Esano ACA represents a significant advancement in regenerative medicine, offering a tri-layer dehydrated human amniotic membrane allograft designed specifically for wound management and tissue repair applications. This comprehensive fact sheet examines the composition, clinical applications, processing methods, and scientific rationale behind this innovative biological product. The membrane’s unique structure combines amnion-chorion-amnion layers to provide enhanced therapeutic potential for various wound types while maintaining the natural healing properties inherent in placental tissues. Its regulatory classification and quality control processes further establish it as a noteworthy option in the growing field of regenerative therapeutics.
Product Composition and Structure
Esano ACA is a tri-layer, decellularized, dehydrated human amniotic membrane allograft composed of three distinct layers: amnion, chorion, and amnion (hence the ACA designation)12. This placental tissue allograft is designed with a specific configuration that provides enhanced rigidity compared to single-layer products, making it suitable for challenging wound environments where structural integrity is essential1. The human amniotic membrane forms the innermost layer of placental tissue, functioning as an avascular membrane that naturally serves as a protective barrier for the developing fetus during pregnancy1. This natural biological structure has been preserved and enhanced through proprietary processing to maintain its inherent regenerative properties while being adapted for therapeutic applications in wound care and tissue repair contexts1.
The membrane’s tri-layer construction contributes to its non-side specific orientation, eliminating concerns about proper placement and simplifying the application process for clinicians1. This design feature provides a thicker membrane particularly suitable for deep wounds or exposed anatomy that requires careful coverage and protection1. The enhanced thickness also allows for improved conformity to complex wound topographies, as the membrane can be easily positioned or repositioned to achieve optimal wound bed contact and coverage1. Furthermore, the product retains important major structural proteins and extracellular matrix (ECM) biochemicals that are naturally present in placental tissue, preserving the biological factors that contribute to its therapeutic effectiveness1.
Therapeutic Properties and Benefits
The Esano ACA membrane functions as a protective covering that aids in wound management by creating a physical barrier between the wound bed and the external environment12. This barrier function is crucial for maintaining optimal wound healing conditions and preventing external contamination that could impede the natural healing process2. The membrane exhibits unique non-immunological properties that make it particularly valuable in clinical settings where immune rejection might otherwise be a concern with biological products1. These properties allow the membrane to be applied to a wide range of patients without triggering adverse immune responses that could complicate the healing process or diminish therapeutic effectiveness1.
The extracellular matrix component of Esano ACA acts as a scaffolding structure that potentiates the migration and adhesion of resident cells at the wound site, facilitating cellular activities essential to tissue repair and regeneration1. This scaffolding function provides structural support while creating an environment conducive to cell movement and attachment, two processes fundamental to effective wound healing across various tissue types1. Additionally, the membrane contains natural cytokines that contribute to its biological activity, providing growth factors that can influence cellular behavior and enhance healing responses in the tissues where the product is applied1. The combination of these structural and biological properties results in a product with enhanced tensile strength that adheres well to wound surfaces and is easy for clinicians to apply in various clinical settings1.
One notable advantage of Esano ACA is its versatility in application, as it can be used in either a hydrated or dehydrated state depending on the specific clinical requirements and practitioner preferences1. When applied directly to the wound following standard wound preparation, the membrane adheres to the wound bed without requiring additional fixation methods, simplifying the application process and potentially reducing procedure time2. This adherence capability eliminates the need for sutures or adhesives in many cases, reducing potential irritation while maintaining proper positioning of the membrane over the treatment area2.
Clinical Applications and Indications
Esano ACA is intended for the repair, reconstruction, replacement, or supplementation of a patient’s injured tissue, making it applicable across a broad spectrum of clinical scenarios involving tissue damage or impaired healing1. The product is specifically designed to serve as a cover or barrier for both acute and chronic wounds, providing protective coverage from the surrounding environment and creating conditions conducive to healing2. This dual functionality makes it suitable for addressing various wound types encountered in clinical practice, from surgical incisions to non-healing ulcers that require additional biological support to progress toward closure2.
The potential applications of Esano ACA span multiple medical specialties and treatment contexts, including podiatry and vascular medicine where wound complications are frequently encountered and challenging to manage with conventional approaches1. The product also has applications in general wound management settings, offering an advanced option for wounds that have failed to respond adequately to standard care protocols or those at high risk for complications1. In orthopedic surgery, the membrane can provide tissue coverage and support healing in surgical sites involving bone, joint, and surrounding soft tissues, potentially enhancing outcomes in complex reconstructive procedures1. Beyond these specific areas, Esano ACA may be beneficial in various other surgical scenarios where tissue protection, enhanced healing, or barrier function are desirable therapeutic goals1.
For Medicare beneficiaries seeking coverage for this product, it must be ordered and applied by a qualified clinician as part of a comprehensive treatment plan2. This requirement reflects the product’s classification as an advanced biological therapy rather than a standard dressing that patients could self-apply2. Patients cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement, highlighting the importance of proper medical oversight in its application and the recognition of its status as a specialized therapeutic intervention rather than a conventional wound care product2.
Processing and Quality Assurance
Esano ACA undergoes rigorous processing in compliance with all current Good Tissue Practices as mandated by the United States Food and Drug Administration and the American Association of Tissue Banks, ensuring adherence to established quality and safety standards for human tissue products1. The manufacturer emphasizes quality standards and testing protocols that exceed industry requirements, reflecting a commitment to product integrity and patient safety in this sensitive biological product category1. The processing begins with extensive donor screening to ensure donor suitability, reducing potential risks associated with tissue transplantation and establishing a foundation for product safety1.
All tissue used in Esano ACA is collected exclusively from caesarean section births, a procurement approach that enhances quality and safety by avoiding potential contamination concerns that might be associated with vaginal deliveries1. Following collection, the tissue is delivered to processing facilities and processing is initiated within 24 hours, minimizing deterioration and preserving the natural properties of the amniotic membrane1. The tissue then undergoes cleaning and processing using proprietary methods developed to maintain structural integrity while removing potential contaminants and preparing the material for clinical use1.
A particularly important safety feature in the production of Esano ACA is terminal sterilization, which provides an additional level of safety beyond the initial processing steps1. This terminal sterilization helps eliminate potential pathogens while preserving the therapeutic properties of the membrane, striking a critical balance between safety and efficacy1. After processing and sterilization, the product is packaged to allow storage at ambient temperatures, eliminating the need for specialized storage equipment and simplifying inventory management for healthcare facilities1. The product is shipped with priority handling and includes storage instructions to maintain product integrity during transit and prior to use1. Each package also includes preparation instructions and access to records portal for HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products) tracking, facilitating compliance with regulatory requirements for tissue product documentation and traceability1.
Product Specifications and Sizing Options
Esano ACA is available in multiple size configurations to accommodate various wound dimensions and treatment requirements, allowing clinicians to select the most appropriate option for each specific clinical scenario1. The small sizes include 2×2 cm (product code EsanoACA-0202), 2×3 cm (product code EsanoACA-0203), and 2×4 cm (product code EsanoACA-0204), providing options for smaller wounds or those in anatomically constrained areas where larger sheets would be impractical or wasteful1. For more extensive wound coverage requirements, large sizes are available including 4×4 cm (product code EsanoACA-0404), 4×6 cm (product code EsanoACA-0406), and 4×8 cm (product code EsanoACA-0408), enabling treatment of larger wound surfaces with a single application1.
The product is provided in an amnion/chorion/amnion configuration specifically designed to provide enhanced rigidity compared to single-layer products, making it particularly suitable for challenging wound environments where structural integrity is essential1. This tri-layer construction contributes to the product’s handling characteristics and performance in clinical applications, providing sufficient strength to withstand placement manipulations while maintaining the flexibility needed to conform to irregular wound surfaces1. The sizing options are based on square centimeter measurements, allowing for precise selection based on wound dimensions and coverage requirements2.
Esano ACA is supplied in single-use packaging to maintain sterility and product integrity until the moment of application2. This packaging approach eliminates cross-contamination risks and ensures that each application uses fresh, uncompromised material with full therapeutic potential2. The packaging also facilitates inventory management and procedure preparation in clinical settings, as each unit is clearly labeled with product information including size specifications and product codes for accurate selection and documentation1.
Regulatory Classification and Positioning
Esano ACA is regulated under Section 361 of the Public Health Service Act, classifying it as a human cell, tissue, and cellular and tissue-based product (HCT/P) that is minimally manipulated and intended for homologous use1. This regulatory classification reflects the product’s nature as a tissue allograft that maintains its native structural properties while being processed to enhance safety and usability in clinical applications1. The homologous use designation indicates that the product is intended to perform the same basic functions in the recipient as it did in the donor, specifically providing protective coverage and supporting tissue repair processes1.
Within the broader category of skin substitutes or cellular and tissue-based products (CTPs), Esano ACA represents one of several options that may provide healing advantages over standard dressings and conservative treatments in certain wound types2. These advanced products are typically considered when standard approaches appear insufficient to effect complete healing after at least a 30-day period of comprehensive conservative therapy, positioning them as second-line interventions for challenging wounds2. Esano ACA specifically falls into the category of human allogeneic matrices derived from human tissue (membrane), distinguishing it from other categories such as human skin allografts from cadavers, composite matrices derived from multiple cell types, or acellular matrices derived from xenogeneic sources2.
The product’s regulatory status and classification have important implications for clinical use and reimbursement pathways, particularly within Medicare and other insurance systems that have specific requirements for biological products2. As previously noted, for Medicare coverage, Esano ACA must be ordered and applied by a qualified clinician rather than being purchased directly by patients, reflecting its classification as an advanced therapeutic product requiring proper medical oversight2. This positioning within both regulatory frameworks and clinical practice guidelines helps define the appropriate contexts for Esano ACA utilization while establishing expectations for documentation, application protocols, and outcome assessment2.
Conclusion
Esano ACA represents a sophisticated approach to wound management and tissue repair, leveraging the natural properties of human amniotic membrane in a processed form that enhances usability while preserving therapeutic potential. The tri-layer amnion/chorion/amnion configuration provides structural advantages over single-layer products while maintaining the biological benefits of placental tissues, including protective barrier function, non-immunogenicity, scaffolding properties, and growth factor content. The product’s versatility across multiple clinical applications, from podiatry to orthopedic surgery, makes it a valuable option in the regenerative medicine toolkit for practitioners addressing both acute and chronic wounds.
The rigorous processing protocols, quality assurance measures, and regulatory compliance demonstrate a commitment to safety and efficacy that aligns with contemporary standards for advanced biological products. Multiple size options accommodate diverse clinical needs, while the product’s ability to be used in either hydrated or dehydrated states provides flexibility in application techniques. As research in regenerative medicine continues to evolve, products like Esano ACA illustrate the potential for human-derived tissues to address significant clinical challenges in wound healing and tissue repair when conventional approaches prove insufficient.
For healthcare providers considering this product, it represents one of several advanced options that may benefit patients with wounds that have failed to respond to standard care protocols. The requirement for physician application under Medicare guidelines underscores its classification as a specialized intervention rather than a conventional dressing, highlighting the importance of proper patient selection, application technique, and follow-up care to maximize therapeutic benefit from this innovative biological product.