RE: Polarean revenue stream30 Oct 2019 19:34
Current revenue is from selling polarisers to medical institutes for research purposes., they cost about $506k/unit. the company has sold about 25 of them to date.
After FDA approval majority of the revenue will come from fees per scan. Broker estimates US$41m in revenue and US$16m in Free Cash Flow with only 78 Clinical polarisers are installed.
The company has about 30 patents associated with this technology, these include Polarimetry patents, Automation patents, Pulmonary gas transfer patents.
My research shows currently no commercially viable competitors in the field of hyperpolarised gas MRI. Competitors will struggle to develop a competitive technology without infringing on Polarean IP, or commiting considerable investment into R&D. Furthermore upon FDA approval Polarean should receive five- years market excluvisity under the 1984 Hatch-Waxman Act.
GE invested US$40m into this technology but in 2012 decided to out licence the program due to an unclear pathway for regulatory approval of drug devices and internal reprioritisation of projects. Since then the US government passed the FDA Safety and Innovation Act and the Medical Gas Acts, which helped clarify the regulatory pathway for the clinical use of polarised gas imaging.