Qnovia’s RespiRx is a handheld, inhaler-like medical device being developed as a smoking cessation therapy. The Richmond startup plans to roll out the product both domestically and in the United Kingdom. (Courtesy Qnovia)
Shortly after securing FDA approval for clinical trials of its smoking cessation inhaler in the United States, a local company has lined up funds to fuel an expansion across the pond.
Richmond-based Qnovia this week closed on a $16 million capital raise. The funding will primarily be allocated toward the submission of an application to British regulators to allow for the commercialization of the company’s RespiRx nicotine inhaler in the United Kingdom.
RespiRx is a portable, hand-held nebulizer – a powered medical device similar to an inhaler that delivers medicine as an inhaled mist. The device uses cartridges and is designed to deliver medicine in metered doses. Qnovia is currently working on commercializing the device as a smoking cessation product, though it could have further medical uses one day.
Qnovia intends to file its marketing authorization application for RespiRx to the British Medicines and Healthcare products Regulatory Agency in 2026, CEO Brian Quigley said. The company’s moves toward commercializing the device in the U.K. come as it works on a similar project in the U.S.
Qnovia is in the midst of clinical trials for the product in the U.S., following the company’s announcement in October that it secured FDA approval to kick off the project.
The company plans to complete phase one of trials in the first quarter of 2025. Additional trials would follow but would require more fundraising by the company, Quigley said.
The first phase of trials in the U.S. involves study of the effects and safety of the device in up to 24 adults who smoke, per a company news release. In 2023, Qnovia announced positive results from a smaller but similar study in the U.K.
Brian Quigley
Qnovia is tentatively planning to introduce the RespiRx to the American market in 2027 or 2028.
Quigley said Qnovia is tackling the U.S. and U.K. regulatory processes concurrently in part because U.K. approval is anticipated to be completed more quickly, and the ability to have RespiRx out in the market sooner not only will allow the company to start to generate revenue faster but also provide a real-world example to facilitate the U.S. process.
“We’re making this decision because the United Kingdom has a unique pathway,” he said. “That pathway allows a company like us to get approved much more quickly than we could in the United States.”
In addition to setting the stage for regulatory approval in the U.K., the recent raise will also help finance further development of RespiRx and exploration of how the device could be used to treat other health issues.
Qnovia is pitching RespiRx as a better way to quit smoking, saying it’s designed to deliver nicotine more quickly than other methods such as patches and gum, and help users manage withdrawals and be more successful in quitting smoking.
Quigley said RespiRx represents an innovative way for smokers to succeed in the challenging task of kicking the habit, and would be offered as a prescription.
“More than half of all smokers try to quit every year, but less than one in 10 are able to quit successfully,” he said. “The primary reason for that is the medicines that are available are 20-plus years old. There really hasn’t been innovation in this space and there’s a huge need.”
Qnovia has contracted with several third-party firms to develop RespiRx, including a device manufacturer in Singapore and a Pennsylvania-based drug manufacturer.
BlueLedge Capital, Evolution VC Partners, Vice Ventures and Ginagels led the latest financing round. Qnoiva has raised $50 million to date. In late 2022, the company secured a $17 million investment.
Qnovia was founded in 2018 in Los Angeles by company Chief Technology Officer Mario Danek. The company later relocated its headquarters to Richmond. Quigley became CEO in 2022, a couple years after he joined Qnovia following a 16-year tenure at tobacco giant Altria.
Qnovia has five employees spread across several states, and plans to add more employees using a portion of the recent raise. The company is based in the Scott’s Addition location of coworking brand Gather.
I quit smoking cigarettes cold turkey about 35 years ago but I know people who have “quit” many times in their lives. It is harder than people think to quit nicotine addiction. I hope this is a good solution and that it helps many people to stop their smoking. Good luck to you!