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 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 Assurance Alar/Nasal SpO2 Sensor to be Showcased at Critical Care and Anesthesia Technology Meetings

Xhale Assurance, Inc., developer of the Alar/Nasal SpO2 Sensor, today announced that the company will demonstrate its SpO2 sensor at two conferences during the month of January.  These conferences include:

  • January 7 – 10, 2015: The Society for Technology in Anesthesia 2015 Annual Meeting, Booth #9, Royal Palms Resort, Phoenix, AZ, USA
  • January 17-21, 2015: The Society of Critical Care Medicine 44th Critical Care Congress, Booth #731, Phoenix Convention Center, Phoenix, AZ, USA

In addition to demonstrating the Alar/Nasal SpO2 Sensor, Dr. Richard Melker, Xhale’s Chief Technology Officer, will be presenting a poster at The Society of Critical Care Medicine 44th Critical Care Congress entitled:  “Nasal Alar Blood Flow is Maintained with Occlusion of Ipsilateral Facial and/or Ophthalmic Arteries.”

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

Assurance’s Alar/Nasal 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™ 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.

Xhale Assurance Issued U.S. Patent on Optimized Gas Supply using Photoplethysmography

GAINESVILLE, August 13, 2014 – Xhale, Inc.

Xhale Assurance, Inc., developer of the Assurance Alar One-SenseTM pulse oximetry sensor, today announced issuance of US Patent US 8755857. This patent expands Assurance’s technology coverage of patient monitoring beyond pulse oximetry.

Monitoring patient parameters on the nasal ala, a site fed by both the external and internal carotid arteries, provides a strong, reliable signal, even when it is difficult to get a signal at the fingertips.

Xhale Assurance’s new patent, entitled “Optimized Gas Supply Using Photoplethsmography,” extends the intellectual property protection for non-invasive monitoring beyond pulse oximetry to other cardiopulmonary parameters including regional blood flow and blood pressure. Claims also include monitoring from other sites in conjunction with monitoring at the nasal ala to provide unique information about shock and other conditions that cause poor peripheral blood flow.

This patent contains 28 claims for sensor designs that include additional sensors and the use of signals obtained at the nasal ala for optimizing oxygenation, oxygen delivery, ventilator settings during mechanical ventilation and blood volume status.

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.

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Download PDF: 08132014 PPG Press Release

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]…

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