Introduction

Level Zero Health, co-founded by innovators Ula Rustamova and Irene Jia, is making ambitious strides toward developing a groundbreaking device designed for continuous hormone monitoring. If proven successful in their efforts—bolstered by promising early results—this technology could transform hormone health management for millions of individuals, much like continuous glucose monitors (CGMs) have done for diabetes care.

The Importance of Hormones

Hormones play a pivotal role in regulating numerous bodily functions, from reproductive health to mood swings, and impact everything from energy levels to the aging process. As Rustamova shared with TechCrunch, “We are increasingly aware of how significantly hormones influence our daily lives.”

Technological Transition

During their presentation at the Startup Battlefield stage at Disrupt, Level Zero showcased their plans to adapt FDA-approved needle technology from CGMs for hormone monitoring purposes. However, while this sounds straightforward in theory, creating such a device poses substantial scientific and technical challenges as the necessary sensors and underlying science are still evolving. CGMs have established protocols for measuring glucose in interstitial fluid, but similar methods for accurately monitoring hormones have yet to be developed.

Aptamer Technology

To tackle this complexity, Level Zero is focused on leveraging aptamers—single-stranded DNA molecules that bind specifically to target hormones. This approach aims to facilitate precise hormone measurement by evaluating the degree of hormone binding to these aptamer DNA strands. The company's initial sensors will target crucial hormones like progesterone, estrogen, cortisol, and testosterone, catering specifically to the high-demand markets of both IVF treatments and low testosterone issues—presenting an estimated $30 billion total addressable market.

Current Market Solutions

Interestingly, while members of the public will not purchase these devices directly—healthcare providers will prescribe them—Rustamova cites the less effective home hormone-testing kits as an inspiration. Despite attempts to assess hormone levels through urine, saliva, or sweat, Rustamova criticizes these methods as "pseudo science," asserting the need for comprehensive blood testing to capture accurate hormone levels. Traditional blood draws, however, only offer a snapshot, leaving many questions unanswered about ongoing hormone health.

Research Foundations

Despite being less than a year old, Level Zero has not yet published peer-reviewed studies outlining its advancements. Nonetheless, the scientific foundational work appears promising, with a 2016 study from the University of North Carolina indicating the viability of using aptamers for measuring progesterone, followed by the development of low-cost sensors for the same hormone in India by 2022.

Expertise and Recognition

Level Zero has also attracted a reputable advisory board of medical experts, notably including Dr. Aaron Styer, a leading infertility specialist at Harvard, and Dr. Kelly Walker, a notable urologist involved with male fertility management.

Background of Founders

The backgrounds of the founders further illustrate their expertise: Rustamova's early success in programming led to her contribution to a wearable technology project before she honed her skills at Palantir; meanwhile, Jia’s journey from a professional ballerina to an industrial designer specializing in biomaterials and biosensors has equipped her with unique insights into medical device development.

Accelerator Program and Prototyping

Recently, both founders were accepted into the prestigious SOSV HAX accelerator program, which provides invaluable access to lab facilities. They currently have a functional prototype that has successfully detected progesterone in interstitial fluid, achieving a key feasibility milestone.

Future Plans

While much work remains before their innovative device reaches the consumer market, Level Zero is progressing swiftly. They have established clinical partnerships with U.S. IVF clinics and plan to initiate two clinical studies in 2025, followed by engineering manufacturing in 2024. The team also aims to conduct clinical trials and begin FDA approval processes by 2026.

Conclusion

“We have devoted significant time engaging with leading clinicians and researchers focusing on fertility and hormonal health to ensure our data is relevant and actionable,” Jia explained. With a team featuring prominent fertility experts from renowned institutions, Level Zero is poised to redefine hormone health monitoring, promising accuracy and practicality in an arena currently dominated by outdated methods. The stakes are high, and the potential rewards could change lives.