- Izotropic (IZO) pivots to adjust to supply chain disruptions and updates IzoView engineering timelines
- Engineering teams are revising aspects of IzoView and building redundancy into critical components to fix disruptions to the supply chain
- Some delays included changing custom components towards modular subsystem parts that now allow for increased device flexibility and more
- Updates on execution points will be regularly disclosed to shareholders in the future
- The company expects to finalize and announce a comprehensive agreement in early July
- Izotropic (IZO) is down 4.41 per cent, trading at C$0.32 at 12:33 pm EST
Izotropic Corporation (IZO) has cemented timeline updates for the initial IzoView commercial prototype build.
There have been issues around the supply chain and unforeseen impacts on engineering, resulting in an estimated delay.
Engineering teams are revising aspects of IzoView and building redundancy into critical components to fix disruptions to the supply chain.
Izotropic’s engineering teams have redesigned internal aspects to make IzoView a more flexible machine.
The hope is this will reduce engineering risks to maintain performance and mitigate further delays and dependence on specific components or suppliers.
Izotropic has experienced delays in transitioning from its previous third-party engineering firm, StarFish Medical, to its in-house engineering and development team, now based in Sacramento, CA.
Some delays included changing custom components towards more modular subsystem parts that now allow for increased device flexibility, modular testing, and future expandability of the IzoView platform.
Supply chain issues, amongst other things, have set back previously projected timelines by two to three quarters.
Updates on execution points will be regularly disclosed to shareholders in the future.
To rectify the current issues in front of Izotropic, it has taken advantage of panel discussions with EXCITE International to modify its clinical study design to expand the comparator group.
The company hopes this will allow for improved participant recruitment by expanding the number of eligible patients for the study, which is expected to decrease the overall length of the clinical study time.
It is also aimed at increasing market adoption of the device following market authorization and assisting in delays associated with IzoView’s overall commercialization plan.
Izotropic continues its ongoing dialogue with the US FDA to obtain feedback on proposed modifications to the trial design and provide additional details on study plans before an Investigational Device Exemption submission is required to initiate the clinical study.
The company expects to finalize and announce a comprehensive agreement in early July.
Izotropic Corporation is the only publicly-traded company commercializing a dedicated breast CT imaging platform, IzoView, for the more accurate detection and diagnosis of breast cancers.
Izotropic (IZO) is down 4.41 per cent, trading at C$0.32 at 12:33 pm EST.