What is Architect?

Architect®  is a unique extracellular collagen matrix (“ECM”) FDA cleared and CE Mark certified for use in managing partial and full thickness wounds, including:

  • Diabetic Ulcers
  • Pressure Sores/Ulcers
  • Chronic Vascular Ulcers
  • Draining Wounds
  • Venous Ulcers
  • 2nd Degree Burns
  • Trauma Wounds (e.g. abrasions, lacerations, skin tears, …)
  • Surgical Wounds (e.g. donor site/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incision, …)

Learn more about the Mechanism of Action Study at OSU

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The Roll of ECMs in Wound Healing?

Magnified image of an ECM

What makes up an ECM?

Extracellular Matrix’s (ECM’s) are a complex meshwork of structural and functional proteins, including collagens and integrins, glycoproteins, hyaluronan, proteoglycans, and glycosaminoglycans (GAGs) that provide structure and support for cells and tissues.  Collagen is one of the major constituents of the ECM existing in many different types depending on the tissue and often forming fibres.  Fibronectin and laminin are two other protein constituents of the ECM.

ECMs stimulate and support cell proliferation’s essential for tissue regeneration by: ¹,²

  • Acting as a reservoir for growth factors and cytokines that are crucial to tissue regeneration.
  • Supporting and regulating the movement of cells.
  • Cell signaling to trigger and modulate the wound healing cascade.

ECMs are commonly used as “skin substitutes” because of these important tissue regeneration properties. Unfortunately, in chronic wounds, ECMs are susceptible to rapid degradation by an excess of various enzymes such as matrix metalloprotease (MMPs) and other proteases. ³

“The unifying pathophysiological hypothesis for chronic wounds is that the inflammatory phase of healing is exaggerated, with the excess of proteases and MMPs in chronic wounds breaking down too many components of the ECM as well as inhibiting growth factors that are essential for tissue synthesis.”

As Muller et al stated.4

In addition, chronic wounds can also have an elevated neutrophil (PMNs) infiltration in response to persistent bacterial infections, which further exaggerates the ECM-degrading environment. 5
Ultimately, many researchers have concluded that continued degradation of an ECM-based dressing . . . exacerbates this inflammatory environment, further delaying healing.” This is the problem we are addressing with Architect® .

Architect® is the only ECM stabilized by the BriDGE® process which prevents premature degradation by the excess MMPs and other proteases found in chronic wounds. Because Architect® remains intact, its ECM healing properties remain intact, including:

  • Helping to deactivate the inflammatory phase (which results in a reduction of MMPs, elastase, and other proteases).
  • Helping to promote the proliferative/healing phase.
  • Preserving cell signaling factors to trigger and accelerate healing.
  • Providing an intact, durable scaffold for uninterrupted support of cellular growth and regeneration of native tissue.

How is Architect different from all other ECM-based Wound Care products?

 

Virtually all skin substitutes used for treating chronic skin wounds are simply ECM’s in one form or another.  The challenge faced by other ECM’s is their rapid degradation by the excess MMPs and other proteases found in chronic wounds.  Not only does rapid ECM degradation potentially extend the inflammatory phase, it requires continual replacement of the ECM to support cellular ingrowth (up to 12 applications in some cases).

Timing the replacement of a degraded ECM is critical, otherwise healing stalls.

Why does Architect®  show faster healing?
Because BriDGE®  Stabilized ECM’s do not stall!

Because Architect® remains intact, its ECM healing properties remain active, causing tissue regeneration to take place:

  • Architect® helps to deactivate the inflammatory phase (which results in a reduction of MMPs, elastase, and other proteases).
  • Architect® serves as a catalyst in the proliferative/healing phase, serving as a homing base for Autologous growth factors (epithelial, fibroblasts, endothelial, immune cells, etc.), creating a gradient for pro-healing cues.
  • Architect® preserves cell signaling factors to trigger an accelerate healing.
  • Architect® provides an intact, durable scaffold for uninterrupted support of cellular growth and regeneration of native tissue.
  • Architect® strengthens anti-microbial defenses such as antimicrobial peptides (AMP).
  • AND these properties are uninterrupted for the duration of treatment.

What is Architect made of?

Architect® is made from a widely available Xenograft commonly used in modern tissue heart valves and many other medical products.  This tissue is strong, homogeneous (over 95% type 1 collagen), durable and porous, making it an ideal wound matrix to support cellular in-growth throughout the healing process.

Magnified (tri-layered) cross section

How is Architect used?

Architect® can be applied to a wound immediately after thorough debridement (no need to wait 4-6 weeks as required for many other products) and Architect® is designed to require only one application to the wound.  In most cases Architect® is applied directly to the properly prepared wound bed, secured to the perimeter of the wound with sutures, staples, or tape (e.g. Steri-Strip®), and a surgical bandage is applied to ensure continual contact of Architect® to the wound bed.  During proper healing, as the wound margins recede, the excess edges of Architect® is trimmed away until the wound finally heals and the remaining portion of Architect® falls off.

Is Architect Convenient?

No skin substitute is more convenient than Architect.

  • Architect® is stored at room temperature in easy to use double peel packs (no complex refrigeration or special equipment required).
  • Architect® can be re-hydrated for use in a matter of minutes for quick and easy application (no complex thawing or preparation procedures).
  • Architect® is strong enough to secure to the wound using sutures, staples, or tape (e.g. Steri-Strip®) ensuring the product remains in place.
  • Architect® is terminally sterilized (not just “aseptically processed”).
  • Architect® requires only ONE application (no need for invasive re-applications / debridements).
  • Architect® is a sterile FDA Cleared Medical Device (meaning no Human Tissue  (HCT/P) / or Biologic tracking is required.)

The ultimate convenience is the fact that Architect
does NOT require re-application.

*or additional debridements

While most alternative products require weekly re-application (often in a surgical setting and requiring additional debridement), Architect® recommends periodic inspection of the secondary dressing (and secondary dressing change as needed to manage exudates) and maintain good hydration of Architect®.   As healing occurs, the edges of Architect® may gradually peel and be trimmed during dressing changes.

There is NO need for re-application (or additional debridement), in most cases.  This makes Architect® the right choice for Doctors, Nurses, and Wound Care professionals who seek to provide their patients with the best quality of care and convenience available.

Is Architect cost effective?

Architect® is very cost effective.  The cost of Architect® is similar to one application of the leading wound matrices.  But clinical studies indicate that the major cost advantage of Architect® comes from its stabilized collagen . . . Architect® will typically require as few as one application (see below) compared to 4‑12 applications for the leading wound matrices.

The Architect Value Proposition

Item Architect® Amniotic Products
Leader (U.S.)
Human Cellular Products
Leader (U.S.)
Sterile? Yes No No
Convenient Storage? Yes Yes No
Applications Needed for Treatment 1 Up to 4 Up to 8
Cost to closure
(Product cost + $300 per application)
$1,300 $6,600 $16,800
Internationally Approved Therapy? Yes No No

Table Data References 5, 6, 7

What Sizes are Available?

SIZE (cm) SOLID FENESTRATED MESHED
2x2 HMT-004-Fx HMT-004F-Fx HMT-004M-Fx
3x3 HMT-009-Fx HMT-009F-Fx HMT-009M-Fx
4x4 HMT-016-Fx HMT-016F-Fx HMT-016M-Fx
6x6 HMT-036-Fx HMT-036F-Fx HMT-036M-Fx
10x10 HMT-100-Fx HMT-100F-Fx HMT-100M-Fx
10x15 HMT-150-Fx HMT-150F-Fx HMT-150M-Fx
*Check with your local rep or contact us for availability in your clinic.
HCPCS Code: Q4147   |   FSS Contract: V797D-50393   |   DAPA Contract: SP0200-16-H-0004

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References:

1. Petreaca M, Martha-Green M; Cell-ECM Interactions in Repair and Regeneration; Principles of Regeneration Medicine; 10.1016/B978-0-12-381422-7; 100002-1; 2001 elsevier, Inc.

2. Agran MS, Wethen, M; The Extracellular Matrix in Wound Healing: A closer Look at Therapeutics for Chronic Wounds; Lower Extremity Wounds 6 (2); 2007 pp.82-97.

3. Fleck CA, Chakravarthy, D; Understanding the Mechanisms of Collagen Dressings; Advances in Skin & Wound Care; vo. 20, no. 5.

4. Muller M, Trocme C et al. Matrix metalloproteinases and diabetic foodt ulcers: the ratio of MMO-1 to TIMP-1 is a predictor of wound healing.  Diabetic Medicine, 25, 419-426 2008.

5. Yeager DA, Alexander JH, Stern DS, et al. Equine Pericardium as a Biological Covering for the Treatment of Diabetic Foot Wounds: A Prospective Study. Journal of the American Podiatric Medical Association. 2012; 102(5):352-357. *Architect utilizes a structurally equivalent EP based ECM to the referenced study.  

6. Zelen CM, Gould L, Serena TE, et al. A Prospective, Randomised, Controlled, Multi-Centre Comparative Effectiveness Study of Healing Using Dehydrated Human Amnion/Chorion Membrane Allograft, Bioengineered Skin Substitute, or Standard of Care for Treatment of Chronic Diabetic Lower Extremity Ulcers. International Wound Journal. 2014: 1-7.  

7. Veves A, Falanga V, Armstrong DG, et al. Graftskin, a Human Skin Equivalent, is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers. Diabetes Care, 24(2):290-295, 2001

8. Wound Healing Rate is factored by initial wound size / time to heal.  Published Clinical Data for each product was used to factor wound healing rates.  Data references are available upon request.

9. Clinical data suggests that stabilized ECMs (such as Architect®) maintain healing properties between treatments. Reference data available upon request.

*This site is for informational purposes only and is not intended as a substitute for professional medical advice.  See Architect® Instructions for Use for approved indications and instructions.  Architect® , BriDGE® , and One and Done® are registered trademarks of Harbor MedTech, Inc. Steri-Strip® is a registered trademark of 3M, Inc.  All rights reserved.

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innovative approach to healing
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Architect® or our
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