wound management - vergenix™fgvergenixfg.com/wp-content/uploads/2019/12/vergenix_fg... · 2019....

A Novel Flowable Gel

for Wound

A recombinant human collagen-based matrix for optimal wound healing

Management

CollPlant, Ltd. | 3 Sapir St. 74140 Ness-Ziona, Israel | Tel: +972 (0) 73 2325600

www.collplant.com

Made of Plant Derived Recombinant Human Collagen

The Ideal Regenerative Building Block

for Wound Management Regenerative Medicine – a new course in wound healing


for Wound


Management


www.collplant.com

- Recombinant human collagen for optimal wound management Vergenix™ Flowable Gel (FG) is an innovative bio-degradable wound care device that provides a scaffold for cellular proliferation and capillary growth. It is comprised of a recombinant type I human collagen derived from bioengineered tobacco plants and demonstrates a profile resembling that of the native human collagen.

This charts a new course in the treatment of acute and chronic wounds.

Vergenix™FG is made of type I recombinant human collagen (rhCollagen) and hydroxypropyl methyl cellulose (HPMC). Vergenix™FG is supplied as a lyophilized material contained in a syringe that, when hydrated with saline, forms a gel.

Vergenix™FG is indicated for the management of acute and chronic wounds, including:

- Full thickness and partial thickness wounds- Pressure ulcers- Venous ulcers- Ulcers caused by mixed vascular etiologies- Diabetic ulcers- Second degree burns- Donor sites and other surface bleeding wounds- Abrasions- Trauma wounds healing by secondary intention- Surgical wounds- Deep and tunneled-undermined wounds


for Wound


Management


www.collplant.com

Vergenix™FG, made of type I rhCollagen and hydroxypropyl methyl cellulose (HPMC), drives the formation of granulation tissue, one of the most important steps leading to an effective wound closure.

0.1 0.3 1 3 10 30 100Days

Innflammation

GranulationTissue

WoundContraction

Remoldeling

• The main property anticipated from a collagen- based scaffold is its ability to attract and trap cells and growth factors to the wound site in order to build and regenerate the missing tissue.

• The collagen scaffold, through integrin and fibronectin binding sites, attracts fibroblasts and immune cells to the wound site to form a new granulation tissue. The granulation tissue contracts and reduces the wound size as well as enables keratinocytes to migrate and re- epithelialize, leading to final wound closure.

• When selecting an advanced wound care product it is of high importance that the matrix material has the ability to provide the optimal structural support to the abovementioned wound healing process.

Owing to its perfect structure, its undamaged binding sites and non-immunogenic properties, therhCollagen in Vergenix™FG can provide the optimal scaffold to promote wound healing as demonstrated in both preclinical and clinical studies. >>

Preclinical evidenceVergenix™FG significantly accelerates wound closure1

In preclinical studies, Vergenix™FG has shown remarkable ability to regenerate skin tissue in several wound healing models. Specifically, Vergenix™FG has demonstrated its ability to jumpstart the wound healing process.

Vergenix™FG promotes the creation of new blood vessels at the wound site1

Angiogenesis is an important process that has to take place during wound healing. Higher blood vessel score at day 7 and fewer blood vessels at day 21 demonstrate an effective and accelerated healing process. Fully maturated tissue should later present fewer blood vessels.

A

Wou

nd c

losu

re (%

day

0)

B

Bloo

d ve

ssel

mic

rosc

opic

ally

sco

re Bovine collagenVergenix™FG

4.54

3.53

2.52

1.51

0.50

7 Days 21 Days

*p < 0.05

Control Tissue extractedhuman collagen

Tissue extractedbovine collagen

Vergenix™FG

50%

40%

30%

20%

10%

0%

-10%

Day 1 Day 3 *p < 0.05

Vergenix™FG significantly accelerates wound closure compared to the bovine commercial control1

Wou

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losu

re (%

day

0)

100

80

60

40

20

0

-200 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Days

Vergenix™FGBovine collagen

Bovine collagen

Vergenix™FG

Day 0 Day 21

Vergenix™FG

Bovine collagen

*p < 0.05

*

Clinical evidence - Single arm open label clinical study2

Patients: 20 hard-to-heal wounds Vergenix™FG application: single Follow up: 4 weeksMean age: 63.6 years [36.1–85.3]

Type of wound:

79% mean wound size reduction within 4 weeks after a single Vergenix™FG application

By week 4:Complete wound closure: 45% of patientsGood granulation tissue: 90% of patients Reduction in pain level: 50% of patients No inflammatory response, edema or erythema No serious adverse events

45%Neuropatic Ulcer

Post Trauma Wound

Venous Ulcer

Post Operative Wound

10%

10%

35%

Week 1 Week 2 Week 3 Week 4

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

30%

62%67%

79%

Mea

n W

ound

Clo

sure

Rat

e (%

) ove

r tim

e (N

=20)

Post Marketing Surveillance3

Patients: 75 hard-to-heal woundsVergenix™FG application: single Follow up: 16 weeksMean age: 65.7 years [17.7-92.2]

Type of wound:

Post-Operative Wounds

Neurophathic Ulcer

Venous Limb Ulcer

Not Reported

Post-Trauma Wounds

Pressure Ulcer39%

8%

11% 25%

12%

5%


48%

58%

69% 72%

Patie

nts w

ith >

90%

Wou

nd V

olum

e Re

duct

ion

(%)

(N=7

5)


90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

76%

84% 85% 88%

p <.0001

Mea

n W

ound

Clo

sure

Rat

e (%

) (N

=75)

88% mean wound size reduction within 16 weeks after a single Vergenix™FG application

By week 16, wound closure observed in 72% of patients

By week 12:Vergenix™FG:- wound closure in 69% of patientsStandard of care:-wound closure in 24% of patients4 * >90% closure

Case studiessingle Vergenix™FG application

0 12Wou

nd v

oulu

me

cm3

(Week)

2,31

0

0 12Wou

nd v

oulu

me

cm3

(Week)

2,5

0

0 12Wou

nd v

oulu

me

cm3

(Week)

7

0

Case Study #10 Post Operative Wound

History: Male, 56. Diabetic, deep wound with bone exposed.

Before treatment 1 month

Results: Patient achieved complete wound closure within 4 weeks.


History: Male, 92. Diabetic. Neuropathic ulcer Grade IIIB.

Before treatment 3 weeks



History: Male, 79. Neuropathic ulcer Grade IIB.


Results: Wound fully healed within 1 month.

0 12Wou

nd v

oulu

me

cm3

(Week)

2,31

0

0 12Wou

nd v

oulu

me

cm3

(Week)

2,5

0

0 12Wou

nd v

oulu

me

cm3

(Week)

7

0


History: Male, 56. Diabetic, deep wound with bone exposed.




History: Male, 92. Diabetic. Neuropathic ulcer Grade IIIB.




History: Male, 79. Neuropathic ulcer Grade IIB.


Results: Wound fully healed within 1 month.

Post Operative Wound

Venous Leg Ulcer

Bef

ore

trea

tmen

t

Case studies reports

25

20

15

10

5

00 1 2 3 8 12

(cm3)

(Week)

Wound Volume Reduction

Case Study #1 Venous Leg Ulcer

History: Male, 82 years old with venous lower limb ulcer with associated peripheral artery disease stage IIB.


5

4

3

2

1

00 1 2 4

(cm3)

(Week)


Results: Wound was in complete resolution within 30 days.


History: Male, 67 years old. Diabetic patient. Post operative wound fol-lowing toe amputation.

Before treatment 3 months

Results: Wound fully healed within 3 months.

Case Study #2 Pressure Ulcer

History: Female, 86 years old with large pressure ulcer in sacral area with medium yellow exudation.


Results: Patient achieved complete wound closure within in 4 months post treatment.

80

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(cm3)

(Week)


Ηard-to-heal case studies


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1 m

onth

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Pressure Ulcer


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4 m

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eatm

ent

1086420

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Case Study #4 Diabetic Foot Ulcer

History: Male, 64 years old with neuropathic leg ulcer with history of ischemia, angioplasty and infection. Patient underwent weekly dialysis for the last 2 years. Patient did not react to any other wound treatment/materials.


Results: Wound fully healed within3 months.

Case Study #6 Post Trauma Wound

History: Male, 34 years old. Wound did not heal for 7 months with other wound treatment/materials.




History: Male, 64 years old with post trauma wound and associ-ated severe edema.


Results: Wound was in complete resolution within 6 weeks.

1086420

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00 1 2 4 6

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00 1 2 3

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Case Study #4 Diabetic Foot Ulcer

History: Male, 64 years old with neuropathic leg ulcer with history of ischemia, angioplasty and infection. Patient underwent weekly dialysis for the last 2 years. Patient did not react to any other wound treatment/materials.


Results: Wound fully healed within3 months.


History: Male, 34 years old. Wound did not heal for 7 months with other wound treatment/materials.




History: Male, 64 years old with post trauma wound and associ-ated severe edema.


Results: Wound was in complete resolution within 6 weeks.

Diabetic Foot Ulcer

3 m

onth

s1

mon

th

What makes Vergenix™FG different?

Flowable GelVergen FGxTM

HUMAN COLLAGEN

HOMOGENOUS

TISSUE REPAIR

FASTER HEALING

NON ALLERGIC


HUMAN COLLAGEN

HOMOGENOUS

TISSUE REPAIR

FASTER HEALING

NON ALLERGIC


HUMAN COLLAGEN

HOMOGENOUS

TISSUE REPAIR

FASTER HEALING

NON ALLERGIC


HUMAN COLLAGEN

HOMOGENOUS

TISSUE REPAIR

FASTER HEALING

NON ALLERGIC


HUMAN COLLAGEN

HOMOGENOUS

TISSUE REPAIR

FASTER HEALING

NON ALLERGIC

“ It is the most effective filler I used so far. It-is easy to use, and in my surgical practice helps me in addressing problems with loss of substance after debridement or bone and joint removal for Osteomyelitis. In 2 words: it works.”Prof. Alberto Piaggesi about Vergenix™FGDirector, Diabetic Foot Section, University of Pisa, Member of Board of Directorsof Diabetic Foot Study Group of European Association. Honorary Secretary – EWMA

Made from truly recombinant human collagen

Wounds heal faster

3-dimentional scaffold for deep/irregular shaped wounds

Promotes new tissue formation

A single application is sufficient

Non immunogenic

Proven in use

Pure and homogenous

Peel open the blister kit and inspect all packaging integrity. Do not use the kit if packaging is damaged. Visually inspect the empty syringe. Do not use if empty syringe contains cracks or visible particulate matter.

Surgically debride the wound bed using standard methods to ensure wound is free of debris and necrotic tissue.

Fill a 5 mL empty syringe with 1.6 mL of saline.

Connect the luer-lock connector supplied to the saline containing syringe and fill the luer-lock volume with the saline up to 5 mm from its edge.

1

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How to apply Vergenix™FG?

Connect the saline containing syringe to the syringe containing the Vergenix™FG through the luer-lock connector.

Hold the two connected syringes in your hands securely and rapidly inject the saline solution into the syringe containing the Vergenix™FG powder.

Tap the filled syringe 20 times on the palm of your hand, wait 5 minutes and then tap the syringe additional 20 times.

Disconnect the empty syringe and adjust the syringe plunger containing the gel to 2 mL.

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Fill the luer-lock with the gel solution and reconnect the empty syringe.

Mix 15 times back and forth to form a whitish gel.

Consider the flowable gel mixed when product appearance is consistent and homogeneous and all the product can be moved from one syringe to the other.

Gather the gel to one syringe and disassemble the empty syringe. Withdraw the remaining gel from the luer-lockto the filled syringe and disassemble the luer-lock.

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When dispensing the Vergenix™FG, first determine thelocation of the base of the wound bed utilizing the cannula and then fill the tissue voids. Upon dispensing product into the wound, avoid pressing the cannula tip directly against the base of the wound to ensure the product is not prevented from exiting the cannula.

After application, use an optimal secondary dressing to maintain the gel adherence and protect the wound area. The optimum dressing is determined by wound location, size, depth and user preference.

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for Wound


Management


www.collplant.com

www.collplant.com

LB27

Rev1

1. Shilo S, Roth S, Amzel T, Harel-Adar T, Tamir E, Grynspan F, Shoseyov O. Cutaneous wound healing after treatment with plant-derived human recombinant collagen flowable gel. Tissue Eng Part A. 2013 Jul;19(13-14):1519-26.

2. Itay Wiser, MD, PhD; Eran Tamir, MD; Hanna Kaufman, MD; Elad Keren, MD; Shalom Avshalom, MD; Doron Klein, MD; Lior Heller, MD; and Eyal Shapira, MD. A Novel Recombinant Human Collagen- based Flowable Matrix for Chronic Lower Limb Wound management: First Results of a Clinical Trial. Wounds 2019 February 14

3. Post marketing surveillance - Data on file4. Lavery LA et al. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results

of a multicenter, controlled, randomized, blinded clinical trial. Int Wound J. 2014 Oct;11(5):554-60.

CollPlant Ltd.

3 Sapir street, POB 4132, Ness Ziona 71 | 414002, Israel

[email protected] | +972(0)73232560

CollPlant is an ISO 13485: 2016 certifed company. Vergenix™FG is CE marked.

wound management - vergenix™fgvergenixfg.com/wp-content/uploads/2019/12/vergenix_fg... · 2019....

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