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Nurami Medical nanofiber technology

Nurami Medical Ltd. has developed a revolutionary, proprietary nanofiber and sealant technology focused on the global soft tissue repair market. Soft tissue repair products must prevent leakage and pathogen entry on the one hand, yet support regeneration of new tissue, as such, these products must be both porous enough to promote tissue growth, yet ensure effective sealing. The current state of the art requires the use of two separate products: porous matrices and liquid sealants.
Nurami’s first product, ArtiFascia, is a Dural Mater Substitute for Neurosurgery.
The dura mater is a tough yet fibrous membrane, made of connective tissue, which protects the brain and spinal cord, supports the dural sinuses and carries blood from the brain to the heart. Dura repair is required in head and spinal trauma where the dura was lacerated, or in the case of neurosurgical procedures where the dura was opened in order to gain access to the brain or spine. Neurosurgical procedures often include dura puncture, both intentional and non-intentional.
Effective dura closure is important in order to prevent cerebrospinal fluid (CSF) leakage, and in order to prevent life threatening pathogens infections . CSF leakage is a common complication in neurosurgical procedures. Dural patches serve as a scaffold for wound repair, and must therefore encourage cellular growth and be degradable. Additional dural sealant is used to prevent CSF leakage.

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Limitations of current technologies:

Dural patches include autologous grafts (taken from the patient himself), allogenic grafts (taken from a cadaver donor), xenografts (non-human alternatives) and alloplasts (synthetic patches). Alloplasts are the least expensive option, but suffer from high rates of post-operative complications. Human grafts perform well, but are expensive to use, while xenografts are associated with a number of adverse effects.
Most of the leading dural substitutes on the market today are based on animal-derived collagen and are associated with a number of drawbacks:
• Unsatisfactory Sealing
• Risk of animal-derived Disease Transmission
• Dangerous Implant Adhesions to the Brain
• Cumbersome Handling
• Poor Mechanical Properties and Difficulties in Suturing
• High Price

Nurami’s Solution:

Nurami has developed ArtiFascia®, an innovative regeneration implant made of synthetic biodegradable nanofibers, with built in sealant. ArtiFascia® utilizes nanotechnology and advanced materials to revolutionize the way soft tissue reconstruction is practiced today and to address an inherent problem in all current soft tissue reconstruction products. In addition to the aforementioned advantages, the ArtiFascia® includes a special, gel-like, sealant built in.
ArtiFascia® is a single use, sterile, absorbable matrix for the repair of dural defects and comes in two sizes: 4X3 and 5X5 cm, with a thickness of 0.25–0.66 mm. It is applied to the dural defect using a suturing technique.

The implant is degraded in the body within several months and is replaced by new dural tissue.
ArtiFascia® is the first multifunctional nanofiber-based tissue reconstruction patch that combines two functions in a single device. The nanofibers enhance tissue regeneration and provide mechanical strength, whereas the sealant prevents the entry of pathogens and the leakage of fluids or air.

A Multi-Billion Dollar Opportunity: 

Nurami's nanofiber with smart sealant is a platform technology, which can be used as a graft for numerous surgical procedures. The global soft tissue repair market reached $16.5 billion in 2017 with the tissue mesh segment comprising a 37.5% of this market of over than $6 billion. The total market is poised to reach $25.6 billion in 2024.
Nurami's preliminary target market is the dural repair market for brain surgeries. According to Allied Market Research (8/2018), the soft tissue dural repair market reached $1.35 billion in 2017, and is projected to reach $2.14 billion by 2025, growing at a CAGR of 5.9% through 2025. Nurami has calculated the total 2018 market for dural grafts and sealant for craniotomies at over $600 million to reach close to $1 billion in 2025.

 

Intellectual property:

• PCT Patent Application No. PCT/IL2019/050604, "AN ADHESIVE LAYERED MATRIX AND USES THEREOF", filed on May 27, 2019.
• US Provisional Patent Application No. 62/876,952, "TISSUE-ADHESIVE MATRIX AND USES THEREOF", filed on July 22, 2019.

Current  status:

• Established in 2014 and raised $5M.
• Successfully completed First-in-Human clinical study in Europe.
• Following a successful pre-sub with FDA, Nurami is launching its pivotal clinical study during October 2019
• Established an R&D lab and a GMP manufacturing facility.
Nurami seeks $3M to achieve CE and FDA approvals
• Nurami is currently working on a next-generation of ArtiFascia® that could adhere to tissues without the need for sutures

Team:

Management:

 

• Doron Birger  – Chairman of the Board. Former CEO of Elron investment company (NASDAQ) and chairman of Given Imaging (purchased by Covidien, $1B).

• Hannoch Marksheid, CEO –extensive experience in leading Medical Device companies to the market.

• Dr. Amir Bahar, COO and Clinical Manager –Co-Founder of the company, a world-class brain-scientist

• Nora Nseir-Manassa, CTO –Co-Founder of the company, M.Sc. in Bio-Medicine, a true innovator

• Dr. Harel Kasuto, Production and Operations - Biotechnological manufacturing expert

• Rodaina Omar, Product and QA Engineer – M.Sc. in BioMedical engineering, expert in tissue engineering

Dr. Peter Siman – Bio-Polymers expert developing new innovative products

Jenny Krupko – Clinical Operations Manager

• Mor Hochberg - Intern

 

Advisory Board:

 

Prof. Issam Awad, Director of the neurovascular division in Chicago University Hospital.

Dr. Sagi Harnof, Head of Neurosurgery, Rabin Medical Center, Israel.

Prof. Eyal Zussman, Technion. A world-renowned expert in nanofibers.


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