Wearable Medtech Can Simplify Hormone Testing
Have you ever felt something was off with your body, but you couldn’t pinpoint why? Well, you are not alone. Many of us experience this at some point, and I am sure you would have also felt this at least once. You shouldn’t blame yourself for feeling this way, but your hormones might be to blame! These tiny chemical messengers control everything from energy levels to our moods.
You are probably familiar with what happens when they fall out of balance. Yes! Weight gain, constant fatigue, and unexplained stress are all silent signs of hormonal imbalance. Now, imagine if you could track and optimize your hormones in real-time.
Level Zero Health is a medical device startup hoping to create a revolutionary continuous hormone monitoring device. The startup was founded by women and has successfully raised an oversubscribed $6.9 million pre-seed funding round to eliminate the need for intrusive blood draws. This invention has the potential to revolutionize the way that hormone-related disorders are treated and open the door for customized hormone-based therapies, including contraception.
Creating a New Market For Wearable Medtech
Ula Rustamova, co-founder and CEO, emphasized that their product is a whole new category with long-term healthcare implications rather than just an improvement on current technology. The company’s mission is to create an entirely new market that is similar to how continuous glucose monitors (CGMs) have transformed the treatment of diabetes.
Step-by-Step Development
Level Zero Health is taking a step-by-step approach to achieving its objective because medical device innovation is complicated. For sporadic hormone testing, the team has initially created a wearable patch that can be used once. The device is designed for targeting medical uses like testosterone replacement therapy (TRT) and in vitro fertilization (IVF). By the year 2025, the device will be getting its regulatory clearance.
The prototype offers a promising alternative to regular blood tests using microneedles to sample interstitial fluid and measure trace hormone levels.
A fully continuous hormone monitor is the long-term goal, and it is expected to be available by 2028. Using interstitial fluid, which is the fluid that is present in between blood plasma and cells, this device can measure progesterone, estrogen, and testosterone in real time, which enables reliable monitoring of hormone levels.
Regulatory and Clinical Milestones In Wearable Medtech
With a focus on clinical validation, the startup hopes to show that hormone levels measured by their patch and conventional blood draws correlate by 90% or more. The team expects to secure FDA approval in the U.S. and CE marking for the European market.
Rustamova emphasized the different risk profiles associated with hormone and glucose monitoring. While fluctuating glucose levels can have fatal consequences in health conditions like diabetes, hormone monitoring deviations pose lower risks at that particular moment. This difference might orchestrate a faster regulatory approval process.
Investor Confidence and Market Potential
The medtech startup’s promising potential is significant because of its capability to draw in investors. Entrepreneur First, SOSV’s HAX accelerator, and industry experts participated in the funding round, which was led by a European venture capital firm.
Philip Kneis, a board member at Level Zero Health and an investor at Redalpine, stated, “One of the holy grails of diagnostics is continuous hormone measurement.” He also mentioned, “We are thrilled to support Level Zero Health in their endeavour to revolutionize hormone tracking with their innovative biosensor, as basic science gives way to engineering.”
Balancing Risk and Innovation
Unlike Continuous Glucose Monitors, which require greater accuracy due to the immediate risks of blood glucose variability, hormone monitoring has a lower risk profile. CEO and co-founder Ula Rustamova recognizes that while correlation with blood readings is essential, hormone levels fluctuate over time, making light variations in data interpretation more manageable.
Also, as the focus of the technology includes both men and women, understanding health dynamics is crucial to determining the broader needs of the market. This is an essential factor in ensuring investor interest. As the startup advances, the team is committed to validating clinical outcomes and establishing itself as a leader in hormone diagnosis for the next generation.
With many investors showing valuable interest in this innovation, Level Zero Health is set to drive change in the healthcare sector. It will enable people to have a continuous hormone monitoring system and will help to improve diagnostics as well as treatment procedures.
Looking Ahead
With its strong foundation, Level Zero Health is poised to redefine hormone monitoring, offering new possibilities for personalized medicine and healthcare innovation. As clinical trials progress and regulatory approvals are secured, the company is set to play a pivotal role in shaping the future of hormone-based treatments and diagnostics.
