Our Forecast and Market Timetable

The Company has met with the FDA to discuss tests required prior to clinical trials and proposed protocols for the Phase I Clinical Trial. The FDA classified our system of injecting gold nanoparticles and applying widely available topical lasers as a medical device, not a drug, thus reducing regulatory risk. They also suggested that final assessment of results be made just 30 days after liposuction, thus reducing the time necessary to complete clinical trials. We hope to complete our Phase I Clinical Trial in the first half of 2021. As a device we face only two clinical trials; we hope to conduct the Phase II trial in late 2021.

 

Our Progress to Market:

  • We have completed ex-vivo trials on human tissue

  • We have completed liposuction trials on pigs

  • We have completed toxicity and bio-compatibility trials on animals

  • We are preparing for Phase 1 clinical trials on humans

  • The laser is already FDA approved

  • The chemicals in the solution (other than the gold nanoparticles) are already FDA approved

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Learn more about eLux Medical

At eLux, we believe there exists a strong latent demand for improved outcomes for both surgical liposuction patients and minimally invasive fat removal patients. And we believe our superior technology will improve outcomes and propel demand for both.