It has been an action-packed 12 months for EnSpectra Health, a Fogarty Institute company that is leading a digital transformation in skin cancer pathology. While 2019 brought a number of notable developments, most recently EnSpectra received a $2 million grant that will expedite the introduction of its groundbreaking skin cancer identification technology.
The impetus for this newest grant came from preliminary activities that were supported by the National Cancer Institute through Phase I of the Small Business Innovation Research (SBIR) program, which EnSpectra was able to successfully extend to Phase II. The funds will support bringing this technology into clinical practice to validate its efficacy and immense opportunity for patients.
The need for EnSpectra’s technology is great, given the rising numbers of skin cancer diagnoses, including in high-risk populations whose immune system is already suppressed. Until now, cutting samples from the body for biopsy has been the only way to assess whether a new growth or lesion on the skin is cancerous. Of the 12 million biopsies conducted each year to determine the presence of skin cancer, approximately half reveal healthy tissue, creating an alarmingly high number of unneeded and costly procedures.
EnSpectra’s current technology entails a hand-held device, the PathWand, which immediately shows images of the same cellular structures that appear in the colored stained slides pathologists and physicians use to identify cancerous cells – but through a simplified process that entails just touching the skin. This promises to reduce the need for traditional biopsies and allow physicians to inspect a larger number of suspicious spots on patients earlier and without pain.
Previous funding sparks impressive progress
A key focus has been team expansion, with EnSpectra adding resources in quality, regulatory and clinical affairs, and reimbursement through three significant hires: Bill Beasley, as president and chief operating officer; Rich Caligaris, as chief commercial officer; and Piyush Arora as its engineering manager.
“The Series A funding we received in 2019 really set things in motion for us,” said Gabriel Sanchez, co-founder and CEO of EnSpectra. “We were previously operating with a very lean team, and adding the experience of these three team members, along with the mentoring we receive from the Fogarty Institute, is vital to help us get to the next level. While we have a lot of opportunities, we need to be deliberate in determining the best strategy as we navigate the hurdles inherent in the medtech environment.”
The next big milestones for the company will include product development for the clinical systems that will be deployed for upcoming clinic trials and pilot human studies, along with moving towards FDA clearance and working on its reimbursement strategies.
Pursuing a bigger vision
While pursuing its current technology, EnSpectra has also been closely following digital pathology trends and realizes the field is on the cusp of a transformation. To meet this demand, the company is working toward the ability to stream large quantities of images at a much faster rate, which would enable doctors who are looking at a concerning spot to see it from multiple views while creating images from different perspectives. Coupled with artificial intelligence, the technology could offer unprecedented additional opportunities to provide noninvasive therapies for skin cancer.
“Current best practices in pathology don’t allow us to know what the tissue looks like until the time of time of excision, but once you cut the tissue, you’ve essentially killed it. Therefore, we don’t know how it would react to treatments, and we can’t determine how it got to that state,” explains Gabriel.
And that’s where EnSpectra’s noninvasive technology steps in, designed to allow dermatologists to assess the health of the tissue and potentially design a topical therapy. Analytical capabilities within the technology also expect to offer predictions on how the tissue might react to therapy – a capability never before possible, offering an unprecedented level of benefit for patients.
In short, current digital pathology is limited to excising the tissue, which is then mounted on slides or scanned or digitized in some way so it can be shared. EnSpectra’s vision is that a dermatologist in California, for example, could touch a patient’s skin with their device, then stream images live to a pathologist in New York, thus allowing them to confer on the tissue in real time — exploring and looking for malignancies in atypical tissues completely noninvasively.
In the long-term, it is EnSpectra’s hope that skin cancer detection can occur before a patient even detects a problem. Through non-invasive technology, its device can be used to screen patients earlier and more frequently to identify potential pre-malignant cells, thus allowing physicians to intervene sooner, ideally with more topical therapies. “It’s a bit like radiology now – surgeons don’t just start cutting; instead they review MRIs and CT scans to plan their procedures. We have never had this capability at the cellular level,” said Gabriel.
“We have seen a lot of interest from doctors, including ones who work with the more vulnerable population of immunosuppressed patients, where skin cancer can become more of a fatality risk. We believe these new digital tools will be transformational for clinical practice and efficiency.”