An astonishing one in five Americans develops nonmelanoma skin cancer (NMSC) at some point in their lifetime; in fact, in the U.S. each year, more people are diagnosed with skin cancer than all other cancers combined. The skin cancer diagnosis typically involves a biopsy, which requires excising skin that is then evaluated under a microscope – an invasive process which Fogarty company Enspectra Health intends to revolutionize.
The startup has developed a novel imaging technology, the VIOTM System, a portable, hand-held device that provides high-resolution images of cellular structures in living skin without an incision. Through real-time evaluation across the surface of the skin, Enspectra’s technology allows clinicians to examine suspicious lesions noninvasively and holds the potential to transform the diagnosis experience for patients and improve the workflow efficiency crisis facing dermatologists today. The company is currently working towards receiving its initial market clearance and, in parallel, continues to advance its technology.
Clinical trial enrollment is a resounding success
Enspectra has received great excitement from the dermatology community. VISTA, its second trial, is a U.S. pivotal study which Enspectra ran in the fourth quarter of 2022. The study was fully enrolled within 10 weeks and met all its demographic targets such as patient gender, skin type, condition and body location to ensure health equity. “That’s an unusually fast rate, which speaks to the unmet clinical need that providers see and the large patient population which would benefit from having access to this technology,” said Gabriel Sanchez, co-founder and CEO of Enspectra.
For the VISTA study, Enspectra partnered with Golden State Dermatology, a leading dermatology practice group with over 20 locations in Northern California. The group helped with patient recruitment and executed the study protocol to collect both Enspectra’s non-invasive in vivo images and the corresponding histopathology via traditional biopsy.
During the enrollment phase of the VISTA study, Enspectra was able to demonstrate that dermatology medical assistants can consistently and reliably capture quality images with the VIOTM System, thereby freeing some of the physician’s time when compared to a traditional invasive biopsy. “This has proven to be a very effective way to alleviate the compressed patient schedules that dermatologists face today and allow them more time to see additional patients,” said Gabriel.
Thanks to this rapid trial enrollment, the company is now working through the necessary steps for FDA clearance that will allow them to bring the technology to market.
Crucial funding supports next steps
The clinical work and FDA submission are being supported by the third and final tranche of funding that Enspectra was awarded from the National Cancer Institute under the National Institutes of Health’s Small Business Innovation Research (SBIR) Program, part of a total Phase IIB grant of $4 million.
“By aligning with the National Cancer Institute, we’ve been able to accelerate our journey to bring this transformative technology to patients,” Gabriel said. “Their support also allows us to focus energy on the future generation of our technology, as we are beginning to look at machine learning models that could further aid dermatologists and ultimately patients.”
Funding is also fueling growth, with several key hires over the past two years. These include Esha Kothari as head of Clinical Operations, who was instrumental in planning and executing the recent studies and currently coordinating data analysis for submission; Shelley Marwah as vice president of Commercial Strategy; Grace Li as vice president of Quality and Regulatory; and Mark Shughart as director of Systems Engineering.
Full speed ahead
Throughout this early phase, Enspectra has been dedicated to understanding the needs of dermatologists. The company has participated in prominent dermatology scientific conferences and has partnered with several key opinion leaders who have been instrumental in helping advance the technology, while providing insight on how it can better integrate into the clinical workflow.
Enspectra is currently raising its next financing round that will support its go-to-market plans post-FDA clearance, conducting additional studies to expanded clinical indications and continuing to advance its technology.