STEP OUT OF INFECTION

• DESIGNED TO

Clean and deslough infected wounds

& initiate the healing process using biological means

• MARKET SEGMENT

Healthcare professionals avoiding use of silver based products

• CLASSIFICATION

Medical device class III

KEY PROPERTIES

• Venous, diabetic and pressure ulcers

• Traumatic and surgical wounds

• Infected wounds or wounds at risk of infection

• Wounds with moderate- to- high levels of exudate

• Sorelex is not indicated for dry wounds

INDICATION

BIOCTHA® ACTIVE LAYER

ACTIVE LAYER

Specially processed combination

of OCTENIDINE AND HYALURONIC

ACID, having both antimicrobial

and biological effect

TRANSMISSION LAYER

Absorbs and leads the excessive

exudate out of the wound

into a secondary dressing

DESLOUGH LAYER

Attracts wound slough which is

removed during wound redressing

€

PRODUCT DESIGN

• Creates a gell in contact with the wound exudate

• Keeps the wound in the moist environment

• Gently sticks to the wound bed and thus perfectly copies

shape of the wound

ACTIVE LAYERFAVORABLE EFFECT ON THE WOUND BED

BIOLOGICAL EFFECT OF SODIUM HYALURONATE

• Substance natural to human body, component of ECM

• Regulates inflammation and sets up correct healing

processes

• Creates natural, moist environment favorable for migration

and proliferation of skin cells

ACTIVE LAYER

• Broad spectrum of antimicrobial efficacy against

Gram-positive and Gram-negative bacteria and fungi.

• Not absorbed into systemic circulation

• Low cytotoxicity to fibroblasts and other cells

ANTIMICROBIAL EFFECT OF OCTENIDINE

ACTIVE LAYER

Clinical trial

Open Labelled, Multicentre Study in Patients with Chronic, Infected

Wounds

Length of the study

6 weeks

Number of dressing changes

3x per week

Average wound duration 103 wks

Wounds enroled in the study

Diabetic ulcer 6

Leg ulcer 36

Mixed ethiology 5

TOTAL NO. 47

Clinical trial

OBJECTIVES OF THE STUDY

Wound dimension changes

Signs of infection

Changes in wound bed tissue

Changes in exudate level

Overall opinion of investigators on Sorelex

AVERAGE WOUND SURFACE

at screening

31,14 cm2

AVERAGE WOUND SURFACE

at final visit

15,19 cm282,1%

70,7% 64,6% 63,6%48,8%

0,0%

20,0%

40,0%

60,0%

80,0%

100,0%

120,0%

WK 1 WK2 WK 3 WK 4 WK 5 WK 6

Clinical trial resultsWOUND DIMENSION CHANGES

Clinical trial - RESULTS

38 % patients with visible signsof infection(bleeding tissue, malodour, pocketing, bridging, abscess, local heat, etc)

No wound deterioration due to theinfection in patients without visiblesigns of infection

100%

80%

60%

40% 40%

20%

0%wk 0 wk 1 wk 2 wk 3 wk 4 wk 5 wk 6

CHANGES IN VISIBLE SIGNS

OF INFECTION

Clinical trial resultsCHANGES IN WOUND BED TISSUE

0,0%

20,0%

40,0%

60,0%

80,0%

100,0%

WK1 WK 2 WK3 WK4 WK5 WK6

Decrease in sloughy

and necrotic tissue

Clinical trial resultsCHANGES IN WOUND BED TISSUE

7,0%

18,1% 17,1%

22,2%

25,3%

33,3%

0,0%

5,0%

10,0%

15,0%

20,0%

25,0%

30,0%

35,0%

WK1 WK 2 WK3 WK4 WK5 WK6

Increase in

epithelial tissue

8 %

49 %

43 %

0,0%

screening

none low moderate high

47 %

47 %

6 % 0,0%

week 6

none low moderate high

Clinical trial resultsCHANGES IN EXUDATE LEVELS

Clinical trial - RESULTSOVERALL RESPONSE TO SORELEX IN COMPARISON WITH PREVIOUS TREATMENT

RESPONSE TO PREVIOUS TREATMENT

RESPONSE TO SORELEX

SIGNIFICANT

IMPROVEMENT

IMPROVEMENT NO CHANGE WORSENING

WORSENING 6 3 2 1 0

NO CHANGE 17 8 6 3 0

IMPROVEMENT 24 17 7 0

Previous treatment: Acticoat, Actisorb Plus, Cutimed Sorbact, Dermacyn, Mepilex Ag,

Aquacel Ag, Nugel, Inadine, Tender Wet, Mepitel, silver alginates, PHMB, PVP.

Clinical trial - RESULTS

SUBJECTIVE EVALUATION OF SORELEX MADE BY INVESTIGATORS

WOUND HEALING EFFECT (1- no wound healing, 8 - extreemly good)

SPEED OF THE HEALING (1- extreemly slow, 8 - extreemly fast)

BENEFICIAL EFFECT IN GENERAL

(1-extreemly low, 8 – extreemly high)

6,1

6,0

6,3

STEP OUT OF INFECTION

• Broad spectrum of antimicrobial activity

• Biactive support of the healing process

• Safe and friendly for skin cells