1. COLLAGEN BASED STERILE MEMBRANE BIO-ENGINEERED SKIN SUBSTITUTE
HELICOLL TM
COLLAGEN BASED STERILE MEMBRANE
BIO-ENGINEERED SKIN SUBSTITUTE

2. Leadership Over 75 years of experience in healthcare
30 years experience in government contracting
17 years experience in medical supply distributions

3. Bio-engineered Collagen to Accelerate
Wound Healing and Skin Regeneration
READY TO USE
FDA APPROVED
STERILE COLLAGEN SKIN SUBSTITUTE
THREE-YEAR SHELF LIFE AT ROOM TEMPERATURE

4. Bioengineered high purity Type I collagen product
Highly bioactive, cell conductive for tissue regeneration
Acellular dermal replacement
Promotes neovascularity & cell migration
Treatment course 1-4 applications
3-year shelf life at room temperature

5. Helicoll FDA approved Indications US FDA K# (Aug 2004) Medicare Recognized as a High Cost Skin Substitute - Q4164 (from July 2016)
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

6. Helicoll Stages of Healing
Day 1 after HELICOLL
Day 5 after HELICOLL
Day 7 after HELICOLL
Day 10 after HELICOLL
Granulation upon absorption of Helicoll
Remarkable Recovery in Just 10 days

7. Helicoll Non-healing chronic wound Treatment
Non-Healing Leg Ulcer Wound. 77yr male Pt
4/12/2007
4/19/2007
4/26/2007
Wound looked much better
at the Helicoll covered site.
Helicoll dressing on half of the Wound to access its efficacy
Significant improvement seen to the
Helicoll covered portion of the wound.
With Helicoll
Helicoll applied
Without Helicoll
5/10/2007
5/24/2007
5/3/2007
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

8. Helicoll 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.

9. Helicoll Simple to applyTM
Simple to apply
Helicoll is soaked in sterile water for 5 minutes, the outer transparent sheet is removed
Apply Helicoll along with the backing sheet – (easy to manage)
Now remove the white backing sheet
The transparent pliable Helicoll sheet is applied on the wound, making sure that all air bubbles are removed

10. Wound biopsy Day 5: Neo-vascularizationTM
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.
H & E light microscopy after Helicoll treatment
Day 5: Neo-vascularization
Helicoll “kick starts” early wound healing process

11. Helicoll TM
Scientific Advantage
4/12/2007
5/3/2007

12. Helicoll Competitive Advantage TM PRODUCT HELICOLL™ DERMAGRAFT®
HELICOLL™ COMPARISION WITH OTHER FDA APPROVED PRODUCTS
PRODUCT
HELICOLL™
DERMAGRAFT®
APLIGRAF®
OASIS™
INTEGRA™
Matrix
Patented high purity bovine Type-I collagen, reconstituted into sheets
Human fibroblast-derived dermal substitute on a polyglactin mesh
Bi-layered neonatal fibroblast -keratinocyte (dermal -epidermal) skin substitute on bovine Type I collagen
Porcine derived acellular small intestinal submucosa (SIS)
Comprised of collagen and glycosaminoglycan and a silicone layer
Size/shape
5x5 cm to 60x60 cm in sizes with 0.2 mm thickness
Rectangular, 5x7.5 cm
Circular, 8 cm diameter, 0.75 mm thickness
3x3.5 cm to 7x20 cm in sizes
5x5 cm to 20x25 cm in sizes
Sterilization
Terminal sterilization
Aseptically processed
Shelf life
3 years at room temperature
30 minutes at room temperature; up to 6 months at -75°C
5 days at room temperature
2 years at room temperature
1 year at room temp.
Handling
Rehydrates in saline in 5 min.; easily handled, sutured & stapled
Shipped frozen; elaborate prep and appln procedures; fragile
Shipped fresh on an agarose nutrient medium; difficult to handle; fragile
Rehydrates in saline; easily sutured & stapled
Can be sutured & stapled; easily handled
Appllications to Heal
1-4 applications
Up to 8 applications
Up to 5 applications
variable
Total Advantages of the product
6 of 6
0 of 6
2 of 6
1 of 6

14. Helicoll Cost & Clinical superiority Highly purified Type-I collagenTM
Cost & Clinical superiority TM
Highly purified Type-I collagen
Flexible sheets with high tensile strength
Easy to apply and visually monitor wound
Bio-re-absorbable and non-immunogenic
No adverse reactions
70 % faster healing with both superficial and deep wounds
Long shelf-life (room temperature storage for three years)
Cost effective
Patients have a decreased hospitalization time (improved quality of life)
Unique advantages to diabetic foot ulcer wound care
Can be used in conjunction with Wound Vac (NPWT).

15. Helicoll CPT Coding TM CPT Description 15271
Application of skin substitute graft to trunk, arms, legs, total wound surface area lesser than or equal to 100 sq. cm; first 25 sq. cm wound surface area.
+15272
Each additional 25 sq. cm up to 100 sq. cm wound surface area, or part thereof. List separately in addition to code for primary procedure.
15273
Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq. cm; first 100 sq. cm wound surface area, or 1% of body area of infants and children
+15274
Each additional 100 sq. cm wound surface area or part thereof, or each additional 1% of body area of infants and children or part thereof. List separately in addition to code for primary procedure.
15275
Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq. cm; first 25 cm or less wound surface area
+15276
Each additional 25 sq. cm wound surface area, or part thereof. List separately in addition to code for primary procedure.
15277
Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq. cm; first 100 sq. cm wound surface area, or 1% of body area of infants and children
+15278
Each additional 100 sq. cm wound surface area, or part thereof. List separately in addition to code for primary procedure.

16. Common modifiers Helicoll JC Recognizes the product as a graft JWTM
Common modifiers 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

17. TM
Helicoll
IMPORTANT PORTION OF THE INSURANCE FORM CMS1500

18. Helicoll BILLING REMINDERS Units Billed Wound Size/LocationTM
BILLING REMINDERS
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 have to be noted.
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.

19. MEDICARE - 2017 National Average Physician Service Payments
Detailed below are the national average payment amounts per CPT for the facility (when the physician treats in the hospital/ASC) or non-facility (when the physician treats in his office).
CPT
Description
National Average Payment
Facility (Hospital/ASC)
Non-Facility (Physician Office)
15271
Skin sub graft trunk/arm/leg
$87.38
$142.86
+15272
Skin sub graft trunk/arm/leg add-on
$17.90
$27.57
15273
Skin sub graft trunk/arm/leg child
$209.10
$302.90
+15274
Skin sub graft trunk/arm/leg child add-on
$47.62
$72.68
15275
Skin sub graft face, scalp, hands, feet, and/or multiple digits
$98.46
$151.45
+15276
$25.78
$35.09
15277
Skin sub graft face, scalp, hands, feet infants and children
$232.37
$328.33
+15278
$59.08
$86.65

20. Hospital Outpatient (HOPD) National Average Payment amounts
Helicoll TM
Hospital Outpatient (HOPD) National Average Payment amounts
CPT
High Bundle Rates
15271, 15275, 15277
$1,427.16
15273
$2,503.63
Ambulatory Service Center (ASC)
CPT
ASC Bundle Rates
15271, 15275, 15277
$771.88
15273
$1,354.26

21. Pricing & Reimbursements
PRICE STRUCTURE OF HELICOLL l TM
Size dimension
2x2 in (5x5 cm)
2x4 in (5x10 cm)
4x4 in (10x10 cm)
8x8 in (20x20 cm)
Size in sq. cm
25 sq. cm
50 sq. cm
100 sq. cm
400 sq. cm
Medicare Reimbursement / Box of 5 Units
$7,056.00
$10,687.00
Medicare Reimbursement / Unit
$1,411.20
$2,137.40
List Price / Box of 5 Units
$6,750.00
$8,400.00
$13,500.00
$14,000.00
Discounted Price to Doctors / Box of 5 Units
$________
List Price / Unit
$1,350.00
$1,680.00
$2,700.00
$2,800.00
Discounted Price to Doctors / Unit
$700.00
$800.00
$1,500.00
$1,700.00

22. PRIVATE DOCTOR OFFICE REIMBURSED ACTUAL AMOUNTS
USING MEDICARE PART B CLAIM
CMS accepts electronic submissions.
Dr. M’s office billed Medicare for 2”x2” Helicoll .
Showed purchased invoice for $800 each.
Got the following reimbursement.
Payment for Helicoll Product = $940.38
Payment for Wound Preparation = $275.89
Payment for Application = $111.70
Total reimbursement for application = $1,327.97

23. Q & A 23

24. 4576 Enterprise Street, Fremont, CA 94538, USA Tel. (510) 396-8581
THANK YOU
Contact Info:
Distributor Details
ENCOLL Corp.
4576 Enterprise Street, Fremont, CA 94538, USA Tel. (510)