FDA 510(k) submission expected in the first quarter of calendar 2019
Sparton’s Watertown facility to provide manufacturing services
GARDEN CITY, N.Y. and REHOVOT, Israel, July 30, 2018 (GLOBE NEWSWIRE) — AIT Therapeutics, Inc. (AITB), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions including serious lung infections and pulmonary hypertension, today announced that it has begun commercial development for its ventilator compatible NO generator and delivery system with Sparton Corporation, a leader in the design and manufacture of highly complex electromechanical devices. AIT and Sparton expect to complete the process in approximately 6 months, and AIT will make a 510(k) submission to the FDA shortly thereafter.
“AIT and Sparton have been working together on the NO generator and delivery system for more than a year with excellent results to date,” said Steven Lisi, Chairman and Chief Executive Officer of AIT Therapeutics. “We are looking forward to a 510(k) submission to the FDA early next year for the ventilator compatible system, as well as initiating studies in both bronchiolitis and NTM with the commercial mask compatible system in 2019. Over the past 18 months the AIT team has successfully executed on three separate programs, and we are looking forward to our efforts resulting in improving the lives of patients over the next several years.”
“Sparton is proud to play a key role in bringing a product that will positively impact the health of many people to the market,” said Mike Gaul, Group Vice President, Manufacturing and Design Services. We look forward to our continued partnership with AIT through the regulatory and manufacturing processes.”
About Nitric Oxide (NO)
Nitric Oxide (NO) is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, both gram-positive and gram-negative, but also against other diverse organisms including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About AIT Therapeutics Inc.
AIT Therapeutics Inc. is a clinical-stage medical device and biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The Company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care, as well as pulmonary hypertension, in various settings. AIT Therapeutics is currently advancing its revolutionary NO Generator and Delivery System in clinical trials for the treatment of bronchiolitis and severe lung infections such as nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
Sparton Corporation (NYSE: SPA), now in its 119th year, is a provider of complex and sophisticated electromechanical devices with capabilities that include concept development, industrial design, design and manufacturing engineering, production, distribution, field service and refurbishment. The primary markets served are Medical & Biotechnology, Military & Aerospace and Industrial & Commercial. Headquartered in Schaumburg, Illinois, Sparton currently has thirteen manufacturing locations and engineering design centers worldwide. Sparton’s website may be accessed at https://www.sparton.com.
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