Avive Solutions Receives FDA Approval of Handheld Automated External Defibrillator (AED) with Unique Capabilities

Groundbreaking Avive Connect AED™ combines cellular and WiFi connectivity, GPS technology, remote maintenance and extreme portability in handheld device.

SAN FRANCISCO — Avive Solutions, Inc., has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA)- the agency's highest level of approval— for its Avive AED™, a unique Automated External Defibrillator (AED).

Customers can pre-order the product now and learn more at www.avive.life. The waitlist currently includes police and fire departments, higher education institutions, cities and counties, nationwide gym chains, small businesses, families and individuals. New orders are expected to begin shipping this summer.

For decades, AEDs have been used to treat victims of Sudden Cardiac Arrest, one of the leading causes of death outside the hospital globally. With a U.S. mortality rate of nearly 90 percent, out-of-hospital cardiac arrest (OHCA) leads to more than 350,000 deaths annually.

"Every minute a person in cardiac arrest does not receive a shock from an AED, their chance of survival drops seven to ten percent," said Sameer Jafri, Avive co-founder and CEO. "Without rapid intervention with an AED and Hands-Only CPR before EMS arrival, their chance of survival is dramatically reduced. To improve those odds, our focus these past five years has been creating and validating a small, fully connected device that's easy to access and use. It's called the Avive Connect AED."

This 2.1 pound device is the only market-ready product with Cellular, WiFi, GPS, and Bluetooth connectivity. This connectivity suite powers Avive's revolutionary REALConnect™ Technology. It's designed to help get life-saving therapy to a person when and where it's needed by integrating with 911 centers through a partnership with RapidSOS. It also seamlessly transfers valuable incident data to 911 telecommunicators, EMS, and medical professionals at the right time. REALConnect™ can also automate remote monitoring of Avive's AEDs to ensure they are properly maintained and fully functional.

It's estimated more than four million AEDs have been deployed around the U.S in an effort to provide quick, lifesaving intervention for OHCA events. However, timely response before EMS arrival and actual use of those deployed AEDs remains below three percent for all cardiac arrest emergencies. The result is survival rates nationwide have remained unchanged for years at about ten percent.

To improve survival rates, the Avive Connect AED was designed for easy placement in a variety of locations, optimized for maximum connectivity, and extensively tested forease-of-use.

"The opportunity to dramatically transform cardiac arrest response and improve outcomes is now possible in ways that weren't imagined even a few years ago," said Rory Beyer, Avive co-founder & President. "The power of our platform is its ability to connect the different elements of a cardiac arrest response. More connections mean more valuable data can get to the right people at the right time. This approach mirrors the paradigm shifts and benefits we have seen connected devices bring to other industries such as smartphones, home security, personal fitness, automobiles and more."

The University of Pennsylvania's Director of the Center of Resuscitation Science, Benjamin Abella, M.D., is a global thought leader in sudden cardiac arrest research who has published more than 250 papers on cardiac arrest and resuscitation. Like a growing number of physician and public safety leaders, he supports the potential of this interconnected, data-driven, "right place, right time" approach for improving outcomes.

"Connected devices are the future of emergency care. Decades of experience tell me that Avive's technology and approach will be game changing," said Dr. Abella. "AEDs have historically been like fire extinguishers. You put one on the wall and forget about it. But when flames erupt, you need it to work, and you need to know where to find it."

"When a cardiac event occurs down the street, where's the fire extinguisher for that, so to speak? Experience says it could be what Avive has created. A powerful, portable device that's interconnected into the public safety and provider ecosystem opens up the possibilities for AEDs to get used more often and more effectively. Also, valuable data from an AED can finally be seamlessly sent to emergency departments to support downstream patient care decisions. That's rare today."

AED maintenance is critical to ensure functionality. While some AEDs have limited wireless capabilities, most have none. This requires AED owners to perform manual inspections of their devices, a burdensome, costly and often unreliable process.

With a full suite of connectivity, Avive simplifies AED monitoring and maintenance for its customers through daily remote monitoring of their fleet of devices using Avive's REALConnect Platform.™ – which customers can easily access from their laptop or mobile phone.

"We’re giving our customers unprecedented insight into their Avive Connect AEDs," said Jafri. "Our REALConnect Platform makes it easy to deploy and manage their devices, whether it's a handful of them or thousands. Customers will now have the tools and information to make sure their AEDs are properly maintained and are where they expect them to be."

About Avive Solutions, Inc.

Avive is a San Francisco-based healthcare technology company and developer and manufacturer of a revolutionary connected Automated External Defibrillator (AED), coupled with a first-of-its-kind software platform to address the major healthcare problem of out-of-hospital cardiac arrest (OHCA). Avive's connected hardware and software platform is designed to integrate with existing public safety and provider ecosystems to create a comprehensive OHCA response solution. The goal is increased survival rates from cardiac arrest emergencies. Stay up to date by subscribing to our newsletter, and following us on LinkedIn, Twitter, and Facebook, and Instagram.

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