Maximize Market Opportunity, Minimize Feedback Loops

Key Learnings From Rafaël & Renato’s Experience

• Bringing a medical device to clinical trials, let alone commercializing them, is a massive challenge. You need a large enough market to justify the investment. Once you have an idea, leverage resources to iterate quickly and cost-effectively, and prove core functionality to win over investors and partners.  

  
  

• During the early development phase, staying under the radar helps shield you from external pressures and allows you to focus on proving your core functionalities. On the other hand, going public increases awareness of your company. A good time to exit stealth mode is when you reach a predictable development path, where major scientific risks are addressed and the technology is proven.

  
  

• Don’t choose the easy route to market. Aim to address multiple use cases and market segments like SAVA is doing with its micro sensor platform technology. Seize the opportunity, even if it means navigating stricter regulatory requirements and securing more funding – as long as you're solving a clear gap that is disruptive in nature. 

Rafaël Michali and Renato Circi met around ten years ago as biomedical engineering students at Imperial College London. With a shared passion for novel technologies, entrepreneurship and preventative healthcare, they began exploring innovative and less invasive techniques to learn more about the human body, eventually co-founding SAVA.

“The future of health is going to be preventative,” says Renato, and continues, “There's a lot that we can improve with information we can extract from the wearable movement.” At SAVA, Rafaël and Renato have developed a minimally invasive biosensing platform that analyzes molecules in the interstitial fluid, just under the skin. This aims to decentralize healthcare by providing users with real-time information about what is happening within their body, empowering users with their own health data accessible directly from a phone.

Wearable tech devices that collect health data aren’t new to the consumer market. We’ve seen products like Apple Watch, Fitbit, Garmin, or Oura Ring collecting bodily data and offering insight into health and wellbeing. However, “These are built for only peripheral metrics like heart rate, sleep, and basic activities. But the next dimension is molecules that flow inside your body. That's where things become very, very exciting,” Renato says.

At SAVA, the biosensor’s capabilities begin with blood sugar levels, for which continuous glucose monitoring (CGM) devices already exist. However, traditional CGMs don’t provide a user-friendly experience and can be uncomfortable due to the needle insertion process with occasional bleeding. They are also expensive – around $50 for a two-week use. What SAVA offers is a biosensor functionalized with tiny microsensors that are much smaller than the standard filament needle and sit just under the skin. This means no nerve endings and capillaries are touched, so the application process is painless and wear is much more comfortable. They also aim to cut the cost by a factor of ten versus current devices, making CGMs more accessible to those with diabetes or at risk.

Currently, the SAVA team is focused on developing this next generation microsensing platform for diabetes management. They've recently secured MHRA clearance to initiate clinical studies in Europe, specifically in the UK, to evaluate the platform's performance against existing CGMs. Rafaël and Renato expect to release initial clinical data by the end of 2024, and validate the platform’s value proposition.

Looking beyond just glucose, the biosensor has been built to monitor multiple molecules simultaneously within the body to provide a holistic view of a user’s health that has never before been possible in real-time with a wearable device. The opportunities are endless, including monitoring lactate, ketones, sodium, cholesterol, histamines, urea, or alcohol levels. This ushers in a new era of preventative healthcare.