Xhale Assurance to Showcase Alar Sensor at AANA2017

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

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

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

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

Gainesville, FL, September 21, 2015

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

About Xhale

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

 

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

Xhale Assurance Announces CE Mark for Nasal Alar SpO2 Sensor

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

About Xhale

 

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

 

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

 

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

 

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

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

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

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

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

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

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

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

About Xhale

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

 

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

 

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

Xhale’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

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

GAINESVILLE, August 1, 2014 – Xhale, Inc.

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

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

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

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

About Xhale

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

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Download PDF: 07312014 Nauman Toor Joins Xhale Final

Xhale’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