Our latest featured recommendation is a medical device company founded to develop ground-breaking technologies for the treatment of Spinal Cord Injury (SCI), explains small cap growth stock expert Tom Bishop, editor of BI Research.
Currently, there is nothing other treatment besides stabilizing the spine with rods and screws. However, InVivo (NVIV) has developed a neuro-spinal scaffold device that is the first material ever implanted in a human spinal cord to alleviate the symptoms of paralysis due to acute SCI.
The scaffold has received a Humanitarian Use Device designation which provides lower hurdles for more rapid approval and is currently being evaluated in a 20 patient pivotal probable benefit trial — called Inspire — for treatment of patients with complete (AIS-A) acute thoracic SCI, with encouraging results to date.
In addition, the company hopes to initiate trials on cervical injuries by mid-year and is also working on combining neural stem cells with a hydrogel to inject trails of stem cells across the site of the spinal cord injuries of chronically injured SCI patients.
In February, the stock was beaten down to $3.66; the price recovery to over $7 currently was fueled by several news releases including one regarding the treatment of a 6th patient and another regarding success (improvement in AIS score) reported for patient number 5.
Also boosting the stock was news that the FDA has agreed to a "modular review process" of its neural spinal scaffold, which it will be able to submit in three modules.
This approach should shorten the review time once the final data for this 20- patient pivotal trial is submitted in late 2017.
This means, if all goes well, two years from now (or so), InVivo could be awaiting final approval.
Acute thoracic spinal cord injury is assessed by grades of severity, with Grade A being complete lack of motor and sensory function below the level of injury and Grade E meaning that all neurological function has been restored.
The Inspire trial will only have to enroll 20 patients. Furthermore, the FDA had agreed to a performance criterion of 25% of these patients improving one AIS grade.
In other words, just 5 out of the 20 patients need to show that they have improved one AIS grade by 6 months as the primary measure of “probable benefit” trial success.
So far, we have seen 3 of the first 5 patients improve by one AIS grade. Therefore InVivo only needs to see similar improvement from just 2 out of the next 15 patients.
In our view, this means that the odds for eventual approval have ratcheted up considerably…as has the stock price.
Note that secondary measures of improvement that will also be considered are improvement in bowel and bladder function (very important to SCI patients), pain, sensory and mobility scores, and so forth that may not rise to the level of an AIS grade improvement but are still important.
There is a lot going on here, a lot improving here and a lot potentially to spur the stock higher, and investors have been waking up to this as it unfolds.
A recent stock offering should now provide funding well into 2018, assuring that InVivo has the funding it needs to not only take the NSS to market if approved but also launch the additional trials noted above. This also brought the stock back into a buying range around $7.
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By Tom Bishop, Editor of BI Research
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