First Warning Systems, the Reno, Nevada-based company that's working on wearable sensors for early detection of breast cancer, has raised $560,000, according to CEO Rob Royea. Steven Welch, a private investor and former COO of BP (not to be confused with DreamIt Health founder Steve Welch) led the round with a $300,000 contribution. The rest came from a syndicate of investors in Singapore, where First Warning intends to launch its product in early 2015.
In late 2012, First Warning Systems announced a breast cancer-sensing bra, a wearable device that caught the attention of the public and received a lot of media attention. However, there were challenges with developing and marketing that technology, and the company faded out of the public eye, drawing back into stealth mode around the same time it hired Royea in February 2013.
The company's approach now is to use the same temperature-fluctuation sensors from the smart bra, but in a small device that can be inserted into a user's existing bra and connect to their smartphone .
"We are no longer building it into fabric, because frankly the product has to be reusable and wearable over a number of uses," Royea told MobiHealthNews. "It will be an insert that can work within different kinds of fabrics. It’s smartphone enabled now, smart device enabled. All the information goes directly into a big data backend."
Breast cancer is much more treatable if detected early, but compliance rates for breast self-exams and mammograms -- even when they're offered for free -- are very low.
The sensor finds cancer by detecting tiny metabolic temperature changes caused by cancerous cells in a tumor. The temperature readings are sent back to a global library where they're run through a proprietary algorithm. Then the results are sent back to a user's phone. In several smaller trials, the device has had a 74 percent correlation with mammography and may work better than a mammogram in patients in the early stages of cancer (when it is often undetected) or with dense breast tissue, a condition that affects over half of women.
Pending FDA clearance for its new device, First Warning plans to sell it through two channels -- selling it to hospitals to give to patients with dense breast tissue or other risk factors for breast cancer, who would take it home and wear it for a couple of days, and selling directly to consumers via pharmacies as part of a wellness screening.
Starting in July, two clinical trials will be conducted with the device. Dr. William Farrar, will lead one study at the JamesCare Breast Center at The Ohio State University. The other study, led by Dr. Josh Ellenhorn at Cedars-Sinai Medical Center in Los Angeles, will be a multisite study, that also includes El Camino Hospital in Mountain View, California.
Royea said the company was launching initially to the Asian market via Singapore for several reasons, including that the device already has a CE Mark and that the need in Asia is great.
"Singapore’s government gave out 10,000 free mammograms and only 30 percent of the population actually came in," he said. "So mammograms are not the favorite choice in Asia. In India breast cancer is the number one epidemic in women’s health and it's spreading into the rest of Asia."
Before the device can launch in the United States, it needs FDA Class II clearance, for which the company plans to file in the next three weeks.
"We can get into it outside of the US much faster, though we do believe the FDA will be fast tracking this a bit because we’re a noninvasive, nonradiative early breast cancer screening technology, but I can’t guarantee that," he said. "So I’m putting our US launch in late 2015 just based on the politics that are involved."