The Problem: Low Back Pain, A Painful Condition with Few Available Treatments

Low back pain affects 12-30% of US adults at a given time and is the leading cause of disability worldwide. Overall, the annual expenditure in the US for low back pain is over $100 billion, creating a significant burden on the economy. Back pain, which can be caused by degenerative disc disease (DDD), results in disability, loss of productivity/wages, and even addiction to pain medication. Current treatment options for DDD are limited during early stages to pain management and alternative care. In late stages, surgical intervention such as spinal fusion may be required but is expensive (>$100,000) and not always successful. Cost-effective solutions for treating painful DDD during the moderate stages of the disease are needed.

Our Solution: Harnessing the Power of Progenitor Cell Science

DiscGenics treats diseases of the intervertebral disc using cell therapy and biomaterials science. We have a patented technology for isolating cells directly from adult human disc tissue and expanding these cells into therapeutic progenitor cells, Discogenic cells, that are used as the active ingredient in our products. The process is both trade-secret and patent protected globally, with 24 issued patents and 11 additional patents pending. Our first product, Injectable Discogenic Cell Therapy (IDCT), is in late preclinical development for the treatment of moderate DDD. This cellular treatment offers a cost-effective and non-surgical solution to patients that currently have few treatment options. Follow-on products utilizing the same cell population with different scaffold carriers are being explored for additional disc-related indications.

Robust Preclinical Safety and Efficacy Data Justify Human Clinical Trials

Since 2012, extensive preclinical evaluation has been performed on Discogenic Cells and IDCT utilizing a wide variety of scientific approaches including in vitro assays, microscopy, biochemical evaluations, and in vivo modeling. The findings have been presented at both national and international scientific conferences. DiscGenics has completed multiple regulatory meetings in order to establish the preclinical studies and manufacturing process required to enter clinical trials in multiple global markets.

Competitive Advantage

Few companies exist that seek to heal and restore normal function to a degenerated disc. Pre-clinical testing shows that discogenic cells have the potential to modulate the degenerative disease state by reducing inflammation and regenerating tissue, thereby reducing the pain and disability associated with DDD. We believe that this treatment can produce a regenerative effect in patients as seen in our preclinical studies, versus short-term pain mitigation alone. IDCT is an off-the-shelf, homologous cell therapy, meaning our Discogenic Cells are derived from the same tissue they will treat which provides an important biological advantage.

These investigational products are under development by DiscGenics and have not been approved by the FDA or any other regulatory agency for use in human.