Alar One-SenseTM Sensor at its exhibit at the STA meeting. The Alar One-SenseTM Sensor detects blood oxygen saturation and heart rate at the nasal ala, the fleshy lateral part of the nostril. The rich vasculature at this site makes it attractive for pulse oximetry measurement, providing earlier detection of saturation changes than does a sensor placed at the extremities(1). Measurement at the nasal ala is also less prone to drop out that can be experienced by traditional finger sensors when there is diminished perfusion to the extremities, which may occur in nearly 80% of at-risk patient populations(2).

Andrew E. Kersey, President of Xhale Assurance, Inc., stated, “The research presented at STA demonstrates the faster response time of the Alar One-SenseTM sensor, compared to traditional finger sensor placement, to identify desaturations. It also provides evidence that measurement at the nasal ala can provide additional information to the clinician including the presence of both obstructive and central apnea as well as other abnormal breathing patterns that may provide early indication of patient respiratory compromise. This type of information, and its timely delivery to the clinician, is important when monitoring critical or anesthetized patients.

“The single-point-of-contact Alar One-SenseTM Sensor provides capabilities that are unmatched by traditional pulse oximetry. Our continued innovation in monitoring at the nasal ala, supported by clinical research, will build upon the foundation we are developing in measurement of blood oxygen saturation and additional physiological parameters.”

The abstracts being presented include:

Disordered Spontaneous Breathing Patterns Detected Using an Alar Sensor. Melker R, et al. Monitoring at the nasal ala provides information on not only oxygen saturation and heart rate, but also provides insight into the presence of apnea and other abnormal breathing patterns in spontaneous breathing patients undergoing monitored anesthesia care.

Earlier Detection of Desaturation from the Nasal Ala. Tan H, Cannon R, et al. Faster detection of the onset and the nadir of desaturation during monitored anesthesia care was demonstrated by monitoring at the nasal ala rather than at a finger (physiologic delay), with the possibility of additional delays added by pulse oximeters (device delay).

The educational session is in the Cutting Edge Clinical Technology segment of the program:

Analysis of the Alar PPG
Presented by Richard Melker, MD

  1. Melker RJ, et al. Earlier detection of desaturation from the nasal ala during MAC. Post Graduate Assembly in Anesthesia. Dec 2013.
  2. Davis DP, et al. Latency and loss of pulse oximetry signal with the use of digital probes during prehospital rapid- sequence intubation. Prehosp Emerg Care. 15(1):18-22. Epub 2010-Sep21.

About Xhale Assurance, Inc.

Xhale Assurance 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 are designed to monitor central blood flow by placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries which also supply the brain. The unique physiology of the site provides strong, robust pulse oximetry signals. Measurement from this site will enable monitoring a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

Xhale Assurance is a wholly owned subsidiary of Xhale, Inc., 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. Xhale, Inc. and its subsidiaries own exclusive licenses for various intellectual property and patents licensed from the University of Florida.

(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: 2014-01-17 STA2014

LionsGate Technologies and Xhale Assurance announce a codevelopment agreement to bring the Xhale Alar One-Sense™ Pulse Oximetry Sensor to Mobile Health

Bringing together two leading sensor technologies to offer accurate and accessible vital signs monitoring at a fraction of the cost of current market solutions.

VANCOUVER, B.C., GLASTONBURY CT — LionsGate Technologies Inc. (LGTmedical) and Xhale Assurance Inc. today announce the signing of an agreement that will see the two companies co-develop a first-of-its-kind multi-parameter sensor connected and driven through the universal audio-port of almost any mobile device.

Xhale Assurance Inc. introduced its revolutionary Alar One-Sense™ Sensor in May of this year. The Alar- One Sense Sensor detects Blood-Oxygen saturation and Heart Rate, and soon will offer breath-to-breath Respiration Rate, at the nasal ala. This site is especially attractive for pulse oximetry measurements because its consistently robust perfusion substantially improves measurement reliability and accuracy.

LGTmedical, through the development of a universal interfacing framework, known as the Vital Signs DSP™, has developed ultra-low cost, mobile vital signs monitoring by connecting compatible medical sensors through the audio port of virtually any mobile device. This novel, audio-based interface will make vital signs monitoring available to healthcare workers and consumers for a fraction of the price of current devices.

“The Mobile Health industry faces significant challenges producing meaningful, low-cost, cross-platform solutions for the healthcare market. With our unique audio-based connectivity, we are developing software defined medical apps that drive medical sensors,” Tom Walker, CEO, LGTmedical stated. “Connecting the Alar-One Sense Sensor allows our connectivity platform to drive the most innovative and powerful sensor technology available today.”

Andrew E. Kersey, President of Xhale Assurance, Inc. added, “We are excited to be forging new ground in the mobile health space through our partnership with LGTmedical. They share our common goal of accessible and accurate health care monitoring systems for everyone, and this is a great opportunity to bring these affordable mobile solutions to the market that deliver superior performance and usability.”

The Alar One-Sense Sensor with Vital Signs DSP integration is currently being demonstrated at the LionsGate Technologies booth at mHealth Summit held in Washington DC, from December 8th – 12th at The Gaylord National Resort and Convention Center.

About LionsGate Technologies (LGTmedical)

LionsGate Technologies (LGTmedical) develops globally accessible mHealth solutions. The Vital Signs DSPTM is the company’s proprietary signal processing platform for the development and commercialization of ultra-low cost vital signs monitoring applications in mHealth. LGTmedical is developing a suite of mHealth technologies to meet the important global need for accurate, accessible and affordable medical diagnostics. For more information, please visit http://lgtmedical.com

About Xhale Assurance

Xhale Assurance, Inc., developer of the unique Assurance® Alar One-SenseTM Pulse Oximetry Sensor, 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 are designed to monitor central blood flow by placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries which also supply the brain. The unique physiology of the site provides strong, robust pulse oximetry signals. Measurement from this site will enable monitoring a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

Note: The LionsGate Vital Signs DSPTM and Xhale Assurance respiratory functionality described above have not been reviewed by the FDA, and are therefore not available for sale or for patient use.

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2013-12-9B LGTmedical_Xhale_CoDevelopment_PressRelease[FINAL _ APPROVED]…

Xhale SMART Achieves Significant Milestone with ISO 13485 Certification

GAINESVILLE, FL December 2, 2013 – Xhale, Inc.

Xhale SMART, Inc., a subsidiary of Xhale, Inc. which is marketing a breakthrough medication adherence monitoring system, today announced it has received ISO 13485 certification, an internationally recognized quality standard for medical devices.

The ISO 13485 certification covers the design, development, production, sales and service of the SMART® Adherence System, the only technology available that definitively verifies that the right person took the right dose of the right medication at the right time. The certificate demonstrates that Xhale SMART has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing.

“This achievement demonstrates Xhale’s continued commitment to the highest level of quality management and design controls to ensure delivery of safe and effective products,” said Douglas M. Crumb, Vice President of Operations for Xhale SMART, Inc. “Our customer base can be assured that the products we deliver today are of the highest standards, and that the ISO 13485 criteria will provide a quality foundation upon which we will develop our medication adherence products.”

ISO (the International Organization for Standardization) is the world’s largest developer and publisher of International Standards.

About Xhale SMART

Xhale SMART , a wholly-owned subsidiary of Xhale, is commercializing 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: 12022013 SMART Press Release

Assurance® Alar One-Sense™ Pulse Oximetry Sensor Highlighted in Three Clinical Presentations at American Society of Anesthesiologists Annual Meeting

A New Technology “Right Under Our Nose” – Highlights Benefits of Pulse Oximetry Monitoring at Ala and Identifies Unique Ability to Detect Respiratory Parameters from a Single Point of Contact Sensor.

GLASTONBURY, CT (October 10, 2013) – Xhale Assurance, Inc., developer of the unique Assurance® Alar One-Sense™ Pulse Oximetry Sensor, today announced that its new Alar One-Sense™ Sensor will be highlighted in three clinical research presentations at the American Society of Anesthesiologists (ASA) annual meeting in San Francisco, October 12-14, 2013. The ASA conference, ANESTHESIOLOGY™ 2013, is the most comprehensive anesthesia-related educational event in the world, with 10,000 anesthesiologists expected to attend.

Xhale Assurance, Inc. will be exhibiting at the meeting, showcasing its new Alar One-Sense™ Sensor, introduced in May of this year. The Alar-One Sense™ Sensor detects blood-oxygen saturation and heart rate, and soon breath-to-breath respiratory rate, at the nasal ala, the fleshy lateral part of the nostril2. This site is attractive for pulse oximetry measurement because of the rich perfusion by branches of both the external and internal carotid arteries. The nasal ala provides pulse oximetry signals when traditional finger sensors fail, such as when there is diminished perfusion to the extremities, a condition that studies have identified in nearly 80% of at-risk patient populations(1).

Andrew E. Kersey, President of Xhale Assurance, Inc. stated, “Research has shown the Alar One-Sense™ Sensor detects desaturations and recovery up to 30-60 seconds faster than finger sensors(2). Being able to reliably deliver the earliest indication of change in oxygenation status is important when monitoring critical or anesthetized patients.”

Alar One-Sense™ Sets a Higher Clinical Standard –While prior research has already shown the Alar One-Sense™ Sensor to be more accurate and reliable than pulse oximetry devices using finger clip sensors(3), new research studies being presented at the ANESTHESIOLOGY™ 2013 conference goes on to demonstrate effectiveness of the Alar One-Sense™ Sensor in detecting significant elements of patient respiratory status including: breath-to-breath respiratory rate, respiratory depression and respiratory effort (airway obstruction), and disordered breathing including apnea and hypopnea.

Mr. Kersey continued, “The unique monitoring location at the nasal ala enables measurement of a range of additional parameters with this Single Point of Contact sensor. This capability is unmatched by traditional pulse oximetry meeting a clear, as yet unmet clinical need for real-time data on critical physiological processes and patient safety. We believe our continued innovation in these areas of critical market need will create a strong platform for future growth.”

Richard J. Melker, PhD, MD and Chief Technology Officer of Xhale Assurance, Inc. commented, “The studies being presented at the ASA meeting add to our growing body of research, demonstrating the clinical performance and efficacy of the alar sensor for both pulse oximetry and for measurement of additional physiologic parameters. Alar photoplethysmography can detect individual breaths and provide information on respiratory patterns. This information is critical for early detection of opioid-induced respiratory depression, a life-threatening problem that can occur with patients receiving post-operative opioid pain control therapy including patient controlled analgesia (PCA).”

The abstracts being presented include:

Robust Respiratory Rate Detection Using Alar Photoplethysmography and a Thermistor. Cohen S, et al. The nasal ala allows the monitoring of alar pulse oximetry and airway flow with a single integrated sensor, providing robust respiratory rate determination. (Abstract A1178)

Detection of Airway Obstruction Using Alar Photoplethysmography. Melker RJ, et al. Indices derived from the photoplethysmography signal can be used to detect airway obstruction, an indicator of impending respiratory failure in non-intubated spontaneously breathing patients. (Abstract A1184)

Disordered Breathing Detected During Ambulatory Surgery Using an Alar Sensor. Morey T, et al. Alar pulse oximetry was used to identify mini-desaturations, desaturations, apnea, hypopnea, ataxic breathing and airway obstruction. Sleep disordered breathing is an indicator of Obstructive Sleep Apnea (OSA) which is estimated to affect 1 in 5 people and a safety concern in post surgical patients on opioid pain control therapy4. (Abstract A3164)

  1. Davis DP, et al. Latency and loss of pulse oximetry signal with the use of digital probes during prehospital rapid-sequence intubation. Prehosp Emerg Care. 15(1):18-22. Epub 2010-Sep21.
  2. Melker RJ, et al. Earlier detection of desaturation from the nasal ala during MAC. Post Graduate Assembly in Anesthesia. Dec 2013.
  3. Comparative Desaturation Study performed at Xhale Assurance, Inc. and University of Florida, 2012. Data on file at Xhale Assurance, Inc.
  4. http://en.wikipedia.org/wiki/Obstructive_sleep_apnea

About Xhale Assurance, Inc.

Xhale Assurance 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 are designed to monitor central blood flow by placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries which also supply the brain. The unique physiology of the site provides strong, robust pulse oximetry signals. Measurement from this site will enable monitoring a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

(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: 2013-10-10 Alar Sensor ASA Announcement

Assurance Biosense to Unveil Next-Generation Alar Sensor at the International Anesthesia Research Society Meeting

New Device Surmounts Shortcomings of Existing Fingertip Sensors

GLASTONBURY, CT (May 1, 2013) – Assurance Biosense, a subsidiary of Xhale, Inc., today announced that it will unveil its next-generation Assurance® Alar Sensor at the International Anesthesia Research Society (IARS) meeting in San Diego May 4-7, 2013. The IARS meeting is attended by more than 1,000 of the world’s leading anesthesia educators and investigators and focuses on the latest advances in research and the best practices in anesthesia critical care.

The Assurance Alar Sensor, which recently received U.S. Food and Drug Administration (FDA) 510(k) clearance, monitors oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients. The sensor measures blood flow at the nasal ala, the fleshy lateral part of the nares, and research has shown it to be more accurate and reliable than existing pulse oximetry devices using clip-on fingertip monitors. Moving the sensor from the hands to the ala improves patient comfort and allows patients greater freedom of movement.

The nasal ala is a superior measurement point because it is rich in vasculature and fed by both the external and internal carotid arteries, the same central blood supply as the brain. This multi-directional arterial supply provides strong, reliable signals that are highly responsive to change. This measurement site, unlike the fingertips, is unaffected by reductions in peripheral perfusion common in patients with cardio-respiratory comorbidities who are undergoing trauma-related shock, those receiving vasoactive drugs and those who are just cold as they are transported into the operating room for a procedure.

Additionally, the Alar Sensor’s design and placement makes it immune to interference from ambient light, including sunlight, a common problem with fingertip sensors. Assurance Alar Sensors are compatible with a variety of monitors currently in the market, including all that use Nellcor OxiSmart II sensors.

“The Assurance Alar Sensor is the next generation pulse oximeter sensor,” said Richard J. Melker, M.D., Ph.D., CTO (Professor of Anesthesiology and Pediatrics at the University of Florida College of Medicine and co-founder of Xhale). “We believe that participants at the IARS meeting will appreciate its superiority over existing technology.”

The Assurance Alar Sensor improves patient safety because it detects signals even at low oxygen saturation, senses changes in oxygenation sooner and reduces false alarms that commonly occur with existing pulse oximetry devices using clip-on fingertip monitors to measure a patient’s blood flow.

Pulse oximeters have become ubiquitous in hospitals for monitoring virtually all patients because they can give clinicians an early warning of low arterial blood oxygen saturation levels, known as hypoxemia. Early detection is critical because hypoxemia can result in brain damage or death in a matter of minutes.

However, conventional fingertip-measured pulse oximetry can lead to false readings that compromise the quality of patient care. Studies have found that more than 70 percent of the conventional pulse oximetry alarms outside the operating room are false. In the operating room, studies show that in up to 9 percent of cases, conventional pulse oximeters fail to give any measurements due to low perfusion.

The Assurance Alar Sensor is designed for the continuous non-invasive monitoring of SpO2 from the nasal ala of adult and pediatric patients (weighing >30kg). The sensor fits to the nasal ala without adhesives and is easily checked or repositioned by the clinician as necessary, allowing it to remain on the patient for the full length of stay. Studies at the Hypoxia Research Laboratory at the University of California San Francisco demonstrate the Assurance Alar Sensor’s consistent accuracy throughout the ranges of 70-80 percent, 80-90 percent and 90-100 percent oxygen saturation.

“IARS is an ideal meeting to first show our Assurance Alar Sensor,” said Andrew E. Kersey, President of Assurance Biosense. “Pulse oximetry is widely considered the fifth vital sign and is a critical component of assessing a patient’s condition. We believe this sensor offers a unique solution to improve upon the measurement of pulse oximetry, providing faster and more reliable detection of oxygen saturation changes than conventional sensors.”

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 monitor central blood through are uniquely designed to monitor by placement on the nasal ala, a region rich in vasculature, fed by the external and internal carotid arteries which also supply the brain. The unique physiology of the site provides a much stronger signal than that from a fingertip or extremity, delivering more robust pulse oximetry signals. Measurement from this site will enable monitoring a range of critical physiologic parameters which cannot be monitored via conventional pulse oximetry.

About Xhale

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 two current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance®, a single-point-of-contact sensor that monitors multiple patient parameters 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: 2013-05-01 Assurance IARS Announcement

Assurance Biosense Receives FDA 510(k) Clearance to Market Alar Sensor

  • Unique Nasal Ala Pulse Oximetry Sensor

  • Alar Sensing Promises High-Levels of Accuracy, Stability and Monitoring Reliability

  • Sensor Compatible with Large, Existing Installed Base of Pulse Oximeters

GLASTONBURY, CT — Assurance Biosense, Inc., a subsidiary of Xhale, Inc., today announced receipt from the U.S. Food and Drug Administration (FDA) of 510(k) clearance to market its Assurance® Alar Sensor for monitoring of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients.

The nasal ala, the fleshy part of the nose adjacent to the opening of the nares (nostril), is a region rich in vasculature and offers a unique monitoring site for pulse oximetry. This site is fed by both the external and internal carotid arteries; the latter also provides blood to the brain. This multi-directional arterial supply provides strong, reliable photoplethysmography signals that are rapidly responsive to changes in the patient’s arterial oxygen saturation. This measurement site is less susceptible to patient movement or loss of signal due to variations in peripheral perfusion as are the extremities, and is easily accessed by an anesthesiologist during surgery.

The Assurance Alar Sensor is intended for the continuous non-invasive monitoring of SpO2 from the nasal ala of adult and pediatric patients (weighing >30kg). The single patient use sensor attaches comfortably to the nasal ala without the need for adhesives at the placement site and can easily be checked and moved by the clinician as necessary, allowing it to remain on the patient for the full length of stay. The sensor is compatible with the large installed base of monitors compatible with the Nellcor Oxisensor-II sensor.

Andrew E. Kersey, President of Assurance Biosense, stated, “We are excited to receive clearance to market our unique Assurance Alar Sensor. We plan to begin initial shipments to select customers over the coming weeks. This revolutionary new sensor offers the benefits of reliable central monitoring while using existing legacy pulse oximeters and at no additional cost to that of traditional disposable finger-tip based oximeter sensors.”

“Clinical testing has shown central monitoring of pulse oximetry to be an improvement over peripheral sites such as the finger-tips used by traditional sensors”, Mr. Kersey continued, “further improving the measurement of this vital sign and improving patient care. Compared to monitoring at the finger-tip, central pulse oximetry has been shown to offer reliable measurements during extremely low perfusion, as well as faster detection of desaturation and resaturation events particularly during low perfusion. The nose is an excellent site for ease of access during surgery, while the hands are not readily available to anesthesiologists. This first product in our portfolio will be an important foundation upon which we will add future products that capitalize on the benefits of measurement at the alar site.”

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 PPG/oximetry sensors monitor 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, 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, and with fewer false alarms, than finger-based pulse oximetry.

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Download PDF: Assurance FDA 510k Clearance 04-16-13

Assurance Biosense Announces Key Addition to Executive Team – Jack Auer Joins as Vice President of Marketing

GLASTONBURY, CT — Assurance Biosense, Inc., a subsidiary of Xhale, Inc., announced today that Jack Auer has joined the executive team as Vice President of Marketing. Mr. Auer will lead the market launch and establishment of distribution channels for the Company’s planned Assurance® product line.

Mr. Auer is a marketing and brand strategist with over 20 years of experience in the medical device industry. He was most recently Vice President of Marketing with Oridion Capnography, Inc. (now a Covidien company), a global medical device company that specializes in the development and marketing of capnography capital and consumable products. During his 8 year tenure at Oridion, Mr. Auer has been instrumental in expanding CO2 monitoring throughout the hospital and in pre-hospital use in resuscitation and medical transport. Prior to Oridion, Mr. Auer held senior marketing positions at Siemens Medical Systems USA, Inc. / Draeger Medical Systems, Inc. Mr. Auer holds a Bachelor of Arts in Business Administration from the Wharton School at the University of Pennsylvania.

Andrew E. Kersey, President of Assurance Biosense, stated, “Jack’s expertise in marketing and business development strengthens our executive team and will be of immediate benefit as we launch our first product and prepare for future growth. His proven ability to recognize and capitalize on opportunities to establish and build markets through development and delivery of products, programs and teams will be an important asset to Assurance Biosense. I am pleased to welcome him on board.”

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 PPG/oximetry sensors monitor 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, 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, and with fewer false alarms, than finger-based pulse oximetry.

Assurance® products have not been cleared for sale or use within the United States. The company is neither soliciting nor accepting any orders for the products. All benefits and claims made are concerning future generations of the product line, which are still under development.

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Download PDF: 2013-04-04 Assurance VP Marketing Auer

Xhale’s SMART Biotechnologies Poised to Provide Solutions for Costly Drug Development

GAINESVILLE, FL – February 21, 2013 – Xhale, Inc.

The urgent need to increase the efficiency of clinical drug trails was highlighted last Fall in the Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation, written by the President’s Council of Advisors on Science and Technology (PCAST). The report points to the importance of new tools and innovations in regulatory science to address the crisis in drug development caused by increasing costs and declining financial support. The SMART® Adherence System, developed by Xhale and being commercially launched by its subsidiary SMART Biotechnologies, is a breakthrough technology that measures, monitors, reports, and improves adherence to prescribed medication regimens. The innovative technology is poised to provide important solutions for pharmaceutical companies by increasing the efficiency of clinical trials and lowering the costs of drug development.

The PCAST report states that the “inefficiency in clinical trials” is one of the “two critical areas related to drug discovery and development that must be addressed to advance innovation.” Adherence to medication regimens among participants in clinical trials has been identified as one of the problem areas that increase drug development costs. The SMART® Adherence 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 utilizes exhaled breath, and wirelessly reports on medication adherence of participants in clinical trials.

In a related news article published in the Financial Times on December 6, 2012- Pharma Executives Seek To Reduce Clinical Trial Costs- key executives with two major pharmaceutical manufacturers stated their goals of cutting the expenses associated with conducting clinical trials by 50% within five years. Franz Humer, the chairman of Roche, stated that he “believes cost-cutting can be achieved by designing, coordinating, and implementing clinical trials more efficiently.” The cost of clinical trials alone is nearly 40 percent of the total R&D budget of major pharmaceutical companies.

Xhale is positioning the SMART® Adherence System as the gold standard for monitoring and improving medication adherence in clinical trials and in disease management and prevention. “The implementation of SMART® in drug development can lead to reduced development costs while providing regulators and pharmaceutical companies with better information”, says Donn Dennis, CSO of Xhale. “It can directly impact the success and efficiency of drug approval, and help lower costs.”

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: SMART Presidents Report release 2-21-2013

Chief Science Officer of Xhale subsidiary SMART Biotechnologies, Inc. elected an NAI Charter Fellow

The Chief Science Officer of the Xhale, Inc. subsidiary SMART Biotechnologies, Donn M. Dennis, M.D., F.A.H.A., has been elected a Charter Fellow by the National Academy of Inventors.

GAINESVILLE, FL – February 15, 2013

Xhale, Inc. announced today that the Chief Science Officer of their subsidiary, SMART Biotechnologies, Inc., has been elected by the National Academy of Inventors (NAI) as a Charter Fellow. Dr. Dennis is one of the 98 NAI elected academic innovators worldwide who has “demonstrated a highly prolific spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development, and the welfare of society.”

Dr. Dennis is a co-founder of Xhale, Inc., a medical technology innovator headquartered in Gainesville, Florida. He is a board-certified anesthesiologist and previously served in various pharmaceutical company executive positions in the San Francisco area.

The 2012 Fellows elected by The National Academy of Inventors together hold more than 3,200 U.S. patents and were “nominated for outstanding contributions to innovation in areas such as patents and licensing, innovative discovery and technology, significant impact on society, and support and enhancement of innovation.” The Charter class includes eight Nobel Laureates, two Fellows of the Royal Society, 12 presidents of research universities and non-profit research institutes, 50 members of the National Academies (National Academy of Sciences, National Academy of Engineering, Institute of Medicine), 11 inductees of the National Inventors Hall of Fame, three recipients of the National Medal of Technology and Innovation, four recipients of the National Medal of Science, and 29 AAAS Fellows, among other major awards and distinctions.

As Chief Science Officer of Xhale and Xhale’s SMART Biotechnologies subsidiary, Dr. Dennis is leading the delivery of the SMART® Medication Adherence System to the medical market. This breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. Dr. Dennis is a co-inventor on numerous patents, including patents underlying the SMART® System, the Assurance® patient monitoring system, and Xhale’s breath-based propofol monitoring and glucose monitoring technologies.

Dr. Dennis stated that he is “humbled to be named a member of this group,” and adds that, “My singular remaining career goal is to see the SMART® Adherence System become the de facto gold standard for measuring drug adherence in the majority of clinical trials and for optimizing disease management.”

In addition to his work with Xhale, Inc., Dr. Dennis is a professor in the Departments of Anesthesiology, Psychiatry and Pharmacology & Experimental Therapeutics in the College of Medicine at the University of Florida, where he holds the Joachim S. Gravenstein M.D. Endowed Chair in Anesthesiology and serves as Director of Nanomedicine. His career has focused on developing innovations in patient-centric medicine, particularly technologies to improve the safety and efficacy of drugs and to reduce the incidence of adverse events in medical settings.

The NAI Charter Fellows will be inducted by Margaret A. Focarino, the U.S. Commissioner for Patents from the United States Patent and Trademark Office (USPTO), during the 2nd Annual Conference of the National Academy of Inventors in Tampa, Florida on Feb. 22, 2013.

For more information on the NAI Fellows Program:

http://www.eurekalert.org/pub_releases/2012-12/uosf-nao121712.php

The 2012 NAI Charter Fellows are listed here:

http://nai.usf.edu/naiweb/search-fellows.asp

For more Information on Donn M. Dennis, MD, FAHA

http://anest.ufl.edu/research/the-gravenstein-scholars-program/donn-m-dennis-md-faha/

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: 2013-02-15 Donn Dennis NAI Fellowship

Assurance Biosense Announces Two New Scientific Abstracts Presented at 2013 Society for Technology in Anesthesia Meeting

GLASTONBURY, CT – January 11, 2013

Study Received an Award for Best Research

Assurance Biosense, Inc., a subsidiary of Xhale, Inc., announced today the presentation of two new clinical abstracts at the annual meeting of the Society for Technology in Anesthesia (STA) underway in Phoenix, AZ. One abstract, “Single Breath Detection During Spontaneous Ventilation Using Alar Photoplethysmography,” was one of just five abstracts to receive an award for the best research at the 2013 STA meeting. The STA conference is attended by physicians and other practitioners in the field of anesthesia from around the world.

The abstracts, presented by physicians from the University of Florida and Xhale, highlight the benefits of the Assurance® Alar Sensor for pulse oximetry measurement. The abstract “Accuracy of a Nasal Alar Pulse Oximetry Sensor” presents pulse oximetry accuracy data from a 12 subject study performed in the Hypoxia Research Laboratory at the University of California San Francisco. The results demonstrate the Assurance® Alar Sensor’s consistent accuracy throughout the ranges of 70-80%, 80-90% and 90-100% oxygen saturation.

The abstract “Single Breath Detection During Spontaneous Ventilation Using Alar Photoplethysmography” presents respiratory rate accuracy data from 39 subjects using the photoplethysmography (PPG) signal from the Assurance® Alar Sensor. The results show strong correlation between the PPG-derived respiration and that from thermistor flow in detecting individual breaths in spontaneously breathing patients. This holds the promise of reliable respiratory rate detection with a low incidence of false alarms.

“One of our key strategic goals is to build a solid base of published clinical data in support of the upcoming launch of our Assurance® Alar Sensor,” said Andrew E. Kersey, President of Assurance Biosense. “The data presented highlights the accuracy and performance of our unique sensor not only as a highly accurate pulse oximetry sensor, but as a means to reliably extract respiration rate from the PPG signal.”

“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, presenting author and Chief Technology Officer of Assurance Biosense. “In an August, 2012 Sentinel Alert issued by The Joint Commission, opioid analgesics were reported to 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 Joint Commission has published recommendations to address these risks, including urging hospitals to continuously monitor patients’ blood oxygenation and ventilation. Our single-point-of-contact Assurance® Alar Sensor can provide a unique solution, capable of monitoring both ventilation and oxygenation of spontaneously breathing patients in a simple, cost effective manner.”

Abstracts

Accuracy of a Nasal Alar Pulse Oximeter Sensor. Richard J. Melker, Ph.D., M.D.; Timothy E. Morey, M.D.; Mark J. Rice, M.D.; Donn M. Dennis, M.D.; Department of Anesthesiology, University of Florida, Gainesville, FL. (Abstract # 22).

Single Breath Detection During Spontaneous Ventilation Using Alar Photoplethysmography. Richard J. Melker, Ph.D., M.D.; Timothy E. Morey, M.D.; Mark J. Rice, M.D.; Judith Wishin, R.N.; Donn M. Dennis, M.D.; Department of Anesthesiology, University of Florida, Gainesville, FL and Michael Stahl, M.S., Assurance Biosense, Gainesville, FL. (Abstract # 23).

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 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 single-point-of-contact sensor that will monitor multiple patient parameters 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: 2013-01-11 Assurance STA Abstracts

SMART Biotechnologies, Inc. Announces the Appointment of Thomas J. Bigger as New Company President

GAINESVILLE, FL – January 8, 2013

SMART Biotechnologies, Inc., the newest subsidiary of the medical technology innovator, Xhale, Inc., has just appointed Mr. Thomas J. Bigger as its new president. Mr. Bigger comes to SMART with over 20 years of experience building shareholder value in pharmaceutical companies globally. Mr. Bigger most recently held the positions of President and CEO of Paratek Pharmaceuticals in Boston, MA, where he built a fully integrated pharmaceutical company that develops products for serious diseases. He also held senior positions at Magainin Pharmaceuticals, Advanced Polymer Systems and Rhone-Poulenc Rorer.

Mr. Bigger joins SMART Biotechnologies at a crucial and exciting juncture as the company prepares to launch its new product line, the SMART® Adherence System. This breakthrough technology 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 SMART® system is patient-centric and noninvasive. Utilizing exhaled breath, the system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose.

“We are excited to have Mr. Bigger leading SMART Biotechnologies”, said Richard R. Allen, CEO of Xhale. “There is a tremendous need for SMART® in the industry, and it’s imperative that we execute extraordinarily well on serving our pharmaceutical partners. Tom has the background and expertise we need for this important role.”

Mr. Bigger said, “The SMART® system will have a direct impact on the success of drug approval, and help provide safer, more efficient and effective drug development. We believe the SMART® Adherence System will become the gold standard for monitoring and improving medication adherence in clinical trials and in disease management and prevention”.

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: 2013-01-08 SMART President Appointed

Assurance Biosense Issued European and Japanese Patents for Unique Pulse Oximetry Sensors and Monitoring Systems

Glastonbury, CT – November 16, 2012

Assurance Biosense, Inc., a wholly owned subsidiary of Xhale, Inc., a leading innovator in patient safety solutions, announced today the recent issuance of European Patent EP1513443 and Japanese Patent JP5134367, which include claims to novel sensors, devices, systems and methodsfor monitoring pulse oximetry.

The European patent, entitled “Perfusion Monitor and System, Including Specifically Configured Oximeter Probes and Covers for Oximeter Probes,” describes unique probes and probe sleeves for monitoring pulse oximetry across the vascular tissue of a lip or cheek. This monitoring location enables faster detection of oxygen saturation levels than finger sensors. “This technology can significantly improve optimal oxygen delivery to medical patients,” says Dr. Richard Melker, M.D., Ph. D., Chief Technology Officer of Xhale, Inc. “This patent protection will enable Assurance Biosense to market this and related technologies,” adds Melker. This patent was issued on October 3, 2012.

The second patent, “Methods and Devices for Countering Gravity Induced Loss of Consciousness and Novel Pulse Oximeter Probes,” was issued in Japan on November 16, 2012. This patent describes methods and devices of obtaining photoplethysmography(PPG) readings and utilizing PPG to identify when pilots are about to experience gravity-induced loss of consciousness (GLOC). Additionally, the patent claims GLOC monitoring devices and systems that include a pulse oximeter probe secured to a central source site on the nose, such as the nasal nares, nasal septum or nasal alar. Such systems can be used to warn a pilot that he is about to enter GLOC and if necessary direct the plane to take predetermined corrective actions to avert catastrophic damage or injuries.

Andrew E. Kersey, President of Assurance Biosense, stated, “We are pleased that our portfolio of protected technologies continues to grow, both in the US and internationally. The technology protected by these new patents, in concert with our other technologies, can provide unique solutions to reliably monitor PPG and oxygen saturation under the most extreme conditions.”

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 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, 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 AssuranceTM, 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: PressRelease_16Nov2012_2Patents_FINAL