Visby Medical has secured approximately $55 million in new funding, with the potential to reach $65 million, to accelerate the commercial launch of its recently FDA-authorized at-home Women's Sexual Health Test. The financing round was led by Catalio Capital Management, with participation from existing investors including ND Capital, Cedars Sinai Medical Center, Blue Water Life Science Advisors, Pitango Ventures and John Doerr.
The San Jose-based company, founded in 2012, has developed what it describes as the first single-use, disposable PCR diagnostic that delivers results within 30 minutes through a connected smartphone app. The technology represents a significant advancement in at-home diagnostics, bringing laboratory-grade accuracy to consumer testing for sexually transmitted infections.
Breakthrough Technology Platform
Visby Medical's proprietary platform delivers true PCR results in under 30 minutes through what the company calls the world's first instrument-free, single-use PCR tests that fit in the palm of your hand. The at-home Women's Sexual Health Test is designed to provide the same accuracy as traditional PCR machines while offering unprecedented convenience and privacy.
"We are excited to partner with Catalio Capital Management, a true industry powerhouse, as we advance our mission to transform healthcare through rapid and convenient at-home diagnostics that deliver the same accuracy as traditional PCR machines," said Adam de la Zerda, PhD, Founder and CEO of Visby Medical. "This funding round will enable Visby to deliver on our vision of empowering consumers with reliable and lab-accurate health information from the comfort of their homes, starting with our at-home test for sexually transmitted infections for women."
Strategic Leadership Additions
The funding round brings significant industry expertise to Visby Medical's leadership team. Isaac Ro, a partner at Catalio Capital Management, joins the company's board as an observer, while Chuck Alpuche, Chief Operating Officer at Imperative Care and former EVP and Chief Operating Officer at Insulet Corporation, joins as an independent director.
Alpuche brings extensive operational leadership experience, including manufacturing scale-up and cost efficiency expertise from his roles at major healthcare and consumer companies including PepsiCo. "I am thrilled to join Visby Medical's board at this transformative time," Alpuche said. "Visby's FDA-authorized at-home STI test is redefining convenience and accessibility in diagnostics, and now the company is uniquely positioned to scale. I'm particularly excited to contribute my operational experience to help Visby streamline manufacturing and drive down unit costs — essential steps in making the technology accessible to millions and building a strong foundation for long-term growth."
Market Impact and Accessibility
Isaac Ro emphasized the breakthrough nature of Visby's technology, stating, "Visby Medical has delivered the first and only laboratory-grade STI testing solution that can be made directly accessible to individuals. We were eager to invest in Visby ahead of their FDA clearance, knowing this would represent a breakthrough moment for the diagnostics industry. We are proud to support the company in its mission to reshape healthcare delivery."
The diagnostic platform addresses a critical gap in healthcare accessibility by enabling users to receive positive results and seamlessly connect with telemedicine providers for consultation and treatment, enhancing both healthcare accessibility and privacy. This integrated approach represents a comprehensive solution that extends beyond testing to include care coordination.
Commercial Launch Timeline
Visby Medical's at-home Women's Sexual Health Test will be available starting July 2025 through major direct-to-consumer channels. The company currently offers FDA-cleared tests for sexually transmitted infections available in both point-of-care settings and directly to consumers at home, as well as respiratory infections including COVID-19, flu A and flu B for point-of-care settings.
The company is actively expanding its platform with plans for a wide range of future tests for both at-home and point-of-care markets, positioning itself as what it calls "the premier at-home testing company." The funding will specifically accelerate the launch and distribution of the Women's Sexual Health Test while supporting the company's broader strategic focus on at-home diagnostics.
