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Leaf Healthcare, Inc. Receives 510(k) Clearance
Leaf Healthcare receives clearance by FDA 510(k) to market a system that aids in the prevention of pressure ulcers.

Newark, CA (November 18, 2013) — Leaf Healthcare, Inc., an innovative medical technology company focusing on wireless patient monitoring solutions, announced today that it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Leaf Patient Monitoring System designed to assist healthcare providers in their efforts to reduce patient's risk of developing pressure ulcers.

About the Leaf Patient Monitoring System

Addressing the need for improved pressure ulcer prevention and treatment methods, the Leaf Patient Monitor features a small wearable wireless body sensor that enables hospitals, long term acute care facilities (LTAC), and nursing homes to wirelessly monitor the real-time position, movement and activity of patients susceptible to pressure ulcers. This innovative system provides alerts when patient movement or activity deviates from individualized turn management protocols set by the healthcare provider.

"We are excited to receive clearance to introduce this proven safe and efficacious technology that provides caregivers with accurate information regarding a patient's position and movement over time," said Mark Weckwerth PhD, Chief Executive Officer of Leaf Healthcare. "An assurance that all patients are repositioned per their prescribed turn protocol is an integral component of successful pressure ulcer prevention programs."

About Pressure Ulcer Prevention

Pressure ulcers, commonly known as bed sores, are a vast and growing problem in the United States and account for over $10 billion dollars in annual health care spending. Each year, over 1 million patients will suffer from hospital-acquired pressure ulcers (HAPUs), which often result in extended hospital stays, increased pain, discomfort and can even be a cause of death. Pressure ulcers occur most commonly in the elderly, which is the fastest-growing segment of the population. As a result, the number of patients at risk for developing pressure ulcers is expected to increase dramatically in the coming decades. Given the tremendous burden that pressure ulcers place on the healthcare system, there is a substantial need for improved prevention methods.

"To prevent pressure ulcers, the currently accepted standard of care is to turn high-risk patients at least every 2 hours, day and night," says Barrett Larson, MD, Chief Medical Officer at Leaf Healthcare. "In many healthcare facilities, such a turning schedule can be hard to maintain due to nursing workload demands, difficulty monitoring patient position, ineffective turn reminders, and interruptive tasks."

About Leaf Healthcare, Inc.

Leaf Healthcare is a medical technology company dedicated to preventing hospital-acquired pressure injuries/ulcers and other immobility-related complications, which are some of the most common and costly hospital-acquired conditions. Several studies have shown that the FDA-cleared Leaf Patient Monitoring System is a powerful tool that reduces hospital-acquired pressure injuries/ulcers, allows providers to prioritize care, and helps provide a safer environment for patients. The Leaf System is available through Leaf Healthcare and Smith & Nephew.

To learn more, visit www.leafhealthcare.com.

Media Contact:

Mark Smith
Vice President
Leaf Healthcare, Inc.