ZOLL Medical receives PMDA approval to distribute AED Plus, AED Pro in Japan

ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that it has been granted approval by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) to import and distribute the AED Plus^® and AED Pro^® in Japan.

“We have had very limited sales of monophasic defibrillation products to Japan in recent years while awaiting regulatory approval for our biphasic waveform.”

These products are automated external defibrillators that incorporate ZOLL's real-time CPR feedback technology—Real CPR Help^®—for rescuers to assist them in providing high-quality CPR associated with emergency care of sudden cardiac arrest victims. These will be the only AEDs with CPR feedback capability available in the market in Japan.

These product approvals also represent approval for the ZOLL Rectilinear Biphasic™ Defibrillation Waveform for which supporting clinical data on safety and efficacy were reviewed. This waveform approval greatly simplifies the review process for other ZOLL Advanced Cardiac Life Support defibrillators, including the E Series^® and R Series^®.

The Japan AED market is second in unit sales to the United States, and since approval and use by non-medical professionals began in 2004, it has expanded to 70,000-80,000 units annually with a value of approximately $200 million. The largest market participants include Nihon Kohden, distributor of Cardiac Science devices as well as its own newly-introduced product; Philips Medical through distributors Fukuda Denshi and Laerdal Medical; Medtronic Physio- Control; and CU Medical of Korea.

ZOLL is concluding negotiations with a major Japanese distributor to include multi-year minimum purchase commitments in exchange for exclusive distribution rights, and expects shipments of the AED Plus to begin later this year.

"Approval of the AED Plus and AED Pro is a significant milestone that will open up many additional opportunities for growth in this important market," said Jonathan Rennert, President of ZOLL. "We have had very limited sales of monophasic defibrillation products to Japan in recent years while awaiting regulatory approval for our biphasic waveform."

As in the United States, sudden cardiac death is a major public health problem in Japan, with about 50,000 deaths annually, 125-140 deaths every day, that are potentially preventable with the widespread availability of AEDs and high-quality performance of CPR.