First Approval of ZOLL Rectilinear Biphasic Waveform Clears Path to Resume Distribution to World’s Second Largest Defibrillator Market
July 29, 2010─CHELMSFORD, MASS.–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.
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.
About ZOLL Medical Corporation
ZOLL Medical Corporation develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies which help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and critical care.
A NASDAQ Global Select company and a Forbes 100 Most Trustworthy Company in 2007, 2008, and 2009, ZOLL develops and manufactures its products in the United States, in California, Colorado, Illinois, Massachusetts, Pennsylvania, and Rhode Island. More than 400 direct sales and service representatives, 1,100 business partners, and 200 independent representatives serve our customers in over 140 countries around the globe. For more information, visit www.zoll.com.
Certain statements contained in this press release, including statements regarding the future business of the Company, and other statements contained herein regarding matters that are not historical facts, are “forward-looking” statements (as defined in the Private Securities Litigation Reform Act of 1995). Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those factors discussed in the section entitled “Risk Factors” in the Company's Quarterly Report on Form 10-Q filed with the SEC on May 14, 2010. You should not place undue reliance on the forward looking statements in this press release, and the Company disavows any obligation to update or supplement those statements in the event of any changes in the facts, circumstances, or expectations that underlie those statements.