Tag: respira

  • Qnovia Raises $17 million for Nebulizer

    Qnovia Raises $17 million for Nebulizer

    Photo: Qnovia

    Qnovia has raised $17 million to continue development of its RespiRx nicotine-replacement product, reports Richmond Business Sense.

    RespiRx is a portable, hand-held nebulizer, a powered medical device that delivers medicine as an inhaled mist and is similar to an inhaler. The device is designed to deliver a nicotine hit more quickly than existing therapies, thus enabling users to better manage withdrawals and, therefore, increase the likelihood of smoking cessation.

    Qnovia was founded in 2018 in Los Angeles by Mario Danek as Respira Technologies and rebranded in September. In May, the company appointed former Altria executive Brian Quigley as CEO and Danek as chief technology officer.

    The company also moved to Richmond, Virginia, in part because that state offers a more business-friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.

    In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.

    Qnovia will use the newly raised funds to develop a proof of concept for RespiRx as a nicotine-replacement therapy product and move it through an FDA approval process before the anticipated start of human clinical trials in 2023.

    The product is expected to hit the market as a prescription treatment. Qnovia is also interested in exploring how RespiRx can be used for asthma, pain management, vaccines and other uses.

  • Respira Appoints Brian Quigley as CEO

    Respira Appoints Brian Quigley as CEO

    Photo: jirsak

    Respira Technologies as appointed former Altria Group executive and current Respira COO Brian Quigley as its new CEO. Respira’s founder, Mario Danek, will transition to the role of chief technology officer.

    Quigley spent 16 years at Altria Group, with seven years as president and CEO at Altria’s smokeless and innovative products/vapor businesses. Quigley has been an active investor in both the cannabis and alcohol spaces and sits on the boards of Mustgrow Biologics and Belle Isle Craft Spirits.

    With Respira in the midst of securing financing for clinical trials, Danek made a significant change to the structure of the company’s leadership team. Quigley’s background as a successful business leader and Fortune 150 CEO in the space will help drive Respira to its next phase as it advances to an investigational new drug submission to begin human clinical trials. This transition will enable Danek to focus on the technology behind Respira, concentrating on inventing and refining its innovative inhalation device across multiple potential indication areas and target markets.

    Respira is a California venture-backed health tech company focused on commercializing proprietary inhalation device technologies to improve patient outcomes. The company is currently engaged with U.S. Food and Drug Administration Center for Drug Evaluation and Research  to pursue a combination product authorization as the first inhalable prescription smoking cessation therapy.

  • Drug Application for Inhalable Nicotine Replacement Therapy

    Drug Application for Inhalable Nicotine Replacement Therapy

    Photo: Respira

    Respira Technologies plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration in 2022 for the world’s first inhalable nicotine-replacement therapy.

    “There is a void of innovation in solving the smoking crisis from traditional healthcare companies, and as a result, Big Tobacco is trying to position itself as the solution to the problem they’ve created. At Respira, we believe only our technology can effectively help end the death and disease caused by smoking while simultaneously meeting CDER’s [Center for Drug Evaluation and Research] high standards for both safety and efficacy,” said Mario Danek, CEO and founder of Respira Technologies, in a statement.

     “We are very pleased with the productive and collaborative discussion with FDA and have confidence that FDA’s guidance will help us achieve our goal to end the death and disease caused by smoking,” said Danek. “The Pre-IND is just the first of many major milestones Respira will achieve, and we are excited to advance our plans to submit our IND to begin human clinical studies.”

    In 2020, the company said it aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Respira’s senior management includes Chief Operating Officer Brian Quigley, who spent 16 years at Altria Group where he was CEO of the smokeless tobacco business from 2012 to 2018.

  • Altria Veteran Brian Quigley Joins Respira

    Altria Veteran Brian Quigley Joins Respira

    Photo: Jakub Jirsák | Dreamstime.com

    Brian Quigley has joined Respira Technologies as chief operating officer.

    Quigley spent 16 years at Altria Group where he was CEO of the smokeless tobacco business from 2012 to 2018.
     
    “We are thrilled to have Brian join the Respira team as we prepare to enter the commercial phase of our company’s growth,” said Mario Danek, Respira’s Founder and CEO. “Brian’s vocal leadership for responsible industry practices and harm reduction combined with his impressive track record of driving business performance in FDA-regulated businesses make him the perfect leader for the next phase of growth for our unique product platforms.”
     
    Respira has developed two proprietary drug delivery platforms designed for safe aerosol-based delivery of drugs to patients and end users, without the creation of harmful byproducts and compounds. According to Respira, the platforms have applications in nicotine-replacement therapies, reduced-harm tobacco products and pharmaceutical drug delivery.
     
    “I am excited to be joining Respira Technologies at this critical moment in the company’s journey,” said Quigley. “I look forward to working with our team, investors and partners as we prepare to commercialize our proprietary drug delivery platforms.”

  • Respira to Submit Nebulizer for FDA Approval

    Respira to Submit Nebulizer for FDA Approval

    Photo: Respira Technologies

    Respira Technologies plans to submit an inhaler device to the U.S. Food and Drug Administration by late 2021 for authorization as nicotine-replacement therapy.

    The company aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Based in West Hollywood, California, USA, Respira Technologies says that the Covid-19 pandemic has sparked new interest in quitting, and today’s users of vapor devices and e-cigarettes need updated cessation products.

    “The reality is we have folks who are addicted to nicotine who never tried combustible products before,” Respira CEO Mario Danek told Bloomberg Technology, referring to tobacco products that are burned like cigarettes and cigars.

    “They’re used to sleeker products, and we have that design.”