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Every
wound
is personal
An evidence-based
therapy for hard-to-heal
diabetic foot ulcers
The 3C Patch® Story
2
2008
Reapplix develops 3C Patch®, a novel
wound therapy for hard-to-heal diabetic foot
ulcers
3
2009
First use of the 3C Patch® System
The 3C Patch® Story
The 3C Patch® Story
4
2011
CE-mark is obtained;
Pilot study results prove efficacy, safety and
potential clinical benefit
CE is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area
5
2013
Multicenter cohort study completed:
59% of the diabetic foot ulcers in the
study healed
The 3C Patch® Story
6
2017
FDA clearence is obtained for the 3C
Patch® System
The 3C Patch® Story
FDA clearance is a regulatory approval to market the product in the US market
7
2018
International randomized controlled trial:
The results indicate that 3C Patch® almost
doubles the chance of healing compared
to best standard of care
The 3C Patch® Story
8
2019
International Working Group on Diabetic
Foot recommends the use of 3C Patch® for
the treatment of hard-to-heal diabetic foot
ulcers
The 3C Patch® Story
9
2020
3C Patch® is used by clinics in Denmark,
Sweden, Norway, Belgium, Netherlands,
Germany, UK and the US
The 3C Patch® Story
10
3C Patch® Treatment Steps
1. Collection of blood
18 ml of the patient’s blood is
drawn by vacuum into the sterile
device without any additives
2. Centrifugation
3CP® Technology generates a
3C Patch® in a table top
centrifuge within approx. 20
minutes.
3. Application
The device is opened and the 3C
Patch® is applied directly to the surface
of the patient’s wound
11
3C Patch® Structural Overview
In vitro studies show that 3C Patch® has a
high concentration of active cells,
responsible for orchestrating the healing
response
12
89% more likely to heal when accounted for
the wound size distribution between 3C
Patch® and control group
(linear regression model defined in the study protocol CI 1.09-
3.31, p=0.0237, odds-ratio 1.89)
RCT Primary Outcome
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
13
Time to healing shorter in 3C Patch® group
(72 days) compared to standard of care
group (84 days)
(p=0.0246)
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
14
Greater reduction in ulcer area in the 3C
Patch® group (p=0.0168)
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
15
No adverse events associated
with the application of 3C Patch®
RCT Secondary Outcomes
1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management
of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology.
Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
16
https://3cpatch.com/
3C Patch® is a clinically
proven wound therapy
that resets the body’s
capacity to heal.

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3C Patch therapy for hard-to-heal diabetic foot ulcers

  • 1. Every wound is personal An evidence-based therapy for hard-to-heal diabetic foot ulcers
  • 2. The 3C Patch® Story 2 2008 Reapplix develops 3C Patch®, a novel wound therapy for hard-to-heal diabetic foot ulcers
  • 3. 3 2009 First use of the 3C Patch® System The 3C Patch® Story
  • 4. The 3C Patch® Story 4 2011 CE-mark is obtained; Pilot study results prove efficacy, safety and potential clinical benefit CE is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area
  • 5. 5 2013 Multicenter cohort study completed: 59% of the diabetic foot ulcers in the study healed The 3C Patch® Story
  • 6. 6 2017 FDA clearence is obtained for the 3C Patch® System The 3C Patch® Story FDA clearance is a regulatory approval to market the product in the US market
  • 7. 7 2018 International randomized controlled trial: The results indicate that 3C Patch® almost doubles the chance of healing compared to best standard of care The 3C Patch® Story
  • 8. 8 2019 International Working Group on Diabetic Foot recommends the use of 3C Patch® for the treatment of hard-to-heal diabetic foot ulcers The 3C Patch® Story
  • 9. 9 2020 3C Patch® is used by clinics in Denmark, Sweden, Norway, Belgium, Netherlands, Germany, UK and the US The 3C Patch® Story
  • 10. 10 3C Patch® Treatment Steps 1. Collection of blood 18 ml of the patient’s blood is drawn by vacuum into the sterile device without any additives 2. Centrifugation 3CP® Technology generates a 3C Patch® in a table top centrifuge within approx. 20 minutes. 3. Application The device is opened and the 3C Patch® is applied directly to the surface of the patient’s wound
  • 11. 11 3C Patch® Structural Overview In vitro studies show that 3C Patch® has a high concentration of active cells, responsible for orchestrating the healing response
  • 12. 12 89% more likely to heal when accounted for the wound size distribution between 3C Patch® and control group (linear regression model defined in the study protocol CI 1.09- 3.31, p=0.0237, odds-ratio 1.89) RCT Primary Outcome 1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
  • 13. 13 Time to healing shorter in 3C Patch® group (72 days) compared to standard of care group (84 days) (p=0.0246) RCT Secondary Outcomes 1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
  • 14. 14 Greater reduction in ulcer area in the 3C Patch® group (p=0.0168) RCT Secondary Outcomes 1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
  • 15. 15 No adverse events associated with the application of 3C Patch® RCT Secondary Outcomes 1. Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. www.thelancet.com/diabetes-endocrinology. Published online September 19, 2018 http://dx.doi.org/10.1016/S2213-8587(18)300240
  • 16. 16 https://3cpatch.com/ 3C Patch® is a clinically proven wound therapy that resets the body’s capacity to heal.