Breaking Down Barriers in Women's Health

Navigating the Regulatory Pathways: A Different Approach to Market Access

When Claire first shared Neuraura's strategy to bring LoOop to market as an over-the-counter device, reactions from traditional medtech veterans were predictably skeptical.

"We've taken a lot of flak from more traditional medtech stakeholders," she acknowledges. "They're like, 'Why would a woman use something if their doctor doesn't tell them to? How are you going to get your customer acquisition cost down?'"

But the women Claire spoke with told a dramatically different story. After more than 100 one-on-one conversations with PCOS sufferers, she found overwhelming enthusiasm for an accessible solution they could use without navigating the often frustrating healthcare system.

"When we actually talk to end users, the people who are going to be our customers, I've had probably 110, 120 one-on-one conversations in private, and they all want it," she says. "It's not even a question."

Neuraura has crafted a pragmatic regulatory strategy, aiming to pursue initial 510(k) pathway for relieving the symptoms and alleviating the burden of PCOS under the generic TENS (Transcutaneous Electrical Nerve Stimulation) for pain relief. This initial pathway enables them to enter the market while concurrently generating the clinical evidence required to support a future De Novo submission for advanced PCOS indications. It’s a phased approach that accelerates market entry while laying the groundwork for advancing a broader vision to transform care for chronic conditions.

“Our first clearance will be a transcutaneous electrical stimulator for pain,” Claire explains, outlining their phased approach. “Based on our discussions with the FDA, the feedback was that our electrodes are consistent with a percutaneous TENS. Although they only penetrate the outer layers of the skin, they are comparable in risk to traditional TENS devices.”

“We have a deep scientific heritage. We believe that women deserve evidence-backed solutions, although we're going over the counter. But that doesn't mean we need to dilute down in terms of the quality of the information, the quality of the solution, and the evidential backing,” Claire emphasizes.

The urgency for this approach becomes clear when Claire discusses the diagnostic challenges women with PCOS face. Approximately 75% of women with the condition remain either undiagnosed or have fought for years to receive proper diagnosis.

"A lot of women know or suspect they have the condition but maybe have to fight for a decade or two to get a formal diagnosis," she notes. "We're going over the counter to make it as accessible as possible.”

Claire's vision extends beyond PCOS with a long-term goal of addressing other chronic health conditions such as insulin resistance and endometriosis—areas where significant gaps in care remain. By establishing their platform for generating real-world evidence, Neuraura aims to create both immediate value for patients and a foundation for addressing multiple conditions that modern medicine has historically overlooked.

Designing a Medical Device with the Whole Person in Mind: Beyond Symptom Management

For the Neuraura team, developing LoOop transcends creating a device — it's about addressing the full experience of living with PCOS. This whole-person approach has fundamentally shaped their product design and development process, particularly for the digital platform accompanying the hardware.

Claire recalls a pivotal moment with an all-male development team working on the app. Despite technically sound code, she recognized a fundamental disconnect.

"We just started from a completely wrong paradigm," she explains. "One of the core symptoms of PCOS is irregular or absent periods. Although a lot of the period-tracking apps out there are looking at the PCOS market, if you open up something and you see a calendar view, that's probably quite triggering."

This realization prompted Neuraura to scrap the initial design and start over with a more personalized approach centered on the diverse goals of women with PCOS.

"We're now paying much closer attention to that and we'll be really focused on giving them the lens that makes most sense for what their goals are," Claire says. For some women, PCOS experience and needs vary widely. One person might focus on lowering cholesterol or reducing their risk of dementia, while another might prioritize weight management. While other women might be more focused on getting pregnant in the next few years.

Neuraura is building its platform with a future in mind where diverse health needs can be addressed in a unified way. Their phased market approach and product development are designed to align with these diverse and evolving goals. To ensure their development remains aligned with real user needs, Neuraura assembled an end-user advisory board that provides quick feedback on iterations. They've also adopted agile methodologies typically associated with software and applied them to hardware development.

The company has leveraged creative resources to advance their development despite limited capital. Early device iterations came through student projects, with one team member joining after initially working on Neuraura technology for her capstone project.

"We've been incredibly fortunate," Claire notes with genuine appreciation. "We haven't been awash with capital, but we have been awash with in-kind support and great talent."

This whole-person approach extends to Neuraura's marketing and education efforts as well. Claire recognizes that developing a device isn't enough — the company needs to address the significant information gap surrounding PCOS. By taking a goals-based approach tied to specific symptoms, Neuraura aims to make its solution meaningful to the diverse population of women affected by this condition.