Revolutionizing Healing. Changing Lives.

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Revolutionizing Healing.

Changing Lives.

®

Surgical Applications

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RESTRATA’S

HYBRID-SCALE FIBERS HUMAN TISSUE XENOGENIC COLLAGEN

Restrata is engineered to be structurally similar to

native human extracellular matrix.

3 • Fiber size and structure supports cellular _{ingrowth and retention}1, 2 • Porosity supports granulation and

vascularization2

• Controlled resorption rate via hydolysis1,2 • Resistant to enzymatic degradation2 • Excellent biocompatibility1, 2

• Tensile strength similar to human skin1 • Slightly acidic byproducts, potentially lowering pH of local microenvironment4

In an animal model, 100% of-full thickness wounds treated with Restrata granulated after 15 days compared

to 20-50% of wounds treated with Integra after 15 days.2_{Restrata supported more rapid formation of}

granulation tissue, faster wound closure, significantly reduced inflammation, and significantly increased

neovascularization compared with Integra.2

Hybrid-Scale Fiber Matrix

Technology

Restrata Compared with Integra

®

_{Bilayer Wound Matrix}

The Restrata

®

_Difference

Structure and Scale Matter

30 0 10 20 W ound Ar ea (c m 2) Time (Days)

Integra Bilayer Wound Matrix Restrata Wound Matrix

0 2 4 6 8 10

• Surgical and trauma wounds • Partial and full-thickness wounds • Acute and chronic wounds • Tunneling and exudating wounds • VLUs, DFUs, and pressure ulcers • Burns

Restrata is indicated for a variety

of wound types including:

3

INTEGRA RESTRATA

Gross evaulation of inflammation and wound healing. (A) Wound area (average ± SD) as determined by planimetric analysis of wound photographs.

*p < 0.05, Student’s t-test, n=6 (Day 1-15) or n=3 (Day 19-30). (B) Average wound scores from gross wound observation.

Hematoxylin and eosin (H&E) stained sections from wounds treated with (A) Integra Bilayer Wound Matrix or (B) Restrata Wound Matrix at Day 15. G-granulation tissue, N-neutrophils, S-Seroma, Arrowheads-wound matrix material, Arrows-multinucleated giant cells surrounding wound matrix

Results of a Comparative Trial in a Large Animal Model Restrata’s hybrid-scale fiber architecture closely resembles the structure and scale of native ECM, allowing for cellular ingrowth and neovascularization before completely

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“

The value of hybrid-scale fibers and electrospinning

has been demonstrated by many publications, but

Acera is the first company to develop it beyond the

research lab for patient healing.”

– Agnes Rey-Giraud, CEO, Acera

®

Restrata has a tensile strength similar to

human skin and can be run through a

surgical mesher, sutured, or stapled as

desired, and can be applied after surgical

debridement in the OR.

Restrata is Easy to Apply

DEBRIDE all non-viable tissue

SELECT appropriate size

FENESTRATE if desired

CUT to fit

HYDRATE as needed

FIXATE with Steri-Strips, staples, or sutures 1. 2. 3. 4. 5. 6. OR MESH FIXATE CUT FENESTRATE DEBRIDE

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• Primary dressing: Non-adherent dressing.

• Secondary dressings: For dry to light exudate, adding hydrogel is recommended. For moderate to heavy exudate, fenestrate Restrata to allow for drainage to pass through and utilize appropriate absorptive dressing.

• All dressing products can be used safely after application of Restrata.

• Restrata has been used in conjunction with Negative Pressure Wound Therapy. It is recommended that the Restrata is adequately fenestrated and the pressure is reduced. • Primary dressing should remain intact for the course of a week and the secondary

dressings can be changed as necessary.

• Restrata is engineered to remain in the wound bed, providing a continuous scaffold for cellular ingrowth.

• Restrata is resorbed via hydrolysis and the resorption rate is relative to the moisture content of the wound.

• At the first dressing change, some or all of the Restrata may be resorbed. • Restrata can be reapplied at the physician’s discretion.

Examples of Aftercare

What to Expect and When to Reapply

Restrata prior to

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Wounds should be routinely examined following application:

• Pieces adherent to wound... Leave in place • Pieces non-adherent to wound... Remove and debride

Initial application

Initial application with non-adherent primary dressing

One week, partially integrated

One week, Restrata matrix not resorbed but fully adhered to wound bed

Two weeks, mostly integrated

Two weeks, Restrata 50% resorbed, re-epithelialization at wound edges

Three weeks, fully resorbed

Examples of Restrata Resorption Over Time

What Should Be Removed Upon Examination?

Restrata applied to a tumor excision surgical leg wound

Chronic VLU post debridement

PRE-APPLICATION AFTER FIRST APPLICATION AFTER SECOND APPLICATION

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Abdominal wound after 2nd_{hernia repair and six months}

non-healing. Progress of two Restrata applications over eight weeks.

Limb salvagescenario with exposed joint capsule on a diabetic foot ulcer. Two Restrata placed to wound closure.

Post-Merkel cell resection. One Restrata application in conjunction with tissue expander. Z-flap conducted one week after application.

Case Studies of Surgical Applications with Restrata

Segmental

mandibulectomy

with metal recon bar wrapped with pectoral muscle. Restrata added to back side of the flap. One Restrata application to closure.

Restrata can be utilized for Surgical wounds, such as amputation sites, to expedite granulation and epithelialization while potentially reducing post-operative complications.

STSG donor site – Restrata applied to STSG donor site. Patient healed after one application of Restrata in nine days and had markedly reduced pain. Skin pigmentation returned to treated area.

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®

Traumatic wounds– Crush injury to the heel with Restrata applied to tissue defect.

Surgical wounds– Restrata healed a four-month-old BKA stump wound with one application in eight weeks.

Scalp wound – Restrata applied with hydrogel to wound after debridement.

Post-Mohsover-ear cartilage. One Restrata application to closure.

Patient: Left ear, post MOH’s procedure, one application of Restrata Burn

Exposed bone and joint capsule. One application to heal.

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®

Call/fax Acera Customer Service

(844) 879-2237

Or visit

acera-surgical.com

FSS #V797P-36F79718D0525

HOW TO ORDER

Acera Surgical, Inc., St. Louis is a bioscience company commercializing a portfolio of synthetic hybrid-scale fiber matrices for medical applications.

RESTRATA IS EASY TO USE

REFERENCES

Made in USA

Serving our veterans

No human or animal tissue components–no special storage and handling requirements Suitable for use in patients with specific ethnic or religious objections to tissue grafts No requirement for specific orientation when applied Terminally sterilized Latex-Free

Six sizes available to reduce waste and cost

Two-year shelf life

Sufficient strength to suture or staple if needed ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓

SIZES UP TO 10 X 12.5 CM

Actual size of product. Store at room temperature.

3 x 3 in P a r t # R W M 1 - 3 X 3 7.5 x 7.5 cm 2 x 2 in P a r t # R W M 1 - 2 X 2 5.0 x 5.0 cm 1 x 1 in P a r t # R W M 1 - 1 X 1 2.5 x 2.5 cm 1 x 3 in P a r t # R W M 1 - 1 X 3 2.5 x 7.5 cm 1 x 2 in P a r t # R W M 1 - 1 X 2 2.5 x 5.0 cm

ALSO AVAILABLE:

Size (in): 4 x 5 | Size (cm): 10.0 x 12.5 | Part #: RWM1-4X5 _{1. MacEwan MR, MacEwan S, Kovacs}

TR, et al. (October 2, 2017) What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus Journal of Medical Science 9(10): e1736. doi:10.7759/cureus.1736 2. MacEwan MR, MacEwan S, Wright AP,

et al. (August 27, 2017) Comparison of a Fully Synthetic Electrospun Matrix to a Bi-Layered Xenograft in Healing Full Thickness Cutaneous Wounds in a Porcine Model. Cureus Journal of Medical Science 9(8): e1614. doi:10.7759/cureus.1614

3. MKG-20002 IFU 4. EDS-70023 5. Data on file

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Restrata is engineered to be structurally

similar to native human extracellular matrix

5

Restrata is indicated for a

variety of conditions including:

5

• Surgical and trauma wounds • Partial and full-thickness wounds • Acute and chronic wounds • Tunneling and exudating wounds • VLUs, DFUs and pressure ulcers • Burns

Restrata nanofiber matrix features:

• Fiber size and structure supports cellular ingrowth,

differentiation, and retention1, 2

• Porosity supports granulation and vascularization2

• Controlled resorption rate via hydrolysis2

• Resistant to enzymatic degradation2

• Excellent biocompatibility1, 2

• Tensile strength similar to human skin1

• Slightly acidic byproducts, potentially lowering pH of local microenvironment4

85% of wounds treated with Restrata achieved complete closure at 12 weeks, with an average time

to complete wound healing of 4.8 +/- 3.0 weeks3

Restrata demonstrated increased granulation, neovascularization and epithelialization versus Integra Bilayer Wound Matrix in a large animal model2

100% of wounds treated with Restrata

were granulated after 15 days,

compared to 20-50% of wounds treated with Integra Bilayer Wound Matrix2

0 5 10 15 20 RESTRATA® Integra® 30 0 10 20 W ound Sc or e W ound Ar ea ( cm 2) Day 30 Day 15 Time (Days) Integra® RESTRATA®

Integra® Bilayer Wound Matrix Restrata® Wound Matrix 0 2 4 6 8 10

Wound Edges Exudate Quantity Epithelialization

Resorbable

Electrospun Matrix

FDA clearance: April 2017

Restrata’s Fibers Human Tissue Xenogenic Collagen

All wounds (n=82) (n=34)DFUs (n=34)VLUs Other wounds (n=14) Complete wound closure at 6 weeks Number of wounds, n (%) 53 (64.6%) 21 (61.8%) 23 (67.6%) 9 (64.3%) Complete wound closure at 12 weeks Number of wounds, n (%) 68 (85.0%) 28 (84.8%) 30 (90.9%) 10 (71.4%) Mean ± SD 4.8 ± 3.0 4.7 ± 2.7 5.3 ± 3.4 3.7 ± 2.7 Closure in multiple wound types3

Nanofiber Matrix

Restrata is engineered to be structurally

similar to native human extracellular matrix

5

Restrata is indicated for a

variety of conditions including:

5

Restrata nanofiber matrix features:

Resorbable

Electrospun Matrix

Nanofiber Matrix

Restrata is engineered to be structurally

similar to native human extracellular matrix

5

Restrata is indicated for a

variety of conditions including:

5

Restrata nanofiber matrix features:

Resorbable

Electrospun Matrix

Nanofiber Matrix

Restrata is engineered to be structurally

similar to native human extracellular matrix

5

Restrata is indicated for a

variety of conditions including:

5

Restrata nanofiber matrix features:

Resorbable

Electrospun Matrix

Nanofiber Matrix

Restrata’s

Hybrid-Scale Fibers Human Tissue Xenogenic Collagen

Restrata hybrid-scale fiber matrix features:

Restrata is engineered to be structurally

similar to native human extracellular matrix

5

Restrata is indicated for a

variety of conditions including:

5

Restrata nanofiber matrix features:

Resorbable

Electrospun Matrix

Nanofiber Matrix

Fiber size and structure supports cellular ingrowth and

retention1, 2

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Size up to 10 x 12.5 cm

Acera Surgical, Inc. (“Acera,” St. Louis, MO) is a bioscience company commercializing a portfolio of implantable

for medical applications.

References

1. MacEwan MR, MacEwan S, Kovacs TR, et al. (October 2, 2017) What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Sc old. Cureus Journal of Medical Science 9(10): e1736. doi:10.7759/cureus.1736

2. MacEwan MR, MacEwan S, Wright AP, et al. (August 27, 2017) Comparison of a Fully Synthetic Electrospun Matrix to a Bi-Layered Xenograft in Healing Full Thickness Cutaneous Wounds in a Porcine Model. Cureus Journal of Medical Science 9(8): e1614. doi:10.7759/cureus.1614

3. Regulski M, MacEwan M; Implantable Nanomedical Sca ilitates Healing of Chronic Lower Extremity

Part Number Size (cm) Size (in)

RWM1-1X1 2.5 x 2.5 1x 1

RWM1-1X2* 2.5 x 5.0 1x 2

RWM1-2X2 5.0 x 5.0 2x 2

How to Order

Call/fax Acera Customer Service (844) 879-2237

Or visit acera-surgical.com

7.5 x 7.5 cm

2.5 x 7.5 cm 5.0 x 5.0 cm

2.5 x 2.5 cm

Actual size of product Store at room temperature

Restrata is easy to use



Terminally sterilized



Two-year shelf life



No human or animal tissue components—no specials torage and handling requirements



Six va ailable sizest or educe waste and cost



No requirement for specific orientation when implanting



Suitable for use in patients with specific ethnic or religious objections to tissue grafts

Restrata is easy to apply

1. Select appropriate size 2. Fenestrate if desired 3. Cut to fit

4. Hydrate as needed

5. Fixate with Steri-Strips, staples, or sutures RWM1-3X3 7.5 x 7.5 3 x 3 RWM1-4X5* 10.0 x 12.5 4 x 5 RWM1-1X3 2.5 x 7.5 1 x 3 FSS #V797P-36F79718D0525 2.5 x 5.0 cm

*Available as open market purchase items in VA facilities.

®



S tore at ambient temperature for off-the-shelf use

Synthetic Hybrid-Scale Fiber Matrix

Synthetic hybrid-scale fiber

®

Acera Surgical, Inc. (“Acera,” St. Louis, MO) is a bioscience company commercializing a portfolio of synthetic hybrid-scale fiber matrices for medical applications.

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RESTRATA® Benefit and Response During COVID-19

Differentiating Restrata from Other Wound Treatments

A Non-biologic is the Preferred Option

The benefit of a non-biologic resonates even more during the COVID-19 crisis. Non-biologics can be

clearly differentiated in terms of non-risk to the patient and the facility in comparison to skin substitutes

or Human Cellular Tissue products (HCT/P) that can pose a risk to patients and facilities due to the

biologic component inherent in these products. Many require special handling and licensure by each

State that is no doubt being challenged during the pandemic. This was previously borne out with the Zika

virus where hospital personnel questioned the potential risk in utilizing HCT/P products.

Benefits of Restrata

•

Restrata is a non-biologic, synthetic matrix that is terminally sterilized and presents no risk of

disease or viral transmission

1

_{in contrast to HCT/Ps or other skin substitutes.}

•

Restrata is wholly manufactured in the USA and Acera's supply chain is not at risk of interruption

due to disease or foreign threats. Restrata's manufacturing capabilities risk no interruption as

harvesting of human or animal tissues is not required.

•

Some human amniotic suppliers are finding restricted access to labor and delivery units at

hospitals when procuring placentas for HCT/P processing. Additionally, there are preliminary

studies suggesting vertical transmission of COVID-19 through the placenta to the fetus is a risk.

2

•

Restrata does not require weekly re-application; it persists in the wound for weeks, reducing the

number of clinic visits for patients translating to less risk of exposure to COVID-19 or other viruses.

•

Emergent wound cases requiring surgical intervention may be reduced with the positive healing

outcomes demonstrated with Restrata.

•

Restrata time-to-healing may reduce inpatient cases freeing hospital beds for COVID-19 cases.

•

Restrata ease-of-use does not require extensive monitoring as it is NOT a dressing and is NOT

removed

3

_.

•

Restrata provides a cost benefit to Medicare due to the need for fewer applications throughout

the wound healing process. The facility can save monies with less product purchases required.

•

Restrata does not require special storage or handling and can be transported, stored, and utilized

in alternative health care sites of service

3

_.

•

Restrata’s two-year shelf life is advantageous for hospitals/clinics that want to stock-up product to

reduce contact with vendors contracts minimizing frequent deliveries.

•

Religious and ethnic concerns do not exist with Restrata as with HCT/P products from human

origin, as Restrata is a non-biologic, non-human, and non-animal product. This may eliminate

concerns and religious objections of patients who are Native American, Muslim or Jehovah’s

Witness.

1_{MacEwan MR, MacEwan S, Kovacs TR, et al. (October 2, 2017) What Makes the Optimal Wound Healing Material? A Review of Current Science and}

Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus Journal of Medical Science 9(10): e1736. doi:10.7759/cureus.1736 2_{JAMA. 2020;323(18):1788-1789. doi:10.1001/jama.2020.4868}

3_{MKG-20002 Restrata IFU. Please refer to the Restrata package insert for approved indications and instructions for use.}

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Coding and Reimbursement News

Restrata

®

_{Billing and Coding Recommendations}

PRODUCT CODE – OUTPATIENT PLACE OF SERVICE ONLY – effective 7/1/2020

HCPCS

Descriptor

C1849 Skin substitute, synthetic, resorbable, per square centimeter

Source: https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

PRODUCT CODE – INPATIENT PLACE OF SERVICE ONLY – Patient Admits - effective 1/1/2019

HCPCS Descriptor

A6460 Synthetic resorbable wound dressing, sterile, pad size 16 sq. in. or less, without adhesive border, each

dressing. Effective 1/1/2019

A6461 Synthetic resorbable wound dressing, sterile pad size more than 16 sq. in. but less than or equal to 48

sq. in., without adhesive border, each dressing. Effective 1/1/2019

REVENUE CODE – HOSPITAL FACILITY

(Source: NUBC; 2010)

UB-04

Descriptor

INPATIENT

510 Outpatient clinic

361 Operating room services, minor surgery

490 Ambulatory surgery center

761 Treatment room

PROCEDURE APPLICATION CODE – OUTPATIENTS ONLY Medicare Payment*

CPT

Descriptor

APC

Payment

HOPD

Payment

ASC

15271 Application of skin substitute graft to trunk, arms, legs, total wound surface

area up to 100 sq. cm., first 25 sq. cm. or less wound surface area 5054 $1622.74 $819.95

+15272 each additional 25 sq cm wound surface area, or part thereof (List

separately in addition to code for primary procedure) Packaged

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 areas of infants and children 5055 $2,976.96 $1,504.38

+15274 each additional 100 sq cm 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) Packaged

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 sq cm or less wound surface area 5054 $1,622.74 $819.95

+15276 each additional 25 sq cm wound surface area, or part thereof (List

separately in addition to code for primary procedure) Packaged

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 m; first 100 sq cm wound surface area, or 1% of body area of infants and children

5054 $1,622.74 $819.95

+15278 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 primary procedure code) Packaged

Source: CPT 2020 Professional Edition, American Medical Association, Chicago and https://www.cms.gov/Medicare/Medicare-Fee-For-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates

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Coding and Reimbursement News

Restrata Billing Example – UB-04 Claim

Form (CMS-1450)

Part Number UPC Restrata Product Description Total SQ CM Units to Bill (per sq cm) HCPCS Code

RWM1-1x1 854258006068 2.5 cm x 2.5 cm 6.25 6 C1849 RWM1-1x2 854258006129 2.5 cm x 5 cm 12.5 13 C1849 RWM1-1x3 854258006075 2.5 cm x 7.5 cm 18.75 19 C1849 RWM1-2x2 854258006082 5.0 cm x 5.0 cm 25 25 C1849 RWM1-3x3 854258006099 7.5 cm x 7.5 cm 56.25 56 C1849 RWM1-4x5 854258006112 10 cm x 12.5 cm 125 125 C1849

Restrata is billed per square centimeter; one billed unit is 1 cm2.

Frequently Asked Questions

Q. What is the “Q” code for Restrata®?

A. Restrata is classified as a synthetic skin substitute, with the assigned HCPCS code C1849 in the HOPD/ASC. Q. What CPT code does the physician bill for the application of Restrata in the HOPD or ASC?

A. CMS has confirmed that the provider bills the skin substitute application coding series CPT 15271-15278. Q. What is the Medicare reimbursement rate for Restrata in the HOPD?

A. CMS assigned C1849 to the high cost APC bundle payable at the National Medicare allowable of $1,622.74.

Medicare will pay 80 percent of the allowable, with the patient responsible for the remaining 20 percent.

Q. What is the Medicare reimbursement rate for Restrata in the ASC?

A. There is no separate payment for C1849 in the ASC. It is bundled into the application codes and payable at

$819.95 in 2020 for CPT application codes 15271, 15275, and 15277 and at $1,504.38 for code 15273.

Q. How is Restrata reimbursed by Medicare when applied in the Operating Room for a patient admitted? A. Restrata is reimbursed the same as any other like product in the O/R setting. If the patient is admitted to a

hospital bed, the reimbursement is bundled into the assigned DRG and paid as a lump-sum payment. There is no separate line item payment for the surgical supply item/product. If used in the Critical Access Hospital (CAH)

the hospital is reimbursed by Medicare at cost plus one percent and not the DRG lump sum payment.

Q. When are the UB-04 revenue codes used?

A.

It is recommended that revenue cycle managers add Restrata to the charge master with related revenue codes to ensure tracking of costs to the facility cost center where the product is used.

Q. What CPT code does the provider bill for product application when the patient is admitted to the hospital post-treatment in the Operating Room?

A. Providers bill CPT codes related to site preparation (CPT 15002-15005) or debridement (CPT 11042-11047) if the

patient is admitted to the hospital and the A6460/A6461 code is billed for Restrata.

Q. Is Restrata subject to Medically Unlikely Edits (MUEs) in the Hospital Outpatient Department?

A. Medicare confirmed there are no MUEs associated with HCPCS C1849.

RESTRATA REIMBURSEMENT SUPPORT HOTLINE – CALL (877) 893-2570 OR

[email protected]

Disclaimer: This has been prepared for providers using Restrata and is intended for informational purposes only. It does not represent a statement promise or guarantee by Acera Surgical, Inc. concerning coverage, levels of reimbursement, payment, or charges. It is not intended to increase or maximize reimbursement. The decision as to how to complete a reimbursement claim form is exclusively the responsibility of the provider. Reimbursement policies change frequently. The ultimate responsibility for coding and claims submission belongs with the physician, clinician, hospital, or other facility.