New York, NY – November 5, 2025 — HITLAB, a global leader in digital health innovation and evidence generation, today announced a strategic partnership with Cern Corporation, Inc., a pioneering women’s health technology company headquartered in Southern California. The collaboration aims to advance a groundbreaking, non-drug treatment for vaginal infections that leverages low-level microbicidal light and a proprietary photosensitizer-lubricant — marking a bold step toward a new era of evidence-based, drug-free women’s health solutions. 

Under the agreement, HITLAB will conduct a comprehensive heuristic evaluation and testimonial data analysis of the Cern Device™, a first-of-its-kind at-home treatment for women suffering from recurrent fungal and bacterial vaginosis. The study will rigorously assess the device’s usability, accessibility, safety, and patient engagement — key factors in ensuring widespread adoption and clinical impact. 

“Cern Corporation represents the next wave of women’s health innovation — science-driven, non-invasive, and empowering,” said Amy West, Principal, Advisory Services, HITLAB, and Chair of HITLAB’s Women’s Health Tech Initiative. “Millions of women struggle with recurring infections and limited treatment options. Cern’s approach could fundamentally shift that reality by offering a safe and effective alternative to traditional drug therapies.” 

Cern’s treatment targets primary pathogens responsible for most yeast & bacterial vaginal infections — C. albicans and G. vaginalis — while sparing beneficial bacteria such as L. crispatus, which is essential for a healthy vaginal microbiome. Cern’s approach has also demonstrated efficacy against problematic, drug-resistant strains. By avoiding the pitfalls of antibiotic and antifungal resistance, Cern’s targeted, non-drug mechanism can significantly reduce the need for systemic therapies, lowering both recurrence and resistance rates. The Cern Device™ is unique in its ability to address both yeast and bacterial pathogen effectively. 

Cern’s novel approach has already attracted the attention of major health organizations and innovation programs, including ISSVD, The Innovation Institute, and the NSF I-Corp Discovery Program. Experts have lauded the technology’s potential to improve clinical outcomes, reduce healthcare costs, and empower women to manage their reproductive health more proactively. 

“Partnering with HITLAB allows us to bring scientific rigor and digital validation to our mission,” said Gregg A. Klang, MBA, CEO and Founder of Cern Corporation. “This 

collaboration accelerates our path toward FDA review and market introduction while ensuring our technology meets the highest standards of safety, efficacy, and patient usability.” 

Regulated as a Class II de novo medical device, the Cern Device™ will be available by prescription following FDA clearance. Future development plans include integrating AI-enabled data analytics, connected sensors, and secure data-sharing features to enable continuous remote monitoring and personalized treatment insights.