CurrentPremera BluecrossPolicy 7.01.113

Bioengineered Skin and Soft Tissue Substitutes

Defines medical necessity, investigational uses, documentation and coding for bioengineered skin and soft tissue substitute products used in wound care, burns, and reconstructive procedures for Premera Blue Cross members and providers.

Policy Summary

PayerPremera Bluecross

PolicyBioengineered Skin and Soft Tissue Substitutes

Policy CodePolicy 7.01.113

Change TypeInterim review (no material changes)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document wound history, standard therapy and product-specific indication before submitting requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~60+HCPCS/C codes listed

MultipleRCTs cited

newRECELL CPT codes

YesDocumentation required

Coverage Criteria and Medical Necessity

Breast reconstruction (allogeneic acellular dermal matrix)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered when specified product-specific criteria are met

Breast reconstruction with allogeneic acellular dermal matrix: Allogeneic acellular dermal matrix products listed may be considered medically necessary for breast reconstructive surgery when ANY of the following apply: there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required; OR there are viable but compromised or thin postmastectomy skin flaps at risk of dehiscence or necrosis; OR the inframammary fold and lateral mammary folds have been undermined during mastectomy and reestablishment of these landmarks is needed.

Derived from product-specific criteria in policy; apply only to listed allogeneic ADM products

Wound and burn indications

Covered when specified wound/burn indications and prior conservative therapy criteria are met

Diabetic lower-extremity ulcers (full-thickness): Treatment of chronic, non-infected, full-thickness diabetic lower-extremity ulcers using the listed tissue-engineered skin substitute products may be considered medically necessary.

See product list in policy

Venous insufficiency lower-extremity ulcers: Treatment of chronic, non-infected, partial- or full-thickness lower-extremity skin ulcers due to venous insufficiency using the listed tissue-engineered skin substitute products may be considered medically necessary when a one-month period of conventional ulcer therapy has failed to promote healing.1 month trial of conventional therapy

Explicit requirement before advanced product use

Dystrophic epidermolysis bullosa: Use of OrCel (and listed product) may be considered medically necessary for treatment of dystrophic epidermolysis bullosa when standard wound therapy has failed for mitten-hand deformity AND it is provided in accordance with the humanitarian device exemption (HDE) specifications of the U.S. Food and Drug Administration.HDE compliance

Product-specific HDE requirement

Second- and third-degree burns: Use of Integra Dermal Regeneration Template, Epicel (under HDE), and similar listed products may be considered medically necessary for treatment of second- and third-degree burns when used in accordance with the product indications and clinical context described in the policy.

Burns indication; follow product labeling

Evidence-based coverage by indication

Coverage stance summarized by clinical indication and product-level evidence

Breast reconstruction with allogeneic ADM: Randomized trials and systematic reviews show ADM use can inform individualized decision-making in breast reconstruction when tissue coverage is limited; evidence is sufficient to conclude improvement in net health outcome for selected patients, recognizing higher rates of some complications (eg, seroma, infection) in some reports.

Apply when clinical criteria for ADM use are met

Diabetic lower-extremity ulcers: For diabetic foot ulcers, RCT evidence demonstrates improved complete wound healing at ≥12 weeks for certain products (eg, AlloPatch, Apligraf, Dermagraft, Integra, mVASC, TheraSkin); evidence supports medical necessity for those products. Evidence for other ADM products (eg, DermACELL, GraftJacket, Cytal, PriMatrix, Oasis, Kerecis) is limited, subgroup-restricted, or pending further study and is considered insufficient to establish net health benefit for general use.

Product-specific evidence distinctions noted

Venous insufficiency lower-extremity ulcers: RCTs support the efficacy of Apligraf and Oasis Wound Matrix over standard of care for venous insufficiency ulcers; these products have sufficient evidence to be considered medically necessary when other criteria are met. Evidence for other products is insufficient or mixed.

Apply prior conservative therapy requirement as specified

Deep dermal burns: Biosynthetic skin substitutes such as Integra Dermal Regeneration Template and Epicel (HDE) have comparative evidence or regulatory approvals supporting improved outcomes for deep dermal/full-thickness burns; ReCell has mixed/limited evidence and requires additional RCT data for definitive conclusions.

Follow product indications and evidence

Tendon/rotator cuff repair: Limited RCT evidence (eg, GraftJacket) shows potential benefit in rotator cuff repair but additional larger studies are needed; current evidence is insufficient to conclude a consistent net health outcome improvement for routine use.

Consider investigational/not medically necessary when criteria not met

Hernia/parastomal reinforcement: RCTs comparing acellular collagen scaffolds to synthetic mesh or no reinforcement have not shown outcome advantages; evidence is insufficient to determine net health benefit for these indications.

Not supported as routine therapy based on current evidence

Dystrophic epidermolysis bullosa: OrCel received HDE approval for hand reconstruction in dystrophic epidermolysis bullosa with case series evidence; overall evidence is insufficient to establish improvement in net health outcome beyond the HDE context.HDE context

Use limited to HDE-specified applications

BEAR implant for ACL repair: RCTs and systematic reviews suggest BEAR implant may be noninferior to ACL reconstruction on several outcomes at 2 years with potential advantages (eg, hamstring strength) but possibly higher revision rates; longer-term data and broader experience are needed to fully define net health outcomes. Indicated for skeletally mature patients ≥14 years with complete ACL tear and intact tibial stump.Patient age ≥14 years; skeletally mature; intact tibial stump

Apply device-specific indication and evidence

When to consider dermal/skin substitutes (NICE)

Use of dermal or skin substitutes per cited guidance

NICE recommendation for DFU: Consider dermal or skin substitutes as an adjunct to standard care only when healing has not progressed and on the advice of the multidisciplinary foot care service.

Reference: NICE 2023

Coverage conditioned on approved indications and supporting evidence

This section lists products and their FDA-approved/cleared indications; coverage decisions require alignment with those indications and supporting clinical evidence.

Product-indication alignment: Product selection must match the FDA-cleared or FDA-approved indication described for that product (examples: Apligraf for noninfected venous insufficiency ulcers and for certain diabetic lower-extremity ulcers; Dermagraft for diabetic foot ulcers; Epicel under HDE for extensive burns; Recell per PMA indications for specified burn and full-thickness skin defect indications).

Document product indication and supporting evidence; prior authorization may be required

All uses of bioengineered skin and soft tissue substitute products that are not explicitly listed as medically necessary in this policy are considered investigational and may be denied. This includes all products and indications not included in the policy’s medically necessary statements and product-specific criteria.

Providers should expect that requests for products or indications designated investigational will require documentation demonstrating clinical rationale and may not meet coverage requirements under the member’s benefit plan.

The policy lists many commercially available bioengineered skin and soft tissue substitute products but is not an exhaustive list. Some products included in the policy do not require FDA approval or clearance, and omission of a product from this list does not imply endorsement or coverage.

Because products vary in regulatory status and labeling, lack of FDA approval or 510(k) clearance for a specific product may affect coverage determinations and should be considered when submitting prior authorization or claims.

Some human cell, tissue, and cellular and tissue‑based products (HCT/Ps) qualify for regulation solely under section 361 and 21 CFR Part 1271 when they meet criteria for minimal manipulation, intended for homologous use, and other conditions. Products that do not meet HCT/P criteria are regulated as devices and/or biological products and are subject to applicable premarket review and regulation.

When an HCT/P does not meet these criteria, the product’s regulatory classification may require FDA premarket review (e.g., 510(k) clearance or PMA), and such regulatory status can limit or change the supported uses under this policy.

Use of products outside the FDA‑cleared or FDA‑approved labeling (including device PMA, 510(k) clearance, or HDE conditions) may be considered outside the supported indications in this policy. Such off‑label or unsupported uses can affect coverage and may be subject to additional review or denial.

For devices that have specific labeled indications (for example, living cell therapies or Recell per PMA indications), documentation must demonstrate alignment with the product’s approved context to support coverage.

Coverage for medical services and supplies described in this policy is subject to the limits and conditions of the member benefit plan. Providers and members should consult the member benefit booklet or contact customer service to confirm coverage for a specific service or product.

This medical policy does not apply to Medicare Advantage (governmental) programs; providers should verify coverage rules and limitations that apply to those payers separately.

Unless an indication or product is specifically described in the policy as medically necessary, that use is considered investigational and is not eligible for coverage under the terms of this policy.

Requests for services or products not specified as medically necessary should be accompanied by supporting clinical evidence and rationale, but may still be denied based on the investigational classification.

For many non‑wound indications the available evidence is limited or inconsistent. Examples include: tendon repair (GraftJacket) where small RCTs showed some benefit but additional larger studies are needed; hernia or parastomal reinforcement with acellular collagen scaffolds where RCTs have not shown superiority over synthetic mesh; and OrCel for dystrophic epidermolysis bullosa where evidence is limited to small series and HDE‑specific use.

Given the limited evidence base for these and similar non‑wound indications, extrapolation of positive wound‑care results to other surgical or reconstructive uses should be done cautiously and is generally not sufficient to establish coverage.

The FDA has not determined the safety and effectiveness of some acellular dermal matrix (ADM) uses for certain indications (for example, some ADM products for breast reconstruction), and FDA communications have raised concerns about higher complication rates with particular ADMs in implant‑based breast reconstruction.

Because ADM products may be regulated differently depending on processing and intended use, FDA availability of an ADM for a specific reconstructive indication does not by itself establish that all ADM uses are safe and effective for all surgical contexts.

The policy history documents prior investigational designations, coding changes, and periodic literature reviews. Past updates have added or removed products from investigational lists and have recorded coding additions or reclassifications over multiple review cycles.

Readers should note that investigational categorizations and code listings have changed over time (see history entries), and current coverage depends on the policy’s present medically necessary statements and product‑specific criteria.

Coding, HCPCS/CPT, and Product/Device Codes

RECELL CPT codesCPT

15011	Harvest of skin for skin cell suspension autograft; first 25 sq cm or less (RECELL)
15012	Harvest of skin for skin cell suspension autograft; each additional 25 sq cm or part thereof
15013	Preparation of skin cell suspension autograft; requiring enzymatic processing; manual mechanical disaggregation of skin cells, and filtration; first 25 sq cm or less of harvested skin
15014	Preparation of skin cell suspension autograft; requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; each additional 25 sq cm of harvested skin or part thereof
15015	Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing; trunk; arms, legs; first 480 sq cm or less
15016	Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing; trunk; arms, legs; each additional 480 sq cm
15017	Application of skin cell suspension autograft to wound and donor sites, including hands, feet; and/or multiple digits; first 480 sq cm or less
15018	Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing, face; scalp, eyelids, mouth, neck; ears, orbits, genitalia, hands, feet; and/or multiple digits; each additional

HCPCS/C/Q product codesHCPCS

A4100	Skin substitute, FDA cleared as a device; not otherwise specified
Q4100	Skin substitute, not otherwise specified
A2002	Mirragen Advanced Wound Matrix, per sq cm
A2004	XCelliStem, per sq cm
A2006	NovoSorb SynPath dermal matrix, per sq cm
A2007	Restrata, per sq cm
A2008	TheraGenesis, per sq cm
A2009	Symphony, per sq cm
A2010	Apis, per sq cm
A2011	Supra SDRM, per square centimeter

1–10 of 95

1/10

C-codes (selected)CPT

C9353	Microporous collagen implantable slit tube (NeuraWrap Nerve Protector), per cm length
C9354	Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm
C9356	TenoGlide Tendon Protector Sheet, per sq cm

Covered HCPCS/C codes (partial list)HCPCSCovered

C9360	Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
C9363	Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm
C9364	Porcine implant; Permacol, per sq cm
Q4103	Oasis Burn Matrix, per square centimeter
Q4104	Integra bilayer matrix wound dressing (BMWD), per sq cm
Q4107	Graftjacket, per square centimeter
Q4108	Integra Matrix; per square centimeter
Q4110	PriMatrix, per square centimeter
Q4111	GammaGraft; per square centimeter
Q4112	Cymetra, injectable

1–10 of 25

1/3

Covered HCPCS/C codes (continued)HCPCSCovered

Q4146	TenSIX, per square centimeter
Q4147	Architect; Architect PX, or Architect FX, extracellular matrix; per square centimeter
Q4149	Excellagen; 0.1 cc
Q4152	DermaPure per square centimeter
Q4158	Kerecis Omega3, per sq cm
Q4161	bio-ConneKt Wound Matrix, per square centimeter
Q4164	Helicoll, per square centimeter
Q4165	Keramatrix or Kerasorb, per square centimeter
Q4166	Cytal, per square centimeter
Q4167	Truskin; per square centimeter

1–10 of 25

1/3

ModifiersModifier

JC	Modifier: Skin substitute used as graft
JD	Modifier: Skin substitute not used as a graft

FDA product codes (examples)mixed

FTM	FDA product code cited for some ADM and living cell therapy products
OXF	FDA product code cited

FDA product codes (xenogenic)mixed

KGN	FDA product code cited for xenogenic products
FTL	FDA product code cited for xenogenic products
FTM	FDA product code cited for xenogenic products

Autologous device product codemixed

QCZ	FDA product code for Recell autologous cell harvesting device

FDA product codes — living cell/allograft productsmixed

FTM	FDA product code listed for living cell therapies (Apligraf etc.)
PFC	FDA product code listed
OCE	FDA product code listed
ODS	FDA product code listed

Autologous harvesting device product codemixed

QCZ	ReCell autologous cell harvesting device PMA product code

FDA product codes — biosynthetic productsmixed

FRO	FDA product code listed for biosynthetic products (e.g., TransCyte)
MDD	FDA product code listed
MGR	FDA product code listed

FDA product code — nerve wrapsmixed

JXI	FDA product code listed for nerve wraps

FDA product code — BEAR implantmixed

QNI	FDA product code listed for BEAR implant

Coding updates and HCPCS/CPT historymixed

Q4166-Q4167	HCPCS codes added effective 01/01/17 (as noted in history)
Q4169-Q4175	HCPCS codes added effective 01/01/17 (as noted in history)
Q4193,Q4195,Q4196,Q4197,Q4200,Q4201,Q4202,Q4203,Q4204	HCPCS codes added effective 01/01/19 (as noted in history)
A6460,A6461	HCPCS codes added 2020 (history)
Q4238	HCPCS code added under investigative section in 2020 (history)
C1849,C9354,C9356,C9358,C9360,C9363,C9364	HCPCS codes added 2020 (history)
A2001-A2034,A2036-A2039,A2026-A2029	Series of A2xxx HCPCS codes added across 2022–2025 (history)
C1763,C9353	HCPCS codes added for investigational items (BEAR implant C1763, C9353 moved in 07/01/25)
15011-15018	New CPT codes added 01/01/25

Individually mentioned HCPCS codes in history notesHCPCS

Q4104,Q4114,Q4108,Q4101,Q4102,Q4105,Q4106,Q4107,Q4116,Q4122,Q4128

Various HCPCS codes referenced in coding corrections and updates across history

inv-31: Trial of conventional ulcer therapy — required duration

Required duration of conventional ulcer therapy before advanced products1 month trial of conventional ulcer therapy must have failed to promote healing before using listed skin substitute products for venous insufficiency lower‑extremity ulcers.

inv-32: BEAR implant size/volume — device dimension and blood saturation detail

BEAR implant dimensionsImplant size 44 mm x 22 mm.

Blood saturation volumeImplant is saturated with 10 ml of autologous blood prior to implantation.

Clinical implantation contextInserted via mini‑arthrotomy into the intercondylar notch to bridge torn ACL ends; intended for skeletally mature patients ≥14 years with intact tibial stump.

Provider Responsibilities, Prior Authorization, and Documentation

Denial Risk

FDA status and coverage risk

Products without FDA approval/clearance or those cleared via 510(k) may carry coverage risk. When using products outside their FDA-indicated or cleared uses, document the rationale and supporting clinical evidence; such uses may be denied as investigational.

Verify FDA status (PMA, 510(k), HDE, or not cleared) for the product prior to ordering or application.
Document when a product is being used outside its FDA-cleared/approved indication and include supporting clinical justification in the medical record.

Note

Benefit limitations and member contract

Coverage is subject to the member's contract. Confirm member benefits and any applicable limits or prior authorization requirements before scheduling procedures.

Check the member benefit booklet or call customer service to confirm coverage, benefit limits, and any site-of-service restrictions.
Authorization or denial decisions may vary by product and by the member's specific plan.
This policy does not apply to Medicare Advantage — verify Medicare Advantage plan rules separately.

Documentation Required

Device-specific use and provider qualifications

Some devices and procedures require an appropriately licensed provider and adherence to the manufacturer's instructions for use (IFU). Use by unqualified staff or deviation from IFU may result in denial.

Ensure the procedure is performed by an appropriately licensed and credentialed clinician.
Document provider qualifications and that product use followed the manufacturer's IFU.
For autologous cell-harvesting systems (e.g., Recell), verify the provider meets the device-specific training and point-of-care use requirements.

Documentation Required

Required product indication documentation

Document the specific product, FDA indication (if any), and the clinical indication for use in the medical record. Include operative details and how the product selection aligns with FDA-approved or medically accepted indications.

Record the product name, HCPCS/C-code (when applicable), lot/batch number (if available), and amount/area treated.
Describe the indication being treated and cite relevant FDA labeling or peer-reviewed evidence when using outside labeled indications.
When applicable, document that use conforms to HDE specifications (eg, Epicel) or to FDA-approved/cleared labeling.

Step Therapy

Conservative therapy trial requirement

For certain chronic lower‑extremity ulcers and other wound indications, a trial of conservative (standard) wound therapy is required and its failure must be documented before advanced substitutes are used.

Document standard wound care measures (eg, offloading, debridement, infection control, compression therapy for venous ulcers) and duration.
For diabetic or venous ulcers, include a one‑month trial of conventional ulcer therapy and documentation that healing did not progress before using some products.
Include dates, treatments provided, response, and rationale for escalation to a skin substitute.

Step Therapy

Stepwise treatment context

Advanced bioengineered skin and soft tissue substitutes are considered part of a stepwise treatment approach and are generally used after standard wound care has failed to achieve expected healing.

Consider bioengineered products only after appropriate conservative measures have been tried and documented.
Coordinate care with the multidisciplinary wound care team (eg, vascular surgery, endocrinology, podiatry) when escalating therapy.
Reference national guidance (eg, NICE) recommending adjunctive use only when healing has not progressed.

Prior Authorization

Consider substitutes after lack of healing

When healing has not progressed with standard care, consider bioengineered substitutes as adjuncts — document multidisciplinary input and wound status to justify use.

Document that the multidisciplinary team has evaluated the wound and concurs that progression is inadequate.
Include objective wound measures (size, depth, appearance) and prior treatment responses showing lack of healing.
Consider alternatives and document why the chosen product is preferred (eg, evidence base, product characteristics).

Background and Rationale

Bioengineered skin and soft tissue substitutes are artificial alternatives to live skin grafts manufactured from human tissue (autologous or allogeneic), nonhuman (xenogenic) tissue, synthetic materials, or combinations thereof. These products include acellular dermal matrices (ADMs), cellular skin substitutes containing living cells, biosynthetic dressings, synthetic membranes, autologous cell‑harvesting systems, nerve wraps, and implantable scaffolds.

They are used across a range of clinical situations — primarily for wound care and burn management, and in reconstructive procedures — with product‑specific regulatory approvals or clearances for particular indications (for example, Apligraf and Dermagraft for certain ulcers, Epicel under an HDE for extensive burns, and device‑specific PMA or 510(k) indications for others).

Definitions and Product Types

inv-55: Bioengineered skin and soft tissue substitutes — definition and purpose

DefinitionArtificial alternatives to live skin grafts made from human tissue, nonhuman tissue, synthetic materials, or combinations, used for wound care and tissue reconstruction.

SourcesMay be derived from autologous or allogeneic human tissue, xenogenic (nonhuman) tissue, synthetic materials, or composites.

PurposeUsed as temporary or permanent wound coverings to support healing in wounds, burns, and reconstructive procedures.

inv-56: Full-thickness wound — definition

DefinitionA full‑thickness wound affects all layers of the skin (epidermis and dermis).

Clinical notePolicy documentation for wound care should specify whether a wound is full thickness versus superficial or deep dermal.

Use caseFull‑thickness diabetic lower‑extremity ulcers are listed indications for certain tissue‑engineered skin substitutes.

inv-57: Acellular dermal matrix (ADM) — definition and composition

DefinitionAcellular dermal matrix (ADM) products are dermal tissues with cellular material removed that act as a scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin.

CompositionDerived from sources such as human dermis, pericardium, or intestinal mucosa and vary by additives, hydration, and preparation method.

Regulatory noteAllograft ADM from cadaveric human skin is often regulated as banked human tissue and may not require FDA approval for homologous use when minimally manipulated.

inv-58: Cellular skin substitute — products containing living cells (examples)

DefinitionCellular skin substitutes contain living cells (e.g., fibroblasts, keratinocytes) within a matrix that may be autologous, allogeneic, or xenogeneic and can provide growth factors to stimulate healing.

ExamplesApligraf (bilayered keratinocytes + fibroblasts), Dermagraft (cryopreserved human fibroblasts on a mesh scaffold), Epicel (autologous cultured keratinocytes under HDE).

Intended effectMay supply viable cells and growth factors to promote wound healing in indicated ulcers and burn applications.

inv-59: BEAR implant — definition and clinical context

DefinitionBEAR implant is a bovine decellularized extracellular matrix collagen scaffold used to bridge complete ACL tears and promote ligament repair.

Key characteristicsSaturated with autologous blood to form a fibrin clot that bridges torn ACL ends; bioabsorbable and replaced by native tissue over weeks.

IndicationIntended for skeletally mature individuals aged ≥14 years with complete ACL rupture and an intact tibial stump.

inv-60: HCT/P — human cells, tissues, and cellular and tissue-based products regulatory definition

DefinitionHCT/Ps are human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient and are regulated under section 361 of the PHS Act and 21 CFR Part 1271 when criteria are met.

Regulatory criteriaTo be regulated solely under section 361, the HCT/P must be minimally manipulated, intended for homologous use, and not combined with other articles beyond specified exceptions.

ImplicationProducts that do not meet HCT/P criteria are regulated as devices and/or biological products and may require premarket review.

inv-61: Skin substitute (general) — note that FDA has no single category

DefinitionSkin substitute is a heterogeneous group of products used to replace or support skin and soft tissue; there is no single FDA‑recognized category for these products.

Regulatory diversityIncludes products that may not require FDA clearance as well as products cleared via 510(k) or approved through other pathways; regulatory status varies by product.

Clinical implicationProduct selection and coverage decisions must consider the individual product's regulatory clearance/approval and labeled indications.

inv-62: Living cell therapy — examples and brief definition

DefinitionLiving cell therapy products contain living human cells intended to contribute to wound healing (e.g., Apligraf, Dermagraft, Epicel).

ExamplesApligraf (bilayered keratinocytes and fibroblasts), Dermagraft (cryopreserved fibroblasts on scaffold), Epicel (autologous cultured keratinocytes under HDE).

Regulatory noteSome living cell therapies have FDA approval or clearance for specific ulcer or burn indications; FDA product codes for living cell/allograft products include FTM, PFC, OCE, ODS.

inv-63: Autologous cell harvesting device — Recell example and definition

DefinitionAn autologous cell harvesting device prepares an autologous regenerative cell suspension at point of care for direct application (e.g., Recell prepares RES Regenerative Epidermal Suspension).

Example and statusRecell (Avita Medical) is an FDA‑approved PMA autologous cell harvesting device (PMA BP170122) with indications for treatment of partial‑thickness burns and expanded indications including application with meshed autografting and full‑thickness defects in patients ≥15 years.

Use requirementMust be used by an appropriately licensed healthcare professional at the patient's point of care per labeled indications.

inv-64: Biosynthetic / Synthetic products — definition and examples

DefinitionBiosynthetic products combine biological components and synthetic materials; synthetic products are fully synthetic membranes used for temporary wound coverage.

Examples (biosynthetic)Biobrane (silicone film with nylon fabric), Integra Dermal Regeneration Template (bovine collagen/GAG with silicone), TransCyte (human fibroblasts on nylon mesh with synthetic epidermal layer).

Examples (synthetic)Suprathel (synthetic copolymer membrane) used for temporary coverage of superficial dermal burns and wounds.

inv-65: Nerve wraps — definition and intended use

DefinitionNerve wraps are biocompatible barrier devices (often collagen‑based or extracellular matrix) used to encase injured peripheral nerves to reduce scarring and compression and support nerve healing.

Intended useApplied when the nerve is intact but needs protection from scarring or compression; used in peripheral nerve repair and protection.

ExamplesProducts include AxoGuard nerve connector (small intestine submucosa) and other FDA 510(k) approved nerve wraps such as NeuraWrap and NeuroMend.

inv-66: Bioengineered skin constructs / substitutes — umbrella definition

DefinitionBioengineered skin constructs/substitutes are engineered or processed biological products (allografts, xenografts, acellular dermal matrices, engineered cell‑based products, and other biologic scaffolds) used to replace or support skin and soft tissue for wound healing and reconstructive indications.

ScopeEncompasses a wide range of products across classes (acellular, cellular, biosynthetic, synthetic, autologous devices, nerve wraps, implants) with varying evidence and regulatory status.

Clinical roleUsed for wounds, burns, reconstructive procedures, and other applications where grafting or tissue support is required; evidence base differs by product and indication.