As a teenager, Surbhi Sarna, nVision Medical CEO and founder, had complex, repeat ovarian cysts. They were painful and worrisome. They couldn’t be biopsied for fear of spreading cancer, and she said the rest of the diagnostics were so poor she and her doctors basically were left to watch and see if they grew. Now, a medical device mover and shaker listed on the Forbes 30 Under 30 list for science, she wants to meet this need. She entered the startup space specifically to create a company devoted to women’s health, she said. She’s starting with in-office diagnostics, an improved one for ovarian cancer and another for Fallopian tube blockage.
“Most gynecologists I speak to agree that the biggest unmet need in women’s health is an early detection of ovarian cancer,” Sarna said. According to the American Cancer Society: “If ovarian cancer is found (and treated) before the cancer has spread outside the ovary, the 5-year relative survival rate is 92 percent. However, only 15 percent of all ovarian cancers are found at this early stage.”
However, there are many obstacles in the way of early detection. The cancer often presents as nearly asymptomatic, and the current diagnostics are lacking. Transvaginal ultrasound can only detect a mass, meaning it’s late stage, and blood test CA-125 often produces false positives, as much as 40 percent of the time, Sarna said.
“It’s an incredibly scary disease and incredibly hard to treat,” she said. The “unnecessarily” long wait times for diagnostic results alone can be anxiety-inducing.
“I think because I’ve been a patient . . . when I think about designing for a product I don’t just think about designing for a physician, I think about designing for a patient.”
This combination of perspective led Sarna to the conclusion the test should be pap smear-like and catheter-based and allow gynecologists to extract cells without fear of potentially spreading cancer.
The company’s other diagnostic is a hydraulically-propelled endoscope to detect Fallopian tube blockage, a leading cause of infertility. The standard of care currently is X-ray, Sarna said, which would just show a black line obstructing the tube in a patient with blockage.
But with an endoscope, the nature of the blockage can be determined, it keeps patients from radiation exposure and it can be done in-office with a gynecologist instead of a radiologist. This would cut cost from care, including fertility treatment plans.
For commercialization, nVision will target physicians who have access to hysteroscopes. Because the hysterscope’s required for Conceptus’ Essure sterilization procedure (remember that $1.1B deal?), which has been widely adopted in the women’s health community, many physicians already have obtained the $40,000 device, Sarna said.
Fingers crossed, if all goes according to plan, the two 510(k) Class-II devices will be FDA cleared sometime in 2015, Sarna said.
nVision moved into the Fogarty Institute for Innovation in January. She said the value propositions of an alliance with Fogarty were obvious, especially regarding networking along regulatory and reimbursement pathways. Plus, of course, it limits overhead.
What started as “provisional patents, a slide deck and a dream” has turned into a venture-led company with very promising tech. It raised its $4.5M Series A round in spring of 2013, led by Catalyst Health Ventures. Draper Associates, Seraph Group and Astia followed. Sarna said that will fund the company for the near future. “Fundraising’s not all that fun compared to executing.”
To read more about how the Fogarty Institute is at work to come up with real solutions for women’s health, click here.