Intellectual property (IP) forms the basis on which many firms are valued. In the second instalment of a four-part series, NephTech's co-founders, Dr James Lim and Ms Toh Yanling, talk to Marissa Lee about how they are building their start-up's IP in order to power growth.
Q: How did NephTech get started?
Ms Toh: When we first met, we were colleagues at A*Star (Agency for Science, Technology and Research) working for a start-up in the nephrology or kidney space.
We were working on an implant, which would take really long to go to market. While working on the implant project, we realised (there were) other more dire problems which we could address and help an even larger market. And so, we decided to start NephTech to pursue these new problems.
We started our company in January last year.
Q: What is your product?
Ms Toh: It's a monitoring device to assess the health of a special blood vessel that has to be surgically created for patients to undergo dialysis.
In haemodialysis, blood is drawn, pumped through an artificial kidney, cleaned, and brought back in. This has to be very high pressure, high volume. No normal person would have a special blood vessel for that. If you prolong the lifespan of this blood vessel, you prolong the lifespan of the patient.
If the vessel is blocked, the patient cannot undergo dialysis and will ultimately die in a few weeks.
But if we can keep it open or predict when it's going to be blocked, we can do surgery to unblock it.
Q: How are these vessels being monitored right now?
Ms Toh: At this point, there are no non-invasive technologies for monitoring except in the hospital. Most of the time, dialysis centres or patients themselves are not able to assess this narrowing.
The technologies all require some form of needle going in, and because the costs are high, doctors don't prescribe them so often. But stenosis, which is the narrowing of the blood vessel, can occur within six weeks. That's when the emergency cases happen.
About 60 per cent of patients will experience some form of stenosis.
Q: But you've found a simpler way to do this?
Ms Toh: We're working on something non-invasive, like a blood pressure cuff, which you can use every day and even at home. If it's invasive, it has to be done at a dialysis centre and results have to be interpreted by a nurse.
Q: How does it work?
Ms Toh: We have a sensor that basically functions like a stethoscope. As some narrowing happens in the blood vessel, the sound characteristics change. At first if the path is clear, it's a very deep sound. But as the path narrows, it becomes very high-pitched.
You just need to wear the cuff for 10 seconds and you will be able to tell when there's some narrowing through the sounds you receive.
But sounds are not enough, so we're using a proprietary algorithm. We are collecting patient data and teaching the AI (artificial intelligence) to tell you the extent of the narrowing by listening to the sounds.
Q: How accurate are your readings so far?
Dr Lim: We've collected data from over 400 patients, and with this 400, we have managed to achieve 80 per cent to 85 per cent accuracy.
Ms Toh: The current gold standard is about 75 per cent sensitivity.
Dr Lim: But in order to obtain even better accuracy, we need to go down into the specificities, like patients with heart conditions, patients with hypertension, diabetes; how will these adversely affect our predictive algorithm?
Ms Toh: So we are working with hospitals, like Singapore General Hospital, as well as dialysis centres to collect more data.
To us, their partnership is already a huge validation.
Because in the clinical community, for them to work with us, they must believe in the fundamentals of this science.
Q: When will your product be ready?
Ms Toh: We will have to undergo larger clinical studies. After getting regulatory clearance, we hope to launch our product by the end of next year. Because our device is non-invasive, the criteria are less stringent. It doesn't take as long to bring the product out as compared to an implant.
Q: Why has NephTech chosen to work on this problem?
Dr Lim: There are over 7,000 dialysis patients in Singapore and it is very common for stenosis to go undetected in the early stages. When it becomes late-stage, the cost of repair increases exponentially.
To give you an overall perspective on how much patients are spending, dialysis treatment itself accounts for only 33 per cent of their total spending. Any cost associated with blood vessel monitoring and repair work accounts for another 33 per cent. So that's actually quite a significant amount that we're trying to reduce.
For other chronic diseases like hypertension and diabetes, they have equipment at home that they can use to monitor their conditions 24/7 if they want to. But surprisingly, for a treatment (dialysis) that has been around in the world for 70 years already, there isn't any device out there for patients to use to monitor their own condition.
All that the doctors and nurses can say is: "Please exercise your arm regularly and check for thrill (vibration) and bruit (murmur) every day."
Q: How is NephTech funded?
Dr Lim: Medtech has an extended runway so a lot of investors don't have the appetite to come on, but we've got support from Spring Singapore and the National Research Foundation.
This early-stage funding allowed us to move the technology forward and give more clarity to private investors to come in. And that's the stage we're in now.
To date, we have gathered sufficient private support to bring this product through to regulatory approval. Almost half of this comes from clinicians.
Q: How do you protect your intellectual property?
Ms Toh: We have a patent on our hardware, but that's not the only thing because patents are not water-tight. For the prototypes that we are going to use in clinical trials, we will be applying for a design patent.
In our business partnerships, we do NDAs (non-disclosure agreements) with key partners and licensees.