Kerecis® Omega3 Wound

Kerecis® Omega3 Wound Intact fish skin grafts for tissue regeneration

• Rich in Omega3 and homologous to human skin

• Two double-blind RCTs

• Faster healing than amnion membrane and mammalian tissue

• Superior economic performance

• Natural microbial barrier

• Sustainably harvested

What is Kerecis® Omega3 Wound?

Scanned electron microscopy images of human skin (left) and Kerecis® Omega3 Wound (right) show the structural similarities between the skin types.

Kerecis® Omega3 Wound is intact fish skin that is homologous to human skin and is used for tissue regeneration and grafting. Kerecis Omega3 Wound is FDA indicated for multiple clinical applications.

Because there is no risk of a viral-disease transfer from Atlantic cod to humans, the fish skin needs only mild processing for medical use and maintains its natural structure and elements, including Omega3 fatty acids.

When grafted onto damaged human tissue, such as a burn or a wound, the fish-skin recruits the body’s own cells, supporting the body’s own ability to regenerate. The fish skin is a natural microbial barrier.

The superior clinical and economical performance of Kerecis Omega3 Wound has been demonstrated in two non-industry funded, double-blind, randomized clinical trials and in numerous other clinical studies.

Human skin Intact fish skin

Epidermis

Dermis

Room temperature storage

3 years shelf life

Durable for staples & sutures

No cultural or religious conflicts

Sizes from 3cm2-140cm2

Clinical Advantages

Kerecis® Omega3 Wound is homologous to human skin

Left table: Comparison of skin components of Human Skin, Kerecis Omega3 Wound, and Processed Mammalian Tissue. The table highlights the similarity between human skin and fish skin and the components lost in processed mammalian tissue.

100 μm100 μm

MOLECULESIN HUMAN

SKIN

INTACTFISH SKIN

PROCESSED MAMMALIAN

TISSUE

Collagens

Elastin

Laminin

Fibronectin

Proteoglycans

Glycans

LipidsNo Omega3s

Includes

Omega3s

The Kerecis® Omega3 Wound intact fish skin graft facilitates significantly more three dimensional cellular ingrowth than occurs in amnion/chorion tissue. The fish skin is thicker and the microstructure more porous, compared to mammalian matrixes and human amnion/chorion membranes.

The unique biomechanical properties of the fish skin and the size of its pores facilitate cell ingrowth, a critical step for tissue regeneration. In-vitro tests of the fish skin shows significantly more (p<0.0001) three-dimensional cell ingrowth than human amnion/chorion membranes.

Early cellular ingrowth

Lower row: Confocal microscopy images following cell seeding and fluorescent labeling, indicated with red arrows, show examples of cell infiltration in fish skin and human amnion/chorion. Scale bar on all images 100μm.

Kerecis® Omega3 Wound

Human amnion/chorion membrane

Proven resultsSuperior clinical and economic performance of Kerecis Omega3 Wound in two separate randomized controlled trials published in peer-review journal.

Kerecis® Omega3 Wound vs EpifixPatients=85

Kirsner et al. Fish-Skin Grafts Compared to Human Amnion/Chorion Membrane Allografts: A Double-Blind, Prospective, Randomized, Clinical Trial of Acute Wound Healing. Wound Repair and Regeneration, (2019).

Kerecis® Omega3 Wound vs Oasis Patients=81

Top row: Scanned electron microscopy images of fish skin show a pore size of ~10-150 μm. This is suitable for human cell infiltration because typical human cells range from ~10-100 μm in diameter.

Amnion/chorion membrane has an avg pore size of 1.3 μm which is more than 10 times smaller than typical human cells.

100 µm

Kerecis® Omega3 Wound Epifix

P=0.0014

Kerecis® Omega3 Wound Oasis

P=0.041

14 21 25

70

60

50

40

30

20

10

0

105%

26%17%

# of

Hea

led

Wou

nds

14 18 21 25 28

70

60

50

40

30

20

10

0

80

Days DaysBaldursson, B. T. et al. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa. Int. J. Low. Extrem. Wounds 14, (2015).

75%

78%

48%

28%

10%

KERECIS2200 Clarendon BoulevardSuite 1400AArlington, Virginia 22201Phone: (703) 287-8752Email: [email protected]

www.kerecis.com

OUR VISION To become the world leader in tissue regeneration by sustainably harnessing nature’s own remedies

KERECIS REIMBURSEMENT HOTLINE Phone: (844) KERECIS | (844) 537-3247FAX: (844) 529-3247HCPCS Code: Q4158Email: [email protected]

FDA approved, U.S. and international patents and trademarks granted and pending.

• Diabetic ulcers

• Chronic vascular ulcers

• Venous ulcers

• Pressure ulcers

• Draining wounds

• Trauma wounds: abrasions, lacerations, second-degree burns, skin tears

• Surgical wounds: donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence

• Partial and full-thickness wounds

Indications for use

Ordering information [email protected]

Room temperature storage. 3 year shelf life.

Description Size Billable Units (cm2)

Kerecis® Omega3 Wound Disk, 14 mm diameter 2


Kerecis® Omega3 Wound 1.75 x 1.75 cm 4

Kerecis® Omega3 Wound 3 x 3.5 cm 11

Kerecis® Omega3 Wound Fenestrated 3 x 3.5 cm 11

Kerecis® Omega3 Wound 3 x 7 cm 21

Kerecis® Omega3 Wound Fenestrated 3 x 7 cm 21







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Kerecis® Omega3 Burn Intact fish skin grafts for tissue regeneration

• Rich in Omega3 and homologous to human skin• Rich in Omega3 and homologous to human skin

• Natural microbial barrier• Natural microbial barrier

• Preserved microstructure facilitates dermal • Preserved microstructure facilitates dermal regeneration regeneration

• Rapid revascularization• Rapid revascularization

• Sustainably harvested• Sustainably harvested

Challenges in burn care Intact fish skin graftsBurn injuries present unique challenges that include slow wound healing, inflammation, bacterial infection, pain and hypertrophic scarring. The rapid contraction and scarring process in burn wound healing can leave patients with limited functionality while inflammation and infection can endanger their lives. Providing burn wound treatment that creates a barrier to infections and enhances the body’s own response to heal is essential in reducing mortality rates of burn patients.

Tissue regeneration Dermal regeneration templates have shown the ability

to regenerate dermal layers of the skin and reduce

contraction by providing structures that reduce

myelofibroblast activity. Natural skin structures provide

the best results in burn wound care by preventing

foreign body reactions and seroma formation. The

gentle processing of Kerecis® Omega3 Burn uniquely

retains the homologous structure of the fish skin,

including the Omega3 fatty acids. This makes Kerecis

Omega3 Burn an ideal template for cells to migrate into

and regenerate the wound.

Kerecis® Omega3 Burn is an intact fish skin that is homologous to human skin and uniquely designed to address the challenges of burn healing. Because there is no risk of a viral-disease transfer from Atlantic cod to humans, the fish skin needs only mild processing for medical use and maintains its natural structure and elements, including Omega3 fatty acids.

Human skin Intact fish skin

Intact fish skin populated with cells

Epidermis

Dermis

Faster revascularization

Day 1 Day 3 Day 14 Day 21 Day 28 Day 45

DPT Kerecis® Omega3 Burn

DPTFetal Bovine Dermis

Laser speckle images (LSI) indicating more rapid revascularization of the Kerecis® Omega3 Burn graft compared to fetal bovine dermis.2

1) Alam K and Jeffery SLA. Acellular Fish Skin Grafts for Management of Split Thickness Donor Sites and Partial Thickness Burns: A Case Series. Military Medicine. 2019 Mar 1;184(Supplement_1):16-20.

2) R Stone, II et al. Comparison of Omega-3 Rich Fish Skin Dermis and Fetal Bovine Dermis on Deep Partial Thickness Burns. Journal of Burn Care & Research. 2018 Apr 9;39 (suppl.1) S156

Effective natural microbial barrier

Porcine Type I

Collagen Matrix

Ovine Collagen

Extra-cellular Matrix

Human Amnion/Chorion

Membrane Allograft

Kerecis® Omega3

Burn

Hou

rs

0

10

20

30

40

50

60

70

Bovine Collagen

Matrix

DPT Kerecis® Omega3 Burn

DPTFetal Bovine Dermis

In vitro two chamber bacterial barrier assay. The results show the average time the products were able to stand as a bacterial barrier to S. aureus.

The FDA approved fish skin that Kerecis® Omega3 Burn is made of is a natural microbial barrier making it ideal for use in burn wound treatments.1 Randomized, comparative animal burn models have shown that Kerecis® Omega3 Burn provides the right environment

for wound healing. It prevents contraction and speeds up healing of deep partial thickness wounds compared to bovine dermis grafts. The Kerecis® Omega3 Burn graft vascularizes significantly faster.2


www.kerecis.com




What is Kerecis® Omega3 Burn?

Kerecis® Omega3 Burn is intact Icelandic fish skin that is homologous to human skin and is used for tissue regeneration. Because there is no risk of a viral or prion transfer from Icelandic cod to humans, the fish skin only needs gentle processing for medical use and maintains its natural structure and elements. The fish skin is a natural microbial barrier.



Indications for use


Catalog # Type Size (cm) Billable (cm2) UOM Quantity

50202S03B2D Solid 7 x 10 70 Box 10

50202S21B2D Solid 7 x 20 140 Box 10

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Easy to use. No tissue tracking. Room temperature storage. 3 year shelf life.

Kerecis® Omega Burn

Case Kerecis® Omega3 Wound Intact fish skin grafts for tissue regeneration

Dr. Patrick McEneaneyDehisced surgical wound

Dehisced surgical wound

Patient• 67-year-old male admitted three weeks after foot

surgery

• Obese, heavy drinker, COPD, arthritis

• Sepsis following an injury

• Dehisced surgical wound

Treatment• Incision, drainage and antibiotic bead placement

• Irrigation, debridement, antibiotic bead removal, necrotic tendon excised a week later

• Kerecis® Omega3 Wound applied three times over six weeks

• Wound fully healed in 14 weeks

CASE PRESENTED BY

Patrick McEneaney, DPM, FACFAS Northern Illinois Foot & Ankle Specialists

Dr. Patrick McEneaney is a podiatric surgeon from Crystal Lake, Illinois.He is the owner of Northern Illinois Foot & Ankle Specialists, which is a He is the owner of Northern Illinois Foot & Ankle Specialists, which is a six-doctor practice. Dr. McEneaney is currently president-elect of the Illinois Podiatric Medical Association. His professional interests involve advanced reconstructive surgery of the foot and ankle. He specializes in post-traumatic injury management, adult and pediatric deformity correction, wound care and limb salvage. He is also the co-director of the Northwest Illinois Foot & Ankle Foundation.

Surgical problemThe patient is a 67 year old male who presented with a post-operative infection and a dehisced incision site with exposed hardware after a forefoot reconstructive procedure.

Delayed closure of a dehisced wound increased the risk of osteomyelitis and desiccation. Prompt incision and drainage was needed to manage the infection. Intact fish skin graft was placed to speed up the healing process.

Initial treatmentThe patient was admitted for sepsis and was started on IV antibiotics. The wound extended from the first metatarsophalangeal joint to the dorsal midfoot. A part of the first metatarsal bone and the EHL tendon were exposed. Incision and drainage were performed with vancomycin impregnated antibiotic bead placement.

Kerecis® Omega3 Wound applicationA week later the patient was taken back to the operating room for repeat irrigation and debridement. The EHL tendon had necrotized and further excision of tissue was needed. The antibiotic beads were removed and the necrotic EHL tendon excised. Kerecis® Omega3 Wound was applied to a full thickness wound.

The Kerecis® Omega3 Wound graft was cut to size and secured, scale side up, with staples to the sharply debrided wound edges. This provided tight apposition of the graft to the wound bed for optimal cell ingrowth and skin regeneration.

After discharge the patient received local wound care until three weeks later when the second Kerecis® Omega3 Wound application was performed. The third application took place 16 days later.

1 WEEK PRIOR

After first bunion surgical procedure. Patient was readmitted to hospital after injury to the original location. Incision and drainage with antibiotic bead placement.

The first application of Kerecis® Omega3 Wound after incision and drainage.

Second application of Kerecis® Omega3 Wound in place.Wound status 19 days after the first Kerecis® Omega3 Wound application. Wound prepared for second application.

The wound is healing well with Kerecis® Omega3 Wound integrated 30 days after third staged surgery.

Wound healed with minimal scar contracture.

DAY 1

DAY 19DAY 19

DAY 67 DAY 101

Treatment outcomeComplete wound healing was achieved without further tissue necrosis and with minimal scar contracture. The wound was fully closed 14 weeks after the original Kerecis® Omega3 Wound application. Kerecis® Omega3 Wound is an effective tool for post-operative wound dehiscence caused by infection.


www.kerecis.com



FDA approved, US and international patents granted and pending.

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• Diabetic ulcers

• Chronic vascular ulcers

• Venous ulcers

• Pressure ulcers

• Draining wounds


• Surgical wounds: donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence


Indications for use


Room temperature storage. 3 year shelf life.

Description Size Billable Units (cm2)



Kerecis® Omega3 Wound 1.75 x 1.75 cm 4

Kerecis® Omega3 Wound 3 x 3.5 cm 11

Kerecis® Omega3 Wound Fenestrated 3 x 3.5 cm 11









Fish skin on thin-skin graft donor sites

(Independent 21 Patient Comparative Trial)

SOC(10 patients)

Fish-Skin(11 patients)

P=0.126150

100

50

0

Day

s

SOC(10 patients)


6

4

2

0

P=0.034

VAS

SOC(10 patients)


100%

60%

40%

0%%

Infe

ctio

n

80%

20%

60%

0%

P=0.0039

Faster Healing Less Pain

HEALING TIME PAIN VISUAL ANALOGUE SCALE

(VAS)

5 days after surgery

LOCAL INFECTION

FISH SKIN - DAY 20

Standard of Care: Traditional care with vaseline

dressing. Change every other day.

Fish Skin: Left in place until fully integrated. Covered with gauze and egaderm.

Donor site: Inner side of ipsilateral arm

Thickness = 0,4 mm Size = 30 to 45 sq. cm

No Infections

DONOR SITE SOC - DAY 25

Article Summary

Authors: Nathalie Badois, MD1,2; Pierre Bauër, PhD; Maxime Cheron,RN1; Caroline Hoffmann, MD1; Marguerite Nicodeme, RN1; Olivier Choussy, MD PhD2; Maria Lesnik MD3; Florence Canoui Poitrine, MD

PhD4; Isabelle Fromantin, RN PhD1,2; 1Department of Head and Neck surgical oncology, Institut Curie, Paris, France; 2University PSL, Paris, France; 3Research and Wound Care Unit, Institut

Curie, Paris, France; 4Paris-Est University (UPEC), DHU A-TVB, IMRB, EA 7376 CEpiA (Clinical Epidemiology And Ageing Unit), F-94000, Créte France; 5APHP, Henri- Mondor Hospital, Public Health Department, F-94000, Créteil, France.

Published: Journal of Wound Care. 28. 624-628. 10.12968/jowc.2019.28.9.624.


www.kerecis.com


KERECIS REIMBURSEMENT HOTLINE Phone: (844) KERECIS | (844) 537-3247FAX: (844) 529-3247CMS CPT Code: Q4158Email: [email protected]


Prospective, comparative, cohort study on 21 Patients: SOC vs Fish-Skin Graft for Cervico-facial and reconstructive surgery

Groups

1 2

SOC(10 patients)

Fish Skin

(11 patients)

Challenges: • Healing takes up to 5 months • Painful donor sites • High likelihood of infection

Conclusion / Key Message

Paraffin gauze applied immediately after surgery and subsequently a thick layer of Vaseline was added daily if dressings dried up.

Dressings was changed on the 4th day then every 2 days until complete re-epithelialization is obtained.

The results of the study showed significant decrease of local infection (p = 0.0039) and pain (p = 0.034) with the use of Kerecis compared to standard wound care. Heal time was approximately 50% faster than standard wound care. The authors discussed that the porous structure of fish skin and its natural omega-3 content play an important role in its regenerative and bacterial barrier properties. This was an independent study and the authors declared no conflict of interest.

Kerecis applied immediately after surgery, positioned over wound with an excess of 1-2 cm. Covered with 1 or more moist compresses and a semi-permeable film dressing. Kerecis left until it is fully integrated.

If full integration is <48 hours, another graft is applied to a maximum of 3 grafts. If not completely re-epithelialized after 3 grafts, a silicone coated nylon (Mepitel) was applied to complete the healing process.

About Head and Neck Cancer Surgery

Head and neck cancer surgeries often requires radial forearm free flap reconstructions. Once tissues are harvested from the forearm, it requires a split thickness skin graft (STSG) to close the harvest site. The donor site is often painful with possible infections and long healing time. Presently, there is no consensus in the management of donor sites.

Cancer Free Flap Split Thickness

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Fish skin grafts compared to human amnion/chorion membrane allografts: A double-blind, prospective, randomized clinical trial of acute wound healing

Article Summary

Study: Randomized double blind comparative trial on 85 patients with 170 full thickness acute wounds.

Authors: Robert S. Kirsner, MD, PhD1; David J. Margolis, MD, PhD2,3; Baldur T. Baldursson, MD, PhD4 ; Kristin

Petursdottir, MD4; Olafur B. Davidsson, MSc5; Dot Weir, RN, CWON, CWS6; John C. Lantis II MD, FACS7

1Dr Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, Florida,2Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania,3Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania,4Department of Dermatology, Landspitali University Hospital of Iceland, Reykjavik, Iceland,5Mathematics Division of the Science Institute, University of Iceland, Reykjavik, Iceland,6Catholic Health Advanced Wound Healing Centers, Buffalo, New York, and7Division of Vascular/Endovascular Surgery, Mount Sinai St. Luke’s—West Hospitals, Icahn School of Medicine, New York, New York

Published: Wound Repair & Regeneration. 28(1), 75-80 (2020)

Method:

Each patient received two full thickness, 4 mm punch biopsy wounds. Participants acted as their own control, one wound randomized to treat with Kerecis and second wound on the same forearm treated with Epifix (dHACM). Wounds are assessed at 7, 14, 21, 25, 28 by four independent medical proffessionals.

Proportion of healed wounds at each time point with fish skin graft and dHACM. Wounds treated with fish skin healed significantly faster with a hazard ratio of 2.37 compared to dHACM allograft-treated wounds (p = 0.0014).

Kerecis® Omega3 Wound Epifix

P=0.0014

14 18 21 25 28

70

60

50

40

30

20

10

0

80

Days

75%

78%

48%

28%

10%


www.kerecis.com


KERECIS REIMBURSEMENT HOTLINE Phone: (844) KERECIS | (844) 537-3247FAX: (844) 529-3247CMS CPT Code: Q4158Email: [email protected]


Statistical Analysis To estimate whether the differences in time to heal between the studied materials in this accumulated data was significant, a mixed-effects Cox proportional hazard model was used. The model incorporates a fixed effect for the treatment, a random individual effect to account for each individual receiving both wounds, and a random wound effect to account for the variance introduced by the different reviewers of each wound

Results Wounds treated with fish skin healed significantly faster with a hazard ratio of 2.37 (95%CI: 1.75–3.21) and a p-value of 0.0014 compared to dHACM-treated wounds. Healing trajectories of the materials at each day and per evaluator show consistent superiority of the fish skin grafts.

Conclusion Full-thickness acute wounds treated with fish-skin grafts heal significantly faster than wounds treated with dHACM. When chronic wounds are treated with products such as the fish skin graft and dHACM, they need to be thoroughly debrided. With debridement, the chronic wounds approach the physiological state of an acute wound. Therefore, results derived from studying acute wounds can have logical implications for debrided chronic wounds.

Trajectories of the number of healed wounds to time by evaluator and wound-healing material. Orange: Intact fish skin. Blue: dHACM.

Representative subject followed up to the healing of punch wounds. From top to bottom: D0, D7, D14, D25. Wound on the left side of the figure was treated with fish-skin graft, while the right wound was treated with dHACM.

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Kerecis® Omega3 Wound