Top picks 2012: InVivo Therapeutics
The medical device company tackles spinal cord injury with multiple technologies.
By Tom Bishop, BI Research
The financial impact of spinal cord injury (SCI) is staggering, estimated at between $244,000 and $829,000 in the first year alone. Over a lifetime the costs could add up to $1 to $4 million.
The annual global market for SCI is estimated at $10 billion. There are currently no successful treatment options for SCI patients.
InVivo Therapeutics (NVIV) utilizes biodegradable polymers as a platform technology to develop treatments to improve function in individuals paralyzed as a result of traumatic spinal cord injury.
In 2005 Frank Reynolds and Robert Langer, ScD., professor at MIT and finalist for the Noble Prize in Medicine this year, founded InVivo on the basis of proprietary technology co-invented by Dr. Langer and Joseph P. Vacanti, M.D. with Massachusetts General Hospital.
The current standard of treatment for acute SCI is to stabilize the backbone, but not touch the spinal cord itself. However, it's a three-week process of inflammation followed by scarring that paralyzes 90% of those with such an injury. If this process could be halted, most SCI patients would be able to function again.
InVivos "scaffold" is a biopolymer material already approved by the FDA for other uses, such as sutures, that ultimately dissolves into CO2 and water. While the doctor is undertaking the mandatory stabilization of the spine, a piece of this material is cut to fit into the torn area of the spinal cord and the patient is closed back up. It takes an extra couple of minutes.
Long story short, 100% of paralyzed monkeys treated in this way were walking again in three to five weeks. Paralyzed monkeys that were only stabilized were not. Nobody in history had previously restored function to paralyzed monkeys.
The company is currently awaiting the green light from the FDA to begin an open 10-patient trial. While there is a pretty big leap in going from tests in lab rats to humans, the leap from monkeys to humans is not so great at all.
But this is not even InVivo's best technology. Shortly it will be working with the FDA on its second product, a drug releasing hydrogel, also for acute spinal cord injuries. And this technology works even better than using scaffolding alone.
A third technology involving the use of scaffold polymer material laced with human neural stem cells works best of all. However, this one will require a lot more money to bring through the trial process and so has been slotted for submission in early 2014. All three technologies enable monkeys to walk again -- 100% of the time. There is video on the company's website to prove it.
However, SCI is not the only application for the three technologies (and other combinations InVivo has developed, and protected with over 100 patents filed). In fact millions of peripheral nerve procedures are performed every year, and the company will leverage its technology by also submitting its injectable hydrogel with drugs for use on peripheral nerve injury later in 2012.
And down the road InVivo expects it may be able to apply its technologies to restoring prostate nerve function. This nerve is damaged 50% of the time due to cutting and stretching when the prostate is removed, leading to erectile dysfunction. This is also huge -- another Holy Grail of medicine.
And talk about Holy Grails of medicine -- InVivo has yet another technology whereby the scarred damaged portion of the spinal cord that has caused paralysis for those in wheel chairs for years would be cut out and replaced by scaffold material seeded with neural stem cells.
InVivo has sufficient cash (from a $13 million stock offering), plus more that can be called in as needed from 18 million warrants at $1.40.
The heavy involvement of co-founder Dr. Langer, who headed the FDA's Science Board and whose patents are licensed by over 220 companies, lends added confidence to this investment. But of course, there are no guarantees.
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Since the FDA application is for a medical device, using a material that has already been approved for use in the body for other applications once the trial is approved both the enrollment should be rapid and if successful the results obvious within several months.
Success would create enormous pressure on the FDA for accelerated approval.
For every month the FDA delays approval based on 12,000 spinal chord injuries per year in the US potentially 500 more Americans would be condemned to a life of devastating disability.
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