Level Zero Health, co-founded by Ula Rustamova and Irene Jia, is pursuing an ambitious goal: the creation of a groundbreaking technology for continuous hormone monitoring. If successful, this medical device could revolutionize hormone health in a manner similar to continuous glucose monitors (CGMs) for diabetes management.

Hormones play a crucial role in regulating numerous bodily functions, influencing everything from reproductive health to mood and energy levels. “All of that is regulated by your hormones,” stated CEO Rustamova. This underscores the importance of accurately monitoring hormone levels for various health outcomes.

The startup presented its vision during the Startup Battlefield at Disrupt, focusing on adapting FDA-approved needles from CGM devices to measure hormones continuously. Although the concept is straightforward, the execution is complex. The scientific groundwork for monitoring hormone levels using interstitial fluid—a fluid surrounding cells—is still in its infancy compared to glucose monitoring.

Level Zero aims to develop a sensor capable of detecting hormone levels by utilizing aptamers, which are single-stranded DNA molecules that bind specifically to target hormones. This method involves measuring how much hormone binds to these DNA strands, allowing for real-time monitoring of various hormones. The initial focus will be on progesterone, estrogen, cortisol, and testosterone, targeting high-demand areas like IVF treatments and testosterone deficiency, which represent a substantial combined market of $30 billion.

Rather than selling devices directly to consumers, Level Zero plans to work with healthcare providers. The founders criticize the existing home hormone testing kits that measure hormones through urine, sweat, or saliva, describing them as unreliable. Rustamova emphasizes that the most accurate hormone measurement still relies on blood draws, which only provide a snapshot in time rather than continuous data.

As a relatively new company, Level Zero has not yet published peer-reviewed research but has shown promising signs of progress. Rustamova indicates that they are currently keeping their technology under wraps as they seek patent protection. Nevertheless, past research suggests that the scientific principles they are based on are sound. Notably, a 2016 study from the University of North Carolina demonstrated the successful use of aptamers for measuring progesterone, and researchers in India created a low-cost sensor in 2022.

The founding team has also gathered an impressive advisory board, including notable medical professionals from institutions like Harvard and Mount Sinai. This collaboration is vital as they refine their device to ensure its clinical relevance.

Rustamova, who previously worked at Palantir and developed a wearable posture-correcting device in her teens, partnered with Jia, who transitioned from a ballet career to industrial design and medical device development. Their strong backgrounds complement each other as they lead Level Zero toward its goals.

Recently accepted into SOSV’s HAX accelerator program, Level Zero has gained access to essential lab equipment and resources. They have already reached a significant milestone by developing a prototype sensor capable of detecting progesterone in interstitial fluid.

While there is still considerable work ahead, Level Zero has outlined a promising roadmap. The company is establishing clinical partnerships with IVF clinics in the U.S. and plans to conduct two clinical studies in 2025. Manufacturing engineering will begin next year, and clinical trials along with FDA approval processes are set for 2026.

The founders have committed extensive time to consulting with experts in fertility and hormone health to ensure their device meets clinical needs. “We believe it is also why some of the leading names in fertility from Harvard, Mount Sinai, and Hims have joined our team and are continuously guiding us,” Jia noted. This dedication to collaboration and innovation positions Level Zero Health at the forefront of hormone monitoring technology.

TECHCRUNCH