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’s SMART® Adherence Technology Enabled Through Collaboration with Catalent

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

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

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

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

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

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

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

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

  

About Xhale

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

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

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

 

 About Catalent

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

More products. Better treatments. Reliably supplied.™

Xhale’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 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

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

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

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

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

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

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

About SMART Biotechnologies

SMART Biotechnologies, a subsidiary of Xhale, has developed the SMART® Adherence System for the pharmaceutical industry, where it is being launched as a clinical trials tool for use in drug development. The breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. The SMART® system is the only technology available that definitively verifies that the right person took the right dose of the right medication at the right time. The system is patient-centric and noninvasive. Utilizing exhaled breath, the SMART® system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose. SMART® technology is expected to have a direct impact on the success of drug approval, and help provide safer, more effective drug development.

About Xhale, Inc.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance®, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: SMART Presidents Report release 2-21-2013

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

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

GAINESVILLE, FL – February 15, 2013

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

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

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

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

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

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

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

For more information on the NAI Fellows Program:

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

The 2012 NAI Charter Fellows are listed here:

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

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

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

About SMART Biotechnologies

SMART Biotechnologies, a subsidiary of Xhale, has developed the SMART® Adherence System for the pharmaceutical industry, where it is being launched as a clinical trials tool for use in drug development. The breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. The SMART® system is the only technology available that definitively verifies that the right person took the right dose of the right medication at the right time. The system is patient-centric and noninvasive. Utilizing exhaled breath, the SMART® system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose. SMART® technology is expected to have a direct impact on the success of drug approval, and help provide safer, more effective drug development.

About Xhale, Inc.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance®, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2013-02-15 Donn Dennis NAI Fellowship

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

GAINESVILLE, FL – January 8, 2013

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

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

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

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

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART®, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2013-01-08 SMART President Appointed

Xhale Awarded National Institute of Drug Abuse (NIDA) Grant for Further Development of Innovative Breath-Based SMART® Adherence Tool.

GAINESVILLE, FL – August 22, 2012

Xhale, Inc. announced today it has been awarded a $1.7 million Small Business Innovation Research (SBIR) Phase II grant by the NIH National Institute of Mental Health (NIMH) to continue the development of SMART® (Self Monitoring and Reporting Therapeutics), a breath-based medication adherence system for HIV/AIDS therapies.

In 2007, NIH / NIMH awarded Xhale an SBIR Phase I grant to test the technical merit of SMART®. SBIR Phase II grants enable SBIR Phase I grantees to further develop their technology and prepare it for commercialization. Xhale will use the Phase II grant to develop and test additional functionality, accuracy and system usability. The result will be a commercial version of the system which will have multiple benefits to patients, doctors, researchers and pharmaceutical companies.

As with the Phase I SBIR, Dr. Richard Melker, CTO of Xhale, will be the principal investigator for the project. “Medication adherence has tremendous impact on patient health,” said Dr. Melker. “This is particularly true with HIV/AIDS patients where just a 10% change in adherence is associated with doubling of viral load and a 21% increase in the risk of developing full blown AIDS. NIHM was particularly interested since non-adherence to antibiotic or antiviral regimens also pose a serious threat to public health through the emergence of resistant organisms.”

“Building on our Phase I achievements, we will design and deploy a handheld, breath-based medication adherence device,” reports Dr. Donn Dennis, project Co-investigator and CSO for Xhale. “The system will first remind the patient to take their medication. After ingesting their medication, the patient will blow into the device which will detect and document that the appropriate medication was taken at the proper time. This technology should improve adherence rates, especially in high-risk populations, and provide pharmaceutical companies and the FDA with a higher quality data set for evaluating drug safety and efficacy in clinical trials.”

The New England Healthcare Institute (NEHI) in its August 2009 report noted that poor medication adherence costs the U.S. as much as $290 billion annually (13% of total health care expenditures),and affects virtually every aspect of the health care system. Besides an estimated $47 billion each year for drug-related hospitalizations, not taking medications as prescribed has been associated with as many as 40% of admissions to nursing homes and with an additional $2,000 a year per patient in medical costs for visits to physicians’ offices.

This is the third time in two years that Xhale has been awarded an SBIR grant. Previous awards were SBIR Phase I awards from the National Institute of Mental Health and the National Institute on Alcohol Abuse and Alcoholism.

There is a great need for a method to improve drug compliance which provides simple monitoring of medication dosing which is non-invasive, intuitive, and sanitary. Non-compliance of patients to drug regimens prescribed by their physicians results in excessive healthcare costs estimated to be around $100 billion per year through lost work days, increased cost of medical care, higher compliance rates, as well as drug wastage. Non-compliance refers to the failure to take the prescribed dosage at the prescribed time which results in under medication or overmedication. Non-compliance of patients with communicable diseases costs the public health authorities millions of dollars annually and increases the likelihood of drug-resistance, with potential for widespread dissemination of drug-resistant pathogens resulting in epidemics.

This method determines whether a patient has taken a medication, by providing a patient a medication comprising a combination of a least one active therapeutic agent and an odorous compound or olfactory marker, which is then detectable in gaseous exhaled breath. The patient then blows into an electronic SMART™ device which analyzes the patient’s exhaled breath for detection, or absence, of the odorous compound or olfactory marker to determine compliance. Presence of the markers indicates the patient has taken the medication at the prescribed time and in the prescribed dosage. The system is also expected to be an important tool for use in pharmaceutical clinical trials as part of drug development.

Xhale, 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: 2011-08-01 Xhale NIH Naltrexone Grant

Xhale Completes NIH-Funded Study on SMART™ Adherence Monitoring System

Xhale, Inc. announced today the successful completion of an NIH-funded study of usability on its SMART™ Medication Adherence Monitoring System.

Gainesville, FL July 26, 2012 — Xhale, Inc. announced today the successful completion of a study sponsored by the National Institutes of Health (NIH) to assess the usability of the SMART™ Medication Adherence System.

SMART™ is being launched as a clinical trials tool and a service platform for the pharmaceutical industry, to address the very significant problem of noncompliance of participants in drug trials. Studies and reports have estimated that between 25% and 50% of study participants are either not taking the study drug per protocol, or not taking it at all. The result of noncompliance and unknown compliance rates in drug trials is flawed data and, ultimately, failed studies and failure to gain approval for important drugs. SMART™ definitively monitors who is taking the medication and who is not, in real-time, allowing intervention within a short period of time after a dose has been missed, driving compliance rates higher and generating superior data sets.

The NIH sponsored study was designed to assess the usability of SMART™ technology by subjects with disease (HIV/AIDS) in real-world environments (home). In the SMART™ system, a subject swallows a capsule containing FDA-designated direct food additives, termed adherence-enabling markers (AEMs). After being absorbed in the upper GI tract including the stomach, the AEMs rapidly generate volatile breath compounds, termed exhaled drug ingestion markers (EDIMs), which can be detected in the breath. The subject exhales directly into a small handheld SMART™ device, and the breath sample is analyzed for the presence of EDIMs. SMART™ devices in development will transmit data to a central repository in a HIPAA-compliant manner. The presence of EDIMs in exhaled breath coupled to a positive biometric authentication (i.e., facial recognition) indicates “definitive” subject adherence to the medication on a dose-by-dose, time-stamped basis without the expense and burden of directly observed therapy (DOT).

In response to interview questions, 100% of study participants generally liked the idea of a system documenting adherence, and 92% indicated that they would be willing to use the SMART™ device again in a clinical study if asked. Overall, subjects were willing to use the SMART™ Adherence System and generally satisfied with its operation. Subjects effectively used the SMART™ Adherence System during the observed initial interactions with the device and throughout the 10-day study period. Future SMART™ devices are expected to increase usability even further.

Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its two current product lines under development include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2012-7-26 Xhale Completes NIH SMART Study

Xhale Completes Spin Off of SMART Biotechnologies

GAINESVILLE, FL – Oct. 1, 2012 – Xhale, Inc.

Xhale, Inc. announced today the completion of the spin off of SMART Biotechnologies, a wholly owned subsidiary of Xhale, Inc. The company is located at the Xhale headquarters in Gainesville, Florida, and is focused on the development of a breakthrough technology for measuring, monitoring, reporting and improving adherence to prescribed medication regimens, including clinical trials.

The SMART™ Adherence system is the only technology currently available that definitively verifies that the right person took the right dose of the right medication at the right time. “This technology is crucial for the treatment of patients taking prescription medication, as well as the success of clinical drug trials,” states Susan Baumgartner, Pharm. D., MBA, Vice President of Business Development at SMART™ Biotechnologies.

This new technology uses a unique breath-based medical drug adherence monitoring system, which involves packaging safe food additives as adherence enabling markers (AEMs), together with the medication into a “smart” drug formulation. Once the patient ingests the SMART™ drug, the AEMs are absorbed in the stomach and rapidly metabolized into a taggant, or marker. The markers can then be detected in the breath using the non-invasive SMART™ device that collects and analyzes the breath to verify oral ingestion of the medication. The information is wirelessly transmitted to a HIPAA-compliant server and distributed to key stakeholders, such as health care providers who provide basic care to the patients, or clinical study coordinators. For the first time, stakeholders can access real-time information on medication adherence and receive alerts of non-adherence in order to investigate and intervene.

Richard Allen, CEO of Xhale commented, “We are excited to see the launch of our newest subsidiary, SMART™ Biotechnologies and look forward to the expansion of their innovative technology”. The group is lead by Dr. Donn Dennis. M.D., F.A.H.A, and Susan Baumgartner, Pharm. D., MBA, who both have extensive experience in the pharmaceutical industry. Mr. Allen adds, “We believe that the SMART™ Adherence System will become the gold standard for monitoring and improving medication adherence in clinical trials and in disease management and prevention.”

About SMART Biotechnologies

SMART Biotechnologies, a subsidiary of Xhale, has developed the SMART™ Adherence System for the pharmaceutical industry, where it is being launched as a clinical trials tool for use in drug development. The breakthrough technology measures, monitors, reports, and improves adherence to prescribed medication regimens. The SMART™ system is the only technology
available that definitively verifies that the right person took the right dose of the right medication at the right time. The system is patient-centric and noninvasive. Utilizing exhaled breath, the SMART™ system wirelessly reports – in real time – on medication adherence of participants in clinical trials, allowing immediate intervention when a participant misses a dose.
SMART™ technology is expected to have a direct impact on the success of drug approval, and help provide safer, more effective drug development.

About Xhale, Inc.

Xhale, Inc. is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors that analyze vapor and exhaled breath and is focused on novel patient-centric monitoring solutions. Its current product lines include SMART™, the world’s only definitive medication adherence monitoring system, and Assurance™, a replacement for conventional finger-based pulse oximetry which will monitor multiple patient parameters from a single-point-of-contact sensor, more comfortably and conveniently than finger-based pulse oximetry with fewer false alarms.

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Download PDF: 2012-10-01 SMART Biotechnologies Spinoff