ZOLL Medical Corporation  

269 Mill Road
Chelmsford,  MA  01824

United States
http://www.zoll.com
  • Booth: 2723


http://www.zoll.com

ZOLL, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. The Asahi Kasei Group contributes to life and living for people around the world. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.


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 Press Releases

  • ZOLL ANNOUNCES CLOSING OF ACQUISITION OF ITAMAR MEDICAL

    December 16, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has successfully completed its previously announced acquisition of Itamar™ Medical Ltd. (Nasdaq and TASE: ITMR) (“Itamar Medical”), a medical device and digital health company that provides at-home testing for sleep apnea.

    "We are pleased to announce the closing of the acquisition of Itamar and welcome its employees to the ZOLL family," said Jon Rennert, ZOLL CEO. "Together, ZOLL and Itamar Medical will help more patients receive diagnosis and treatment for sleep-disordered breathing and help strengthen the collaboration between the worlds of cardiology and sleep medicine."

    Itamar Medical will operate as a business division within ZOLL, and Gilad Glick, who previously served as Itamar Medical’s CEO, will lead the division as its President. Itamar Medical’s principal operations in Caesarea, Israel will continue with no material changes to operations currently anticipated. Moving forward, ZOLL will focus on the continuity of Itamar Medical’s business while using ZOLL’s global infrastructure and strong brand to accelerate and expand growth opportunities.

    Transaction Details

    ZOLL acquired all outstanding ordinary shares of Itamar Medical for $1.0333333 (equivalent to approximately NIS 3.24) per ordinary share, or $31 per American Depository Share (ADS), in cash (without interest, less any applicable withholding taxes and, in the case of ADSs, less applicable cancellation fees).

    As a result, Itamar Medical’s ordinary shares will cease to be traded on the TASE market and Itamar Medical will no longer have reporting obligations under applicable Israeli securities laws.

    In addition, Itamar Medical has requested that trading of its ADSs on the Nasdaq Capital Market (Nasdaq) be terminated and further that Nasdaq file a Form 25 with the U.S. Securities and Exchange Commission (SEC) notifying the SEC of the delisting of its ADSs on the Nasdaq and the deregistration of Itamar Medical’s registered securities.

    Itamar Medical intends to promptly file with the SEC a Post-Effective Amendment to Form F-3 Registration Statement and Post-Effective Amendment to Form S-8 Registration Statement to deregister Itamar Medical’s unsold securities that are currently registered pursuant to Form F-3 and Form S-8, respectively. Thereafter, Itamar Medical intends to terminate its reporting obligations under the Securities Exchange Act of 1934, as amended (Exchange Act), by promptly filing a Form 15 with the SEC. Itamar Medical’s obligation to file with the SEC certain reports and forms, including Form 20-F and Form 6-K, will be suspended immediately as of the filing date of the Form 15 and will terminate once the deregistration becomes effective.

    Advisors

    Goldman Sachs & Co. LLC acted as financial advisor to ZOLL, and Cooley LLP and Gornitzky & Co. served as legal advisors to ZOLL for the transaction. Piper Sandler & Co. acted as financial advisor to Itamar Medical, and Latham & Watkins LLP and Goldfarb Seligman & Co. acted as its legal advisors.

    About ZOLL Medical Corporation

    ZOLL, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

    About Asahi Kasei

    The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.  For more information, visit www.asahi-kasei.com.

    About Itamar Medical Ltd.

    Itamar Medical is a medical technology company focused on the development and commercialization of non-invasive medical devices and solutions to aid in the diagnosis of respiratory sleep disorders. Itamar Medical commercializes a digital healthcare platform to facilitate the continuum of care for effective sleep apnea management with a focus on the core sleep, cardiology and direct to consumer markets. Itamar Medical offers a Total Sleep Solution to help physicians provide comprehensive sleep apnea management in a variety of clinical environments to optimize patient care and reduce healthcare system costs. The Company’s key product, WatchPAT, is commercially available within major markets including the U.S., Japan, and Europe. Itamar Medical is a public company traded on the Nasdaq and on the Tel Aviv Stock Exchanges, and is based in Caesarea, Israel with U.S. headquarters based in Atlanta, GA. For additional information visit www.itamar-medical.com.

    Forward-Looking Statements

    This press release contains certain information that may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. These statements relate to future events that are based on current expectations, estimates, forecasts and projections. These statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. All statements other than statements of historical fact or relating to present facts or current conditions included in this communication are forward-looking statements. Such forward-looking statements include, among others, Itamar Medical’s current expectations and projections relating to its financial condition, results of operations, plans, objectives, future performance, business and relating to the closing of the merger. Forward-looking statements can usually be identified by the use of terminology such as “anticipate,” “believe,” “could,” “continue,” “estimate,” “expect,” “goals,” “intend,” “likely,” “may,” “might,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and variations of such words and similar expressions. Those risks, uncertainties and assumptions include (i) the effect of closing of the merger on Itamar Medical’s business relationships, operating results and business generally, (ii) risks that consummation of the merger disrupts current plans or operations, (iii) potential difficulties in employee retention as a result of consummation of the merger, (iv) risks related to changes in management or diverting management’s attention from Itamar Medical’s ongoing business operations, (v) the outcome of any legal proceedings that may be instituted against Itamar Medical related to the merger, (vi) unexpected costs, charges or expenses resulting from merger and (vii) other risks described in Itamar Medical’s filings with the SEC, such as its Annual Reports on Form 20-F and Reports of Foreign Private Issuer on Form 6-K.

    Copyright © 2021 ZOLL Medical Corporation. ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

    Copyright © 2021 Itamar Medical Ltd. All rights reserved. Itamar Medical is a registered trademark of Itamar Medical Ltd. in the United States and/or other countries.

    All other trademarks are the property of their respective owners.

    Contact: Matt Hogan

    ZOLL Medical Corporation

    +1 (978) 805-6561

    media@zoll.com

  • AMERICAN MEDICAL ASSOCIATION ISSUES NEW CATEGORY III CPT CODE FOR ZOLL MEDICAL'S THEROX SSO2 THERAPY

    August 9, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the American Medical Association (AMA) CPT Editorial Panel issued a new Category III CPT® code, effective July 1, 2021, for its TherOx® SuperSaturated Oxygen (SSO2) Therapy. The code, 0659T (transcatheter intracoronary infusion of supersaturated oxygen in conjunction with percutaneous coronary revascularization during acute myocardial infarction, including catheter placement, imaging guidance [e.g., fluoroscopy], angiography, and radiologic supervision and interpretation), is effective July 1, 2021 for SSO2 Therapy including treatment of patients with left anterior descending ST-elevation myocardial infarction (LAD STEMI) heart attacks. SSO2 Therapy is the first and only FDA-approved treatment that has been clinically proven to significantly reduce cardiac muscle damage in heart attack patients after coronary angioplasty with stenting.1

    SSO2 Therapy is indicated for patients who suffer LAD STEMI — also known as "widowmaker" heart attacks due to the high mortality rate — and are treated within six hours of symptom onset. The therapy delivers high levels of dissolved oxygen at 7–10 times the normal amount directly to the damaged heart muscle immediately after the coronary artery has been successfully opened via angioplasty and stenting. Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy to reduce infarct size.1,2,3

    The Category III CPT code for SSO2 Therapy was supported by the leadership of the Society for Cardiac Angiography and Interventions (SCAI) and the American College of Cardiology (ACC). The decision was based on a review of published, peer-reviewed literature, the need for an accurate national code for physicians to use in reporting SSO2, and the importance of SSO2 as an emerging, innovative technology.

    "The AMA issuing a CPT code for TherOx's SSO2 Therapy is a significant milestone for the millions of patients who could benefit from its use," commented Neil Johnston, President of ZOLL Circulation. "More and more hospitals are adopting this therapy to treat patients with the most serious form of heart attacks, and now the Category III code provides another major step forward toward capturing data on SSO2 and demonstrating improved patient outcomes."

    CPT codes are granted by the AMA CPT Editorial Panel and are widely used by government payers, including Medicare and Medicaid, and commercial health plans to process claims and determine reimbursement for healthcare services and procedures.

    SSO2 Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL Medical Corporation.

    About ZOLL Medical Corporation

    ZOLL Medical Corporation, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

    About Asahi Kasei

    The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

    1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75.
    2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405.
    3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.

    Copyright © 2021 ZOLL Medical Corporation. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

    CPT numbers and descriptors are copyrighted by the American Medical Association. CPT® is a registered trademark of the American Medical Association.

    Contact: Matt Hogan

    ZOLL Medical Corporation

    +1 (978) 805-6561

    media@zoll.com

  • ZOLL ANNOUNCES APPROVAL OF NEXT-GENERATION remedē SYSTEM FOR THE TREATMENT OF CENTRAL SLEEP APNEA (TRANSVENOUS PHRENIC NERVE STIMULATION)

    The new remedē EL-X model delivers extended longevity, reduced size, and an enhanced suite of diagnostics

    August 5, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the remedē® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients.1 CSA is a serious condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias.

    The next-generation remedē EL-X System combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. Features of the new device include:1

    • Extended longevity: 40% longer average battery life versus previous version2
    • Reduced size: Approximately 25% smaller than the previous version
    • Simplified implant: Single lead, single-port system that provides both stimulation and sensing from a single lead
    • Data-driven clinical insights with DRēAM View: Enhancements include full-night, comprehensive diagnostic capabilities

    "The next-generation remedē System is built on the proven success of the current platform, with the needs of both patients and clinicians in mind," said Pete Sommerness, President of ZOLL Respicardia. "The increased longevity, smaller size, enhanced diagnostics, and simplified implant procedure will substantially benefit patients."

    "We are very excited to offer DRēAM View, a full-night diagnostic report that will allow clinicians deeper insight into how the patient is responding to remedē therapy," added Todd Goblish, Vice President of Research and Development at ZOLL Respicardia. "DRēAM View diagnostics will enable clinicians to better tailor therapy settings for each individual patient."

    A phased launch of the remedē EL-X System will commence immediately in implanting centers in the United States.

    The remedē System and Central Sleep Apnea

    The first-generation remedē System was approved by the FDA in 2017. The remedē System is an implantable device that activates automatically each night to stimulate a nerve in the chest (phrenic nerve) that sends signals to the breathing muscles (diaphragm) to help restore a normal breathing pattern.3 The Post Approval Study followed patients from the pivotal trial through five years post implant.

    Central sleep apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects sleep quality, quality of life, and is associated with poor outcomes. CSA results from the brain's inability to send appropriate signals to the respiratory muscles to stimulate breathing. Many patients with CSA also have heart disease, especially heart failure.4 Patients with CSA and heart failure are at increased risk for hospitalizations and even death.5,6

    About ZOLL Medical Corporation

    ZOLL Medical Corporation, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

    About Asahi Kasei

    The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

    IMPORTANT SAFETY INFORMATION

    Indications for Use
    The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.

    Contraindications
    The remedē System is contraindicated for the following:

    • Patients with an active infection
    • Patients known to require magnetic resonance imaging (MRI)

    Warnings

    • Diathermy — Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively referred to as diathermy) on patients implanted with the remedē System.
    • Electric Shock — When operating under AC power, the remedē System Programmer must be connected to a grounded power source to avoid risk of electric shock.
    • Concomitant Active Implantable Devices — Use the remedē System with caution in patients with an active implantable device that may be susceptible to unintended interaction with the remedē System. Consult Respicardia to assess the possibility of interaction.
    • Patients with Evidence of Phrenic Nerve Palsy — Therapy with the remedē System may be ineffective in patients who have evidence of phrenic nerve palsy.
    • Pediatric Use — The safety and effectiveness of the remedē System has not been established for pediatric use.

    Precautions
    It is recommended that testing for oversensing of remedē stimulation therapy by the concomitant cardiac device occur at the time of implant and prior to initiating remedē System therapy in patients with a concomitantly implanted cardiac device. Use remedē System therapy with caution in pacemaker-dependent patients without a physiologic escape rhythm. Device interaction may lead to over or undersensing resulting in a loss of pacing. The safety and effectiveness of the remedē System during pregnancy has not been established. See the Device Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

    Adverse Effects
    Possible adverse events which may be associated with the implantation and use of the remedē System include, but are not limited to, the following: adverse contrast dye reaction such as allergic reaction, pulmonary edema, or worsening renal function, adverse reaction to radiation exposure, thromboembolism, air embolism, bleeding, cardiac perforation including tamponade, hematoma, seroma, local bruising or swelling, hypotension, local wound healing issues at device implant site including wound dehiscence, pocket erosion, extrusion, movement of implanted device, keloid formation, pneumothorax, hemothorax, vascular damage, e.g., venous dissection, perforation, adverse biocompatibility reaction to the implanted system, infection, lead breakage, lead dislodgement, lead not connected or secured appropriately in device header, implantable device malfunction, requirement for more energy to stimulate the nerve or ineffective stimulation, venous occlusion, crosstalk with another implanted device, disrupted sleep, muscle fatigue or discomfort in diaphragm, chest or abdomen from appropriate stimulation, nerve dysfunction, perturbation of blood gases causing hypoxia, hypercapnea and/or hypocapnea, inappropriate sensations, worsening heart failure, respiratory status or overall health, anxiety, arrhythmia, including ventricular fibrillation, death, depression, hypotension, pain, skin irritation or local allergic reaction, thrombus or embolism, potentially leading to pulmonary embolism or stroke.

    CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete "Directions for Use" for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator's Instructions.

    1 FDA PMA P160039, Supplement 006, Physician Manual.
    2 Under normal use settings
    3 Costanzo M.R., et al. The Lancet. 2016;388:974–82.
    4 Bekfani T, Abraham WT. Europace. 2016;18(8):1123–34. Epub 2016 May 26.
    5 Khayat R, et al. J Card Fail. 2012;18:534–40.
    6 Khayat, R et al. European Heart J. 2015;36 1463–69.

    Copyright © 2021 ZOLL Medical Corporation. All rights reserved. ZOLL, Respicardia, and remedē are registered or unregistered trademarks of ZOLL Medical Corporation and/or its affiliates in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

    Matt Hogan

    ZOLL Medical Corporation

    +1 (978) 805-6561

    media@zoll.com

  • ZOLL MEDICAL RECEIVES FDA IDE APPROVAL FOR INITIATION OF ISO SHOCK (INCORPORATING SUPERSATURATED OXYGEN IN SHOCK) FEASIBILITY STUDY

    May 13, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for a randomized prospective study evaluating the use of TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device. The ISO SHOCK study will assess the safety and feasibility of SSO2 Therapy in patients with this complex and highly fatal condition and potentially lay the groundwork for future trials to benefit high-risk heart attack patients.

    Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy to reduce infarct size resulting from high-risk heart attacks such as LAD-STEMI1,2,3 by delivering hyperoxemic levels of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after percutaneous coronary intervention (PCI). The ISO SHOCK study will determine the safety and feasibility of delivering SSO2 Therapy to patients presenting with STEMI and cardiogenic shock, a subset of high-risk patients with a mortality rate between 40 and 60 %,4 compared to standard practice and outcomes demonstrated in the National Cardiogenic Shock Initiative (NCSI).

    A STEMI heart attack is associated with a 2-fold increased risk of developing cardiogenic shock,5 a life-threatening condition in which the heart cannot pump adequate oxygenated blood to vital organs. Cardiogenic shock represents the highest risk category of STEMI with the greatest myocardial damage from ischemia. SSO2 Therapy could potentially mitigate damaged tissue while improving left ventricular structure and function in this complex patient population.

    “Cardiogenic shock remains one of the most challenging diagnoses for interventional cardiologists to manage, especially in the setting of STEMI,” said William O’Neill, MD, Cardiologist at Henry Ford Health System and co-investigator of ISO SHOCK along with M. Babar Basir, MD. “I have utilized SSO2 Therapy in previous trials for anterior STEMI and seen positive results, and I think there is a significant potential benefit for this high-risk population as well.”

    The ISO SHOCK study will randomize 60 patients in 20 sites across the U.S. to assess whether SSO2 Therapy could provide benefit to these complex patients compared to the current standard of care. The primary safety endpoint will assess mortality at 30 days with the SSO2 Therapy group compared to the control group as well as against the historical 32% mortality from the NCSI. The feasibility endpoints will measure completion of a 60-minute SSO2 infusion after successful PCI, and obtaining an MRI 3–7 days after PCI.

    “SSO2 Therapy was designed to recover damaged myocardium in heart attack patients, with the intention of preventing devastating heart failure and potentially death,” added Neil Johnston, President of ZOLL Circulation. “The initiation of the ISO SHOCK trial for the sickest of these patients — those in cardiogenic shock — only reinforces our commitment to this cause.”

    SuperSaturated Oxygen (SSO2) Therapy is the first and only FDA-approved treatment to significantly reduce cardiac muscle damage in heart attack patients after percutaneous coronary intervention.1 It is currently indicated for patients who suffer LAD STEMI and are treated within six hours of symptom onset.

    SSO2 Therapy was developed by Irvine, California-based TherOx, Inc., now part of ZOLL Medical Corporation.

    About ZOLL Medical Corporation

    ZOLL Medical Corporation, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

    About Asahi Kasei

    The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

    1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75
    2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405
    3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9
    4 Kapur NK, et al. Methodist Debakey Cardiovasc J. 2020 Jan-Mar; 16:1:16–21
    5 Vahdatpour C, et al. J Am Heart Assoc. 2019 Apr 16;8:8:e011991

    Copyright © 2021 ZOLL Medical Corporation. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

    Matt Hogan

    ZOLL Medical Corporation

    +1 (978) 805-6561

    media@zoll.com

  • ZOLL MEDICAL CORPORATION ACQUIRES RESPICARDIA, INC.

    Innovative treatment for patients with respiratory and cardiovascular disease expands ZOLL’s critical-care portfolio

    April 12, 2021 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has acquired Respicardia, Inc., a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA). CSA is a serious condition that is often associated with heart failure, coronary artery disease, and certain cardiac arrhythmias.

    Respicardia’s remedē® System is a revolutionary treatment for CSA, and is the only implantable device approved by the U.S. Food and Drug Administration (FDA) to treat moderate to severe CSA in adult patients with reduced cardiac function.1 CSA results in shallow or disrupted breathing during sleep, and many patients with CSA also have heart disease, especially heart failure.2 Within this population, patients with CSA are at increased risk for hospitalizations and even death.3,4

    “ZOLL and Respicardia both develop innovative therapies for conditions with large unmet clinical needs, and we share a deep commitment to improving patient outcomes,” said Jon Rennert, CEO of ZOLL Medical. “With this acquisition, ZOLL will combine its expertise in cardiac and respiratory care with Respicardia’s novel remedē® System to make a meaningful difference in the health and quality of life for many patients.”

    CSA occurs when the brain fails to send appropriate signals to the breathing muscles that stimulate a regular breathing pattern. CSA symptoms include chronic fatigue, excessive daytime sleepiness, cognitive impairment and inability to get restful sleep. CSA is distinct from Obstructive Sleep Apnea (OSA), which results from a blockage of the upper airway.5

    Respicardia’s remedē® System is implanted by a cardiac electrophysiologist during a minimally invasive outpatient procedure. The remedē® System delivers electrical pulses to one of the phrenic nerves, which send signals to the diaphragm, restoring a more normal breathing pattern during sleep. Respicardia estimates there are more than one million CSA patients in the U.S. alone who could benefit from the remedē® System,6 which has been shown to improve sleep, enhance well-being, and reduce daytime sleepiness, enabling better overall health.7

    “Respicardia is excited to be joining the ZOLL family,” said Peter Sommerness, CEO of Respicardia. “As an innovator of safe and effective therapies that address the unmet needs of respiratory and cardiovascular patients, we see tremendous potential ahead with the support of ZOLL’s strong brand and global reach.”

    ZOLL, which has been a significant investor in Respicardia for more than three years, will welcome all Respicardia employees into its global workforce, and will maintain Respicardia’s current headquarters in Minnetonka, Minnesota.

    About ZOLL Medical Corporation

    ZOLL Medical Corporation, an Asahi Kasei company, 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 cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit www.zoll.com.

    About Asahi Kasei

    The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit www.asahi-kasei.com.

    1 FDA PMA P160039
    2 Bekfani T, Abraham WT. Europace. 2016 Aug;18(8):1123-34. doi: 10.1093/europace/euv435. Epub 2016 May 26.
    3 Khayat R et al. Central sleep apnea is a predictor of cardiac readmission in hospitalized patients with systolic heart failure. J Card Fail 2012;18:534–40.
    4 Khayat, R et al. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure, European Heart Journal 2015;36 1463–1469.
    5 Costanzo M.R., Khayat R., Ponikowski P., et al. Mechanisms and clinical consequences of untreated central sleep apnea in heart failure. J Am Coll Cardiol. 2015; 65:72–8
    6 Javaheri and Dempsey, Comprehensive Physiology 2013; 3:141-163; Dymedex data on file, 2014
    7 Costanzo M, et al. Transvenous neurostimulation for central sleep apnea: a randomised controlled trial. The Lancet. 2016; 388: 974–82

    Copyright © 2021 ZOLL Medical Corporation. All rights reserved. ZOLL is a registered trademark of ZOLL Medical Corporation in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

    Matt Hogan

    ZOLL Medical Corporation

    +1 (978) 805-6561

    media@zoll.com


 Products

  • LifeVest® Wearable Cardioverter Defibrillator
    The LifeVest® wearable cardioverter defibrillator is worn by patients at risk of sudden cardiac death. LifeVest is designed to detect certain life-threatening rapid heart rhythms and automatically deliver a treatment shock to restore a normal rhythm....

  • The LifeVest® wearable cardioverter defibrillator (WCD) is designed to protect patients at risk of sudden cardiac death (SCD), when a patient’s condition is changing and permanent SCD risk has not been established. 

    While some defibrillator devices are implanted under the skin, the LifeVest WCD is worn directly against the skin. It is lightweight and easy to wear, allowing patients to return to most of their daily activities with peace of mind that they have protection from SCD. LifeVest is designed to detect certain life-threatening rapid heart rhythms and automatically deliver a treatment shock to save a patient’s life.

    LifeVest is used for a wide range of patients, including those who have a reduced heart function following a heart attack, before or after bypass surgery or stent placement, or those with cardiomyopathy or heart failure that places them at particular risk. On any given day, tens of thousands of people worldwide have protection from SCD by wearing the LifeVest WCD.

  • The remedē System
    The remedē® System is a proven implantable system that safely and effectively treats moderate to severe central sleep apnea (CSA) in adults. Safety: remede.zoll.com...

  • The remedē® System is a proven implantable system that safely and effectively treats moderate to severe central sleep apnea (CSA) in adult patients. CSA is a serious breathing disorder that disrupts the normal breathing pattern during sleep.

    The remedē System stimulates a nerve in the chest (phrenic nerve) to send signals to the large muscle that controls breathing (the diaphragm). These signals stimulate breathing in the same way that the brain signals breathing.  The most serious risk is implant site infection.

  • Cardiac Diagnostics
    ZOLL Cardiac Diagnostics offers cardiac monitoring solutions to support patient diagnosis and care plans.
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  • ZOLL Cardiac Diagnostics offers cardiac monitoring solutions to support patient diagnosis and care plans.

    Clinicians can access reports and insights for a wide range of ZOLL patients via a unified portal – the ZOLL Patient Management Network – including ZOLL Cardiac Monitors, ZOLL Arrhythmia Management System (AMS), and ZOLL LifeVest.