Our Strategy

Axial Biotech’s strategy is to develop gene-based products by characterizing the genetic foundation of spinal disorders, to market its products through partnerships with industry leaders, and to use revenue generated by early sales of its tests and fusionless devices to fund development of products, including bio-mechanical implants, aimed at the most widespread spinal disorders. Medical science has thus far been unsuccessful in developing new therapies or prognostic tests for spinal disorders because of a fundamental lack of understanding of the molecular mechanism causing these disorders. Through the unique combination of Axial’s widely experienced team, its large collection of coordinated genetic and genealogic data and its exclusive access to cutting-edge, proprietary technology, Axial is well on its way to developing this critical understanding in its first area of focus: adolescent idiopathic scoliosis. Axial's genetic tests will be performed by highly skilled personnel in the Axial reference laboratory. This service will be available as soon as the validation, currently underway, is completed. Pre-symptomatic DNA testing will create new opportunites for prevention or early intervention long before these devastating spinal disorders progress. Developing a proprietary understanding of the genetic foundation of spine disorders will allow Axial to marry its genetic and device assets to create bio-mechanical implants that offer treatment on both the molecular and mechanical levels.

Axial's first test will be used on pre-symptomatic adolescents and as a prognostic in those with early idiopathic scoliosis. The US market for a gene based test for adolescent idiopathic scoliosis is estimated by Medtronic and Axial to be in excess of $180 million annually.

Axial’s devices may dramatically expand the scoliosis implant market. Currently, spinal fusion is the only surgical option generally available but is offered only in the most severe cases of scoliosis (curve > 40º). However, this relatively small patient population creates an annual US market of $140 million for fusion implants for the treatment of scoliosis. The population of patients with a “moderate” curvature (< 40º but > 25º) is approximately ten times that of patients with a severe curvature. At present the only option for these patients is an external brace, used merely to arrest the curve, and then effective in only 50% of cases. When combined with an objective and conclusive early genetic diagnosis or prognosis, Axial’s fusionless devices will introduce the possibility of earlier treatment through minimally invasive corrective surgical intervention to the “moderate” curvature population, creating a potential new implant market in excess of $1 billion.

Over the next several years, Axial will also launch product development programs for:

• Gene-based diagnostics/prognostics for other spinal disorders (degenerative disc disease, spondylolithesis, Scheuermann’s disease and osteoporosis)
• Improved minimally invasive surgical instrumentation and bio-mechanical devices
• Gene-based therapeutics and/or pharmaceuticals targeting spinal disorders