# Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions

> **NIH NIH R43** · ANANYA HEALTH INC · 2022 · $396,587

## Abstract

Abstract
While cervical cancer deaths have dramatically fallen in high-income countries, cervical cancer is one of the
leading causes of cancer deaths in low- and middle-income countries (LMICs). Cervical cancer accounted for
341,800 deaths in 2020, with approximately 90% of these deaths occurring in LMICs. Treatments for
precancerous lesions are highly effective for preventing cancer progression, so the key is to identify and treat
lesions early. However, most low-income countries that offer cervical cancer screening lack accessible treatment
services. The lack of readily accessible treatment options means referral of patients to larger hospitals, which is
an obstacle to proper treatment, leading to disease progression to cancer. While loop electrosurgical excision
procedure is the gold standard in the treatment of lesions, it requires highly trained clinicians and an operating
environment rarely found in LMIC clinics. The World Health Organization recommends cryotherapy for cervical
precancer treatment in LMICs, but the key drawback for current cryotherapy systems is their dependence on
consumable cryogen gas. Access to a cryogen gas supply is unreliable, consumable gas costs are high, and
heavy and bulky gas cylinders limit portability to remote clinics. Other LMIC-targeted options have been
attempted, but they were poorly adopted due to high cost and discontinued manufacturer support (CryoPen) or
insufficient depth of tissue necrosis for fully effective treatment (heat-based thermal ablation). Taken together,
no single system exists to provide an appropriate and cost-effective solution that is suitable for widespread LMIC
use. With an LMIC-appropriate treatment solution, cervical cancer mortality could be reduced by 33% (~300,000
deaths) by 2030. With NIH SBIR Phase I support, Ananya Health’s goal is developing the Ala System, a portable,
battery-powered, closed-loop cryotherapy system for the treatment of cervical precancerous lesions in LMICs.
By recirculating the cryogen fluid in a closed-loop system, the Ala System eliminates the need for consumable
cryogen gas. The rechargeable battery allows for treatment independent of electrical grid availability. Preliminary
studies have shown we can achieve tissue-freezing temperatures on an ovine uterus tissue model with a battery-
powered closed-loop prototype. For this proposal, first, we will use a benchtop cervical model to further optimize
system parameters to meet the established cervical tissue cryotherapy requirement: ≥5 mm depth of tissue
reaches ≤-20°C for ≥1 min in a ≤5 min procedure (Specific Aim 1). Second, we will make in-person visits to two
LMIC clinical sites to interview and observe ≥6 clinicians to identify critical User Needs and system requirements
to ensure the Ala System design will suit the clinical, usability, and operational needs of primary care facilities in
LMICs (Specific Aim 2). The development work in Phase I will lay the foundation for final device testing, user
des...

## Key facts

- **NIH application ID:** 10602226
- **Project number:** 1R43CA278186-01
- **Recipient organization:** ANANYA HEALTH INC
- **Principal Investigator:** Wei-Hsiang Chang
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $396,587
- **Award type:** 1
- **Project period:** 2022-09-12 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10602226

## Citation

> US National Institutes of Health, RePORTER application 10602226, Portable, low-cost cryotherapy system that does not require consumable cryogen gas for the treatment of cervical precancerous lesions (1R43CA278186-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10602226. Licensed CC0.

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