Thank you for your interest in Imbed Biosciences! We hope this list of frequently asked questions helps you find the answers you need. If you need additional information, please contact us over the phone at (888) 472-9898 or e-mail at cs@imbedbio.com.
Ordering
How do I order products?
Please email us at cs@imbedbio.com to learn more about our ordering process and to connect with our Sales team.
Is a product demonstration recommended, and how do I schedule one?
It is recommended that an Imbed Biosciences representative conduct a live demonstration, to provide guidance and answer questions related to product application and use. To schedule a call or visit with an Imbed Biosciences sales representative, please complete this form, call us at (888) 472-9898 or e-mail us at cs@imbedbio.com.
What are Imbed Biosciences standard warranty and indemnification policies?
Please see our Terms and Conditions here.
SAMatrix™ – Synthetic Antimicrobial Matrix Technology & SAMatrix™ with PainGuard®
How does SAMatrix™ work?
All SAMatrix™ Technology products serve as a primary layer for acute and chronic wounds to conform to the wound bed1, allow cellular growth,2† and resorb3 while providing sustained antimicrobial protection on the matrix4,5† and — with the PainGuard® line extension — reducing topical pain6.
Is the silver in SAMatrix™ harmful to healthy cells?
No. Because of the highly conformal nature of SAMatrix™, it is able to reach the micro-contours of the wound bed and is 99.99% effective on the matrix across a wide range of common wound pathogens,4,5† while having a very low level of silver — 0.16mg/in2 (2.5 mg/100 cm2)6,7.
Is SAMatrix™ active against resistant microorganisms such as MRSA or VRE?
Yes. SAMatrix™ has been demonstrated in vitro to be effective against a wide range of microorganisms, including Candida albicans, Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococcus (VRE), Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, Escherichia coli, and Candida tropicalis. SAMatrix™ delivers sustained antimicrobial action for at least 72 hours on the matrix.4,5†
Is SAMatrix™ indicated for use on infected wounds?
Yes, however, SAMatrix™ is not indicated to treat infected wounds. Please note that it is not contraindicated for use on infected or at-risk wounds and is indicated for use on all wounds.6 Physicians should follow proper wound bed debridement prior to application and administer systemic antibiotics when indicated.
Can SAMatrix™ be used to manage surgical wounds?
Yes, SAMatrix™ products are biocompatible8, non-pyrogenic9, and have FDA clearance to manage surgically-created wounds6, with no contraindications related to closure techniques.
SAMatrix™ is so thin compared to other matrices. How is it so effective?
The ultrathin form factor of SAMatrix™ is a key design element of the product. It allows SAMatrix™ to conform to the wound bed1 and brings the matrix functionality to the “nooks and crannies” of the wound. Comparatively, bulky macro-scale matrices and traditional antimicrobial wound dressings sit well above the wound bed and force the granulation cells to come to them.
Can SAMatrix™ be used at the onset of wound treatment (day 1)?
Yes. Clinically, SAMatrix™ can be used from day 1 on a freshly debrided wound to help manage bioburden and support a wound healing environment. These products can be integrated into the protocol of care for that wound type and used in conjunction with other wound management technologies and solutions. Important to note: if application is occurring in an outpatient care setting where separate product reimbursement may be possible, please refer to and confirm payer policy guidelines.
What if the wound is dry?
We recommend that a dry wound be moistened with sterile saline after routine debridement and prior to application of SAMatrix™. A non-adherent gauze and light pressure to the matrix can also be applied to achieve maximum conformity to the wound bed and its edges.
Can SAMatrix™ be used with vacuum-assisted closure (wound VAC) or NPWT (Negative Pressure Wound Therapy)?
Yes, in clinical cases, SAMatrix™ has been demonstrated compatible with wound VAC/NPWT, although it has not been formally studied for safety and effectiveness.
What do I cover SAMatrix™ products with after I apply it to the wound?
SAMatrix™ should be covered with a non-adherent dressing and any other dressings needed to maintain a moist wound environment. Change the cover dressing as needed to maintain a moist wound environment or whenever SAMatrix™ is reapplied.
How often do I need to reapply SAMatrix™?
Reapply SAMatrix™ depending on the wound and the healing progression, or when clinically indicated. To reapply, carefully remove the cover dressing(s). Gently irrigate wound with sterile saline to remove necrotic tissue. It is not necessary to remove any residual SAMatrix™ — including the PainGuard™ version — observed during cover dressing changes.
Can you tile SAMatrix™ matrices, including SAMatrix™ with PainGuard®?
Yes, they may overlap without concern. Regarding PainGuard® matrices, please follow the dosing guidance charts to determine (by body weight) the maximum number of pieces that can be safely applied within a 24-hour period.
Is there a limit to the number of PainGuard® sheets that can be used on a patient?
Yes, there is a limit that becomes a clinical consideration at low body weights and/or larger-sized pieces of SAMatrix™ matrix. The patient cannot exceed the maximum 24-hour lidocaine dose of 4.5 mg/kg.
Why are there color differences (varying shades of yellow) within individual PainGuard® matrices?
Color differences within the matrix may occur and are expected because of slight variations in the size of metallic silver particles. However, this does not impact product performance.
Can I cut SAMatrix™ products?
Yes. SAMatrix™ products should be cut to size slightly larger than the wound. Multiple pieces may be used to cover the wound bed and the wound margin.
What are the contraindications for SAMatrix™ and SAMatrix™ with PainGuard®?
Do not use on individuals who are sensitive to silver, lidocaine, or any local anesthetics of the amide type, or who have had a prior allergic reaction to SAMatrix™ or any of its components.
What warnings and precautions should be considered when using SAMatrix™?
Prior to use, please refer to the full Instructions for Use (IFU) for complete prescribing information. Avoid concomitant use with iodophor-containing products, which may reduce the antimicrobial effectiveness of silver in the dressing. For SAMatrix™ with PainGuard™, avoid contact with the eyes.
What’s the shelf life for SAMatrix™ Technology?
SAMatrix™ products without lidocaine have a shelf life of 4 years. SAMatrix™ with PainGuard® products have a shelf life of 2 years.
Do Microlyte® and Microlyte® PainGuard® have billable product codes?
Microlyte® and Microlyte® PainGuard® have been assigned HCPCS Level II codes A2005 and A2040, respectively, by CMS. These codes support product identification for billing purposes. Coverage and reimbursement are determined by individual payers and are subject to applicable policies, contracts, and patient-specific circumstances.
† As demonstrated in vitro.
References: 1. Product Handleability Evaluation Report, Data on file. 2. Agarwal, A., et al. Biomaterials, 31 (4), 680-690, 2010. 3. Systemic Toxicity, Local Tissue Response, and Wound Healing Study of Microlyte Ag, Following Repeated Treatment to Full-Thickness Wounds in Rats – 28 Days. Data on file. 4. Microlyte Shelf Life and Stability. Data on file. 5. Measurement of Antimicrobial Activity of Microlyte Ag. Data on file. 6. U.S. Food and Drug Administration. 510(k) Summary K211943: Microlyte Ag/Lidocaine. FDA. gov. Published July 2021. 7. Silver-Lidocaine Release Profiles of Microlyte Ag/Lidocaine Wound Dressing (DOC-907). Data on file. 8. Biocompatibility testing in accordance with ISO 10993 standard, Data on file. 9. USP Rabbit Pyrogen Study, Material Mediated, Data on file.