Our injectable polymer-based therapeutic uses readily available chemicals to ablate lesions without the need for electricity, or battery power.
The WHO recommends the use of ablative therapies, including cryotherapy and thermocoagulation, to treat cervical dysplasia in resource-limited settings because they cost less than LEEP excision of the cervix, do not require removing tissue, therefore leaving the cervix intact, and can be performed by non-specialists.
While both technologies effectively treat the superficial layers of cervical tissue, neither therapy effectively treats microinvasive disease or early carcinomas (stage IA and IB), which can extend beyond 5 mm in depth. Thus, there is a need for an accessible, robust therapeutic to treat deeper lesions.
To develop a complementary therapeutic that can address these limitations, we have developed a simple formulation combining ethanol and an inert polymer, ethyl cellulose to induce necrosis through protein denaturation and cytoplasmic dehydration. Ethyl cellulose is a freely flowing fluid in its soluble form; however, it undergoes a phase change into a biodegradable polymer gel in aqueous media encapsulating the solvent within a hydrophobic shell localizing the volume of destruction to the region where the injection is made.
It has the added benefit of enhanced control in selecting needle depth and location(s) within the cervix. This therapeutic has an excellent strong safety profile with no deviations from normal vital signs, limited side effects, and no adverse events within 24 h of ablation.
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Numerous countries have taken part in our clinical investigations and benefited from improved access to women’s healthcare options.
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We have expanded to 8 sites around the world and continue to grow our reach with powerful women’s health innovations.
1300+
We have enrolled over one thousand patients, providing necessary access to healthcare technology previously outside the reach of these countries.
We've conducted clinical investigations in over 8 countries across 4 continents. Our latest product launch, The Pocket Colposcope, received FDA clearance in September 2018.