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.

 

Douglas M. Crumb Appointed President of Xhale, Inc.

Douglas M. Crumb Appointed President of Xhale, Inc.

GAINESVILLE, FL June 2, 2015

Xhale, Inc., a medical technology company developing and commercializing unique monitoring solutions for the pharmaceutical and healthcare industries, announced the appointment of Douglas M. Crumb to the role of President and Chief Operating Officer of the company. In this position, Mr. Crumb is responsible for completing the commercial launch of Xhale’s Assurance® and SMART® product lines, and leading the company’s highly-skilled team as they deliver medication adherence monitoring to the pharmaceutical industry and advanced patient monitoring to the hospital and healthcare industry.

Mr. Crumb joined Xhale in 2012 as Vice President of Operations, before advancing to the role of Chief Operating Officer in 2014. He has extensive experience with medical device companies in both the private equity and publicly traded sectors, including having managed multiple manufacturing facilities while VP of Operations for ConMed Corporation, and overseeing the construction and startup of a large ConMed medical manufacturing operation in Mexico. Prior to that role, Mr. Crumb was VP of Operations for Smiths Medical – DHD Healthcare, and after ConMed Mr. Crumb served as VP of Operations, Engineering/R&D, Quality and Regulatory for IZI Medical Products. Mr. Crumb’s areas of special expertise include lean manufacturing, project management, product development and driving profitability. He holds a Masters in Advanced Engineering from the State University of New York.

“I am extraordinarily pleased to announce the appointment of Douglas Crumb to the role of President of Xhale,” said Richard R. Allen, CEO of the company. “Douglas has demonstrated gifted leadership over the past three years, and has been vital to our success as we bring these important technologies to the market. His expertise and leadership will advance the mission of Xhale, which is to make the drug development process more effective, less risky and less costly, and to provide more effective patient monitoring”.

About Xhale

Xhale, Inc. is a medical technology company commercializing two broad technology 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®. SMART® reports – in real-time, via wireless cellular to the web – whether a participant in a pharmaceutical clinical trial has swallowed the medication and if the medication reached their stomach, addressing the problem of the large number of clinical trial participants who aren’t taking the study drug or following the dosing protocol. Through its Xhale Assurance, Inc. subsidiary, Xhale is commercializing the Assurance® pulse oximetry sensor, a simple, highly-effective single-point-of-contact sensor that can reliably monitor critical parameters under challenging conditions for patients.

 

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’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

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