ArtiFascia®

ArtiFascia^® is a multilayer, Dural repair graft made of biocompatible and bioabsorbable polymers with an integrated barrier layer and a biomimetic structure of electrospun fibers designed to promote neodura regeneration.

ArtiFascia^®, a patented product, is available for commercial use in the USA.

ArtiFascia^® has FDA 510(k) clearance.

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Unique formulation

ArtiFascia’s^® is indicated for dural repair and features porous biomimetic electrospun outer layers designed to act as scaffolds to support regeneration, along with an integrated non-porous thermoplastic layer designed to protect against CSF leaks.

ArtiFascia’s^® morphology and thickness of only 0.35 mm, mimics the morphology and thickness of the native Dura.

Advantages

ArtiFascia^® provides an innovative solution for Dura repair, through several exceptional features:

Biomimetic, porous scaffold

ArtiFascia^® is resorbable and composed of electrospun fibers, which create a biomimetic morphology that supports neodura regeneration

Dual functionality

ArtiFascia^®is the only 2-in-1 Dura repair graft combining a porous biomimetic scaffold with a non-porous barrier layer

Non biological

No animal or human sourced materials, mitigating the risk of disease transmission, as well as sourcing challenges

Performance Under Wet Conditions

Flexible, strong, mechanical features are stable, even under wet conditions

Tightens around suture holes

At body temperature, thermo-responsive, the Smart Polymer layer becomes highly conformable, enabling it to flow into suture holes to support mitigation of CSF leakage

Zero cases of CSF fistula & pseudomeningocele in clinical study

Clinical evidence

In a prospective, randomized, controlled, single blind clinical study comparing ArtiFascia^® to commercially available dural grafts, ArtiFascia^® was found to be non-inferior in terms of CSF leakage rate and other clinical outcomes.

During the 6-month post-operation period, the 58 patients implanted with ArtiFascia^® showed:

Higher usability scores as rated by surgeons*

*Usability scores documented as part of the clinical study.

No CSF leakage in posterior fossa (11 patients implanted with ArtiFascia^®)

No device related infections or inflammation

In a non-inferiority clinical study, ArtiFascia showed only 1.7% CSF leakage rate compared to 7.4% in the control group (primary endpoint)

Validation

Water permeability test

Burst pressure – sutured graft

Suture retention

Strength and Flexibility

Mean leakage rates of dural grafts as measured over 5 minutes, under pressure of 8 mmHg (n=3 each group) - ArtiFascia^® does not leak and completely seals at physiological CSF pressure.

Sutured ArtiFascia^® holds maximal pressure of 1.7 Psi (88 mmHg)

According to mechanical tests performed in comparison to other products, ArtiFascia^® holds sutures better than other suturable products

ArtiFascia ^® is mechanically strong (it has high ultimate tensile strength) but also highly flexible (it can elongate 6 times its original length before breakage)

*Data on File

Intended Use

ArtiFascia^® is indicated as a dura substitute for the repair of dura mater. ArtiFascia^® is indicated for defects of 25cm² (3.87 in²) or less in area.
For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size

ArtiFascia is available in different sizes:

1.2”x1.5”

2”x2”

2.75”x2.75”

Science & Technology

Nurami Medical develops innovative sealants and surgical grafts for optimal tissue engineering and regeneration based on unique combinations of advanced biomaterials and customized, electrospun nanofiber scaffolds.

Nurami identifies the specific needs of various surgical and wound healing procedures, and develops a proprietary formulation of biocompatible polymers to address these needs.

Electrospun nanofiber scaffolds made of medical grade, resorbable polymers highly resemble the natural extracellular matrix (ECM) structure creating biomimetic scaffolds for tissue engineering and regeneration. These scaffolds, have tunable porosity, high surface-to-volume ratio and pliability. Electrospun nanofiber scaffolds are poised to become the next generation of surgical patches, offering a different approach to the currently-used animal derived materials.

Product pipeline

Nurami’s pipeline includes ArtiFascia^®, a Dura repair patch, currently available in the US.

Our second product is a next generation adhesive graft/implant ArtiFix^® (under development), which can be used as a suture-less dural substitute. ArtiFix^® will be especially suitable for spine surgeries and neurosurgeries wherein suturing is challenging, and for additional clinical indications to be developed in the future. ArtiFix^® is based on a novel, integrated, adhesion technique, creating the first degradable adhesive product with the ability to adhere to wet tissues. Currently undergoing clinical studies, ArtiFix^® is designed to provide an effective seal for soft tissue surgeries with adhesive capabilities.