Introducing the First and Only hydrogel Dermal Regeneration Template

Fesarius Therapeutics Announces FDA 510(k) clearance for Dermisphere hydrogel Dermal Regeneration Template
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DUAL COLLAGEN DENSITIES

Facilitates rapid cell invasion and neovascularization

DermiSphereTM hDRT is an advanced biphasic biomaterial that features a novel microarchitecture comprised of differential density interfaces created by combining a collagen based hydrogel with more dense collagen microspheres. DermiSphereTM hDRT facilitated cell invasion
throughout the template 3 days after placement and becomes fully vascularized in just 7 days when vigorously tested pre-clinically.1

DUAL RESORPTION TECHNOLOGY

Fosters an optimal healing environment to support tissue regeneration

Designed with different rates of resorption, the less dense hydrogel component is rapidly replaced by the patient’s own collagen, while the denser microspheres are replaced more slowly enabling the deposition of stable vascularized neodermal tissue.

The DermiSphereTM Difference

In a pre-clinical study, DermiSphereTM hDRT facilitated fast and effective cellular invasion and vascularization of the template, leading to early, reliable deposition of functional neodermal tissue. By Day 3, DermiSphereTM hDRT demonstrated 100% wound bed incorporation and fully vascularized the template by Day 7 (Figure 1).1 Assessment of the newly formed dermal tissue revealed robust dermal thickness in DermiSphereTM hDRT treated wounds of 1.5mm on day 7.1

MAXIMIZED CONFORMABILITY

A pliable biomaterial that conforms to native tissue

The collagen hydrogel formula is designed to maximize
conformability, ensuring that DermiSphereTM hDRT
maintains intimate contact with the wound bed,
even in irregular wound topographies, ensuring
support of the wound healing process.

IMPROVED EASE OF USE

A translucent template that supports multidirectional cell invasion

DermiSphereTM hDRT is omnidirectional and can
be applied or adjusted in any direction without
compromising its fit or function. Additionally, it can
be trimmed in the wound bed, improving its ease of
use and simplifying the need to manage it clinically.

Choose the DermiSphereTM Difference

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  1. Data on file. Fesarius Therapeutics, NY, NY. Pre-clinical results do not necessarily translate to clinical outcomes.

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DermiSphere™ Indications

DermiSphereTM is indicated for use in the management of wounds, including:

  • Partial and Full-Thickness Wounds
  • Pressure Ulcers
  • Venous Ulcers
  • Diabetic Ulcers
  • Chronic Vascular Ulcers
  • 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

DermiSphereTM: A Collagen Microsphere Dermal Regeneration Template

In a porcine model of full-thickness skin loss, DermiSphereTM successfully supported simultaneous split thickness skin grafting by rapidly inducing functional vascularized neodermal tissue deposition. 2

In a novel 2-stage rat model of full thickness skin loss that closely mimics clinical practice, the composite hydrogel induced rapid cell infiltration and neovascularization, creating a healthy neodermis after only 1 week onto which a skin graft could be placed. 1
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  1. Weisel A, Cohen R, Spector JA, Sapir-Lekhovitser Y. Accelerated vascularization of a novel collagen hydrogel dermal template. J Tissue Eng Regen Med. 2022;16(12):1173-1183. doi:10.1002/term.3356
  2. Luong D, Weisel A, Cohen R, Spector J, Sapir-Lekhovitser Y. Successful reconstruction of full-thickness skin defects in a swine model using simultaneous split-thickness skin grafting and composite collagen microstructured dermal scaffolds [published online ahead of print, 2023 Jun 14]. Wound Repair Regen. 2023;10.1111/wrr.13102. doi:10.1111/wrr.13102

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