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Biotech innovation
Biotech innovation Pixabay

The World Health Organization (WHO) estimates that between 250,000 and 500,000 people worldwide suffer from a spinal cord injury (SCI) each year. It's also been estimated that around 291,000 people in the US currently live with an SCI, while the European SCI population is up to 500,000 people. Statista also reports there's an average of 18,000 spinal cord injuries in the US yearly (and 40 to 80 new SCI cases per million people worldwide each year). It's a growing concern, especially since the average age at spinal cord injury in the US is 43, according to Statista's report.

As workplace accidents, road accidents and other medical conditions continue to rise, the National Spinal Cord Statistical Center (NSCSC) estimates the global spinal cord injuries (SCI) therapeutics market will grow at a compound annual rate of 17.84% to reach $9.61 billion by 2028. These figures show a big challenge: Spinal cord injuries are rising in America, especially among older populations.

On top of that, the NSCSC notes that "the average life expectancy for individuals with spinal cord injuries has not improved since the 1980s, remaining significantly lower than life expectancies of those without SCIs." But, increasingly, many companies are on the quest to solve this problem with innovative technologies. One of such companies is NurExone Biologic, a biotech company developing treatments in the SCI field.

The healthcare landscape is changing dramatically and has seen no dearth of innovations, with more tech-enabled solutions bursting onto the scene. One of the innovations that have been touted to solve the growing SCI challenge is an effort of Italian researchers to develop spinal implants shaped like Pasta, referred to as "Bucatini," which scaled animal testing. In a separate development, a startup worked on dealing with the pains associated with SCI with a non-opioid solution. However, Israel-based NurExone claims it's developed a totally new and efficient approach to solving spinal cord injuries.

A new approach to solving spinal cord injuries

Founded in 2020 by Prof. Shulamit Levenberg (Technion, Israel Institute of Technology) and Prof. Daniel Offen (Tel Aviv University) together with serial Bio-Tech entrepreneur Yoram Drucker, NurExone says it's developing a groundbreaking biological technology, based on exosomes (extracellular vesicle – EV), for the treatment of traumatic damage in the central nervous system (CNS). Exosomes are lipid-bound microvesicles that are naturally secreted from cells and contain biologically active cargoes such as proteins and nucleic acids to achieve intercellular communications.

The preliminary results of NurExone's SCI exosome treatment have shown significant potential. In a joint study conducted on rats at the Technion, Israel's Institute of Technology, together with the Tel Aviv University, NurExone's SCI treatment showed spinal cord nerve regeneration following the complete transection of the spinal cord, and enabled the rats to walk again. Significantly, both motor and sensory improvement was evidenced. In another development, NurExone recently announced in a press release it had successfully demonstrated its patent-pending platform technology for loading exosomes with therapeutic molecules. "In exosome-based therapies, loaded exosomes are biologically guided to target inflamed tissues to 'dock' and unload their therapeutic cargo, creating a healing environment. The company's platform for exosome-based therapy production is planned to include: (i) a large-scale exosome production, (ii) a therapeutic cargo and (iii) a unique technology to load the therapeutic cargo," the press release said.

NurExone's primary focus is exosome-based technologies and smart delivery systems to revolutionize the treatment of spinal cord injuries (SCI) around the world. Exosome technology has piqued the interest of the healthcare industry and researchers for years, and it is now a suitable manipulative platform for biomedical applications such as targeted drug delivery, gene therapy, cancer diagnosis and therapy, vaccine development, tissue regeneration and more.

Gaining entry into the US SCI market

The technology is already promising results. NurExone is preparing for a meeting with the US Food and Drug Administration (FDA) to submit a pre-investigational new drug (pre-IND) application. On November 2, the company announced that the FDA informed NurExone that it was ready for a pre-IND meeting. Pre-IND is a critical milestone that can save time and money, as it provides guidelines for the preparation of clinical studies for the company's product.

This meeting is expected to reduce the time to market required for regulatory approval and avoid clinical holds as it gives a clear idea of what the FDA is expecting and helps better design the next stage of studies. This discussion with the FDA will aid in the preparation for the submission of complete investigational new drug applications and advancement to the next stage of drug development, (i.e., human trials.) This indicates that NurExone may enter the US SCI market sooner than expected, which bodes well for the company and investors seeking exposure to the expanding exosomes market.

In addition, NurExone is expanding its proprietary SCI technologies [published in Science Times] into a platform that leverages its breakthroughs in exosomes license it to several companies. As a result, NurExone could achieve revenue much quicker than previously thought, showing an upward trajectory for the company.

NurExone is led by CEO Dr. Lior Shaltiel, who maintains an impressive background in biotech entrepreneurship, in addition to biomedical engineering, pharmacology and the advancement of smart delivery systems — all of which are vital components to the company's mission. The formula behind NurExone's solution is a two-pronged strategy: To concentrate exosome technology as the main fuel and practically treat SCI patients via a smart delivery platform This combination, which is planned to medically administer the therapy into the body through the nose, has a natural effect in targeting neuron damage.