Shining Light on Women’s Health: A New Non-Drug Vaginal Therapy

In this interview, I spoke with Dr. Melanie Santos, Chief Medical Officer at Cern Corporation, about a novel low level, microbicidal light-based treatment comprised of a novel device and proprietary gel designed to treat both bacterial vaginosis and fungal vaginitis, which in and of itself is a unique value proposition. We explored why a non-drug approach resonates with patients and clinicians, the technology progression and regulatory pathway associated with the Cern Device™ evolution from what will debut as a therapeutic, and evolve into a platform for telemedicine/remote health through integration of sensors enabling use as a “connected” at-home–capable device, and how trial design is adapting to real-world use. Melanie shares insights on adherence, diagnostics, equity, and the potential to expand beyond BV and yeast infections, all while keeping the patient experience central. The discussion also explores future directions, including considerations of antimicrobial resistance and the broader implications for women’s health technology.

Moe: Stigma around BV and vaginitis shapes care, trial recruitment, and regulation. Why is low level, microbicidal light-based treatment compelling for patients and clinicians, and how does it impact our regulatory approach?

The design philosophy also informs recruitment and regulatory strategy. We can attract individuals seeking an effective, low-burden option who still value physician oversight and diagnostic clarity. Our messaging emphasizes safety data from our work related light-based vaginal devices and the feasibility of validating outcomes in pragmatic endpoints. In practice, that means outlining clear inclusion criteria, home-use instructions, and remote monitoring capabilities that reassure both patients and regulators that risk is minimized and benefit is real. The ultimate goal is to translate a familiar, even comforting concept into a credible therapeutic pathway that resonates with clinicians, patients, and payers alike.

Moe: You mentioned clinician and patient receptivity in surveys. What biases exist against non-drug interventions, and what evidence are you leveraging to address them?

I see a persistent bias toward pharmaceuticals in women’s health, but light-based therapies are already embedded in healthcare—think catheter approaches for UTIs or devices that leverage low level, microbicidal, visible light. Our pretrial surveys with physicians and women showed strong support, with over 90% recognizing a real need and valuing the concept. That feedback, combined with existing safety data from related light-based vaginal devices (there are none…we are it!), helps establish credibility with clinicians, regulators, and potential trial sites. I’m framing the approach not as a universal replacement for all therapies, but as a credible, evidence-backed option that can complement standard care. Importantly, diagnostic capabilities embedded in the device provide meaningful decision support that can reduce uncertainty and guide appropriate treatment.

We’re also mindful of the broader narrative around non-drug modalities. The device’s diagnostic potential creates a tangible bridge between patient autonomy and physician oversight, which can ease the transition from traditional care to virtual or hybrid care models. By emphasizing real-world endpoints—symptom improvement, time to resolution, and patient satisfaction—we aim to demonstrate that non-drug options can deliver reliable, measurable benefits without sacrificing safety. The literature and early clinician discussions support this, but we’ll continue to build the evidence base with diverse patient populations and in various care settings to strengthen adoption and policy alignment.

Moe: Adherence is a perennial challenge for at-home therapies. How will the Cern device navigate home use, and what safeguards and data-tracking features balance autonomy with oversight?

Our first-in-human work involves supervised, short-duration use with the device returned to the center, ensuring a safe, controlled start. For the future, I envision safety features like auto-locking to prevent prolonged use and potential misuse, ensuring patient safety while preserving autonomy. Adherence will be tracked by built-in sensors, and a companion app could offer reminders, usage history, and progress metrics. This creates a hybrid model where patients gain convenient home use, but clinicians stay informed through objective adherence data, aligning with virtual care workflows already common for other devices.

Data flow will be carefully managed to protect privacy while enabling clinical insight. We’ll implement secure transmission of anonymized data to a central system, with dashboards that clinicians can consult to verify adherence patterns and correlate them with symptom trajectories. By combining objective usage data with patient-reported outcomes, we can refine dosing schedules, optimize timing, and identify when additional clinician input is needed. This approach acknowledges real-world challenges—busy lives, varying home environments—while ensuring safety, reliability, and meaningful clinical benefit.

Moe: You highlighted diagnostic capabilities integrated into the device. How do these features influence the patient–physician dynamic, particularly around autonomy and virtual care?

The device will provide basic diagnostic signals—like vaginal pH/acid levels, temperature cues, and indicators related to white blood cells—to help distinguish yeast from BV. This empowers patients with at-home triage information while preserving physician oversight. I see virtual care becoming more data-driven: clinicians review diagnostic data, interpret trends, and adjust treatment plans remotely, reducing unnecessary clinic visits and expediting care for those in need.

In practice, this shifts the dynamic to a collaborative, data-informed partnership. Patients can initiate care at home when appropriate, guided by clear symptom signals from the device, while physicians monitor data streams to validate the diagnosis, confirm progress, and intervene if safety or efficacy concerns arise. The workflow supports timely care without abandoning professional judgment, and it aligns with broader shifts toward telemedicine and digitally enabled care. With robust data stewardship and user-friendly interfaces, we can enhance trust and engagement on both sides of the care equation.

Moe: From a regulatory standpoint, you mentioned an expedited pathway. What does “expedited” mean in practice, including IDE versus 510(k) considerations, and why is this route efficient for this indication?

I’m pursuing an expedited Class 2 de novo path, supported by a strong regulatory team and the safety history associated with our device/treatment based on the wavelength of light we incorporate. . The translation from proven low level, microbicidal, light-based technologies helps us shorten timelines and reduce uncertainty, because we’re not starting from scratch with safety profiles or device physics. The IDE/510(k decision hinges on how our modifications align with prior devices and whether the core design, materials, and indications stay within established boundaries. In practice, expedited review accelerates development, allows more timely access to patients, and enables iterative learning through real-world endpoints that reflect how people actually use the device.

This route isn’t a shortcut; it’s a streamlined process built on prior evidence, careful risk assessment, and robust post-market monitoring. By leveraging existing safety data and a clearly defined scope—diagnostic capabilities, home use, and targeted indications—we can present a compelling package to regulators that emphasizes benefit, safety, and feasibility. The aim is to shorten the path to market without compromising rigorous evaluation, ensuring clinicians have confidence in the device and patients experience meaningful, accessible care sooner rather than later.

Moe: Equity in access is critical for infections that affect underserved populations. How are you thinking about equity in recruitment and ensuring reach outside urban or well-resourced settings?

Equity is central to our strategy. The initial device is designed to be powered with a standard cell phone charger, which reduces infrastructure barriers in remote areas. We’re exploring applications in the military and other underserved groups where access to care is limited, recognizing that these populations often bear a disproportionate burden of infection and delayed treatment. Our goal is to provide a safe, simple option that can be deployed beyond high-resource settings, supported by remote monitoring and virtual care to maintain oversight without frequent in-person visits.

Beyond access, we’re mindful of cultural and linguistic diversity in recruitment and training materials. We’ll engage community stakeholders, adapt education resources, and ensure study sites reflect diverse populations. By prioritizing flexible logistics, affordable devices, and scalable support, we aim to reduce disparities in outcomes and demonstrate that a non-drug, light-based therapy can be a viable option for women across different geographies and socio-economic contexts. This is how we translate innovation into meaningful health equity.

Moe: Looking ahead, what lessons from your development journey could guide the next generation of non-drug women’s health innovations? What strategies would you offer to avoid common missteps?

A key lesson is that adopters may be those with chronic, recurrent infections who have struggled with traditional therapies. We’re shifting from an acute-use framework to a chronic-maintenance model, which changes endpoints, duration, and recruitment strategy. This means designing flexible protocols, anticipating protocol amendments, and embracing real-world use as a primary driver of study design. The emphasis is on practicality, patient needs, and resilience to evolving evidence.

As innovators, we should expect and plan for adaptation, not view amendments as failures. The next generation should build diagnostic capabilities that empower patients and enable remote clinician oversight, create robust adherence data, and design care pathways that integrate smoothly with telemedicine. By engaging diverse patient populations early, validating real-world endpoints, and communicating clearly about risk-benefit, we can accelerate the translation of non-drug therapies while maintaining scientific rigor and patient safety.

Moe: Finally, antimicrobial resistance is a critical concern. Do you see the device addressing AMR, and what’s the potential for expanding beyond BV and yeast infections?

We’re starting with the basics—BV and fungal vaginitis—but I see the platform as expandable to a broader range of infections and has in fact shown significant results in vitro addressing drug resistant strains of yeast such as Fluconazole resistant Candida albicans, C. krusei and C. glabrata which all proving problematic and whose prevalence are increasing. The device could function as a diagnostic–therapeutic framework that supports a balanced vaginal microbiome and reduces unnecessary antibiotic exposure, addressing AMR pressures. Even if we don’t eradicate every pathogen, maintaining microbial balance through targeted light-based modulation facilitates restoration of the microbiome stability to a desired symbiotic state while lowering infection risk and antibiotic use, contributing to resistance mitigation.

The concept of a “light probiotic”—a non-pharmacologic means to support healthy flora—fits into a larger health strategy. If we can verify that this approach reduces recurrent infections and preserves microbiome stability, we’ll have a compelling case for broader indications and longer-term health benefits. Our roadmap prioritizes safety, evidence, and patient-centered outcomes, while remaining open to partnerships that broaden the reach and impact of this technology in women’s health.