Hospitech Respiration Ltd. Announced Clearance of a 510(k) Pre-Market Notification for the AnapnoGuard System

The AnapnoGuard System provides respiratory therapists a new therapeutic approach based on a system for continuous, closed loop control of trachea sealing and endotracheal cuff pressure.

TEL AVIV, Israel--(BUSINESS WIRE)--Hospitech Respiration Ltd., announced US Food and Drug Administration (FDA) clearance of a 510(k) pre-market notification for the AnapnoGuard 100 System¹. AnapnoGuard 100 system is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube’s cuff.

The AnapnoGuard System provides respiratory therapists a new therapeutic approach based on a proprietary system for continuous, closed loop control of trachea sealing and endotracheal cuff pressure. Over 400 patients at 7 clinical sites in 3 countries have been successfully treated with the AnapnoGuard System under clinical trials or standard-of-care use. AnapnoGuard is currently CE² cleared.

Gil Bolotin MD, PhD, Director, Department of Cardiac Surgery, Rambam Health Care Campus (Haifa, Israel), Co-Principal Investigator for the AnapnoGuard Clinical Trial ("ACT") commented, "I am excited to see AnapnoGuard received FDA pre-market clearance. For many years we have struggled to find solutions for ventilation associated complications ("VAC") for those patients requiring ventilator support post-surgery. Our clinical results suggest that AnapnoGuard utilizing continuous, closed loop control of endotracheal cuff pressure, can suppress the incident of VAC. I look forward to seeing AnapnoGuard™ broadly utilized in the clinic for ventilator patient management."

Yaron Bar-Lavie MD, Chairman, Division of Critical Care Medicine, Rambam Health Care Campus (Haifa, Israel) Co-Principal Investigator for the AnapnoGuard Clinical Trial ("ACT") commented, "I'm pleased to see the AnapnoGuard system receiving FDA pre-market clearance. We have been using the AnapnoGuard system in our department since 2010 initially during clinical trials and today as routine care. We believe the continuous closed loop control of endotracheal cuff pressure as well as evacuation of subglottic secretions are very effective. Clinical results have suggested significant reduction in ventilator associated complications ("VAC") and mainly Ventilator Associated Pneumonia ("VAP"). We look forward to seeing the system broadly used in mechanically ventilated patients."

About Gil Bolotin MD, PhD
Prof. Gil Bolotin MD, PhD is a graduate of the Faculty of Medicine at the Hebrew University in Jerusalem. He completed his clinical training at the Department of Cardiothoracic Surgery at Carmel Medical Center in Haifa. In addition, Dr. Bolotin was awarded a Doctorate degree from the University of Maastricht, Netherlands. Dr. Bolotin trained in mitral and robotic surgery (fellowship in North Carolina, 2002-2003), and in heart transplant, assist devices, and atrial fibrillation (Visiting Professor, The University of Chicago, 2003-2004). He also served as a Visiting Professor in the Department of Cardiothoracic Surgery, Academic Hospital Maastricht, Maastricht, Netherlands (2006-2007). Dr. Bolotin’s main research and clinical interests are in the fields of heart valve repair and replacement, surgery of the aorta, surgical treatments for heart failure, robotic and minimal invasive cardiac surgery, and surgical treatments for atrial fibrillation.

About Dr. Yaron Bar-Lavie
Dr. Yaron Bar-Lavie is Chairman, Division of Critical Care Medicine, Rambam Medical Center, Haifa. Dr. Bar-Lavie is also the Chairman, Board of Anesthesia, Critical Care and Pain, Technion - Israel Institute of Technology, School of Medicine. From 1993-1996 Dr. Bar-Lavie was a Fellow & Attending Physician, Critical Care Medicine, Shock-Trauma Center, Baltimore, MD, USA. Dr. Bar Lavie holds an M.D. from Ben-Gurion University in Beer-Sheva.

About the Rambam Health Care Campus
Rambam Health Care Campus is a 1,000-bed academic hospital serving the over 2 million residents of Northern Israel. Providing comprehensive medical services in all medical specialties, Rambam is the tertiary referral center for 12 district hospitals. Our commitment is to the entire spectrum of patient care, ranging from the best treatments and therapies, to the support of clinical research. Rambam Health Care Campus was recently ranked as one of the most recommended hospitals in Israel. In addition to the citizens of Northern Israel, Rambam serves the Israel Defense Forces Northern Command, UN Peacekeeping Forces, and the US 6th Fleet. Many of Rambam’s physicians are world renowned in their clinical specialty. Physicians participate in cutting-edge research projects to bring new therapies and treatments not only to their patients, but the greater community of the world.

About the AnapnoGuard System
The AnapnoGuard System provides respiratory therapists a new therapeutic approach based on a system for continuous, closed loop control of trachea sealing and endotracheal cuff pressure. The system detects air leakage from the lungs by measuring CO₂ levels above the cuff. Detection of high CO₂ levels above the cuff is an indication of leakage. The system continuously monitors CO₂ levels above the cuff and adjusts cuff pressure required to maintain the seal at appropriate pressure, avoiding tissue contact damage due to over pressurization currently experienced following manual over-inflation using current methods. AnapnoGuard also provides effective evacuation of subglottic secretions through simultaneous rinsing and suctioning procedure, while controlling flow and suction levels to avoid trachea injury. The system comprises a control unit, proprietary endotracheal tubes (“ETT”) and a connection kit. Over 400 patients at 7 clinical sites in 3 countries have been successfully treated with the AnapnoGuard System under clinical trials or standard-of-care use. AnapnoGuard is CE cleared.

About Hospitech
Hospitech Respiration Ltd. (www.hospitech.co.il) is an innovative, privately held medical device company (“Hospitech” or the “Company”) that has developed a multi-product platform of airway management solutions aimed at reducing complications arising from mechanical ventilation and reducing hospitalization costs associated with mechanically ventilated patients. The need for mechanical ventilation is the primary reason for admission to the Intensive Care Units (“ICU”) with more than 100 million³ patients intubated annually. The global airway management segment of the respiratory market is projected to reach $4.4 billion in 2016⁴. There is a significant rate of ventilation associated complications ("VAC") after 48 hours of intubation resulting from improper management of upper airways and improper ventilation pressure and timing. The Company’s solutions successfully address the above complications. AnapnoGuard clinical results have demonstrated more than 60% reduction in VAC⁵, potentially representing enormous savings in morbidity management. The Company’s solutions comprise (i) The AnapnoGuard™ System, an automated patient monitoring and control unit, as well as (ii) the AnapnoGuard multi lumens ET tube, (iii) the Cuffill⁶, a disposable cuff pressure management device and, (iv) Manual Aspiration of Subglottic Secretions (“MASS⁷”), a single-use subglottic secretion evacuation device. The Company has commercially launched Cuffill.

¹ AnapnoGuard is protected by US and International Patents, both issued and pending

² Conformité Européenne, or "European Conformity" ("CE") registration process required for European commercial distribution

³ Frost & Sullivan

⁴ World Market for Respiratory Devices, Kalorama Information

⁵ Company data on file

⁶ The Cuffill, a manual disposable (recommended for single patient use) inflator and manometer for use in Cuffed airways. The Cuffill offers an easy, accurate and accessible pressure regulation of airway cuffs in all clinical settings. The Cuffill is CE, FDA, and Japanese regulatory cleared. The Cufill is currently sold in US, Europe, Japan, Australia, New Zealand and Israel.

⁷ The MASS™, a disposable, single use device that operates with the Company’s ETTs and is used where the automated control unit is not available. The MASS is CE and FDA cleared.