Development Plan

The Company has developed a 36-month roadmap with clearly defined milestones that ultimately lead to CE Mark and commercialization in Europe.  Because of the expense, complexity and ongoing product development, this roadmap does not include every detail (timing, cost and duration) to complete FDA trials; however, the Company will be prepared to also undertake FDA trials. Additional details can be found below.

LENTICULAR RESEARCH GROUP, LLC

CLINICAL STUDY ACTION PLAN:  ANIMAL & HUMAN

Cadaver Lens StudyCompleted in 2014

  1. Reconfigure MPM – Design Process
  • Goal – Redesign MPM imaging unit for Live Animal and Human use
  • Build prototype, Develop calibration technique and performance specifications, Test and refine system.
  • Contract with GLP lab for Live Animal Study (Rabbit)
  1. Live Animal StudyTargeted Completion: End of “Year 1”
  • Goal – Spots can be accurately and consistently delivered within 2-5 microns below the lens capsule
  • Imaging system is robust and allows for the visualization of the anterior lens epithelium

Target Achievements: Proof of Concept ‘Target & Alter Growth of Germinative Cells in Live Rabbits’

  • The targeted lens epithelial cells are no longer viable
  • Boundary condition testing to evaluate collateral effects are satisfactory
  • Target 40 Rabbit eye treatments – Estimate 3 Month Lab time
  • Capture pre, intra & post op images 
  • Develop live lens treatment algorithm & file additional patents accordingly
  • System operation – unit is functional and calibrates within specification

III. Early Human TrialsTargeted Completion: End of “Year 1”

  • Goal – Demonstrate ability to maintain accommodative capability
  • Pre-Clinical:
  • Contract with clinic in Dominican Republic, Venezuela or Costa Rica for pre-clinical work