Level Zero Health, a startup co-founded by Ula Rustamova and Irene Jia, has secured $6.9 million in pre-seed funding to advance its hormone monitoring technology. The company is developing a wearable device designed to track hormone levels continuously, reducing the need for frequent blood tests.

The funding, backed by investors like Redalpine, HAX (SOSV), and Entrepreneur First, will help Level Zero Health refine its technology, conduct clinical studies, and move toward regulatory approval. If successful, this innovation could provide real-time hormone tracking for people undergoing fertility treatments, managing hormone-related conditions, or monitoring testosterone levels.

Key Takeaways

Level Zero Health has raised $6.9 million in pre-seed funding for developing a wearable device that continuously monitors hormone levels.

  • The company is using FDA-approved needles to collect interstitial fluid and aptamer-based biosensors to track hormones like progesterone, estrogen, cortisol, and testosterone.
  • Clinical trials are planned for 2025 with the aim of achieving FDA approval by 2026, making the device available to consumers by 2028.
  • The technology aims to improve fertility treatments, menopause management, hormone replacement therapy, and personalized medicine.

A new way to track hormones

Level Zero Health is working on a device that uses tiny, FDA-approved needles to collect interstitial fluid— the liquid surrounding cells in the body. This approach is similar to how continuous glucose monitors work for diabetes management. The device will allow users to track their hormone levels in real-time, providing an easier and less invasive alternative to traditional blood tests.

At the core of this technology are aptamer-based biosensors. These sensors use specially designed DNA molecules that can bind to specific hormones, allowing the device to detect and measure hormone levels with high accuracy. Early tests have been promising, particularly in tracking progesterone, a key hormone in reproductive health.

The device is being designed to monitor other hormones as well, including estrogen, cortisol, and testosterone. This could be a game-changer for people dealing with fertility issues, menopause, hormone replacement therapy, and conditions like polycystic ovary syndrome (PCOS).

Clinical trials and regulatory plans

To ensure the accuracy and reliability of its technology, the company has planned two clinical trials for 2025. These trials will test the device’s performance and compare its results to traditional blood tests.

After gathering clinical data, the company aims to start the FDA approval process in 2026. If everything goes as planned, the full wearable device could be available to consumers by 2028.

While working on the long-term goal of a continuous monitoring device, also developed a disposable hormone-testing patch. This single-use patch, expected to receive regulatory clearance within the next year, will provide occasional hormone measurements for people who don’t need continuous tracking. The patch could be particularly useful for fertility treatments and testosterone therapy.

One of the company’s key goals is to achieve a 90% correlation between its device’s measurements and standard blood tests. While hormone monitoring doesn’t require the same level of precision as glucose monitoring for diabetes, high accuracy is still critical for making the device a reliable tool for medical use.

Improving reproductive and hormonal health

Highlighting Level Zero Health’s hormone monitor could transform the management of fertility treatments, menopause, and conditions like PCOS. Real-time hormone tracking may help improve IVF success rates and allow doctors to adjust treatments more precisely.

Men undergoing testosterone replacement therapy (TRT) could also benefit from continuous monitoring, ensuring more accurate dosage adjustments. Athletes tracking cortisol and testosterone levels could optimize their training and recovery. By making hormone tracking easier, this technology could lead to better treatments, more informed health decisions, and a new era of personalized medicine.

The future of wearable health technology

With Level Zero Health’s work highlights the growing potential of wearable medical devices. Continuous hormone tracking could provide valuable insights into health, much like how continuous glucose monitors have transformed diabetes care.

By combining advanced biosensor technology with real-time data analysis, the company aims to make hormone monitoring easier and more accessible. This could help people better understand their bodies, manage health conditions more effectively, and receive more personalized medical care.

With strong financial backing and a clear development roadmap, Level Zero Health is positioned to bring a significant breakthrough to the healthcare industry. If successful, its wearable hormone monitor could change the way hormone-related conditions are diagnosed and managed, making real-time tracking a routine part of medical care.