About InnovaMatrix® PD

About InnovaMatrix® PD

InnovaMatrix® PD was cleared by the FDA on September 28, 2022, via the 510K pathway – K211902.

InnovaMatrix® PD is an important advancement in the treatment of wounds, giving physicians a placental-derived particulate product that can replace the human particulate amnion-chorion products pulled from the market.

  • No preparation required

  • No tissue tracking required

  • No special storage requirements

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The introduction of InnovaMatrix® PD is an important and innovative advancement in the management of wounds. As a next-generation technology, InnovaMatrix® PD offers all the inherent benefits2 of the placenta plus the quality control, reliability, and safety profile of a medical device5. Manufactured with by our proprietary TriCleanse Placental Extracellular Matrix (ECM) Process, InnovaMatrix® PD is the next-generation particulate placental device designed for the management of wounds, including full- and partial-thickness wounds, surgical wounds and traumatic wounds.

Balancing Decellularization Efficiency and the Denaturing of ECM Proteins

As a placental medical device processed with the proprietary TriCleanse™ Process, InnovaMatrix® was extensively biochemically characterized to identify and quantify the different structural and functional proteins. These results were then compared to a SIS membrane device as a base line for comparison.

Cellular Debris Comparison10

The presence of intact cells and nuclei creates an immunogenic response as cellular antigens are recognized as foreign by the host’s immune system.

The immune system has the innate capability to recognize nucleic acids not contained within the nucleus via pattern recognition receptors and mount an inflammatory response to their presence.

Hematoxylin and Eosin Staining11

Hematoxylin and Eosin (H&E) staining is commonly used to stain tissue for histology evaluation8. H&E stains nuclei blue and extracellular matrix and cytoplasm pink and other tissues shades in between.


The H&E staining shows a minute quantity of residual nuclei in the finished product.

SIS Commercial Membrane

The H&E staining shows clearly stained blue nuclei are distributed throughout the finished product.

HCT/P Commercial Graft

The H&E staining shows blue stained nuclei present in the entirety of the graft with areas of high concentration.

First-ever placental-derived particulate medical device cleared by the FDA for wound management 

The amount of FDA-required material, research, and testing for InnovaMatrix® products contrasts starkly with a simple three-page registration required for HCT/P products.

The InnovaMatrix® Platform material addresses graft variability due to:

  • Genetic variability
  • Environmental/lifestyle factors
  • Diet and activity levels

Indicated for the Management of Wounds Including:

*See package insert for full list of indications.

  • Partial- and full-thickness wounds
  • Venous ulcers
  • Chronic vascular ulcers
  • Trauma wounds (abrasions, lacerations, and skin tears)
  • Draining wounds
  • Partial-thickness second degree burns
  • Pressure ulcers
  • Diabetic ulcers
  • Tunneled/undermined wounds
  • Surgical wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscience)

The device is intended for one-time use.

This device is derived from porcine collagen and should not be used on patients with sensitivity or allergy to porcine materials; sensitivity or allergy to collagen; or active or latent infection in or around the application site.
This device is not indicated for use in third degree burns.

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InnovaMatrix® PD Documents

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Available Sizing

Part # Description Size SQ CM Surface Area
IMP-0100-01 InnovaMatrix® PD 100mg 50 cm2


  1. Fairbairn, N. G., Randolph, M. A., & Redmond, R. W. (2014). The clinical applications of human amnion in plastic surgery. Journal of Plastic, Reconstructive & Aesthetic Surgery, 67(5), 662-675
  2. Shaifur Ra, M., Islam, R., Asaduzzama, S.M., & Shahedur R, M. (2015). Properties and Therapeutic Potential of Human Amniotic Membrane. Asian Journal of Dermatology, 7(1), 1-12. doi: 10.3923/ajd.2015.1.12
  3. Malinda KM, Wysocki AB, Koblinski JE, Kleinman HK, Ponce ML. Angiogenic laminin-derived peptides stimulate wound healing. Int J Biochem Cell Biol. 2008;40(12):2771-80
  4. Litwiniuk M, Krejner A, Speyrer MS, Gauto AR, Grzela T. Hyaluronic Acid in Inflammation and Tissue Regeneration. Wounds. 2016 Mar;28(3); 78-88.
  5. Cardinal, L.J. (2015). Central tendency and variability in biological systems. J Community Hosp Intern Med Perspect, 5(3), 27930. doi:10.3402/jchimp.v5.27930
  6. O’Huallachain, M., Karczewski, K. J., Weissman, S.M., Urban, A. E., & Snyder, M. P. (2012). Extensive genetic variation in somatic human tissues. Proc Natl Acad Sci U S A, 109(44), 18018-18023. doi: 10.1073/pnas.1213736109
  7. Data on file. A Pre-Clinical Comparison of Healing Efficiency between InnovaMatrix(R) and a Commercially Available Dehydrated Human Amnion/ Chorion Membrane.
  8. Hinton, J. p., Dvorak, K., Roberts, E., French, W.J., Grubbs, J. C., Cress, A. E.,…Nagle, R.B. (2019). A Method to Reuse Archived H&E Stained Histology Slides for a Multiplex Protein Biomarker Analysis. Methods Protoc, 2(4)
  9. Grinnell F, Billingham RE, Burgess L. Distribution of fibronectin during wound healing in vivo. J Invest Dermatol. 1981 Mar;76(3):181-9.
  10. Londono R, Dziki JL, Haljasmaa E, Turner NJ, Leifer CA, Badylak SF. The effect of cell debris within biologic scaffolds upon the macrophage response. J Biomed Mater Res A. 2017 Aug;105(8):2109-2118. doi: 10.1002/jbm.a.36055. Epub 2017 Apr 12. PMID: 28263432Cardinal, L. J. (2015). Central tendency and variability in biological systems. J Community Hosp Intern Med Perspect, 5(3), 27930. doi:10.3402/jchimp.v5.27930;
  11. Data on File – RDR-002