Dr. DeLeon Study

• Number of patients = 200, Number of wounds = 285
• Mean previous duration without healing = 48.1 weeks
• All etiologies: In 2.2 weeks with 2.8 Aurix  applications
  • 90.5% of the wounds had 63.6% volume reduction
  • 86.3% of the wounds had 47.5% area reduction
  • In 1.8 weeks with 2.5 Aurix applications:
    • 89.4% of the wounds had 71.9% undermining reduction
    • 85.7% of the wounds had 49.3% sinus tract/tunneling reduction
• Pressure ulcers (n=142 wounds) : In 2 weeks with 2.6 Aurix applications
  • 90.8% of the wounds had 61.0% volume reduction
  • 88.0% of the wounds had 46.8% area reduction
  • 90.9% of the wounds had 66.5% undermining reduction
  • 94.1% of the wounds had 39.0% sinus tract/tunneling reduction
• Venous ulcers (n=32 wounds) : In 2.1 weeks with 2.4 Aurix applications
  • 93.8% of the wounds had 56.6% volume reduction.
  • 87.5% of the wounds had 40.2% area reduction
  • 100% of the wounds had 100% undermining reduction
  • No wounds with sinus tracts/tunneling
• Diabetic ulcers (n=41 wounds): In 3.4 weeks with 4.0 Aurix applications
  • 87.9% of the wounds had 74.0% volume reduction
  • 90.2% of the wounds had 60.2% area reduction
  • In 1.8 weeks with 2.5 Aurix applications:
    • 100% of the wounds had 77.8% undermining reduction
  • In 2.5 weeks with 2.3 Aurix applications:
    • 100% of the wounds had 80.0% sinus tract/tunneling reduction

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Dr. Driver Study

• In the most common sized diabetic foot ulcers, 81.3% healed versus 42.1% control (p<0.036)
• This RCT included a clinically relevant cohort; the most common sized diabetic foot ulcers, area ≥.5 – ≤7 cm2. The mean area of 95.6% of wounds in 9 published prospective, randomized, controlled trials of advanced therapies used to treat diabetic ulcers were within this size range.
• The mean time to healing was 6 weeks
• The Kaplan-Meier time-to-healing was statistically significant in favor of the Aurix (AutoloGel) treated group (log-rank, P = 0.0177)
• The use of bovine thrombin during multiple treatment interventions did not cause any coagulopathies.
• There were no adverse events attributable to Aurix (AutoloGel)

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Dr. Gude study –Double Blinded, Randomized CED study for CMS

• “All comers study” – Smokers, Heart disease, Etc. Not the healthiest patient population that you would normally use for a study… but representative of a normal clinic. Aurix performed very well with all comers.
• Against UCC (usual and customary care) including advanced treatments (Oxygen therapies, Skin substitutes, Negative Pressure). Normally these wouldn’t be included, but Aurix still outperformed them
• All wounds sizes. Very severe wounds, Wagner grade III and IV included. Normally wounds this size aren’t included in studies. Aurix was still able to heal them at a higher rate.

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Dr. Sakata study – Aurix works well on long term tough wounds (wouldn’t heal with other treatments) and multiple comorbidities.

• Wounds in these patients were very severe, Wagner Grade 3 & 4
• 60% of the wounds were on limbs with critical limb ischemia
• Wounds increased in size during a long run-in period (75.3 days) despite quality standard of care including revascularization and debridement.
• Once treated with PRP Gel, the majority healed (83%) in a mean of 145 days (median 105).
• The use of PRP Gel reversed the non-healing trend to a positive trajectory with ultimate healing.

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Studies Recap

• Overall, in wounds that had been present for 48.1 weeks, 97% of them responded positively with a fast-healing trajectory which corroborates with the Carter run-in study.
• The mean area reduction per day varied by wound size with the largest wounds having the largest reduction (1.59 cm2/day); medium wounds (0.189cm2/day); and small wounds (0.068 cm2/day).  The differences between small and medium and small and large wounds were significant (p = 1.0 x 10-14, and p = 1.0 x 10-250, respectfully)
• Deeper wounds had the same positive healing trajectory as shallow wounds.
• These succeeding 210 wounds had the same positive healing trajectory as the initial 65 wounds in the registry (Frykberg, 2010) indicating consistency in outcomes.
• Patients with low lab values (n = 32) had the same positive healing trajectory as those patients with higher lab values (n = 33).
• Medicare beneficiaries (n = 111 wounds) had the same positive healing trajectory as non-Medicare beneficiaries (n = 135 wounds).