Startup Seeks Approval for Inhaler That Would Help Smokers Quit
https://www.bloomberg.com/news/arti...oval-for-inhaler-that-would-help-smokers-quit
16 June 2020
RespiRx Source: Respira Technologies
"... Respira Technologies Inc. plans to submit an inhaler device to the Food and Drug Administration by late 2021 for authorization as nicotine replacement therapy. The nebulizer, which converts nicotine to an aerosol, aims to disrupt an estimated $618 billion market dominated by decades-old gums and patches from pharma companies as well as tobacco companies’ more recent, controversial cigarette alternatives...
The device, called RespiRx, resembles an e-cigarette but works more like some asthma inhalers. It features blue-tooth wireless connectivity and its own app. Triggered by breathing, the RespiRx also emulates the hand-to-mouth experience of a cigarette -- which may prove to be a notable advantage over gums or patches.
The device will seek to wean users off nicotine by providing the ability to meter and gradually reduce nicotine intake via the mobile phone app. Respira aims to sell its product over the counter and its nicotine will be absorbed faster than gums or patches, Danek said.
Unlike e-cigarettes or vape devices, RespiRx doesn’t heat nicotine, meaning it won’t create byproducts that cause secondary concerns about toxicity, Danek said. Some cigarette alternatives, like those from Juul Labs, use a liquid and vapor, whereas others, like Philip Morris International’s IQOS, heat dry tobacco without burning it...
Respira is backed by venture capital firms Evolution Venture Partners, Poseidon Asset Management and DG Ventures and currently has fewer than 10 full-time employees. The company is pursuing FDA approval on its own, but is also in talks for a deal with two multinational companies. One is in the due-diligence phase and the other is in earlier stages, Danek said. The FDA timeline could be accelerated if either deal goes through, he said.
The company hopes to use RespiRx as a platform that goes beyond nicotine, however. Respira is also in talks with other companies about using the device for other drugs, or even vaccines, Danek said."
https://www.bloomberg.com/news/arti...oval-for-inhaler-that-would-help-smokers-quit
16 June 2020
RespiRx Source: Respira Technologies
"... Respira Technologies Inc. plans to submit an inhaler device to the Food and Drug Administration by late 2021 for authorization as nicotine replacement therapy. The nebulizer, which converts nicotine to an aerosol, aims to disrupt an estimated $618 billion market dominated by decades-old gums and patches from pharma companies as well as tobacco companies’ more recent, controversial cigarette alternatives...
The device, called RespiRx, resembles an e-cigarette but works more like some asthma inhalers. It features blue-tooth wireless connectivity and its own app. Triggered by breathing, the RespiRx also emulates the hand-to-mouth experience of a cigarette -- which may prove to be a notable advantage over gums or patches.
The device will seek to wean users off nicotine by providing the ability to meter and gradually reduce nicotine intake via the mobile phone app. Respira aims to sell its product over the counter and its nicotine will be absorbed faster than gums or patches, Danek said.
Unlike e-cigarettes or vape devices, RespiRx doesn’t heat nicotine, meaning it won’t create byproducts that cause secondary concerns about toxicity, Danek said. Some cigarette alternatives, like those from Juul Labs, use a liquid and vapor, whereas others, like Philip Morris International’s IQOS, heat dry tobacco without burning it...
Respira is backed by venture capital firms Evolution Venture Partners, Poseidon Asset Management and DG Ventures and currently has fewer than 10 full-time employees. The company is pursuing FDA approval on its own, but is also in talks for a deal with two multinational companies. One is in the due-diligence phase and the other is in earlier stages, Danek said. The FDA timeline could be accelerated if either deal goes through, he said.
The company hopes to use RespiRx as a platform that goes beyond nicotine, however. Respira is also in talks with other companies about using the device for other drugs, or even vaccines, Danek said."
