The Need for Innovation in the SCI Treatment Market
The demand for spinal cord injury (SCI) treatment has increased significantly because of the growing incidence of traumatic spinal cord injuries. According to a 2018 report from the United States National Library of Medicine, the prevalence of traumatic spinal cord injuries in low and middle-income countries was 8.72% per 100,000 people, while in high-income countries, it was 13.69% per 100,000 people. Today, the estimated number of people with SCI in the U.S is around 291,000, and in Europe, the number is 500,000. Treatment is usually very expensive and focused on life-style adjustments and ongoing care as opposed to full functional recovery. The costs of treatment range from $1 million to nearly $5 million and continue to increase due to a lack of advanced, scalable treatment options.
Depending on the severity of the injury, SCI patients may incur significant yearly healthcare expenses which highlight the need for extensive research and development for effective and affordable alternative treatments to reduce reliance on trauma center visits. As a result, emerging market players are concentrating on the development of non-invasive, less painful treatments, which will drive market growth and open up new opportunities. The global SCI therapeutics market is projected to grow at a CAGR of 17.84% to reach $9.61 billion by 2028 with increasing investment in the development of novel therapeutics such as non-invasive over-the-counter medication to treat SCI.
NurExone Biologic – A Leading Player in Disruptive Exosome-Based Technologies
NurExone Biologic (TSXV: NRX, FSE: J90) is an Israeli biotech company that is developing a revolutionary biological extracellular vesicle (E.V.) technology that has proven to be a suitable manipulative platform for biomedical applications including targeted drug delivery and tissue regeneration. Bio-guided exosomes loaded with a modified small interfering RNA (siRNA) sequence are used to treat traumatic central nervous system damage (CNS). ExoPTEN is NurExone’s first ExoTherapy that is administered intranasally and has been shown in animal studies to promote exon growth, functional recovery, or nerve regeneration. ExoPTEN was developed with technology licensed by Tel Aviv University and the Technion, Israel’s Institute of Technology, two of the country’s leading universities. The company has an exclusive worldwide licensing agreement with Technion for technology development, clinical trials, and commercialization.
NurExone has made significant progress recently, announced numerous partnerships for advanced research and large scale exosome production. The company is preparing for a meeting with the FDA to submit a Pre-Investigational New Drug (pre-IND) application. On Nov 2, the company announced that the US Food and Drug Administration (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 US markets sooner than expected which bodes well for the company and investors seeking exposure to the expanding Exosomes market. Pre-IND applications usually lift the shares of biotech companies higher. For example, Silo Pharma shares surged more than 9% last month after the company announced the decision to seek a pre-IND meeting with the FDA.
With its technology showing very promising results for spinal cord injuries, NurExone is making significant progress toward becoming a market leader in exosome-based treatment. Several NurExone studies have already suggested that the company’s treatment may serve as an effective therapy for patients suffering from acute SCIs. If the IND is approved, NurExone will have a first-mover advantage in groundbreaking exosome-based therapy to treat SCI.
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