We aim to ease back pain
Surgical options do exist but those are costly and complex. Either a prosthesis is implanted or spine segments are fused. Both therapies introduce further complications for the patient, as a prosthesis puts a strain on other parts of the spine and fusion eliminates the range of motion. Furthermore, rehabilitation is tough and lengthy. Of course, these therapies are also not restorative.
The innovative product that will be developed is a medical therapy that is able to restore the biomechanics of the spine, thereby alleviating the common cause of low back pain. The described invention is meant to replace current early-stage treatments, which represent the biggest patient population. As it is very easily administered (a simple injection), NC Biomatrix does not foresee many introductory complications regarding the technology or lacking knowledge. These characteristics mean it is a viable and effective alternative for current early-stage treatments, since it: 1) actually restores biomechanical function instead of treating symptoms, 2) is easily and non-invasively administrable, and 3) will not cost more than current treatments.
NC Biomatrix’s innovation is an injectable viscous gel that is based on the matrix produced by notochordal cells (NC) found in pig tissue. After processing of the tissue, a powder is produced that can be stored for a long period – the exact (regulatory approved) storage time has yet to be determined. When a patient requires therapy, the powder is mixed with a solution to form an injectable treatment. The doctor has to perform an MRI scan to determine the appropriate injection site, e.g. the part in the spine where disc degeneration has occurred. Upon injection, the solution gels, forming a matrix that supports the disc tissue and stimulates restoration of biomechanics.
To date, there is no injectable treatment which can restore the disc function, e.g. height, stability, etc., which will mitigate the patient’s pain, and which provides an optimal environment for regeneration of the biomechanics of the spine. Additionally, no surgery is required, eliminating all risks associated with surgery and accompanying rehabilitation.
The NC Biomatrix product is an acellular processed matrix as a powder which is solubilised prior to injection into the spinal disc core. The primary mode of action is the restoration of disc volume and height thus reestablishing proper biomechanics of the treated spine segment which should, in turn, alleviate the lower back pain. With this mechanical mode of action and a lack of any cellular component, the NC Biomatrix product will be registered as a class 3 medical device.
The NC Biomatrix b.v. technology, developed by Prof. Ito and his group at TU Eindhoven is an acellular injectable matrix based on a powder which is solubilised prior to injection. The matrix material is derived from porcine tissue (“spanferkel”) which is processed and freeze-dried in a proprietory fashion and then terminally sterilised. The matrix which is a viscous gel with very similar properties to the healthy disc core in humans. The matrix is injected using a very fine needle (27G) into the patient’s disc core, reestablishing disc volume and height, which in turn reestablishes normal biomechanics of the treated spine segment. In an initial canine study, an actual regeneration of the disc core was shown as a secondary effect 6 months after treatment. It appears that the mechanical initial mode of action of the NC Biomatrix product provides an ideal environment which supports autogeneration of the spinal disc core.