Cohealyx^®

Cohealyx is a resorbable collagen dermal matrix engineered to prepare complex wounds that require dermal regeneration for definitive closure (ie., skin grafting) as early as Day 5. Its porous architecture provides a scaffold that supports cellular infiltration, formation of new vascularized tissue, and preparation of the wound bed for skin grafting.

Cohealyx was designed to support one of the most important milestones in reconstruction: achieving a healthy, vascularized wound bed ready for definitive closure. By combining purified Type I and III collagen, a highly porous architecture, and a ready-to-use format, Cohealyx helps surgeons prepare wounds as soon as Day 5 while integrating naturally into staged reconstructive workflows.

Cohealyx collagen dermal matrix is indicated for the management of wounds, including:

• Full thickness and partial thickness wounds
• Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
• Surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence)
• Trauma wounds (abrasions, lacerations, and skin tears)
• Draining wounds
• Partial thickness burns

Sheets

• 2 cm x 4 cm (8 cm²), sold as a carton of 1
• 5 cm x 5 cm (25 cm²), sold as a carton of 1
• 10 cm x 10 cm (100 cm²), sold as a carton of 1
• 10 cm x 20 cm (200 cm²), sold as a carton of 1
• 20 cm x 35 cm (700 cm²), sold as a carton of 1

Cohealyx is designed to prepare a healthy, vascularized wound bed for definitive closure. In clinical studies, wounds were ready for grafting as early as Day 5 (median Day 11).* Cohealyx also delivers predictable wound bed preparation; 97% autograft take compared to 85% and 68% seen with leading competitors^{^}, 4x less wound contraction compared to leading competitors^{^}, and 0% infection rate^{^}.

In a single-arm prospective study, Cohealyx supported graft readiness for definitive wound closure as soon as Day 5 (11 median). Timing for your practice should be based on clinical assessment of the wound. Once the wound demonstrates healthy vascularization and is judged ready by the treating surgeon, definitive closure with a split-thickness skin graft, with or without RECELL, may be performed.

Successful reconstruction depends on establishing a healthy, vascularized wound bed. A vascularized wound bed supplies oxygen and nutrients that support tissue regeneration and successful skin graft take. Delays in vascularization may prolong the reconstructive process, whereas establishing a healthy vascular network helps move patients toward definitive closure and supports skin graft take.

Longer time to skin grafting has been associated with longer hospital stays, a higher likelihood of graft-related complications, including infection and graft failure, and increased mortality rates. Cohealyx is designed to support the development of a healthy, vascularized wound bed, helping surgeons progress patients toward definitive closure when clinically appropriate.

Definitive closure should occur when the wound is clinically ready. Prolonged open wounds increase treatment costs and may increase the risk of complications such as infection, fluid loss, repeated procedures, delayed rehabilitation, and hypertrophic scarring. Preparing a healthy wound bed is an important step toward achieving durable closure and optimal long-term outcomes.

After application to a properly prepared wound bed, Cohealyx acts as a temporary three-dimensional scaffold. Host cells migrate into the matrix while new blood vessels develop throughout the collagen architecture. As healing progresses, the collagen matrix is gradually remodeled and replaced with the patient’s own tissue, creating a vascularized wound bed that can support definitive closure in as few as 5 days.

Cohealyx is composed of highly purified young bovine Type I and Type III collagen. These collagen types closely resemble those found in healthy human dermis and are engineered into a porous matrix that supports tissue regeneration.

Cohealyx is derived from bovine dermis, which contains both Type I and Type III collagen. Type I collagen provides much of the structural strength found in healthy dermal tissue, while Type III collagen is more prevalent during the early phases of wound healing and tissue regeneration. By incorporating both collagen types, Cohealyx is designed to provide a scaffold that more closely resembles the composition of native dermis and supports the body’s natural healing process.

Collagen type III is the first collagen produced in the wound bed during healing. It provides cues for cells to produce the other types of collagens required for optimized healing. Many studies have investigated the correlation between the severity of scarring and the amount and type of collagen present in a wound. In a particular animal model, genetically modified mice that cannot produce collagen type III lead to severe scarring outcomes, further highlighting the important role for collagen type III in wound healing.

Cohealyx is manufactured using TetraPure^™ Technology, a proprietary purification process designed to preserve the natural collagen architecture while removing unwanted cellular components and impurities. The result is a sterile collagen matrix with a highly interconnected pore structure that supports tissue ingrowth.

The pore structure of a dermal matrix influences how cells, nutrients, and new blood vessels move throughout the scaffold. A highly interconnected porous architecture allows host cells to infiltrate the matrix more efficiently while supporting neovascularization. This process is essential for creating a healthy, vascularized wound bed capable of supporting definitive closure.

Young bovine dermis was chosen because of the amount of collagen type III present. Younger mammals have more collagen type III in the skin than older mammals.

Cohealyx is crosslinked by a chemical process using an aldehyde agent.

Yes. There is no contraindication to placing Cohealyx over exposed structures in full-thickness wounds. The suitability of application over exposed tendon, bone, or hardware depends on the clinical situation.

Yes. Cohealyx is indicated for partial-thickness wounds, and donor sites are partial-thickness wounds.

Yes.

Yes. Cohealyx may be used as part of a staged reconstructive approach in which the wound is first prepared using Cohealyx before definitive closure with a split-thickness skin graft and RECELL, when clinically appropriate.

No. Cohealyx is indicated for the management of wounds. To specifically obtain approval for use in a 1-stage procedure, a premarket approval (PMA) with clinical data demonstrating safety and efficacy is required. At this time, no clinical studies are ongoing to evaluate its use in this capacity.

For optimal performance, the wound should be:

• Thoroughly debrided
• Free of necrotic tissue
• Adequately vascularized
• Hemostatic
• Free from uncontrolled infection

Proper wound bed preparation is one of the most important factors influencing successful integration of any dermal matrix.

After thorough wound bed preparation and achievement of hemostasis:

1. Trim Cohealyx to fit the wound.
2. Apply Cohealyx directly to the wound bed.
3. Hydrate Cohealyx with room temperature saline.
4. Secure Cohealyx using the surgeon’s preferred fixation method.
5. Apply an appropriate secondary dressing or negative pressure wound therapy when clinically indicated.
6. Monitor the wound during follow-up until adequate vascularization has occurred and definitive closure can be performed.

Always follow the Instructions for Use and institutional protocols.

No. Cohealyx is a homogeneous single-layer product, and it is not “sided”.

No. Cohealyx is supplied ready to use, helping simplify surgical preparation and reduce operating room workflow steps. Based on clinical experience, it is recommended to hydrate Cohealyx before securing it to the wound bed.

Yes. The matrix may be easily trimmed by the surgeon to conform to the size and geometry of the wound.

The choice of secondary dressing depends on the wound and surgeon preference. Cohealyx may be used with commonly accepted wound dressings, including negative pressure wound therapy when clinically appropriate.

Cohealyx is designed to gradually resorb as it is remodeled by the patient’s own tissue. Rather than functioning as a permanent implant, the collagen scaffold is progressively replaced by native tissue during the healing process.

Yes. Cohealyx has controlled resorption in approximately 30 days.

Follow the standard of care or protocol of the facility and/or healthcare provider if an infection is confirmed. Per the Instructions for Use, Cohealyx should not be used on infected or contaminated wounds. Cohealyx should be removed if redness, pain, swelling, or blistering occurs. Cohealyx may be replaced or reapplied at the clinician’s discretion. Cohealyx cannot be re-sterilized or reused. Open, unused Cohealyx must be discarded. In vivo stability may be adversely affected if re-sterilized. Cross-contamination and infection may occur if reused. Do not use if the product sterilization barrier or its packaging is compromised.

No. The wound should be thoroughly debrided and infection appropriately managed before application. Refer to the Instructions for Use for complete contraindications and precautions.

Cohealyx is not indicated for patients with a known allergy to bovine-derived collagen materials. The risk of transmitting bovine spongiform encephalopathy (BSE) or the human variant, Creutzfeldt-Jakob Disease, is extremely low, as BSE has been mostly eradicated worldwide.

Bovine material is sourced from North America.

Cohealyx is manufactured from purified young bovine collagen using a proprietary purification process and terminal sterilization. The purification process is designed to minimize unwanted biological material while preserving the collagen scaffold.

No. The FDA defines an implant under 21 CFR 860.3 as a device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain implanted continuously for a period of 30 days or more.

No. Cohealyx does not need to be tracked. This is in accordance with 21 CFR 821.

The product should be stored at room temperature (15°C/59°F to 30°C/86°F). Avoid excessive heat and humidity. The product is supplied sterile and should remain in its original packaging until ready for use.

No. Cohealyx is shelf stable and does not refrigeration. The product should be stored at room temperature (15°C/59°F to 30°C/86°F).

36 months at room temperature (15°C/59°F to 30°C/86°F).

PermeaDerm is a next-generation biosynthetic wound matrix—transparent, ready to use, and easy to apply for temporary coverage.

PermeaDerm is a next-generation biosynthetic wound matrix designed to provide temporary wound coverage while supporting clinical decision-making. Its transparent, dual-layer design allows continuous wound assessment while maintaining a moist healing environment until definitive closure or re-epithelialization, depending on the clinical indication.

PermeaDerm is a dual layer, fenestrated wound matrix. The outer layer of PermeaDerm is a 2D silicone epidermal analogue, while the inner layer is a 3D micro-support system with biocoating containing a hypoallergenic porcine gelatin and aloe vera.

PermeaDerm functions as a temporary epidermal substitute. Its dual-layer design helps maintain moisture balance, manage exudate, and protect the wound while allowing clinicians to continuously assess the wound bed. The transparent silicone outer layer contains stretchable fenestrations that facilitate controlled movement of gases and exudate. The inner nylon matrix is coated with porcine gelatin and aloe vera to promote adherence and maintain intimate contact with the wound surface.

PermeaDerm’s stretchable fenestrations allow clinicians to control moisture management during application. In their resting state, the fenestrations remain essentially closed to minimize wound desiccation. Gentle stretching opens the fenestrations, allowing excess exudate to pass into the secondary dressing while maintaining a moist wound environment.

PermeaDerm is indicated for partial-thickness burn wounds and other partial-thickness wounds, pressure ulcers (sores), venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Mohs, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second- degree burns, and skin tears) and draining wounds, donor sites and coverage of meshed autograft.

Sheets

• 5.0” x 5.0” (12.7 cm x 12.7 cm; 161 cm²), sold as a carton of 10
• 5.0” x 10.0” (12.7 cm x 25.4 cm; 323 cm²), sold as a carton of 8
• 10.0” x 15.0” (25.4 cm x 38.1 cm; 968 cm²), sold as a carton of 3
• 15.0” x 30.0” (38.1 cm x 76.2 cm; 2,903 cm²), sold as a carton of 1

Gloves

• XXL (1024 cm²), sold as a carton of 2
• XS (406 cm²), sold as a carton of 2
• S (562 cm²), sold as a carton of 2
• M (713 cm²), sold as a carton of 2
• L (871 cm²), sold as a carton of 2
• XL (947 cm²), sold as a carton of 2

PermeaDerm has been evaluated through laboratory studies, preclinical animal models, clinical case series, and multicenter randomized controlled trials. Published evidence supports its engineering design and clinical performance in both partial-thickness wound management and temporary wound coverage prior to definitive closure.

Yes. PermeaDerm has been evaluated in two published multicenter randomized controlled trials in partial-thickness burns. An additional multicenter randomized controlled trial comparing PermeaDerm with cadaveric allograft has been completed. Full study results are currently pending publication.

Temporary wound coverage is intended to protect the wound until autografting is indicated. PermeaDerm combines temporary wound protection with continuous wound visualization, allowing clinicians to monitor wound color, vascularity, adherence, and fluid accumulation.

Compared with cadaveric allograft, PermeaDerm offers several practical advantages:

• Ready-to-use and available in standardized sizes
• Transparent for continuous wound visualization
• Room-temperature storage with no tissue tracking requirements
• Lower product costs in an ongoing randomized controlled trial

Published clinical experience also supports PermeaDerm as an effective option for temporary wound coverage prior to definitive closure.

PermeaDerm is a synthetic, dual-layer biosynthetic wound matrix composed of a transparent silicone outer layer and a nylon matrix coated with porcine gelatin and a purified fraction of aloe vera. In contrast, cadaveric allograft is donated human skin.

PermeaDerm is supplied sterile, ready to use, and stored at room temperature. It does not require tissue tracking or cold-chain storage and is available in standardized sheet and glove sizes. Its transparent design allows clinicians to directly visualize the wound bed during treatment to assess wound color, vascularity, adherence, and fluid accumulation.

PermeaDerm’s transparent design allows clinicians to continuously assess the wound bed. This enables evaluation of key indicators of wound health, including wound color, vascularity, adherence, and fluid accumulation, while maintaining a protected healing environment.

PermeaDerm is designed to temporarily replace the protective functions of the epidermis while creating an environment that supports healing. Its dual-layer biosynthetic design helps maintain moisture balance, protect the wound from external contamination, and facilitate the controlled exchange of gases and wound exudate.

Once PermeaDerm adheres to the wound bed, it is designed to remain in place until healing or definitive closure, depending on the clinical application. Secondary dressings can be changed as needed without routinely disturbing PermeaDerm, helping preserve the wound environment and avoid painful dressing changes.

• Prepare a clean, well-debrided wound bed with meticulous hemostasis.
• Place the bio-coated nylon surface against the wound and gently stretch to remove wrinkles and slightly open the fenestrations.
• Secure with staples, sutures, adhesive strips, or fibrin sealant according to clinician preference.

PermeaDerm should be covered with an appropriate secondary dressing based on the wound and clinical application. Commonly used secondary dressings include a non-adherent contact layer (when indicated), bulky gauze or an absorbent dressing, and a compression wrap to help maintain intimate contact with the wound bed. Outer dressings should be changed as clinically indicated while leaving the PermeaDerm dressing undisturbed whenever possible.

Immediately after application, PermeaDerm should be covered with an appropriate secondary dressing to protect the wound and maintain adherence. Once the dressing has adhered to the wound bed, the bulky outer dressing may no longer be required, depending on the clinical application and physician preference.

PermeaDerm is water resistant after it has adhered to the wound bed. The dressing should not be submerged in water (such as swimming or bathing) unless specifically directed by the treating clinician. Once PermeaDerm has adhered to the wound, patients may generally resume showering, typically after 48–72 hours, or as directed by their healthcare provider. Showering should not interfere with the dressing once adherence has been established.

The length of time PermeaDerm remains in place depends on its clinical use.

• For partial-thickness wounds, PermeaDerm generally remains in place until the wound has re-epithelialized, typically between 7 and 14 days.
• For temporary wound coverage prior to autografting, PermeaDerm is typically left in place until the surgeon determines the wound is ready for definitive closure or earlier if clinical findings indicate further wound management is required. In a recent clinical trial, PermeaDerm wear-time ranged from 3 to 17 days.

PermeaDerm should only be removed when clinically indicated.

• For wounds being temporized before autografting, PermeaDerm should be removed when the surgeon determines the wound is ready for definitive closure or if clinical findings such as infection, non-adherence, or suspicious fluid collections warrant removal.
• For partial-thickness wounds, removal is typically appropriate once the wound has healed and the dressing has become dry and loose. Begin at one corner and gently peel the dressing away from the healed tissue. If resistance, excessive pain, or bleeding occurs, stop the removal and allow additional time for healing before attempting removal again. Petroleum-based ointment or soaking the dressing may facilitate removal when appropriate.

View the application and aftercare guide for more details.

If infection is suspected, manage the wound according to the standard of care. Areas of non-adherence, suspicious fluid collections, or purulent drainage should be promptly evaluated, and PermeaDerm may be removed if clinically indicated.

Small amounts of wound exudate are expected during the early postoperative period. Clinicians should routinely assess the dressing for fluid accumulation. Bubbles, seromas, or hematomas should be managed according to the Instructions for Use, while suspicious or purulent fluid should be promptly evaluated and treated according to the patient’s clinical condition.

PermeaDerm is contraindicated in patients with known hypersensitivity or allergy to any of its components, including porcine-derived gelatin or aloe vera. As with any wound care product, clinicians should review the Instructions for Use before selecting PermeaDerm for patient care.

PermeaDerm should be applied to a properly prepared wound bed following thorough debridement and meticulous hemostasis. Clinicians should routinely monitor wound adherence, fluid accumulation, and signs of infection. Areas of non-adherence or suspicious fluid collections should be promptly evaluated and managed according to the patient’s clinical condition.

PermeaDerm should be stored at room temperature from 40°F (4°C) to 85°F (29°C). Avoid humidity exceeding 80%.

60 months from the date of manufacture when stored at room temperature 40°F (4°C) to 85°F (29°C). The expiration date is printed on the immediate package label. Do not use after the expiration date.

RECELL^® is an autologous cell harvesting device used at the point-of-care that processes a small piece of a patient’s own skin to prepare a multi-phenotype suspension of Spray-On Skin™ Cells to treat wounds and support skin regeneration.^1-2 The application of different cell types stimulates healing and repigmentation throughout the wound bed.^3-4  RECELL can be used for the following types of wounds:

In conjunction with split-thickness skin graft for the treatment of full-thickness:

• Thermal burns
• Traumatic avulsions (e.g. degloving, abrasion)
• Surgical excisions (e.g. fasciotomy, necrotizing infection)
• Surgical resections (e.g. skin cancer removal)

Alone for the treatment of:

• Deep partial-thickness burns

RECELL^® Spray-On Skin™ Cells are a multi-phenotype cell suspension derived from a patient’s own skin and contain keratinocytes, dermal fibroblasts, and melanocytes to promote healing and repigmentation throughout the wound bed.^1-4 Designed for donor sparing, the use of RECELL requires significantly less donor skin than conventional autografting.⁵

RECELL^® Spray-On Skin™ Cells provide fast healing at the cellular level.¹ Activated keratinocytes that harness the ‘free-edge’ signal, driving rapid migration and re-epithelialization across the entire wound bed for optimal healing.¹

In addition to keratinocytes, RECELL Spray-On Skin Cells contain dermal fibroblasts to deposit extra cellular matrix proteins, and melanocytes to produce melanin and allow restoration of natural pigmentation.^2,3

RECELL GO^® is the next generation, FDA-approved RECELL^® System that streamlines preparation of Spray-On Skin™ Cells. It helps reduce medical staff training burden, improve operating room workflow efficiencies, and standardize skin processing to ensure optimal suspension preparation.¹

RECELL^® is a regenerative technology and not a skin graft, although its Spray-On Skin™ Cells suspension can be used in a similar manner to a skin graft and offer reduced pain and improved aesthetic outcomes at the RECELL-harvested donor site. ¹

The RECELL^® System works by following three steps to prepare RECELL Spray-On Skin™ Cells for wound treatment.

• Obtain: The healthcare provider harvests a small, thin skin sample. 1 cm² of harvested donor skin treats up to 80 cm².¹
• Prepare: Patient-derived cells are isolated using RECELL technology.¹
• Deliver: RECELL Spray-On Skin Cells are delivered to the wound site to promote epidermal regeneration.¹

The use of RECELL^® enables significant donor skin reduction compared to conventional autografting.¹ With the RECELL System, 1 cm² of donor skin can be used to prepare enough Spray-On Skin™ Cells to treat a wound of up to 80 cm².

RECELL^® Spray-On Skin™ Cells can be used for a variety of wounds and skin restoration, including:

• Thermal burn wounds: Deep-partial thickness and full-thickness with meshed autograft
• Non-thermal full-thickness wounds with meshed autograft such as traumatic wounds and surgical wounds

RECELL^® can be used to treat complex, difficult-to-heal wounds that have been excised and are ready to graft.

Yes, RECELL^® Spray-On Skin™ Cells can be used on reconstructive plastic surgery wounds. RECELL Spray-On Skin Cells provide the advantage of point-of-care regenerative therapy for wounds, including full-thickness defects and thermal burns, in a single procedure.

RECELL^® is designed for donor sparing, taking up to 97.5% less donor skin compared to conventional autografting and uses a 1:80 expansion ratio.¹ As an example, a 1cm² donor site can treat an area up to 80x its size.