Gaps and Needs

While there have been several successes in IVR products, their widespread adoption has been limited by key gaps and needs in creating truly ‘better’ products.

• Molecule compatibility – To create a successful IVR product using traditional extrusion or injection molding technologies, molecules must be able to withstand the heat and pressure of the manufacturing process. Additionally, the molecule must remain stable within the ring over a period of months to years. As a result, IVRs have historically been limited to highly stable small molecules.
• Limited control over release rates – Traditional IVR technologies rely on the diffusion of the API out of the ring. The rate of diffusion is driven by the chemical and physical properties of the API and ring material, and modification of the release rate is primarily limited to use of a core reservoir rings with added manufacturing complexity or overloading the ring with the API.
• Under utilization of APIs – Relying primarily on diffusion generally leads to 80-90% of API remaining in the ring post use. This can limit the utility of traditional IVRs for expensive or hard-to-make therapeutics, as well as have unintended environment or safety concerns depending on the molecule.

The AnelleO technology utilizes 3D printing and our design-performance evaluation-manufacturing methodology to address those limitations and broaden the landscape of IVR-based therapies.

IVRs with Complex Geometries

We have demonstrated that we can make IVRs with complex geometries which offer precise and tunable control over drug release kinetics. This tunable control also impacts the total amount of drug released, with the AnelleO PRO releasing > 90% of the total drug loading in the target time frame. The AnelleO technology is also compatible across a range of small and large molecules including biologics. Through our proprietary understanding of individual design parameters’ impact on release criteria, AnelleO can match IVRs from our library to target molecules to create the optimum delivery platform.

Such devices will be of great benefit in our first indication, ART, since this delivery route, once optimized, will be shown to

Through our relationship with Carbon, Inc., AnelleO uses a state-of-the-art 3D printing technology, utilizing digital light synthesis (DLS) – a novel 3D printing process (CLIP™) – for rapid, cost-effective manufacturing of geometrically variable (design, surface area, size) intravaginal rings as platforms for drug delivery.

Design and manufacturing

To create a commercializable platform for the design and manufacturing of IVR-base therapies, several key criteria must be realized. 

1. The final product must meet the unique requirements of a given indication and molecule e.g. 8-12 weeks of progesterone delivery for ART
2. Design-performance evaluation must objectively link product properties to decisive, quantitative measures of pharmacological success;
3. Such design and performance evaluation must also account for user perceptions and preferences; and
4. Product manufacturing must be cost effective at scale-up, and enable good manufacturing process control

The AnelleO technology allows us to meet each of those requirements, creating a novel platform for Women’s Health products.

Patented Technology

Intellectual property position: AnelleO IVR technology is covered by an expanding Intellectual Property portfolio, including license rights to IP generated at the University of North Carolina at Chapel Hill.