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. (OTC: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 www.sparton.com.
This press release contains “forward-looking statements.” Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; and our short operating history. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
Steven Lisi, Chief Executive Officer
AIT Therapeutics, Inc.
LifeSci Advisors, LLC