Oscar Commercial Clinical Policy

Oscar Bioengineered Skin and Soft Tissue Substitutes (CG030) Form

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Injuries and Damage to the Skin

Injuries and damage to the skin or underlying soft tissue can occur through a number of different mechanisms. Common causes may include severe burns, accidents, surgical procedures, and ulcers (e.g., diabetic or venous stasis ulcers). In most cases, conservative treatment, such as optimizing blood flow, preventing or treating infections, keeping the tissue moist, and clearing any dead tissue is adequate. However, some wounds require more advanced techniques to promote wound healing in the presence of other comorbidities or due to the extent of the damage. In such cases, biologic or synthetic skin/tissue products may be grafted to the wound. These skin/tissue products can provide living cells and/or a scaffold to encourage wound closure, promote tissue regeneration, or provide structural support. They can be "donated" from another site on the member’s body or bioengineered depending on the specific indication. Such procedures are often part of a multidisciplinary wound care treatment plan.

This guideline outlines the clinical criteria, indications, and exclusions for bioengineered skin and soft tissue substitutes. This document does not address cosmetic or reconstructive skin procedures, blood-derived products for chronic wound healing, hyperbaric oxygen therapy, negative pressure wound therapy, suction devices, infrared or electrical stimulation, or other types of wound management.

Certain skin and soft tissue substitutes may be considered as part of medically necessary breast reconstruction as per the Plan Clinical Guideline: Breast Procedures (CG036).

Definitions
  • Allograft (Allogeneic transplant) is the transfer of tissue from a genetically non-identical donor of the same species.
  • Bioengineered Skin Substitutes, also referred to as Human Skin Equivalents (HSE), are engineered, "artificial skin" products or combinations of skin products and other materials. They can be acellular or cellular, as defined below, and can be contained within a framework called a matrix, which can be synthetic or natural.
  • Cellular Dressing refers to a bioengineered skin substitute containing at least one layer of live cells (e.g., fibroblasts, keratinocytes, epidermal cells, dermal cells, etc). The cells can be derived from the member's own body (i.e., autologous), a human donor (i.e., allogeneic), or from another species (i.e., xenographic). They can also be derived from different tissues other than skin, such as placenta, intestine, or synthetic/composite materials. Cellular dressings provide a framework for the member’s own body to begin wound healing as well as other growth factors and cells to facilitate this process. Some examples are, but not limited to:
  1. AmnioBand/Guardian (Q4151) - an allograft placental matrix comprised of donated human amnion and chorion.
  2. Apligraf (Q4101) - a living, bilayered (epidermal and dermal) skin substitute derived from human keratinocytes and fibroblasts
  3. Dermagraft (Q4106) - a human fibroblast-derived dermal substitute
  4. Epicel (Q4100) - a cultured epidermal autograft
  5. Epifix (Q4186) - a multilayer biologic allograft derived from human amniotic membrane
  6. Grafix Core and Grafix PRIME (Q4132-Q4133) - extracellular matrix containing growth factors designed as allografts with endogenous mesenchymal stem cells; Grafix Core is derived from chorionic placental tissue and Grafix PRIME is derived from the amniotic membrane of placental tissue
  7. OrCel (Q4100) - a bilayered skin substitute consisting of epidermal keratinocytes and dermal fibroblasts in two layers of bovine collagen
  8. Theraskin (Q4121) - a biologically active epidermal and dermal skin substitute consisting of cryopreserved human skin allograft, fibroblasts, keratinocytes, and extracellular matrix
  9. TransCyte (Q4100) - a biosynthetic dressing consisting of allogeneic human dermal fibroblasts
  • Acellular Dressing refers to a bioengineered skin substitute containing matrix or scaffold materials (e.g., collagen, hyaluronic acid) but without any living cells. Acellular matrix provides a foundation for the member’s cells to begin building upon to aid in wound healing. Some examples are, but not limited to:
  1. Allopatch (Q4128)- a hydrated allograft acellular dermal matrix uniquely derived from human tissue processed to remove epidermal and dermal cells
  2. Biobrane/Biobrane-L (Q4100) - a biosynthetic wound dressing constructed from a silicon film with nylon impregnated into the dressing
  3. Cortiva (Allomax/NeoForm) (Q4100), Alloderm (Q4116), FlexHD (Q4128)
  4. DermACELL (Q4122) - human acellular dermal matrix with ≥97% of donor DNA removed.
  5. Integra Bilayer Matrix Wound Dressing (Q4104), Integra Meshed Bilayer Wound Matrix (C9363), and Integra Dermal Regeneration Template (Q4105) - cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layers
  6. Graftjacket Regenerative Tissue Matrix (Q4107) - a cadaveric dermal and epidermal skin substitute
  7. Oasis Wound Matrix (Q4102) - an extracellular matrix material derived from the submucosal layer of porcine small intestine
  • Grafting is when a material (whether organic or synthetic) is transplanted to cover an injury or wound. There are several graft types:
  • "Autologous" grafting (i.e., autograft) refers to a graft derived from the patient’s own skin/tissue, and can be referred to as partial- or split-thickness depending on how it is harvested.
  • "Allogeneic" grafting (i.e., allograft) refers to a graft derived from another human other than the member (e.g., cadaver).
  • "Xenographic" grafting refers to a graft derived from non-human organisms (e.g., cows, pigs, etc.).
  • "Synthetic" grafting refers to a graft that is derived from man-made materials.
  • "Composite" grafting refers to a graft derived from various materials or organisms that can be interlinked to create a final product, such as a combination of human cells and synthetic matrix.
Epidermolysis Bullosa (EB)

"Epidermolysis Bullosa (EB)" is a rare disease characterized by fragile skin and recurrent blisters resulting from minor irritation or trauma, typically presenting in early childhood. The resulting blisters may form large, painful wounds that resemble severe burns, and may require extensive grafting. Epidermolysis Bullosa can be categorized as Epidermolysis Bullosa Simplex (most common type with majority of mutations in the keratin genes KRT5 and KRT14), Junctional Epidermolysis Bullosa (majority of mutations in the laminin-332 genes), and Dystrophic Epidermolysis Bullosa (mutations in the COL7A1 gene).

Clinical Indications

General Criteria

In addition to the product-specific criteria outlined below, ALL of the following criteria must be met:

  1. The procedure is performed by a licensed practitioner per state and federal law; and
  2. Members using tobacco products have received cessation counseling and been informed of the impact of smoking on surgical outcomes prior to the procedure; and
  3. Medical records document ALL of the following (unless the review of request is upon prior auth and wound characteristics are not available until after surgery, the surgery must meet medical necessity and the planned brand of tissue must be identified in request) :
  • a. Medical necessity for the skin/tissue substitute; and
  • b. Wound characteristics, including the size, location, depth, underlying conditions; and
  • c. Previous methods, response, and duration of conservative therapy; and
  • d. Full treatment plan that accompanies the bioengineered skin/tissue substitute.

4. The duration and frequency of the treatment plan is ordered as follows:

  • a. Treatment is limited to one initial application; and
  • b. Additional applications may occur at a minimum of 1 week intervals up to a maximum of 12 weeks (specific number of treatments may vary) and only when there is evidence of wound healing (e.g., reduced ulcer size, increasing epithelialization).
Product-Specific Criteria

Alginate or other fiber gelling dressing (A6196-A6199)

Alginate or other fiber gelling dressing (A6196 - A6199) is considered medically necessary when the following criteria is met:

  • For moderate to heavy exudating partial and full thickness wounds (e.g., pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds, and 1st and 2nd degree burns).

AmnioBand/Guardian (Q4151), AlloPatch (AllopatchHD) (Q4128)

AmnioBand/Guardian (Q4151) or AlloPatchHD (Q4128) are considered medically necessary when the following criteria are met:

  1. For diabetic foot ulcers, when the following characteristics are present:
    • a. The ulcer has no evidence of infection; and
    • b. Full thickness (i.e., extends through the dermis) neuropathic diabetic foot ulcer; and
    • c. The ulcer does not expose bone, tendon, muscle, or joint capsule; and
  2. A minimum of 4 weeks of appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight: and
  3. The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%; and
  4. The member must have adequate circulation to the affected extremity, and may be defined by one or more of the following:
    • a. Transcutaneous oxygen test (TcPO2) ≥30 mmHg; or
    • b. Ankle-brachial index (ABI) between 0.7 and 1.2; or
    • c. Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
    • d. Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).

Artiss (C9250)

Artiss (C9250) is considered medically necessary when the following criteria are met:

  1. Members age 1 or older with severe burns undergoing autologous skin grafting; and
  2. Body surface area of burn(s) is not more than 40%

Breast Reconstructive Surgery

Cortiva (AlloMax/NeoForm) (Q4100), Alloderm/Alloderm RTU (Q4116), DermACELL (Q4122), or FlexHD (Q4128) are considered medically necessary when the following criteria are met:

  1. For use in members when in conjunction with a medically necessary breast reconstructive surgery;and
  2. The member had completed discussion with the provider about the risks and benefits of implant-based breast reconstruction with or without these acellular dermal matrices. (In general, the FDA has provided a safety communication that acellular dermal matrix products have not been approved/cleared for breast reconstruction).

Biobrane/Biobrane-L(Q4100)

Biobrane/Biobrane-L (Q4100) is considered medically necessary when ONE of the following criteria are met:

  1. Biobrane: For the temporary covering of superficial, partial-thickness thermal injury; or
  2. Biobrane-L: Covered when the criteria for Biobrane are met AND the dressing is used as an adjunct to a meshed autograft.

Dermagraft (Q4106)

Dermagraft (Q4106) is considered medically necessary when the following criteria are met:

  1. Dermagraft is not being used in conjunction with Dakin's solution, chlorhexidine, polymyxin/nystatin, or any other cytotoxic solution due to breakdown and loss of effectiveness as demonstrated in clinical studies; and
  2. Dermagraft is not ordered for members under the age of 18, pregnant women, members receiving immunosuppressive therapy (e.g., steroids, chemotherapy), or members with ulcers overlying Charcot's deformity; and
  3. Treatment strictly adheres to FDA labeling guidelines, as documented by the 24-step procedure; and
  4. For dystrophic epidermolysis bullosa wounds; or
  5. For diabetic foot ulcers, when the following characteristics are present:
    • a. Full thickness (i.e., extends through the dermis) neuropathic diabetic foot ulcer; and
    • b. The ulcer does not expose bone, tendon, muscle, or joint capsule; and
    • c. The ulcer has no evidence of infection or a sinus tract; and
  1. e. A minimum of 6 weeks of appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight; and
  2. f. The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%.

DermACELL (Q4122)

DermACELL (Q4122) is considered medically necessary when the following criteria are met:

  1. For diabetic foot ulcers, when ALL the following characteristics are present:
    • a. Full thickness (i.e., extends through the dermis) diabetic foot ulcer; and
    • b. The ulcer does not expose bone, tendon, muscle, or joint capsule; and
    • c. The ulcer has no evidence of infection or a sinus tract; and
    • d. The member must have adequate circulation to the affected extremity, and may be defined by:
      • Transcutaneous oxygen test (TcPO2) ">=30 mmHg; or
      • Ankle-brachial index (ABI) between 0.8 and 1.2; or
      • iii. Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
      • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
    • e. A minimum of 4 weeks of appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight; and
    • f. The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%.

Epicel (Q4100)

Epicel (Q4100) is considered medically necessary per FDA-approved Humanitarian Device Exemption (HDE) when ONE of the following criteria are met:

  1. For deep-dermal or full-thickness burns reaching a total body surface area (BSA) ">= 30%; or
  2. For use in conjunction with split-thickness autografts or alone in members who are not candidates for autografting given the severity and/or extent of the thermal injury or the instability of the current overall condition.

Epifix (Q4186)

Dehydrated Human Amnion/Chorion Membrane (dHACM) Epifix (Q4186) is considered medically necessary when the following criteria are met:

  1. The ulcer has no evidence of infection or malignancy; and
  2. The member does not have an autoimmune connective tissue disease; and
  3. The patient is not being treated with radiation, chemotherapy, or COX-2 inhibitors; and
  4. For diabetic foot ulcers, when the following characteristics are present:
    • a. Full thickness (e.g. extends through the dermis) neuropathic diabetic foot ulcer; and
    • b. The ulcer does not expose bone, tendon, muscle, or joint capsule; and
    • c. A minimum of 4 weeks, and a maximum of 52 weeks, of appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight: and
    • d. The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%; and
    • e. The member must have adequate circulation to the affected extremity, and may be defined by:
      • Transcutaneous oxygen test (TcPO2) ">=30 mmHg; or
      • Ankle-brachial index (ABI) between 0.7 and 1.2; or
      • iii. Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
      • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
  5. The wound is between 1cm2 and 25cm2.
  1. For venous insufficiency skin ulcers, when the following characteristics are present:
    • a. Ulcer must be chronic, non-infected, partial- or full-thickness and due to venous insufficiency; and
    • b. A minimum of 4 weeks of appropriate conventional therapy has failed or been ineffective; and
    • c. Conventional therapy must have included at least 14 days of standard therapeutic compression; and
    • d. The member must have adequate circulation to the affected extremity, and may be defined by:
      • Transcutaneous oxygen test (TcPO2) ">=30 mmHg; or
      • Ankle-brachial index (ABI) between 0.7 and 1.2; or
      • ii. Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
      • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
    • e. The wound is between 2cm2 and 20cm2; and
    • If the member has diabetes, the hemoglobin A1C is less than 10%; and
    • g. The ulcer is not on the dorsum of the foot or at least 50% of the ulcer is below the malleolus.

Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).

Integra Bilayer Matrix Wound Dressing (Q4104), Integra Meshed Bilayer Wound Matrix (C9363), or Integra Dermal Regeneration Template (Q4105)

Integra Bilayer Matrix Wound Dressing (Q4104) or Integra Meshed Bilayer Wound Matrix (C9363) or Integra Dermal Regeneration Template (Q4105) are considered medically necessary when the following criteria are met:

  1. Hemostasis must be obtained prior to application, as blood products may interfere with application; and
  2. Integra Bilayer Matrix Wound Dressing, Integra Meshed Bilayer Wound Matrix, or Integra Dermal Regeneration Templates for deep partial and full-thickness thermal injury (i.e., second and third degree burns), when applied on the day of excision and when ONE of the following characteristics are present:
    • a. There is inadequate remaining skin to perform autografting; or
    • b. The member is too ill for further autografting.

Integra Dermal Regeneration Template for diabetic foot ulcers when ALL of the following characteristics are present:

  1. Full thickness (e.g. extends through the dermis) neuropathic diabetic foot ulcer; and
  2. The ulcer does not expose bone, tendon, muscle, or joint capsule; and
  3. The member must have adequate circulation to the affected extremity, as defined by:
    • Transcutaneous oxygen test (TcPO2) ≥30 mmHg; or
    • Ankle-brachial index (ABI) between 0.7 and 1.2; or
    • Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
    • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
  4. A minimum of 6 weeks of appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight; and
  5. The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%.

OrCel (Q4100)

OrCel (Q4100) is considered medically necessary when ONE of the following criteria are met:

  1. To close and heal wounds in children with dystrophic epidermolysis bullosa who are undergoing hand surgery, including donor sites; or
  2. To be applied to donor sites in members who have been burned and required autografting.

Apligraf (Q4101), Oasis Wound Matrix (Q4102), or Theraskin (Q4121)

Apligraf (Q4101), Oasis Wound Matrix (Q4102), or Theraskin (Q4121) is considered medically necessary when the following criteria are met:

  1. Apligraf is not being used in conjunction with Dakin's solution, chlorhexidine, polymyxin/nystatin, or any other cytotoxic solution due to breakdown and loss of effectiveness as demonstrated in clinical studies; and
  2. For diabetic foot ulcers, when all of the following characteristics are present:
    • Full thickness (e.g., extends through the dermis) neuropathic diabetic foot ulcer; and
    • The ulcer does not expose bone, tendon, muscle, or joint capsule; and
    • The member must have adequate circulation to the affected extremity, and may be defined by:
      • Transcutaneous oxygen test (TcPO2) ≥30 mmHg; or
      • Ankle-brachial index (ABI) between 0.7 and 1.2; or
      • Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
      • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
    • Appropriate conventional therapy has failed or been ineffective, as defined by standard dressing changes, debridement as necessary, and off-loading of pressure/weight
      • For Apligraf, a minimum of 3 weeks; or
      • For Oasis Wound Matrix or Theraskin, a minimum of 4 weeks; and
    • The member has a current diagnosis of type 1 or type 2 diabetes, and the hemoglobin A1C is less than 12%.

For venous insufficiency skin ulcers, when all of the following characteristics are present:

  1. Ulcer must be chronic, non-infected, partial- or full-thickness and due to venous insufficiency; and
  2. A minimum of 4 weeks of appropriate conventional therapy has failed or been ineffective; and
  3. The member must have adequate circulation to the affected extremity, and may be defined by:
    • Transcutaneous oxygen test (TcPO2) ≥30 mmHg; or
    • Ankle-brachial index (ABI) between 0.7 and 1.2; or
    • Triphasic or biphasic doppler arterial waveforms at the ankle of the affected leg; or
    • Palpable foot pulses (e.g., dorsalis pedis or posterior tibial pulses).
  4. Conventional therapy must have included standard therapeutic compression.

TransCyte (Q4182)

TransCyte (Q4182) is considered medically necessary when ONE of the following criteria are met:

  1. For deep partial- and full-thickness thermal injury (i.e., second and third degree burns) after surgical excision has been performed, in members who need temporary wound covering prior to autografting; or
  2. For mid-dermal burns or those of an indeterminate depth that are expected to heal without autografting.

Experimental or Investigational / Not Medically Necessary

Applications beyond 12 weeks are not considered medically necessary. Retreatment of a successfully treated, healed ulcer is generally not covered.

3D bioprinted skin substitutes are considered experimental or investigational, as there is insufficient scientific evidence to evaluate its clinical safety and efficacy.

Skin/tissue substitutes or wound care treatments ordered for any indication not listed in the clinical indications or general criteria are considered investigational and/or experimental. The following skin/tissue substitutes or other wound care treatments are considered investigational and/or experimental (not all inclusive):

  • Affinity™
  • AlloMend™
  • Alloskin AC
  • AlloSkin RT
  • AlloWrap®
  • AlloWrap™ Dry
  • AlloWrap™ DS
  • Alphaplex™ with MariGen Omega3™
  • AmnioArmor™
  • AmnioCare®
  • AmnioClear®
  • AmnioExcel™
  • AmnioFix™
  • AmnioGraft®
  • Amniomatrix™
  • DualG
  • AmnioShield®
  • Belladerm®
  • Amnio wound
  • io-ConneKt®
  • Aongen™ Collagen Matrix
  • ioDDryFlex® Resorbable Ac
  • Architect Extracellular Matrix™
  • ioDExCel™
  • Artacent®
  • ioDfactor™ Zoo
  • Artelon®
  • ioDfence™
  • ArthroFLEX™
  • DOptix™ fe)
  • Atlas Wound Matrix
  • BioFiber™
  • Avance® Nerve Graft
  • BioVance®
  • Avaulta Plus™
  • CellerateRX®
  • AxoGuard® nerve connector
  • Cellesta Cord™
  • Cellesta Duo™

Axolotl DualGraft● BioDDryFlex® Resorbable Adhesion Barrier Cellesta Cord™10● Cellesta Flowable Amnion™● CelluTome™● CG CryoDerm™● CLARIX™ 100 Quick-Peel Wound Matrix● CLARIX Cord 1k● CLARIX™ FLO● CollaFix™● CollaGUARD®● Collamend™● CollaSorb™● CollaWound™● Coll-e-Derm RT™● Collexa®● Conexa™● CorMatrix®● C-QUR™● CRXa™● CryoSkin®● Cuffpatch™● Cymetra®● Cygnus®● Cytal® Wound & Burn Matrix● DeNovo® NT Graft● Dermadapt™Wound Dressing● Derma-Gide™● DermaMatrix™ (no longer distributed)● DermaPure™● DermaSpan™● Dermavest™● Dermavest 2™● DressSkin™● Duraform™● Duragen™ Plus● Duragen® XS● DuraMatrix™● Durepair®Regeneration Matrix● Endobon® Xenograft Granules● Endoform™● ENDURAgen™● EpiBurn®● EpiCord®● EpiDex®● EpiFix™, particulate or injectable form● Excellagen®● E-Z Derm™● FloGraft™● FlowerAmnioFlo™ or FlowerFlo™● FlowerAmnioPatch™ or FlowerPatch™● FlowerDerm™● FortaDerm™ Wound Dressing● Fortiva™Porcine Dermis● Gammagraft™● Genesis Amniotic Membrane● GORE BIO-A® Fistula Plug● Graftjacket™ Xpress injectable● GraftRope™Hyaluronic acidAbsorbent WoundDressing● Helicoll™● hMatrix®● Hyalomatrix®● Inforce®● InnovaMatrix AC (Triad Life SciencesInc. )● Integra™ Matrix Wound Dressing● Integra Flowable Wound Matrix™● InteguPly™● Jaloskin®● Kerecis®● Keroxx™● LiquidGen™● MariGen Omega3● Matriderm®● Matrion™● MatriStem® MicroMatrix● MatriStem/ rebranded to Gentrix Surgical Matrix● Matrix HD™● Medeor™● MediHoney®● Mediskin®● Memoderm™● Menafiex™ Collagen Meniscus Implant● Meso BioMatrix™● Microlyte Matrix (Imbed Biosciences)● Nanofactor™ Flow● Nanofactor™ Membrane● NeoPatch™● NEOX® 100 Quick-Peel Wound Matrix● NEOX® 1k Wound Matrix● NEOX®FLO● Neuragen®● NeuraWrap™● Neuro﹏ex™● NeuroMatrix™11● NeuroMend™● Novachor™● NovoSorb® BTM, NovoSorb SynPath● NuCel®● NuShield®● OrthADAPT™● OsseoGuard®● Ovation®● OviTex, Reinforced Tissue Matrix (TELA Bio mesh)● PalinGen Flow™● PalinGenHydromembrane● PalinGen Membrane● PalinGenSportFlow™SportFlow™● PalinGen XPlus Hydromembrane● PalinGen XPlus Membrane● Pelvicol®● Pelvisoft®● Peri-Guard® Repair Patch● Peri-Strips Dry®● Perlane®● Permacol™● Phasix Mesh™● Preclude® Pericardial Membrane● Preclude® Vessel Guard● Primatrix™● PTFE felt● Puracol®● Puraply™● Puros® Dermis● PX50® and X50® Plus● Repliform®● Repriza™● Restore®Orthobiologic SoftTissue Implant● Restorigin Amnion Patch, Restorigin Amniotic FluidTherapy™Therapy™● Restylane®● Revita● Revitalon™● Seamguard®● SERI® Surgical Scaffold● SIS Wound Dressing II● SJM™ Pericardial Patch● SkinTE™● SportMatrix● SportMesh™● SS Matrix™● Sterishield II Amnion Patch● Stimulen™ Collagen● StrataGraft®● Strattice™● Stravix® / StravixPL● Suprathel®● SurgiGRAFT™, SurgiGRAFT nano, SurgiGRAFT-Dual● SurgiMend®Surgisis® (includingSurgisis® AFP™ AnalFistula Plug,Surgisis® Gold™Hernia Repair Grafts,andSurgisis®Biodesign ™)● Symphony (Aroa Biosurgery)● Talymed ™● TenoGlide™● TenSIX™● TEXAGEN™Amniotic MembraneAllograftAllograft● TheraForm™ Standard/Sheet● TheraGenesis(Bioventus LLC)● TissueMend®● Tornier® BioFiberAbsorbableBiological Scaffold● TranzGraft®● Tutomesh™Fenestrated BovinePericardium● Tutopatch™ Bovine Pericardium● Unite™● Vascu-Guard®● Veritas® Collagen Matrix● VIM Amniotic Membrane (Cook Biotech)● WoundEx®● XCelliStem Wound Powder (Stemsys)● XCM Biologic™● Xelma®● XenMatrix™● XenMatrix™ Surgical Graft● XenoSure® Biologic● X-Repair12● XWRAP® (Hydro,DRY, and ECM)