LEADERSHIP EXPERTISE

• Over 25 years of experience in healthcare

• 30 years experience in Tissue Regenerative Products

• 7 years experience in medical supply distributions

Manufactured & Marketed by:

4576 Enterprise Street, Fremont, CA – 94538 Tel.: +1 (510) 396-8581, Email: guna@encoll.com

Helicoll

Leadership Expertise

Helicoll was chosen for their

“Innovative Technology Program”

HELICOLL WON THE INNOVATIVE AWARD ! AND PRICE CONTRACTED (MS7561) in JULY 2019.

Helicoll

GPO TM

Other collagen preparations yield random structural

configuration that is non-native and stays behind the bioactive

native HELICOLL.

Descriptive Advantages: US Patented acellular dermal replacement, pure, non-cross linked type-I

collagen with high bioactivity.

Faster Healing: Helicoll brings blood capillaries within 4 to 5 days for faster repair. Normally healed with 1 to 4 applications.

Good Esthetic Results: Helicoll provides better esthetic results upon healing.

Easy to use: Helicoll can be cut and sutured for easy use and no need to wash.

Diabetic Wound Care: Diabetic wound heals faster by glycosylative buffering effect of Helicoll.

Pain Reduction: Helicoll significantly reduces the pain and it is clinically proven.

Size options: Helicoll comes in all sizes to accommodate a wider range of wounds.

Cost Effectiveness: Faster healing and tissue remodeling makes Helicoll a cost effective product.

Long shelf life: Helicoll is usable for 3 years in room temperature conditions.

Helicoll

Advantages as a skin substitute TM

Collagen Phosphorylation and Bioactivity

• Encoll's patented process yields high purity Type-I Collagen for maximum biocompatibility.

• Such collagen when phosphorylated results in cell signal transduction. • Exceptional bioactivity of Helicoll collagen is derived due to its

phosphorylation

Helicoll FDA approved Indications US FDA K#040314 (Aug 2004) Medicare Recognized as a High Cost Skin Substitute - Q4164 (cont. since 2017)

Partial and full-thickness wounds

Pressure sores and venous ulcers

Chronic vascular ulcers

Diabetic ulcers

Trauma wounds (abrasions, lacerations, 2nd degree burns)

Surgical wounds, donor sites/grafts, Mohs' surgery,

Post laser surgery, podiatric surgery and wound dehiscence

• Upon opening up the Sterile package using scissors,

please open the folds first. • Helicoll is sandwiched between a transparent and a

white plastic sheet on either side. • Look for "Peel" sticker and remove the white plastic

sheet covering the edges. • Remove the clear plastic sheet as shown in the

picture.

Helicoll

Application Step 1 TM

• In a clean sterile bowl, pour enough sterile saline

solution. • Soak the entire product with the other backing

white plastic sheet in the Normal Saline solution for a minimum of 5 minutes.

Helicoll

Application Step 2 TM

• For larger wounds, apply the product with the white

plastic layer intact. Spread the sheet over the wound without wrinkles and air bubbles.

• For smaller wounds, you may remove the white plastic sheet before applying.

• Properly debride the wound. Use saline solution to wet dry wounds.

• Mild bleeding is preferred. Helicoll adheres to the wound instantly.

Helicoll

Application Step 3 TM

• Apply a non-adherent membrane like

Adaptec/Telfa before placing a secondary dressing to monitor without disturbing the Helicoll on days 2 and later.

• Smear over Helicoll any antibiotic cream or solution for prophylaxis as preferred by the doctor.

• To retain Helicoll in place, edges can be taped/sutured/stapled.

• For deep wounds, press down Helicoll using cotton gauze for intimate contact with the wound bed.

Helicoll

Application Step 4 TM

Day 10

Day 1 Day 5 Day 7

Granulation upon absorption of Helicoll Remarkable Recovery in Just 10 days

Stages of Healing Helicoll

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Helicoll

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Non-healing chronic wound Treatment

Non-Healing Leg Ulcer Wound. 77yr male Pt

Helicoll dressing on half of the Wound to access its efficacy

Significant improvement seen on the Helicoll covered portion of the wound.

Wound looked much better

at the Helicoll covered site.

Helicoll covered site was almost healed.

Helicoll covered site was totally healed. Helicoll applied on the remaining Wound.

Complete healing of initially covered part. Good Progress on later covered wound

5/24/2007

Helicoll applied

5/10/2007

Without Helicoll

5/3/2007

4/26/2007 3/26/2007

HELICOLL HELICOLL

HELICOLL

HELICOLL Healed part

4/12/2007

HELICOLL

Helicoll

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Non-healing chronic wound Treatment

Helicoll Prevented Re-occurring of Wound.

The healed wound remained well after several weeks follow up on

“This dressing can be recommended for the non-healing ulcer wound treatment”

Courtesy: Mathew Kelly, MD, Plastic Surgeon, Jan Parks, RN, St. Francis Memorial Hospital, San Francisco, CA.

13

Helicoll “kick starts” early wound healing process

After Helicoll application- acute inflammatory cells, fibroblasts and blood vessels proliferate into the collagen matrix.(50x). Absence of Lymphocytes evidences the collagen in Helicoll is not immunogenic.

Day 5: Neo-vascularization H & E light microscopy after Helicoll treatment

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Wound Biopsy Helicoll

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4/12/2007

5/3/2007

15

Scientific Advantage Helicoll

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16 Note: Intact tissue based membrane products (like OASIS™, EPIFIX™, AMNIOFIX™, CYTAL™) naturally contain at least 15% of high immunogenic compound namely Elastin,

besides other allergenic biological molecules like glycosaminoglycans and certain types of collagen other than type-I collagen.

HELICOLL™ COMPARISION WITH OTHER FDA APPROVED PRIME PRODUCTS

PRODUCT HELICOLL™ XWRAP® APLIGRAF® OASIS™ INTEGRA™ EPIFIX™ /

AMNIOFIX™ CYTAL™

Manufacturer ENCOLL Corp. Applied Biologics Organogensis Smith&Nephew Integra

LifeSciences MiMedX Acell

Matrix Patented high purity

bovine Type-I collagen,

Amniotic Membrane Derived Allograft

XWRAP

neonatal dermal fibroblast - on bovine

Type I collagen

Porcine small intestinal

submucosa (SIS)

Comprised of collagen and

glycosaminoglycan and a silicone

layer

Dehydrated Human Amnion/Chorion

Membrane Allograft

Porcine urinary Bladder

Xenograft

Size/shape 5x5 cm to 60x60 cm

& Custom sizes 1x1cm to 4x8cm sizes

Circular, 8 cm diameter, disc

3x3.5 cm to 7x20 cm in sizes

5x5 cm to 20x25 cm in sizes

2x2 cm to 4x6 cm in sizes

3x3.5 cm to 10x15 cm in sizes

Sterilization Terminal sterilization Terminal Sterilization Aseptically processed

Terminal sterilization Aseptically processed

Terminal sterilization Terminal sterilization

Shelf life 3 years at room

temperature 2 years &

Requires Refrigeration 5 days at room

temperature 2 years at room

temperature 1 year at room

temp. 5 years at room

temperature 2 years at room

temperature

Handling Rehydrates in saline in 5 min.; easily handled,

sutured & stapled Rehydrates in saline

Shipped on an nutrient medium; difficult to handle;

fragile

Rehydrates in saline; easily

sutured & stapled

Can be sutured & stapled; easily

handled

Can be sutured & stapled; easily

handled

Can be sutured & stapled; easily

handled

Large presence of immunogenic Elastin/ adverse biomolecules

No Yes (approx 15% elastin presence)

No Yes (approx 15% elastin presence)

Yes (significant amnt of GAGs)

Yes (approx 15% elastin presence)

Yes (approx 15% elastin presence)

Bioactivity expressed via neo-vascularizaion &

granulation

Within 4 to 5 days after application

(Clinically proven)

No report indicates lesser than 9 days

No report indicates lesser than 9 days

No report indicates lesser than 9 days

No report indicates lesser

than 9 days

No report indicates lesser than 9 days

No report indicates lesser than 9 days

Appllications to Heal 1-4 applications variable Up to 5 applications variable variable variable variable

Control of hyper glycosylation of Diabetic Foot

Ulcer Wounds to heal fast Yes No No No No No No

Total Advantages of the product 9 of 9 2 of 9 1 of 9 2 of 9 1 of 9 3 of 9 2 of 9

Helicoll

Why it works best for DFU? TM

Differentiating code description based on 2020

CPT Code Total wound surface

area Areas of application

Size usage at the wound

surface

OPPS

payment rate

ASC Bundle

Rates

15271 up to 100 sq cm trunk, arms, legs 1st 25 sq cm or less $1,622.56 $819.95

+15272 up to 100 sq cm trunk, arms, legs additional 25 sq cm

15273 ≥ 100 sq cm trunk, arms, legs 1st 100 sq cm or 1% of body

area $2,976.96 $1,504.38

+15274 ≥ 100 sq cm trunk, arms, legs additional 100 sq cm

15275 up to 100 sq cm head, neck, hand, ft 1st 25 sq cm or less $1,622.56 $819.95

+15276 up to 100 sq cm head, neck, hand, ft additional 25 sq cm

15277 ≥ 100 sq cm head, neck, hand, ft 1st 100 sq cm or 1% of body

area $1,622.56 $819.95

+15278 ≥ 100 sq cm head, neck, hand, ft additional 100 sq cm

Medicare OPPS & ASC Payment rate for CPT 15271 to 15278 Helicoll

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JC Recognizes the product as a graft JW To document the amount of product wasted or un-used.

KX Met the requirements in the medical policy. Coverage criteria for the DMEPOS billed and the Medical Necessity are met.

25 Separate evaluation and management [E/M] service by the same physician on the same day of the procedure

59 Independent procedure or service performed from other non-E/M service performed on the same day.

76 Repeat procedure or service that is non-overlap performed by the same physician on the same day.

XE subset of 59 Service that is occurred during a separate encounter

XP subset of 59 Service performed by a different practitioner

XS subset of 59 Service performed on a separate organ/structure

XU subset of 59 an unusual non-overlapping service.

TA Right foot, great toe defect Treatment TG Left foot, great toe defect Treatment

Common Modifiers Helicoll

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Important portion of the insurance form CMS1500 Helicoll

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Units Billed: Example Helicoll Q4164 (2x2 inches) is billed as 25 units.

Wound Size/Location: Required to select the appropriate CPT code.

Debridement: Debridement has a CPT code and amount when skin substitute applied.

Product Wastage Documentation: Note Product unit use and discarded quantities.

Diagnosis Code: Note ICD10 diagnostic codes on Insurance claims forms.

Modifiers: Enter Modifiers required with HCPCS Q4164 and/or the CPT codes used.

Commercial Insurers/Contracted Rates: Refer to general fee schedule rate or if required get prior authorization from payer.

Medical Necessity/Documentation: Provider review clinical details of Helicoll and follow if there is an applicable LCD or medical policy

for Helicoll to meet all requirements.

Billing Reminders Helicoll

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THANK YOU Contact Info:

ENCOLL Corp. 4576 Enterprise Street

Fremont, CA 94538, USA Tel. (510) 396-8581