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KMC Systems to Produce Rapid Blood Ammonia Testing Instrument

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Elbit Systems of America and KMC Systems have partnered with Aza Technology Inc. to develop a rapid blood ammonia detector. This device, the Rapid Ammonia Monitoring Device (AMD), has received FDA Breakthrough Device designation for point-of-care measurement, crucial for detecting hyperammonemia to prevent serious health issues. KMC will assist in seeking FDA approval and manufacturing the AMD, which aims to significantly reduce ammonia testing times from hours to minutes. This collaboration highlights a commitment to innovative healthcare solutions.

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  • Partnership with Aza Technology to develop a rapid blood ammonia detector.
  • FDA Breakthrough Device designation for Rapid Ammonia Monitoring Device (AMD).
  • Significant reduction in blood ammonia testing times from hours to minutes.
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MERRIMACK, N.H.--(BUSINESS WIRE)-- Elbit Systems of America (“Elbit Systems of America”) and its medical instruments division KMC Systems (“KMC”) today announced a new partnership with start-up company Aza Technology Inc. to provide a rapid blood ammonia detector.

KMC and Elbit Systems of America are dedicated to supporting local science and technology start-up companies like Aza Technology as they work to bring their research to market. With manufacturing and engineering headquartered in Merrimack, NH, and supported through the Cambridge Innovation Center, KMC offers highly advanced clinical and operational solutions to help solve customers’ most complex challenges.

“Our partnership with Aza is another way KMC and Elbit Systems of America are helping to change the landscape of healthcare and drive disruptive technologies in the life sciences space,” said Derek Kane, Vice President and General Manager of KMC. “KMC is focused on patient forward technology and this exciting partnership will help to bring new technology to market that directly impacts patient care and overall patient quality of life.”

As the healthcare landscape continues to push towards rapid testing equipment, Aza Technology has developed a Rapid Ammonia Monitoring Device (AMD) intended for the quantitative determination of ammonia in whole blood, which enables the early detection of hyperammonemia that is critical to prevent irreversible neurological damage, coma, and death. Hyperammonemia can strike at any age and timely diagnosis is limited by the current process and testing technology. The AMD has been granted Breakthrough Device designation from the Food and Drug Administration (FDA) for point-of-care measurement of ammonia for use in pediatric patients, including neonates as an aid in the diagnosis of inborn errors of metabolism. The AMD can be lifesaving as it aims to dramatically decrease blood ammonia processing times from hours to minutes.

“Between hospital and/or clinic visits, parents and caregivers are challenged to know ammonia levels and when their level would require immediate attention or action,” said Kathy Stagni, Executive Director of the Organic Acidemia Association. “The availability of a rapid point-of-care ammonia device, such as the AMD, with the capability of monitoring blood ammonia, will be a game-changer for the patient and the caregivers.”

The AMD was developed in collaboration with Stanford University and Stanford Hospital. KMC will support Aza Technology in seeking FDA approval for the AMD for use in both adult and pediatric patients, as well as manufacturing of the device and its consumables.

“Development of an accurate point-of-care ammonia meter has the potential to improve our care of patients with urea cycle disorders and organic acidemias,” said Dr. Jerry Vockley, MD, PhD, Chief of Medical Genetics & Director for Rare Disease Therapy at Children’s Hospital of Pittsburgh.

“We are thrilled to be in a partnership with KMC and Elbit Systems of America as we continue to develop our lifesaving, medical diagnostic device and seek FDA approval for the AMD,” said Peter Karkantis, CEO & Co-Founder, Aza Technology Inc. “The medical device regulatory and manufacturing expertise that KMC offers is the key factor of why we are excited to be partners in this breakthrough innovation.”

For more information on the AMD please visit: https://news.stanford.edu/press/view/35314.

About KMC Systems

KMC Systems, Inc. is a medical device and life sciences diagnostic company that specializes in contract design and manufacturing services for some of the leading medical devices and life sciences companies around the world. KMC was founded in 1980 and has served the medical device and life sciences industry for 40 years. The company is based out of Merrimack, New Hampshire and is the medical subsidiary of Elbit Systems of America. For additional information, visit http://www.kmcsystems.com/ or follow them on Twitter, and LinkedIn.

About Elbit Systems of America, LLC

Elbit Systems of America, headquartered in Fort Worth, Texas, is a leading provider of high-performance products, system solutions, and support services focusing on the defense, homeland security, law enforcement, commercial aviation, and medical instrumentation markets. With facilities throughout the U.S., Elbit Systems of America is dedicated to supporting those who contribute daily to the safety and security of the United States. Elbit Systems of America, LLC is wholly owned by Elbit Systems Ltd. (NASDAQ: ESLT and TASE: ESLT), a global high technology company engaged in a wide range of programs for innovative defense and commercial applications. For additional information, visit: www.elbitsystems-us.com or follow us on Twitter, LinkedIn and Instagram.

About Elbit Systems

Elbit Systems Ltd. is an international high technology company engaged in a wide range of defense, homeland security and commercial programs throughout the world. The Company, which includes Elbit Systems and its subsidiaries, operates in the areas of aerospace, land and naval systems, command, control, communications, computers, intelligence surveillance and reconnaissance ("C4ISR"), unmanned aircraft systems, advanced electro-optics, electro-optic space systems, EW suites, signal intelligence systems, data links and communications systems, radios, cyber-based systems and munitions. The Company also focuses on the upgrading of existing platforms, developing new technologies for defense, homeland security and commercial applications and providing a range of support services, including training and simulation systems. For additional information, visit: https://elbitsystems.com/, follow us on Twitter or visit our official Facebook, YouTube and LinkedIn Channels.

Trademarks

Elbit Systems of America and other trademarks, service marks and logos are registered or unregistered marks of Elbit Systems of America companies in the United States and in foreign countries. Copyright ©2021 Elbit Systems of America. All rights reserved.

Forward Looking Statement

This press release may contain forward-looking statements (within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended and the Israeli Securities Law, 1968) regarding Elbit Systems Ltd. and/or its subsidiaries (collectively the Company), to the extent such statements do not relate to historical or current facts. Forward-looking statements are based on management’s current expectations, estimates, projections and assumptions about future events. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions about the Company, which are difficult to predict, including projections of the Company’s future financial results, its anticipated growth strategies and anticipated trends in its business. Therefore, actual future results, performance and trends may differ materially from these forward-looking statements due to a variety of factors, including, without limitation: scope and length of customer contracts; governmental regulations and approvals; changes in governmental budgeting priorities; general market, political and economic conditions in the countries in which the Company operates or sells, including Israel and the United States among others; changes in global health and macroeconomic conditions; differences in anticipated and actual program performance, including the ability to perform under long-term fixed-price contracts; changes in the competitive environment; and the outcome of legal and/or regulatory proceedings. The factors listed above are not all-inclusive, and further information is contained in Elbit Systems Ltd.’s latest annual report on Form 20-F, which is on file with the U.S. Securities and Exchange Commission. All forward-looking statements speak only as of the date of this release. Although the Company believes the expectations reflected in the forward-looking statements contained herein are reasonable, it cannot guarantee future results, level of activity, performance or achievements. Moreover, neither the Company nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. The Company does not undertake to update its forward-looking statements. Elbit Systems Ltd., its logo, brand, product, service and process names appearing in this Press Release are the trademarks or service marks of Elbit Systems Ltd. or its affiliated companies. All other brand, product, service and process names appearing are the trademarks of their respective holders. Reference to or use of a product, service or process other than those of Elbit Systems Ltd. does not imply recommendation, approval, affiliation or sponsorship of that product, service or process by Elbit Systems Ltd. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, copyright, trademark or other intellectual property right of Elbit Systems Ltd. or any third party, except as expressly granted herein.

Media Contact

Carson Davie

Wireside Communications, on behalf of KMC Systems, Inc.

201-310-5383

cdavie@wireside.com

Source: KMC Systems, Inc.

FAQ

What is the partnership between Elbit Systems of America and Aza Technology about?

Elbit Systems of America and Aza Technology are collaborating to develop a Rapid Ammonia Monitoring Device (AMD) for rapid blood ammonia detection.

What is the importance of the Rapid Ammonia Monitoring Device (AMD)?

The AMD is crucial for the early detection of hyperammonemia, which can prevent serious neurological damage and death.

What designation has the AMD received from the FDA?

The AMD has received Breakthrough Device designation from the FDA for point-of-care measurement.

How will KMC Systems support Aza Technology?

KMC Systems will assist in seeking FDA approval and manufacturing the AMD for both adult and pediatric patients.

What is the significance of the AMD for healthcare?

The AMD will dramatically decrease blood ammonia processing times, enhancing patient care and monitoring.

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