Medical devices & diagnostics · Cervical cancer prevention
Ananya Health
A battery powered cryoablation device built to freeze cervical precancer in clinics with no cryogen gas and no gynecologist. Six years in: $2.69 million of federal grant money, two SEC filings, and no clearance anywhere.
A positive screen with nowhere to go
“Cryogenic gas is largely unavailable in large parts of the world,” Anu Parvatiyar told Medical Design & Outsourcing in October 2023. That one sentence is the reason her company exists.
Cervical precancer is treatable with a cold probe: freeze the abnormal tissue and the body regrows healthy cells over the following weeks. The machines that do this run on compressed medical grade carbon dioxide or nitrous oxide, delivered in steel canisters that are heavy, costly to ship, and often absent.
A clinic cannot predict how many women will screen positive next month, so it cannot predict how much gas to buy. Plenty resolve that by not offering treatment at all, and the cure becomes a second journey the patient may never make. Ananya Health states that 50% of patients who screen positive never follow up.
The answer is to move the refrigerator inside the device. The CRCL platform, short for Cryo Refrigerant Closed Loop, drives a refrigerant around a sealed circuit with a battery powered compressor and recaptures it. Nothing is vented, nothing is refilled.
The gap it is aimed at
The World Health Organization counted around 604,000 new cervical cancer cases and around 280,000 deaths in 2024. It is the fifth most commonly diagnosed cancer in women worldwide, the leading cause of cancer death in women in 26 countries. Women living with HIV are six times more likely to develop it.
Almost all of it is preventable. Persistent HPV infection produces lesions that usually take 15 to 20 years to turn into cancer, and WHO calls treating those lesions a simple and effective procedure. The global 90-70-90 targets ask countries to vaccinate 90% of girls, screen 70% of women, and treat 90% of those found to have precancer or cancer. The third target has the thinnest infrastructure behind it. Of WHO’s four listed treatments, only thermal ablation and cryotherapy can be done by a nurse with no operating theatre.
Cryotherapy is not the only portable option, and this is where the marketing runs ahead of the record. The Y Combinator profile says the platform “is the only cryo device that will help us achieve the WHO target to eliminate cervical cancer in our lifetime”. In June 2024, Nature Medicine published a randomized noninferiority trial run in Zambia by the International Agency for Research on Cancer: 3,124 screen positive women assigned to a portable, battery driven thermal ablator, to cryotherapy, or to large loop excision. Treatment success at a median 12 months was 74.0%, 71.1% and 71.4%. A battery powered competitor already has its human data.
An engineer who worked on polio
Parvatiyar studied biomedical engineering and economics at Georgia Tech, then spent six years in device research and development, starting at C. R. Bard. She left for West Africa to lead the Global Programs team at eHealth Africa, more than 300 staff who built base maps, data tools and field logistics behind polio eradication in Nigeria.
“90% of medical innovation is designed for 10% of the world’s population,” she wrote in a 2020 MIT Solve application. In the same document she describes returning to the United States, meeting Dr. Daniel Burnett through a mutual colleague, and brainstorming devices for large public health needs. Cervical cancer was the natural fit: preventable, detectable, treatable early, and still killing.
Ananya Health was incorporated in Delaware in 2020 as a benefit corporation with a sister nonprofit, Ethonova. The second name on its paperwork is Wei-Hsiang Chang, a director on both SEC filings and principal investigator on all three National Cancer Institute awards. Y Combinator lists the team at eight.
Grants first, equity later
The funding history runs backwards from the usual venture story. Angel and friends and family money came first, then Y Combinator. “We started out with angel checks, you know, just friends and family pulling money and went through an accelerator in 2021,” Parvatiyar told a National Cancer Institute podcast in 2024.
Then the grants. NCI awarded a Phase I SBIR of $396,587 starting September 2022, then a Phase II that paid $1,172,978 in fiscal 2024 and $1,124,942 in fiscal 2025. Announcing the Phase II in September 2024, the company added that it had raised $250,000 more from existing investors, including eha Impact Ventures, whose chief executive Evelyn Castle became a board observer in early 2024.
Equity paperwork arrived later. The first Form D, filed April 2025, reports a first sale on March 27, 2025 and $200,000 sold to two investors on SAFEs; an amendment filed May 2026 raises the same offering to $404,000 from five. In June 2025 the American Cancer Society’s venture arm, BrightEdge, invested and named Ananya to its 2025 Entrepreneurs cohort of twelve. In September 2026 eha Impact Ventures added $100,000, its third cheque.
The regulatory date moved with each round. In October 2023 Parvatiyar said the company was looking to submit to the FDA the following year; the June 2025 BrightEdge release planned submission for 2026; September 2026 coverage puts clearance at mid-2027.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA status | No 510(k) clearance and no PMA approval on record for Ananya Health or CRCL as of Sep 22, 2026. No CE mark or WHO prequalification found. | Not found |
| NCI SBIR awards | R43CA278186, $396,587, Sep 2022 to Feb 2024. R44CA278186, $1,172,978 in FY2024 and $1,124,942 in FY2025, Sep 1, 2024 to Aug 31, 2026. PI on all three: Wei-Hsiang Chang. Total $2,694,507. | Public record |
| Trials and papers | No registered study and no PubMed-indexed paper as of Sep 22, 2026. The only publication trace is a patent filing, reported by BioWorld in 2024 as the company’s first. | Not found |
| Bench performance | In 2023 Parvatiyar said the system reached “colder than -40° C consistently and really colder than -50° C”. September 2026 reporting repeats the -40 C figure and drops the -50 C one. | Company-stated |
| Clinical performance | The website says the platform “generates standard of care outcomes without consumable cryogen gas” and that the probe delivers a 5mm depth of freeze, called the standard of care. No human outcome data for the device is published or registered. | Claim without evidence |
| “Only cryo device” | WHO recommends thermal ablation alongside cryotherapy, and a portable battery driven thermal ablator has a 3,124 patient randomized trial behind it. | Differs from the record |
| Where it is deployed | Nowhere. The site states that “Certain configurations of the CRCL System shown on this website are under development and not currently available in any geography.” Named relationships in Kenya, Nigeria, India, Mexico and the United States are partnerships, not installations. | Company-stated |
Read plainly: a strong non-dilutive record and no clinical evidence in public. The engineering claim, that a sealed refrigeration loop reaches ablative temperatures on a battery, is backed by bench figures and three rounds of NCI peer review. The clinical claim, that it delivers standard of care outcomes, rests on the physics of the freeze rather than on patients. Nothing is cleared, nothing is published, and the device is on sale nowhere.
What to watch
- A 510(k) submission. Clearance is now put at mid-2027, about three years after the date Parvatiyar described in 2023.
- The first registered clinical study, or a decision to seek clearance on bench and animal data against a predicate device.
- The grant runway. The Phase II project period ran to August 31, 2026, so the NCI money on record has stopped.
- A priced round. Everything filed so far is SAFEs with the offering size left indefinite, so no valuation is on the record.
In their words
“Cryogenic gas is largely unavailable in large parts of the world.”
Anu Parvatiyar, co-founder and CEO, Medical Design & Outsourcing, October 2023 · Interview
“India has 25% of the world’s cervical cancer burden.”
Anu Parvatiyar, Medical Design & Outsourcing, October 2023 · Interview
“90% of medical innovation is designed for 10% of the world’s population.”
Anu Parvatiyar, MIT Solve application, 2020 · Company-stated
“We think it is better business to focus on the large market, you know, globally than just the US market that a lot of US-based pre-regulatory investors are hyper focused on.”
Anu Parvatiyar, NCI SBIR Innovation Lab podcast, November 2024 · Interview
“Every clinical milestone we’ve hit has been built on the assumption that this device needs to work for a midwife in Nairobi and an OB-GYN in Chicago alike.”
Anu Parvatiyar, quoted in The Nation, September 2026 · Independent
“Our follow-on investment in Ananya Health reflects our belief that meaningful impact is created when investors remain committed beyond the first cheque.”
Evelyn Castle, CEO, EHA Impact Ventures, quoted in Punch Healthwise, September 2026 · Investor
Related companies
Sources
- Public recordNIH RePORTER R43CA278186 and R44CA278186
- Public recordForm D and Form D/A, Ananya Health, Inc., CIK 0002064779
- Public record510(k) and PMA databases, searched for Ananya Health
- Public recordCervical cancer fact sheet
- IndependentA portable thermal ablation device for cervical cancer prevention
- InterviewAnanya Health wants to bring battery-powered cryoablation to the global fight
- IndependentAnanya details its cryoablation device for treating cervical cancer
- IndependentEIV invests $100,000 in Ananya Health for cervical cancer device
- IndependentFirm invests $100,000 in cervical cancer prevention device
- InterviewEmpowering Innovation in Women’s Health, episode 23
- CompanyAnanya Health secures $2.3M SBIR grant
- CompanyStrategic investment from BrightEdge
- CompanyAnanya Health website
- CompanyCompany profile and founder bio
- CompanySolution overview and founder essay
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
