Anu Parvatiyar, cofounder of Ananya Health [Image courtesy of Ananya Health]
Cervical cancer is the fourth most common cancer among women and has a high mortality rate globally, according to the World Health Organization. Screening and effective interventions can reduce cervical cancer deaths, but that access is limited in emerging markets and developing countries.
Ananya Health, co-founded by Anu Parvatiyar, is at the forefront of tackling this global health disparity. The company is developing a cryoablation device that can freeze abnormal cells in the cervix at the point of care, all on a battery-powered system designed to bridge the accessibility gap in regions that typically lack these resources.
Typically, when a Pap smear comes back as abnormal in places like the U.S., doctors refer patients to a specialist at a hospital or larger specialty clinic with the tools and operating space to treat the lesions.
But in many places, various socioeconomic and cultural factors cause a reluctance to seek and low prioritization of cervical cancer screening and treatment, Parvatiyar told Medical Design & Outsourcing.
“India has 25% of the world’s cervical cancer burden,” Parvatiyar said. “I’m not even talking about remote villages you’re hiking to that don’t have electricity. I’m just talking about urban areas in countries that have a relatively large middle class. There just aren’t cryogen supplies.”
Following up on abnormal screening results can be difficult if patients travel long distances or to different clinics for confirmation and treatment. This extra step leads to a large decrease in follow-up rates and a greater risk of cervical cancer.
The challenges of treating cervical cancer in emerging markets
Traditional cryoablation equipment requires specialized facilities, staff and consumable supplies that make it difficult for most primary care clinics globally to offer this treatment.
“Cryogenic gas is largely unavailable in large parts of the world,” Parvatiyar said. “India has 25% of the world’s cervical cancer burden. I’m not even talking about remote villages that you’re hiking to that don’t have electricity. I’m just talking about urban areas in countries that have a relatively large middle class. There just aren’t cryogen supplies.”
Demand for those resources is unpredictable for clinics in rural areas and emerging markets. Because clinics don’t know how many women may come in for diagnosis and treatment they don’t know how much cryogenic gas to purchase or how often. That results in clinics not offering the service because there is too much risk.
San Francisco-based Ananya Health has a solution. The company’s battery-powered Cryo Refrigerant Closed Loop (CRCL) system achieves ablative temperatures in a compact format, making it ideal for clinics in India, Africa and emerging markets where cervical cancer is most prevalent.
Ananya Health’s CRCL device rendering [Image courtesy of Ananya Health]
How the CRCL system bridges the gap in care
Closed-system ablation removes reliance on heavy, hard-to-find compressed gas. The portable, battery-powered compressor can be used by trained health workers in any setting, from mobile clinics to hospitals. CRCL is self-contained, allowing clinicians to perform cryoablation procedures as needed over a defined time. The system combines diagnostics and treatment in the same place to eliminate the loss in follow-up rates.
Cryoablation is a relatively low-risk procedure compared to some of the other gold-standard methods, which may require a six-week recovery time. CRCL is used in an outpatient procedure, allowing the provider to treat without potentially losing the patient in the follow-up process.
Ananya Health also uses miniaturization to make the compressor condenser system more accessible. The features are similar to a small refrigerator or freezer that you would put on a boat or in an RV, but it needs to get colder on a smaller point.
“We spent a lot of engineering time making sure that it works in the way that we wanted to. And with that comes a lot of the robustness. You don’t want it to just get in there and stop working,” said Parvatiyar.
Design challenges and looking ahead
However, Parvatiyar said a lot more engineering goes into making the system successful. CRCL combines a refrigeration system with electronics and PCBA interfaces within the system’s body.
Designing a refrigeration/cooling system that can get cold enough using batteries is technically complex. Significant engineering time is required to optimize this.
“With all those subsystems, 90% of the work is in the last 10% of the design,” Parvatiyar said. “And I think just finalizing some of those refrigeration parameters and giving ourselves that time and runway to do that is always a good management challenge.”
The company applied for its second National Institutes of Health (NIH) grant in September and plans to submit its system for FDA review. While the device is pre-regulatory with none on the market, it has had technical wins.
“We’ve been able to get down colder than -40° C consistently and really colder than -50° C,” Parvatiyar said. “We’re seeing really great outcomes on that and looking to submit to the FDA next year.”
Ananya Health has established partnerships with clinical organizations, advocacy groups and screening companies to support adoption in target regions like Kenya, Nigeria and India. Ananya Health works with cervical cancer organizations like those associated with Nigeria’s First Ladies Against Cancer Initiative. The company is also in talks with traditional global health groups that focus specifically on cervical cancer like the Clinton Health Access Initiative, Parvatiyar said.
Fundraising for the CRCL system has been challenging, given its focus on global health markets, but Parvatiyar sees a significant market opportunity for battery-powered cryoablation. If the system is successful at primary care clinics, it could open the door to developing and supplying cryoablation for other procedures in an outpatient setting like dermatology.
“We’re trying to drive the adoption of visits to primary care in emerging markets or even rural areas within the U.S.,” Parvatiyar said. “If you can build the trust, you’ll hear from people what it is they need, and what it is you should be working on next. … Building the kind of tool that people trust in to work anywhere, they are and whatever clinic that they’re in, I think is a great entry point to do lots of different things.”