PerSys Medical Earns FDA Clearance for the NIO Infant

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PerSys Medical, a global leader in the development and marketing of innovative products for pre-hospital and hospital emergency medical situations, proudly announces today it has received US Food and Drug Administration (FDA) clearance for the NIO Infant.

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NIO Infant

The NIO Infant is going to make it easier than ever for medical providers to gain vascular access, in what has been traditionally thought of as a challenging patient population. Dr. Mike Simpson"

PerSys Medical, a global leader in the development and marketing of innovative products for pre-hospital and hospital emergency medical situations, proudly announces today it has received US Food and Drug Administration (FDA) clearance for the NIO Infant.

The NIO Infant is a manual intraosseous (IO) access device that administers intravascular fluids and medications through the proximal tibia as an alternative to IV access during emergency medical situations. Its innovative stepped needle design allows for graduated penetration to the bone marrow cavity. Sensory feedback, in the form of resistance, indicates to the user that the needle is inserted correctly in the bone marrow cavity, thus preventing over penetration. The NIO™ Infant is a single-use, sterile device, eliminating the risk of cross contamination. It does not require batteries or an external power source, thereby making it a well-suited for hospital use, and the pre-hospital setting.

“The first automatic intraosseous device was introduced by WaisMed Ltd, a subsidiary of the PerSys Medical, over two decades ago. It revolutionized the way intraosseous access was established during traumatic medical events” adds Roee Madai, CEO of WaisMed Ltd “After an arduous and comprehensive R&D process, we are excited to introduce the NIO Infant and offer a complete NIO product line for adult, pediatric, and infant populations.”

WaisMed Ltd was founded in 1994 and acquired by PerSys Medical in 2004. WaisMed Ltd quickly established itself as a global leader in the intraosseous access market. In 1998, WaisMed Ltd brought to market the world’s first automatic intraosseous access device, the Bone Injection Gun (B.I.G.). It launched an additional line of intraosseous devices, the NIO (Next Generation IO), in 2014.

The NIO Infant is a continuation of an elite line of vascular access devices which includes the NIO Adult, NIO Pediatric for children ages 3-12, and the NIO Simulation, the most realistic IO training device available. The NIO Adult provides rapid intraosseous (IO) access through the humeral head or tibia insertion site in 10 seconds or less. The NIO Pediatric provides rapid intraosseous (IO) access through the tibia insertion site.

Dr. Mike Simpson, Medical Director of PerSys Medical says, “I am extremely excited about what FDA clearance of our new NIO Infant means. This will be a huge step forward in capabilities to treat emergencies in patients less than three years of age. The NIO Infant is going to make it easier than ever for medical providers to gain vascular access, in what has been traditionally thought of as a challenging patient population."

PerSys Medical will begin commercial distribution of the NIO Infant in the US in the coming weeks.

About PerSys Medical Principal Products:
The Emergency Bandage®
The Emergency Bandage® is a sterile bandage with a unique built-in pressure bar that provides hemorrhage control and wound treatment in pre-hospital situations. The Emergency Bandage® has been proven effective in the combat as well as the EMS and civilian sector. It is also the only pressure bandage that is FDA approved as a non-pneumatic tourniquet.
The NIO – Next Generation IO
The NIO is a simple, automatic, intraosseous device that provides safe, quick, and easy vascular access in emergency situations for the administration of intravenous fluids and medications.
Blizzard Survival Products
Blizzard Protection Systems Ltd.’s line of products is made with Reflexcell™, a unique technology that was developed to reduce the risk of hypothermia and support patient treatment in extreme weather or suffering severe medical trauma. Blizzard Survival products are used globally by the military, EMS, and the private outdoors market.
Micro BVM
PerSys Medical offers a line of compact “pocket sized” collapsible bag valve masks (BVM). They are rugged, compact, are available in several variations. They also have a storage footprint that is 75% less compared with standard BVMs.
About PerSys Medical
PerSys Medical, a Texas based medical device company, is a global provider of emergency medical solutions designed for hospitals, militaries, first responders, civilians, and law-enforcement since the mid-90s. The company’s commitment to research and development has brought to market innovations in intraosseous vascular access, hemorrhage control, hypothermia solutions, and airway management. With a strong corporate brand and superior products, PerSys Medical maintains a worldwide network of distributors and representatives serving more than 60 countries.
For more information about our products, visit: http://www.persysmedical.com
or LinkedIn http://bit.ly/2YeISsY

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Stefanie Saffern
PerSys Medical
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