Novoteris, LLC. Receives FDA and Health Canada Clearance to Start a Phase 2 Clinical Trial of its Thiolanox® Nitric Oxide for the Treatment of Cystic Fibrosis.

Garden Grove, CA—June 5, 2017:  Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced today that both the US Food and Drug Administration and the Therapeutic Products Directorate of Health Canada have cleared its Phase 2 clinical trial application. Novoteris will now begin recruiting subjects into

Novoteris, LLC Announces $2.8 Million Award from Cystic Fibrosis Foundation Therapeutics to Support Development of Inhaled Nitric Oxide Antimicrobial Therapy

Garden Grove, CA– Novoteris, LLC announced today a $2.8 million agreement with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to develop an inhaled nitric oxide antimicrobial therapy for people with cystic fibrosis (CF) who have airway bacterial colonization.

The Novoteris investigators’ pilot trial in Europe of this therapy reported encouraging microbiological and lung function changes following two weeks of treatment in patients with CF. Gaseous nitric oxide’s potent antimicrobial properties, lack of bacterial resistance, and its small molecule penetration capabilities could provide a promising alternative non-antibiotic approach to treating infections in people living with the disease.
Novoteris expects to begin a Phase 2b study by Q3 of 2015 to be supported in part by this award from CFFT. The program was based on nitric oxide antimicrobial research work pioneered by Dr. Chris Miller. Also supporting the program are 12th Man Technologies, Inc., which will provide device development expertise, and Nitric Solutions Inc., which will provide scientific and clinical guidance.

CF is a rare life-threatening hereditary disease characterized by the production of thick, hard to clear mucus within the lung, leading to recurrent lung infections and loss of lung function. Antibiotic therapy, routinely used to treat lung infections in people with CF, becomes ineffective as bacterial resistance develops. The thick mucus within the lungs also makes it difficult for antibiotics to penetrate bacterial colonies so there is a great need to develop alternative agents that can treat bacterial infection in people with CF.

Alex Stenzler, President of Novoteris, said: “Based on the success of our pilot trial, and the broad spectrum of bacteria and fungi that our product has demonstrated effectiveness against, we anticipate a high level of patient eligibility and interest for our Phase II efficacy trial. We are expecting that our program will provide a novel and the first inhalable gaseous antimicrobial agent for the treatment of patients with this devastating disease.”

For more information on cystic fibrosis, go to www.cff.org.

About Novoteris, LLC
Novoteris, LLC is a privately held limited liabilities company that is managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products. The company was formed in 2013 to consolidate the nitric oxide assets and other resources from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions, Inc. (Vancouver, Canada) for the completion of inhaled nitric oxide trials and FDA/EU approval for the treatment of patients with cystic fibrosis. The company received Orphan Drug designations for the treatment of cystic fibrosis from both the FDA and EMA in 2013. Novoteris is headquartered in Garden Grove, California with an EU entity in Belgium (Novoteris GVC). For additional information, please visit www.novoteris.com.

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For further information, please contact:

Novoteris, LLC
Alex Stenzler, President
Tel: +1 (714) 705-4576
Fax: +1 (714) 373-9865
E-mail: alex.stenzler@12thmantec.com

Novoteris, LLC., Medical Device and Pharmaceutical Product Innovators, Receives Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis.

Garden Grove, CA—December 18, 2013 (eReleases):  Novoteris, LLC. A clinical stage medical device and pharmaceutical developer focused on innovative applications for nitric oxide gas where it can be applied for unmet medical needs, announced today that the European Commission, Health & Consumers Directorate-General Medicinal products – authorizations, EMA, has granted it orphan drug designation for

Novoteris, LLC., Medical Device and Pharmaceutical Product Innovators, Receives Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis.

Garden Grove, CA—October 9, 2013 (eReleases):  Novoteris, LLC. A clinical stage medical device and pharmaceutical developer focused on innovative applications for nitric oxide gas where it can be applied for unmet medical needs, announced today that the Office of Orphan Products Development of the US Food and Drug Administration has granted it orphan drug designation