Rehovot, Israel-based Advanced Inhalation Therapies (AIT) has thrown its hat in the ring to raise up to $36.2 million in an IPO on the Nasdaq Exchange. That's despite the recent rocky market and a dearth of med tech IPOs of late.
The clinical-stage company expects to use the offering to raise cash mostly to support Phase II testing of its novel nitric oxide treatment, which involves a novel device that offers high-concentration nitric oxide treatment to eliminate microbial infections.
First up is Phase IIb testing to treat cystic fibrosis and bronchiolitis; the company expects to submit INDs to FDA for trials in each of these indications during the first half of 2016 with U.S. Phase IIb trials expected to start shortly thereafter.
The IPO financing would also back a Phase II study in pneumonia, as well as another to treat asthma. Finally, the company also expects to develop a hospital-grade version of the bronchiolitis treatment system.
In its SEC filing, the company notes that the FDA has never approved a nitric oxide (NO) formulation and delivery system to deliver a high antimicrobial dosage of the gas to the lungs.
AIT has spent almost nothing to date. Founded in 2011, as of Dec. 31 it had only spent a total of $6.4 million.
Summed up the company the company in the filing on its rationale, "NO possesses broad-spectrum anti-microbial activity acting against bacteria, fungi and viruses. NO is produced at high output as part of the innate immune response.
Nitric oxide has shown anti-viral activity, as well as usefulness in preventing bacterial growth on surfaces, AIT noted. Its approach uses intermittent exposure to high-dose nitric oxide in cycles to kill microbes in the lungs that are associated with its various addressable indications.
- here is the SEC filing