Medical startup Qnovia Inc. is primed for growth with a product that helps reduce the urge to smoke.
Qnovia in February revealed positive results from its first in-human FDA trial of RespiRx, the firm’s handheld inhalable nicotine replacement therapy (NRT) to help people quit smoking. The progress is expected to significantly increase its valuation in 2026, according to founder and CEO Mario Danek.
“We’ve now clinically demonstrated the thesis,” Danek told the Business Journal.
The RespiRx, a bit longer than an AirPods case, is a combined medical device and drug product. The handheld device consists of a nebule that houses pharmaceutical-grade nicotine, which connects to the cartridge attached to the mouthpiece that the patient uses to inhale.
The nicotine is converted into a fine mist without using any heat, which helps eliminate other harmful chemicals. The dose is then adjusted down over 12 weeks to help the patient quit.
The Phase 1 clinical trial was conducted in 2025 on 25 healthy adults to evaluate and compare peak nicotine levels (Cmax), nicotine exposure over time (Tmax), the rate at which nicotine reached the bloodstream (AUC), and participants’ urge to smoke.
RespiRx was designed to increase the Tmax, or the speed at which the brain will start sensing it has nicotine in its system, compared to other cessation products like nicotine gum or patches that “haven’t had the ability to produce sustained, long-term quit rates,” according to Danek.
The trial found that the product delivered a cigarette-like nicotine uptake, which is vital to effective craving control, by reaching peak blood levels in seven minutes with just 10 puffs—which outperformed authorized legacy nicotine replacement therapies, according to Qnovia.
Participants also reported a meaningful reduction in urge-to-smoke scores.
It shows that the NRT device “matches the speed and habit-loop of smoking and vaping without the carcinogens,” Danek said.
Following the trial, Qnovia is pursuing U.S. FDA and the U.K.’s Medicines and Healthcare
products Regulatory Agency (MHRA) approval for RespiRx. The startup is preparing to submit in the U.K. this summer while working on a new drug approval (NDA) in the U.S. to get the product to market.
“Inhalation is one of the hardest safety burden hurdles to clear,” Danek said.
Danek said that lately, there have been no significant innovations in the NRT space and that Qnovia could become a leader in public health with the handheld product.
“It takes innovation, but innovation hasn’t been incentivized,” Danek said. “If Qnovia pulls this off at scale, we’re talking about potentially having one of the largest footprints in public health since the advent of penicillin, potentially.”
Qnovia has raised $50 million in funding so far following its Series B funding round in 2024, backed by investors such as Blue Ledge Capital, Vice Ventures, Gaingels, Evolution VC
Partners and Compass Rose Asset Management.
The Irvine-based startup is currently valued at about $300 million, but Danek said that’s about to change with another funding round coming soon.
A Founder’s Return
Qnovia moved to Orange County from Virginia in early 2025.
Danek, who founded the startup in 2018, returned to his post as CEO last April.
Danek said he looks forward to expanding Qnovia’s footprint in OC as it scales to market with more office and manufacturing space. It currently counts six employees in Irvine and 40 contractors worldwide.
To accompany the RespiRx, Qnovia is also developing a behavioral health platform to track patient progress using the NRT device.
