While cervical cancer deaths have dramatically fallen in high-income countries, cervical cancer is one of theleading causes of cancer deaths in low- and middle-income countries (LMICs). Cervical cancer accounted for341,800 deaths in 2020, with approximately 90% of these deaths occurring in LMICs. Treatments forprecancerous lesions are highly effective for preventing cancer progression, so the key is to identify and treatlesions early. However, most low-income countries that offer cervical cancer screening lack accessible treatmentservices. The lack of readily accessible treatment options means referral of patients to larger hospitals, which isan obstacle to proper treatment, leading to disease progression to cancer. While loop electrosurgical excisionprocedure is the gold standard in the treatment of lesions, it requires highly trained clinicians and an operatingenvironment rarely found in LMIC clinics. The World Health Organization recommends cryotherapy for cervicalprecancer treatment in LMICs, but the key drawback for current cryotherapy systems is their dependence onconsumable cryogen gas. Access to a cryogen gas supply is unreliable, consumable gas costs are high, andheavy and bulky gas cylinders limit portability to remote clinics. Other LMIC-targeted options have beenattempted, but they were poorly adopted due to high cost and discontinued manufacturer support (CryoPen) orinsufficient 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 LMICuse. With an LMIC-appropriate treatment solution, cervical cancer mortality could be reduced by 33% (~300,000deaths) 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 consumablecryogen gas. The rechargeable battery allows for treatment independent of electrical grid availability. Preliminarystudies 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 optimizesystem parameters to meet the established cervical tissue cryotherapy requirement: â¥5 mm depth of tissuereaches â¤-20°C for â¥1 min in a â¤5 min procedure (Specific Aim 1). Second, we will make in-person visits to twoLMIC clinical sites to interview and observe â¥6 clinicians to identify critical User Needs and system requirementsto ensure the Ala System design will suit the clinical, usability, and operational needs of primary care facilities inLMICs (Specific Aim 2). The development work in Phase I will lay the foundation for final device testing, userdesign validation, and regulatory approvals via FDA 510(k) in Phase II, followed by widespread deployment ofthe Ala System through global NGOs and local and regional LMIC organizational partnerships.
Public Health Relevance Statement: Narrative
Cervical cancer is the fourth most common cancer in women, and accounted for 341,800 deaths in 2020,
where approximately 90% occurred in low- and middle-income countries (LMICs). The lack of treatment options
in LMICs is a major gap in the screen-and-treat strategy highlighted by the World Health Organization's cervical
cancer elimination initiative, as existing technologies that have successfully driven down case counts in affluent
countries are not suited for clinics staffed with lower- and mid-level health workers with limited resources and
infrastructure. In response to the treatment gap, this Phase I SBIR project furthers the development of the Ala
System, a portable, self-contained cryotherapy unit that is specifically designed with a user-centered focus to
overcome infrastructure and resource constraints and enable widespread primary care treatment of cervical
precancerous lesions in LMICs.
Project Terms:
