Multiple Engineering Breakthroughs Move LuminusMicro towards Rapid FDA Clearance and Market Expansion

Q3 2022

Our engineering team’s continuous innovations have led to significant breakthroughs and extensive new patent opportunities. These breakthroughs are not just incremental improvements; they represent a quantum leap forward in our device designs.

Remarkable reductions in the number of components and layers used in each device enable physically smaller and less expensive devices that can substantially increase profit margins. Moreover, these advancements unlock new opportunities in medical procedures by enabling our devices to reach previously inaccessible anatomical areas.

Furthermore, these enhancements will fortify the physical and mechanical strength of our devices. This translates into products that are more robust, particularly beneficial for surgeons during challenging or prolonged medical procedures.

To validate these advancements, a fleet of Luminus devices will be manufactured to engage in medical procedure labs, where top surgeons will finalize our user friendly training protocols.
Our commitment to innovation extends beyond the laboratory: As in our past medical labs, we will prove these breakthroughs and disseminate our findings in key industry journals. Examples include achieving complete diagnostics within joints and sinuses, coupled with the ability to consistently target medication and regenerative injections.

As we progress with medical validations, we are diligently working with our manufacturer and regulatory firms to prepare and file for FDA clearance. All LuminusMicro departments and vendors have been instructed to adhere strictly to FDA submission protocols. Our regulatory management firms are primed to coordinate and execute this process, leveraging their expertise in securing rapid clearances for market-leading products in the surgical fields we are targeting. Reports indicate that each of their “predicate” devices, substantially equivalent to Luminus by FDA standards, received their respective 510K clearances in under 35 days. These reports serve as a definitive roadmap to achieving swift clearance for LuminusMicro devices.