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.


Download PDF: 2012-10-01 SMART Biotechnologies Spinoff