Innovation doesn’t have to cost more.

InnovaMatrix AC, the first and only placental-derived medical device, represents a significant advancement in wound care creating a new category of amnion/chorion medical devices. InnovaMatrix AC Placental Extracellular Matrix (ECM) is the first and only placental medical device cleared by the FDA for use in complex surgical, burns, and chronic wounds.

As a next generation technology, InnovaMatrix AC preserves the inherent benefits of the placenta while adding the reliability, reproducibility, and safety profile of a medical device.

High Quality Doesn’t Mean High Cost

Starting at less than $50 per sq. cm., InnovaMatrix AC offers a wide variety of sizes for many indications that can reduce your wound care budget by up to 50%!

Triad Life Sciences® MiMedx® Organogenesis® Smith+Nephew/Osiris®
PUBLISHED FSS BEST PRICING FOR 2021
Sizes Prices Sizes Prices Sizes Prices Sizes Prices
15mm Disc $211.50 16mm Disc $299 16mm Disc $375 16mm Disc $450
2×2 cm $457.20 2×2 cm $1,144 2×2 cm $603 2×2 cm $1,136
4×4 cm $882.00 4×4 cm $2,595 4×4 cm $1,010 4×4 cm $1,010
5×5 cm $1,134.00 5×5 cm $2,995 5×5 cm $1,643 5×5 cm $2,679

 

PUBLISHED FSS BEST PRICING FOR 2021
Triad Life Sciences®
Sizes Prices
15mm Disc $211.50
2×2 cm $457.20
5×5 cm $1,134.00
MiMedx®
Sizes Prices
16mm Disc $299
2×2 cm $1,144
4×4 cm $2,595
5×5 cm $2,995
Organogenesis®
Sizes Prices
16mm Disc $375
2×2 cm $603
4×4 cm $1,010
5×5 cm $1,643
Smith+Nephew/Osiris®
Sizes Prices
16mm Disc $450
2×2 cm $1,136
4×4 cm $1,010
5×5 cm $2,679

Material for Advanced Care (AC)

While the benefits of placental-derived allografts are well known, human-derived grafts can be extremely variable due to the unique medical histories and social behaviors of each donor. Knowing this obstacle, Triad selected a source material that is controlled for age, diet, health, and activity level, which greatly reduces the variability of the raw material used to manufacture InnovaMatrix AC.

After an extensive review of Triad’s stringent testing, product characterization, proprietary processing technology, and quality control, the FDA cleared InnovaMatrix AC as the first-ever placental-derived medical device.

This image depicts the stark contrast between the amount of material, research, and testing required by the FDA for a 510(k) submission (InnovaMatrix AC) versus a simple, three-page HCT/P registration.

TriCleanseTM Placental ECM Process

InnovaMatrix AC is manufactured using the breakthrough proprietary TriCleanse Process. While balancing the need to maintain the native properties of the placental tissues, the TriCleanse Process achieves the following:

  • Deactivation of Viruses
  • Disinfection of Tissue
  • Decellularization of ECM

Processing Matters

Because tissue processing for ECM membranes has evolved over time and is performed by numerous processors, it is essential to understand that not all process are similar. Processing variables can include:

  • Heated drying
  • Antibiotics
  • Fixation chemicals
  • Oxidizing agents

These variables may affect the processed tissue in multiple ways, including residuals from the processing chemicals, presence of antibiotics, and moisture content. Those variations can impact performance and safety of the graft.

TriCleanse Process Flow Chart

Material Source
Production begins with a carefully selected tissue that is sourced from a highly controlled, monitored, and exclusive facility. The site is certified to ISO 13485:2016 and ISO 9001:2015 standards and compliant with the FDA’s Good Manufacturing Practices in 21 CFR 820. In addition, the raw placental tissues are compliant with ISO 22442-2 standards.

Physical Processing
The placental tissue undergoes thorough bulk washing, which removes surface contaminants, residual blood, and amniotic fluid.

TriCleanse Process
The placental tissue is subjected to a series of chemical baths and washes that disinfect and decellularize the tissue.

Preservation
The tissue is dried.

Final Processing
The dried tissue is processed to its final configuration.

Sterilization
Terminal irradiation to a SAL 10-6.

InnovaMatrix AC Placental ECM Advantages:

  • No preparation required
  • No specific orientation for placement
  • Easily conforms to wound anatomy

InnovaMatrix AC Placental ECM Indications for Use:

  • Partial- and full-thickness wounds
  • Pressure ulcers
  • Venous ulcers
  • Diabetic ulcers
  • Chronic vascular ulcers
  • Tunneled/ undermined 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)
  • Draining wounds