Nurami Medical’s Biomimetic Dural Repair Tech Gains FDA Nod, Fuels Expansion

Haifa, Israel – November 10, 2025 – Nurami Medical, an Israeli medical device company pioneering biomimetic technologies for soft tissue repair, has received US Food and Drug Administration (FDA) 510(k) clearance for its novel dural repair graft, ArtiFascia®. This approval, coupled with over $43 million in funding, positions the company for significant growth within the competitive, but crucial, $2 billion+ global dural repair market.

Addressing a Critical Need in Neurosurgery

Dural tears and defects, often arising from trauma or surgery, present a significant challenge in neurosurgery. Effective closure of the dura mater (the outermost membrane surrounding the brain and spinal cord) is vital to prevent cerebrospinal fluid (CSF) leakage, infection, and other serious complications. Traditional repair methods have often relied on autografts (tissue taken from the patient’s own body) or allografts (tissue from a donor), which carry risks of infection, immune rejection, and limited availability. Synthetic materials have emerged as a promising alternative, but many lack the biocompatibility and regenerative properties needed for optimal healing.

“There’s been a real need for a reliable, easy-to-use dural repair solution that minimizes complications and promotes natural healing,” explained a leading neurosurgeon, speaking anonymously. “The challenges with current materials often require extensive suturing and can still lead to CSF leaks. A product that addresses those issues would be a significant advance.”

ArtiFascia®: A Biomimetic Approach to Dural Repair

Nurami Medical’s ArtiFascia® aims to meet that need through its unique biomimetic design. The graft is constructed from electrospun nanofibers, creating a scaffold that mimics the extracellular matrix (ECM) of natural dura. This nanofiber structure promotes cell adhesion, infiltration, and tissue regeneration, facilitating natural healing. Crucially, ArtiFascia® also incorporates an integrated thin-film barrier layer to prevent CSF leakage and minimize the risk of infection.

“The key is to create a material that the body recognizes and integrates seamlessly,” stated Nora Nseir, CEO and co-founder of Nurami Medical. “We’ve designed ArtiFascia® to not just seal the defect, but to actively promote tissue growth and restore the natural barrier function of the dura.”

The company highlights that the graft’s structure allows for easy handling and suturing, potentially reducing surgical time and improving patient outcomes. Clinical data, including an 85-patient randomized trial, demonstrate the graft’s effectiveness in preventing CSF leaks and showcasing surgeon preference.

Standing Out in a Competitive Landscape

The dural repair market is populated by established players like Integra LifeSciences, Polyganics, and Acera Surgical. Integra, a market leader, offers a range of collagen-based grafts and sealant systems. Polyganics’ Liqoseal offers a bioresorbable polymer sealant. Nurami Medical differentiates itself through a combination of its biomimetic nanofiber technology and its dual-function design.

“While many products focus on simply sealing the defect, ArtiFascia® aims to go a step further by promoting regeneration,” explained a medical device analyst, speaking on background. “That emphasis on long-term healing could be a significant advantage.”

Furthermore, Nurami’s proprietary manufacturing process allows for precise control over the nanofiber structure, ensuring consistent quality and performance. The company is also exploring additional applications for its nanofiber technology in other soft tissue repair areas.

Fueling Growth with Strategic Funding

Nurami Medical has secured over $43 million in funding from a combination of venture capital, grants, and strategic investors. Key investors include the European Innovation Council (EIC), Israel Innovation Authority, Almeda Ventures, and NGT3VC. This funding has enabled the company to complete clinical trials, obtain FDA clearance, and scale up manufacturing operations.

“The support from our investors has been crucial to our success,” stated Dr. Amir Bahar, co-founder and Chief Commercial Officer of Nurami Medical. “They share our vision of transforming soft tissue repair with innovative biomaterials.”

The company recently closed a $30 million funding round, which will be used to expand its commercial team, accelerate sales and marketing efforts, and further develop its product pipeline. Nurami Medical plans to initially focus on the US market, with plans to expand into Europe and other key regions in the coming years.

Looking Ahead: Expanding the Biomimetic Frontier

Nurami Medical’s success with ArtiFascia® demonstrates the potential of biomimetic technologies to revolutionize soft tissue repair. The company is actively exploring new applications for its nanofiber platform in areas such as nerve regeneration, tendon repair, and wound healing.

“We believe that biomimicry is the future of regenerative medicine,” concluded Nseir. “By mimicking the natural processes of the body, we can create materials that promote healing and restore function.”

As Nurami Medical prepares for commercial launch and expansion, the company is poised to become a key player in the growing field of biomaterials and regenerative medicine, bringing innovative solutions to address critical unmet needs in neurosurgery and beyond.