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Plurivest and Dermavest Technology

Plurivest and Dermavest represent an innovative technology utilizing human amnion/chorion, umbilical cord and placental disk tissue. The tissue is decontaminated while preserving the important cell attachment proteins, growth factors and cytokines that have been proven to have therapeutic value. The tissue is freeze-dried to remove moisture, pressed into a pad and sealed in a foil pouch. A low, 17.5 kGy dose of e-beam irradiation assures sterility and the products are distributed with a three year, room temperature shelf life.

As a replacement or supplement for damaged or inadequate integumental tissue, patients with the following conditions may be clinically indicated for the use of Plurivest and Dermavest:

       •    Partial and full thickness wounds.   •    Diabetic Ulcers

       •    Pressure ulcers                                •    Trauma Wounds (abrasions, lacerations, second degree burns, skin tears)

       •    Venous Ulcers                                  •    Drainage Wounds

       •    Chronic Vascular Ulcers                   •    Surgical (donor sites/grafts post mohs surgery, post laser surgery, podiatric).

FDA Approval

Plurivest and Dermavest are regulated as human cells, tissues, and cellular and tissue-based products (“361 HCT/P”).

The tissue is obtained from normal, healthy, full-term pregnancies. Donors have consented to transfer of the tissue to third parties. Each donor is carefully screened. Comprehensive medical and social histories of the donors are obtained and placentas with attached umbilical cord and amnion are procured, processed, and tested in accordance with standards established by the FDA to minimize potential risks of disease transmission to recipients.

Processing and distribution of Plurivest and Dermavest are conducted by an FDA registered tissue bank with over 20 years of experience. 

Innovative Technology for Protein Delivery

Placental tissue has been used for reconstructive and surgical applications since the early 1900s. In recent years, application of amniotic membranes has expanded to the treatment of chronic ulcers and soft tissue applications. Plurivest and Dermavest are the only products on the market that combine human tissue sourced from the amniotic/chorionic membrane, umbilical cord AND placental disc.

Plurivest and Dermavest represent a new, innovative category of placental tissue based therapy for replacing or supplementing damaged or inadequate integumental tissue. Plurivest and Dermavest contain a myriad of cell attachment proteins (CAP) including collagen, proteoglycans, polysaccharides and cytokine/growth factors (GF’s) that, combined with the structural aspects of the placental connective tissue matrix act as a scaffold for cell infiltration and proliferation. The CAP and cytokine/GF profile of Plurivest and Dermavest are unlike anything that is being offered in the market today. In Vitro studies demonstrate that Plurivest and Dermavest support the proliferation of Type-1 Collagen, Fibroblasts and Mesenchymal Stem cells. 

Placental tissue products have been shown to elicit a markedly different profile of proteins than other classes of skin substitutes including porcine intestinal submucosa, cadaver skin and collagen based wound coverings.  It stands to reason that supplementing amnion and chorion with umbilical cord AND placental disc tisue will drive a novel therapeutic response in the varied In Vivo environments to which Plurivest and Dermavest are applied.

Comparison of the concentration (pg/cm2) of cytokine and growth factor (GF) content in Plurivest, and Dermavest, dehydrated Amnion and Chorion

Two Dosage Forms

Yet another innovative aspect to Plurivest and Dermavest is that, within the same Code (Q4153), they each contain a different tissue CAP and cytokine/GF profile from each other. This allows each product to be applied to chronic wounds at different stages in the wounds progress towards healing. It is well known that chronic ulcers, at different stages in the wound healing process, require different concentrations of Cytokine/GF’s and it could well be that some ulcers would more greatly benefit from the lower concentration profile that can be found in Plurivest. Wounds that are at a stage that would benefit from a higher concentration of CAP and cytokine/GF’s may be better served by an application of Dermavest. 

Particularized Pad that is Easy to Handle

Plurivest and Dermavest are comprised of tissue particulate pressed together into a pad. This configuration results in a more porous, open structure than a contiguous membrane scaffold. This increase in porosity logically allows for easier cell infiltration and thus attachment. Additionally, the larger surface area resulting from a particulate pad allows for increased contact with wound bed fluids and so, presumably, an increased rate of enzymatic digestion of graft tissue and a more efficient transport of cell stimulatory cytokines/cytokine/GFs to the wound bed.

The particularized pad makes it extremely easy to work with in relation to thin membrane products that may need to be maneuvered into specific orientations and that can roll up off of the wound bed. By reason, the easy administration of Plurivest and Dermavest as compared to contiguous membrane products, make them ideal candidates for deep or tunneled wounds.

Clinical Evidence

A 4-week percent area reduction (PAR) for diabetic ulcers of 50% and a 4-week PAR of 40% for venous ulcers have both been shown to be favorably predictive of 12 week and 24 week wound healing (1,2).

When combining data from two case study posters presented at the Society of Advanced Wound Healing conferences in the Spring of 2015 and 2016, Plurivest/Dermavest evidenced the following:

80% (8 out of 10) of diabetic ulcers cases on which Plurivest/Dermavest were used had a 4-week PAR greater than 50%. When compared to historical standard of care (1,4), this translates to at least a 96% probability that when Plurivest/Dermavest is used on diabetic ulcers, more cases will have a greater than 50% reduction in wound size over 4 weeks than standard of care.

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69% (9 out of 13) of venous ulcers cases on which Plurivest/Dermavest were used had a 4-week PAR greater than 40%. When compared to historical standard of care (2,3), this translates to at least a 94% probability that when Plurivest/Dermvest is used, more cases will have a greater than 40% reduction in wound size over 4 weeks than standard of care.

References:

1: Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J, “A Post-hoc Analysis of Reduction in Diabetic Foot Ulcer Size at 4 Weeks as a Predictor of Healing by 12 weeks “, Ostomy wound Management 2010; 56 (3); 44-50.

2: Gelfand JM, Hoffstad O, Margolius D, “Surrogate Endpoints for the Treatment of Venous Leg Ulcers”, J Invest Dermatol 119:1420-1425, 2002

3: Serena TE, Carter MJ, Lam TE, Sabo MJ, and DiMarco DT “A Multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers”, Wound Rep Regeneration 2014; 22; 688-693.

4: Zelen CM, Serena TE, Denoziere G, Fetterolf D “A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers”, International Wound Jrnl 2013; doi: 10.1111/rwj.12097.