28 Aug FDA Update & Future Plans
Earlier this year, 4Dx delivered a 510(k) submission to the FDA for clearance of its 4DxV technology in the radiotherapy setting. Following that submission, the FDA responded with a Request for Additional Information. To clarify the FDA’s request, 4Dx sought and gained a meeting with the FDA. While the FDA identified a potential pathway for success regarding the application, it is clear that significant time and resources would be required.
Through the meeting with the FDA, and further discussions with our regulatory consultants, 4Dx has chosen to take a more streamlined approach in taking its technology to market. This will involve progressing directly with an application for products in the Company’s core target market – the respiratory diagnostics space. To fully focus on this plan, 4Dx has decided to withdraw the current application.
4Dx will focus efforts on this plan to gain clearance for its core product by capitalising on the open dialogue we have with the FDA about the core product’s development. The Company expects to be in a position to present a plan to the FDA in late 2017 and will report back to shareholders in early 2018 with an update.
In forming this strategy, 4Dx sought to increase its access to regulatory expertise beyond our regulatory consultant and FDA agent, Emergo. 4Dx is pleased to announce that Brian Bollwage, a regulatory strategy veteran with nearly 40 years of experience working with the FDA, is now assisting 4Dx in this important area.
In parallel with its regulatory efforts, 4Dx continues to make strong progress in building revenue opportunities, particulalry in business to business market sectors where regulatory clearance is not required.