PROVEN SCIENCE – CLINICAL TRIALS

SAFETY:

On October 18, 2017, Creative Medical Technology Holdings announced the completion of the safety data analysis on 20 patients with pharmacologically-resistant erectile dysfunction treated with the Company’s patented CaverStem™ procedure. Based on the data collected on the trial and there having been no adverse side effects, the procedure has been determined to be safe based on the trial data and the determination from the independent safety monitor. In addition, a similar trial conducted in Europe experienced no adverse or significantly adverse events resulting from the procedure.

EFFICACY:

In published results from a European trial performing the same procedure on 20 patients concluded, “after 6 months, significant improvements versus baseline were noted”. In addition, “At month 6, all patients described on-medication erections sufficient for penetration”.

Proven Science – Animal Research

  • Intense academic interest – Because the technology works
  • 20 Published papers in 2012-2013. 500% Increase over the prior 8 years (Lin C-S et al. Advances in Andrology 2014)
  • All 35 studies reported improved erectile function
  • Many reported improved muscle, endothelium and nerve tissue

Proof of Principle
(Song YS et al. International Journal of Impotence Research 2007;19:378)

  •  Stem cells in an animal model of ED
  •  Proves stem cells translate into smooth muscle tissue

Time-Phase Penis Cell Extractions
Time-Phase Penis Cell Extractions
Green – Transplanted stem cells in penis
Red – Stem cells expressing markers of smooth muscle cells
Yellow – Stem cells taking the morphology of smooth muscle cells in the penis

First-In-Human Proof of Concept

  • Case study published in peer-reviewed journal (Ichim TE et al. Journal of Translational Medicine 2013 Jun 9:11:139)
  • 35 year-old patient with ED
  • Non-responsive to PDE5 inhibitors and injections ineffective
  • Patient received Caverstem procedure
  • 3 Months Later:
    • Marked increase in duration and frequency of erections
    • Ability to sustain erections until orgasm
    • No treatment-associated adverse events