This talk is called From Lab to Market: “Making the Dream a Reality” The technology transfer process.
Start with that great idea … image of 2 little boys labeled Reggie and Yury, followed by image of the aging real Reggie and Yury … we laugh.
How long does it take to get from a rat to a person? 5 years. Then what?
Commercial development, trials, FDA approval, sales and marketing, clinical use. How does this happen? Usually universities hope that some big player will buy it and move it along.
But that hardly ever happens. So what’s the other option?
Start-ups. Which can be crazy. here’s the process:
- THE COST OF GETTING AN IMPLANTED STIMULATOR TO THE MARKET IS 150 MILLION DOLLARS
- what’s the cost to develop your thing? to commercialize it?
- what’s the regulatory pathway? healthcare is unique … not like a new app! and every barrier is more money and time
- what’s the market size? (Nick had to show that this really is a billion dollar market opportunity. If it’s smaller than that the money guys won’t care.)
- is there an un-met need? (this audience thinks so, yeah.)
- is it patent-worthy? is there freedom to operate?
- is there proof that it’s good? is there data?
- are the prototypes, samples, or compounds?
- is the invention really novel?
- who’s going to pay for the patient to have this at the end of the process?
- what will the cost savings be over a lifetime?
- what’s the competition? is there a goliath you’re trying to take on?
- then if you figure all this out, you go to the university and license the product, which gives them a little slice of your product.
- Okay, so then what? What are the steps for commercializations?
- recruit your team
- write (draft after draft) of your business plan
- raise money
- build prototypes
- pay the ongoing patent fees
- survive the valley of death
- raise more money
- commercial development
- get regulatory approval
- What are the challenges to raising money?
- finding the right investor partner …
- Where are things right now?
We formed NeuroRecovery Technologies.
We have two systems: the implantable system and the transcutaneous system. We originally thought that the former would be for A and B patients, and the latter for C and D. But that plan changed when we started seeing A and B patients get results from the transcutaneous system.
Now, we see the external one as a diagnostic and treatment device. It will determine who ought to get an implantable one. Our devices will be for patients who have stroke, MS, cerebral palsy, parkinson’s, TBI, and of course SCI. But hey … if I can do blood pressure improvement for those groups, why not for the regular population? That’s how they’re getting all the money to push this thing forward.
They’ve published the papers that convinced investors, but it took a year or two for each one. A year or two for each paper, while they sat there with their promising results and their ongoing work, trying to get funding to do it faster, a year or two for each paper, because no sane investor would cough up money without peer-reviewed data. Years of peer review. While we waited.
Results to date:
38 subjects so far, success with 33 = 86% in getting voluntary movement. The subjective reports form all the volunteers say that they feel things like “the core of the body turning on” — this happens not in weeks or months but in days. We can get people to stand or move within a day. Then they all report back that they notice changes in blood pressure, in ability to perspire, in ability to feel the full bladder …
Nick chokes up and says “I’m sharing this with you because I know how long you’ve all been waiting.”
We applaud and wait while he gets it together.
Path to market release involves doing 30 or 40 subjects, then waiting a year or so for FDA approval — it should be 2 – 2.5 yrs until it’s on the market. In the meantime we’ll be perfecting and testing the implantable device — which will be WAY BETTER than the existing technology.
The existing technology, as interesting and promising as it is, doesn’t come close to what we’re eventually going to get.