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Preventice Gears Up to Market BodyGuardian Remote Patient Monitoring System

By all industry accounts, interest in remote patient monitoring is expected to remain strong in the coming years, as hospital readmission penalties in the United States take effect in 2013, and as mHealth technologies become more pervasive in the care delivery system, according to a report from Berg Insights.

Berg analysts estimate that 2.8 million people are currently monitored for a variety of conditions outside the clinical setting. This number is expected to continue its upward trajectory, with cardiac rhythm management, sleep therapy and telehealth becoming the most significant categories for remote monitoring devices by 2017.

Preventice, Inc., a leading developer of mHealth solutions, including the BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS) is poised to capitalize on this opportunity through its unique approach to strategic partnerships and its proprietary technology platform. Meanwhile, clinical trials are underway in the United States and Europe to quantify the impact of the BodyGuardian RMS on clinical care delivery.

In good company: Strategic partnerships
According to Jon Otterstatter , co-founder, president and CEO of Preventice, the company has established an enviable ecosystem of partners that have allowed it to build a remote monitoring platform that is secure, reliable and scalable.

"From day one, we have made it a priority to affiliate the Preventice brand with leaders in health care, wireless devices, sensor technology, and production processes," said Otterstatter. "As a result, we have built a remote monitoring platform that meets the most stringent privacy and security standards, that is reliable in a variety of clinical and non-clinical settings and that exceeds the usability expectations of today's sophisticated consumers."

For example, Otterstatter noted that the BodyGuardian RMS was developed in collaboration with Mayo Clinic (which developed the algorithms on which the BodyGuardian RMS technology is based), STMicroelectronics (which provided the sensor technology), and Samsung Electronics (which provided the dedicated wireless environment that contributes to the security and clinical reliability of the BodyGuardian RMS).

Proof of concept: Strong interest in clinical trials continues
To say that the savings potential for mHealth solutions is significant would be an understatement. A recent report by Deloitte Center for Health Solutions predicts that remote monitoring technology will save nearly $200 billion in health care expenses over the next 25 years by improving the management of chronic conditions. However, a recent report by Frost & Sullivan indicates that mobile technology companies need to provide ample clinical trial evidence to validate the effectiveness of mHealth solutions if the industry is to realize its growth potential.

"We have a strong focus and commitment to clinical trials at Preventice. In fact, we have ongoing pilots in Europe and the United States at several leading health care institutions to validate the efficacy and performance of the BodyGuardian RMS in a variety of settings and applications. We are on track to enroll over 500 patients by the end of the year," said Otterstatter. "Prescription-based cardiac rhythm monitoring is applicable to a variety of conditions and situations, which is what makes the potential for this technology so impressive."

Clinical pilots with the BodyGuardian RMS are currently underway in the United States, France, and Italy targeting the use of remote monitoring for various treatment scenarios including:

  • Post-surgical cardiac patients to evaluate how monitoring cardiac rhythms remotely influences all phases of hospital recovery,
  • Patients with congestive heart failure to determine early warning of decompensated heart failure and delivery of more timely interventions that can prevent more serious and expensive complications, and
  • 24/7 continuous monitoring of non-surgical, infrequently symptomatic patients as they go about their daily lives, with the objective of detecting potential arrhythmias by tracking ECG, respiratory rate and activity.

Trials are currently being conducted with Mayo Clinic in Rochester, Minn.; Sanpietro Clinic in Milan, Italy; and Bordeaux Hospital University Center (CHU) in Bordeaux, France--all with the intent to analyze and quantify the clinical impact of advanced monitoring for capabilities such as remote transmission of ECG signals, on-demand event transmission, and centralized analysis of significant amounts of data.

In addition to the clinical trials that are currently in progress, Otterstatter noted that a new clinical trial to study the use of remote monitoring to manage default hospital admissions for cardiac patients is planned for 2013 at Mayo Clinic.

Preventice received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in August, enabling the mobile health solutions company to market and sell BodyGuardian to hospitals and clinics for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients.

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