InnovaBurn™ Placental ECM

About InnovaBurn™ Placental ECM

The InnovaBurn™ Placental ECM is a significant and innovative advancement in biologic wound dressings for complex surgical and burn wounds. InnovaBurn™ combines the benefits of the placenta with the reliability, reproducibility, and safety profile of a medical device. It is processed by Triad’s proprietary TriCleanse™ Process that has been demonstrated to disinfect tissues, deactivate viruses, and thoroughly decellularize the ECM.

A Critical Balance

Effective decellularization removes cells and cellular debris while maintaining the structural proteins of the ECM.

Importance of Decellularization or Removal of Cellular Debris

The presence of cells and or cellular debris in biologic wound dressings can cause an inflammatory reaction resulting in a greater M1:M2 ratio macrophage response by the host immune system at the wound site. The greater amount of M1-activated macrophages is necessary to remove the cells and cellular debris before the presence of M2-activated macrophages increases to support a healing response. In contrast, thoroughly decellularized biologic skin scaffolds allow the host to respond directly with a healing response, generally associated with a greater M2:M1 ratio of macrophages and leading to collagen deposition.1Gilpin, A., & Yang, Y. (2017). Decellularization Strategies for Regenerative Medicine: From Processing Techniques to Applications. Biomed Res Int, 2017, 9831534. doi:10.1155/2017/9831534


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The TriCleanse™ Process
The TriCleanse™ Process balances the need for decellurization while maintaining structural proteins of the ECM. The result is a balanced scaffold that delivers superior wound healing at a lower cost.

Balancing Decellularization Efficiency and the Denaturing of ECM Proteins

As a placental medical device processed with the proprietary TriCleanse™ Process, InnovaBurn™ Placental ECM was biochemically characterized extensively 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 Comparison

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 & Eosin Staining

Hematoxylin and Eosin (H&E) staining is commonly used to stain tissue for histology evaluation.2 H&E stains nuclei blue and extracellular matrix and cytoplasm pink and other tissues shades in between.
Hinton JP, Dvorak K, Roberts E, French WJ, Grubbs JC, Cress AE, Tiwari HA, Nagle RB. A Method to Reuse Archived H&E Stained Histology Slides for a Multiplex Protein Biomarker Analysis. Methods Protoc. 2019 Nov 15;2(4):86. doi: 10.3390/mps2040086.

InnovaBurn™

The H&E staining show 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 throughout the graft with areas of high concentration

1st and only placental-derived medical device.

Get in touch with Triad today to learn more about InnovaBurn™!

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InnovaBurn™ Case Example

  • 80-year-old male neuropathic diabetic suffered a severe burn to the right foot involving the 1st,2nd & 3rd toes
  • Burn Injuries of the 2nd and 3rd toes resolved after 4 applications
  • Majority of burn of the 1st toe resolved after 4 applications, but the distal prominence of the hallux developed osteomyelitis that required amputation

Use the arrows to scroll and see the progression of healing. 

InnovaBurn™ Placental ECM Evaluation Program

In an effort to provide an opportunity to evaluate Triad’s InnovaBurn™ Placental ECM we are introducing this evaluation program. This evaluation program is intended to give the physician the change to evaluate the use of the product and to evaluate the clinical results firsthand.

Because these evaluation kits are provided at no cost, the hospital, clinic, or physician shall not seek any medical reimbursement or any funds from patients for the use of any evaluation product. The units requested are the responsibility of the recipient facility and must be stored in accordance with manufacturer’s requirements. Evaluation units that are lost, damaged, or expired will not be replaced by Triad Life Sciences®.

Please see the package insert of the evaluation units for a complete list of indications or instructions for use, warning, precautions, and other important medical information.

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InnovaBurn™ Indications for Use

Download Instructions for Use (IFU)

Full and partial thickness wounds

  • Pressure ulcers
  • Venous ulcers
  • Diabetic ulcers
  • Chronic vascular ulcers
  • Tunnelled/undermined wounds
  • Draining wounds

Surgical wounds

  • Donor sites/grafts
  • Post-Mohs surgery
  • Post-laser surgery
  • Podiatric
  • Wound dehiscence

Trauma wounds

  • Abrasions
  • Lacerations
  • Second degree burns and skin tears
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Downloadable PDFs

INNOVATIVE

InnovaMatrix® Platform is the only placental-derived medical device technology on the market to address the inherent challenges and related restrictions of Human Cells, Tissue, and Cellular and Tissue-Based Products (HCT/Ps). This patent-pending technology provides an array of regenerative medicine opportunities and is the foundation for Triad’s robust product development pipeline.

RELIABLE

InnovaMatrix® Platform provides a reliable solution in medical device form where the current HCT/P placental technologies are fraught with substantial donor variability, thereby resulting in inconsistent products. Produced under the stringent requirements of Current Good Manufacturing Practice (CGMP) with a highly controlled source material, InnovaMatrix® Platform is a consistent and reproducible alternative for wound care management.

AFFORDABLE

Triad’s mission is to provide safe, cost-effective wound care solutions to the market. To that end, Triad’s state-of-the-art, scalable manufacturing operation maximizes efficiency and creates economic benefits for the patients, healthcare providers, and payors.

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