Preventice, Inc. announced that its BodyGuardian Remote Patient Monitoring System (BodyGuardian RMS) will be commercially available in early 2013. Meanwhile, clinical trials are underway in the United States and Europe to quantify the impact of the BodyGuardian RMS on clinical care delivery. Preventice is demonstrating the BodyGuardian RMS this week at the mHealth Summit in Washington, D.C., December 3-5, 2012.

Preventice has licensed the remote monitoring algorithms for the BodyGuardian Remote Monitoring System from Mayo Clinic, and is working with STMicroelectronics, and Samsung Electronics to bring the BodyGuardian to market.

The BodyGuardian system detects, records and wirelessly transmits physiological data to support remote monitoring of non-lethal, cardiac arrhythmias in ambulatory patients. Data is transmitted to the Preventice mHealth platform, where it can be stored for up to 30 days at a time.

The BodyGuardian sensor adheres to the patient’s skin and is smaller than a cell phone, giving patients complete mobility and freedom to go about their normal lives without restriction. Physicians and medical professionals can securely view the captured medical information on devices such as the iPad, or online. Physicians can retrieve patient data and reports, or choose to receive alerts based on changes in select biometrics.

Advanced patient monitoring systems with wireless capability and other features continue to be one of the fastest growing medical device areas in terms of revenue growth, according to Kalorama Information. The market for these advanced patient monitoring systems includes wireless and remote patient monitors (equipment and applications), applications and equipment for processing data, and applications and equipment for transferring patient monitoring data into an EMR. The U.S. market had a value of $3.9 billion in 2007, increasing to $8.9 billion by 2011.

According to a Kalorama report, advances in remote patient monitoring include new peripherals, real-time audio and video for "face-to-face" interaction between clinicians and patients, wireless communication, systems that "sort" the vast amount of data collected in order to put it into the context of a patient’s condition, portable and ambulatory monitors, web-based access to patient records, systems that transfer data to an electronic medical record (EMR), and full-service outsourcing that includes a clinician to evaluate data and send a report to the attending physician.

Clinical trials 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.

"We’re quickly approaching two significant milestones for the BodyGuardian RMS with the commercial availability of the system in early spring and robust clinical trial activity here in the United States and abroad. The clinical trial volume is a direct indicator of significant interest in BodyGuardian by early adopters and it demonstrates their belief that Preventice is poised to facilitate change in health care," said Jon Otterstatter, co-founder, president and CEO of Preventice. "We’re confident that the BodyGuardian has the potential to become a key element of integrating care management and behavior change with any health care provider’s digital health delivery program. BodyGuardian RMS supports efforts to increase the efficiency and effectiveness of chronic disease management while empowering patients to take a more proactive role in their health care."

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.

"Sanpietro Clinic is pleased to be working with Preventice to provide our patients with remote cardiac monitoring," said Marcello Ruspi, MD, vascular surgeon, clinical director, Sanpietro Clinic. "Many of our patients have cardiac disease and the BodyGuardian RMS will allow us to better monitor and care for them at home, just as if they were at the clinic. Making it easier for patients to stay healthy is the goal here at Sanpietro."

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.