DermACELL AWM

Advanced Decellularized Dermis

Dermacell is a decellularized regenerative human tissue matrix allograft processed using proprietary Matracell® technology from LifeNet Health®.

Adequate blood supply is critical for successful use of decellularized regenerative human tissue matrix allografts.

Matracell the properties required of an allograft intended for use as a bio-implant during breast reconstruction surgery or during the treatment of chronic wounds.

LifeNet Health® has the longest running American Association of Tissue Banks  certification and is also the world’s largest full service provider of organs, tissues,  and cells. LifeNet Health has more than 30 years of experience in tissue regeneration including expertise in advanced sterilization techniques for biologic matrices

Sterile

Sterility assurance level (SAL) 10-6

Ready To Use (RTU)

No rinsing required.

Decellularized using Matracell

A proprietary and patented technology that removes at least 97% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.

Dermacell is sterile – sterility assurance level (SAL) 10-6 and ready to use – no rinsing required.

  • Dermacell is decellularized using Matracell, a proprietary and patented technology that removes at least 97% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.
  • After being rendered acellular, Dermacell undergoes a terminal sterilization step to ensure a Sterility Assurance Level (SAL) of 10-6
  • Low-dose gamma irradiation performed at ultra-low temperatures is used to reach surgical device-grade sterility, which lowers the probability of an active organism in the graft to 1 in 1,000,000 – lower than 10-3 or, a 1 in a 1,000 chance
    • All of this is achieved without compromising the desired biomechanical structures or biochemical properties (i.e. cross-linking) of the biologic matrix

Dermacell AWM

NOVADAQ has recently dedicated a portion of its business to the Wound Care specialization. This specialization is not only focused on products, it will be centered on patient education, outcomes and cost-effective solutions. With you, we are committed to bringing a higher level of awareness around this epidemic.

DermACELL AWM Acellular Dermal Matrix (ADM) provides a cost-effective, one-application treatment solution for patients with chronic lower extremity ulcerations. In the largest and most rigorous randomized control trial to date for ADM products, DermACELL AWM demonstrated superior rates of healing and wound closure in Diabetic Foot Ulcers. Unlike many other human tissue products, DermACELL AWM can be stored for up to 3 years in ambient temperature, does not require special handling and is fast and easy to apply.

The value of DermACELL AWM includes:

  • One, Easy Application
  • Cost-Effectiveness
  • No Special Handling Requirements

Recently Released Level I study highlights:

  • At 16 weeks, combined analysis of all DermACELL AWM-ADM patients demonstrated a statistically significant higher healed rate than conventional care (67.9% vs 48.1%; P = .0385) and a substantially higher rate than Graftjacket-ADM that trended toward significance (67.9% vs 47.8%; P = .1149).
  • The DermACELL arm also exhibited a greater average percent reduction in wound area than the conventional care arm (91.4% vs 80.3%; P = .0791) and the Graftjacket arm (91.4% vs 73.5%; P = .0762).
  • The primary endpoint of this study analysis was assessment of complete reepithelialization with no drainage or dressing requirements up to 16 weeks. In further stringency, an assessment of wound closure required confirmation at 2 consecutive study visits performed 2 weeks apart. The healing rate of wounds at 16 weeks and the percentage of reduction in wound size from baseline up to 16 weeks were also analyzed.

Many commercial payers do not have specific skin substitute medical policies.

Contact the NOVADAQ Reimbursement Support Team to:

  • Confirm coverage
  • Help providers review individual payer policies
  • Provide pre-populated payer prior authorization forms and a template letter of medical necessity
  • Support appeals on facilities/physicians behalf until a final reimbursement decision is obtained

To contact: reimbursement@novadaq.com | 1.844.668.2327 OPTION #3

References

1. Capito AE; Tholpady SS; Agrawal H; Drake DB. “Evaluation of Host Tissue Integration, Revascularization, and Cellular Infiltration Within Various Dermal Substrates.” Annals of Plastic Surgery, 2012. Web..

2. Yu D; Hanna KR; LeGallo RD; Drake DB. “Comparison of Histological Characteristics of Acellular Dermal Matrix Capsules to Surrounding Breast Capsules in Acellular Dermal Matrix–Assisted Breast Reconstruction.” Annals of Plastic Surgery, 2016.

3. Hanna K; Yu D; LeGallo R; Colen D; Drake DB. “Matracell processed, sterilized acellular dermal matrix in implant-based breast reconstruction: clinical and histologic outcomes”. Annals of Plastic Surgery, 2013.

1Yonehiro, et. al., Use of a New Acellular Dermal Matrix for Treatment of Nonhealing Wounds in the Lower Extremities of Patients With Diabetes, WOUNDS. 2013;25(12):340‐344