Amber Therapeutics: Tackling a problem many thought was too difficult and costly to solve

Aidan Crawley and a dream team of scientists have developed a system to address urinary incontinence

At NEA, we are inspired by founders who use innovative technology to address unmet needs — particularly unmet healthcare problems that plague millions of people. NEA partners Ali Behbahani and Tiffany Le had been tracking advances for the treatment of urinary incontinence for more than three years before they heard about Amber Therapeutics’ potentially game-changing technology. After a year developing a relationship with CEO Aidan Crawley and Amber’s exceptional, multidisciplinary founding team, Ali and Tiffany came away with the belief that the company had a solution that could address a seemingly insurmountable challenge.

Which is precisely what Aidan had set out to do. After a successful career in finance and building software companies, Aidan wanted something more. Rather than compete to grab a piece of an established software market, he wanted to take on a unique challenge by solving an important, unaddressed problem that could directly improve people’s lives. He didn’t want to build incremental, “fast follower” technologies, but instead create something that could radically change clinical outcomes for patients worldwide.

Creating implantable-medical-devices businesses is famously difficult, requiring a lot of capital and time to build systems that may never work or pass muster with regulators. After a successful career in finance and as a software entrepreneur, why take this on? 

I got exhausted trying to come up with the next trillion-dollar app in crowded markets, wondering whether we were just inventing problems to solve. I call it existential risk: you go to sleep at night wondering if the market you’re going after is even real. I wanted to work on a problem that is indisputably real, where the difficulty is in the execution. If you've got a cure for a disease that impacts millions of people and you have 55 hurdles to get over, that’s a fun challenge. So my sleeping has improved a little, even if the amount of work hasn’t.

What gave you confidence you could beat the odds, when even the experts said it couldn't be done?

Having co-founders who are the absolute best in the world at what they do. Stefan De Wachter (Head of Urology at Antwerp University Hospital) and Charles Knowles (Professor of Surgery at Queen Mary University of London) are two of the leading authorities on neuromodulation and the physiology of how to treat incontinence. Tim Denison (Professor of Engineering Science and Clinical Neuroscience at Oxford University, and a former executive at Medtronic) is the best person you could have to build a system that could bring Stefan’s and Charlie’s ideas to life. Over a million people have a device in their body with technology that he has helped design.

But in a larger sense, I also believe that when people say something will be too hard, that’s a great reason to do it. People tend to consider a negative market perception as truth, but it’s a lazy truth. So I'm grateful that medtech is commonly seen as such a horrible market to innovate in, because it keeps out a lot of competition.

Urinary incontinence sounds like a niche. Is the market big enough?

It’s more than big enough. It is understood to affect more than 50% of women globally to some degree in their lifetime. More than three million women suffer from mixed urinary incontinence severely enough to be eligible for an implant in the U.S. alone. And if you multiply that number by the existing reimbursement for sacral neuromodulation, you get to a very big number.

How did you decide to go after this market? 

I was entrepreneur-in-residence at Oxford Science Enterprises, an investment company set up to convert the scientific talent and potential at Oxford into successful businesses. I’d had two meetings with Tim, who had pitched me several ideas for targeting the brain because that’s what he thought I was interested in. As we were shaking hands to end our third meeting, he said, “and by the way, I'm also working with a couple of brilliant clinicians on an idea to treat incontinence, which is a massive and completely overlooked problem.” I pulled him back into the room and we talked for three hours. At the end, I told him, “Let's build a company and do this commercially."

What does your success say about what it takes to compete in the medical devices business?

There's been very little therapy innovation in medical devices for the last 30 years because there’s been no way to test a therapy without having your own device, and big companies pretty much own the hardware market. So you need to raise $10-20 million and spend 5-plus years on hardware just to test your therapy idea that may not work. That’s a real barrier to investment compared to software, for example, where you can test ideas instantly for very little money. 

But I was lucky enough to find Tim, who had access to a very good device that had been initially developed for the brain to treat Parkinson’s and which he’d already modified to support academic brain research for other indications. It was being able to use this device to test our therapy in a very short time for a relatively small amount of money that changed the normal medtech model for us. By the time we’d proven our therapy was real, the company that made the device was struggling and we were able to buy it. If that didn’t happen, we may have just become one more group with a promising therapy that didn’t happen because we didn’t have hardware to take it to market.

What does it say about how the industry could change in the future? 

I think Amber offers a glimpse into where the industry could, and should, be in 10 years, where any startup can get off-the-shelf access to whatever configuration of implantable hardware they want. This would unlock an ecosystem of innovation that is currently gated by cost and complexity of building a device. Imagine if every app developer had to also build an iPhone to test their app. That is where we are today. Amber, I hope, is an early example of what’s possible.

However, taking a device through regulatory approval to commercial sales is quite capital-intensive, so it’s critical is to make it as fast and inexpensive as possible to test a therapy concept “in-human” which is what a medtech “MVP” is. Once you know a device works in-human, that is the key clinically derisking step which warrants the big investment. I hope there will be continued advancements and creative strategies to further lower the costs needed to run clinical trials and bring a therapy to market.

What have you learned from building a business in a highly regulated, complex, hardware-centric industry?

Having to slow down has been a surprisingly positive learning experience. As a software person, you think it’s all about speed. You’re like the hare in “The Tortoise and the Hare” — you're running all over the place, making mistakes, having a nap, and then starting over again. With Amber, we’ve moved incredibly far, but we’ve done it methodically and carefully. I'm an impatient person, so it has humbled me to see how much of this regulatory red tape is actually helpful.