Scientifically speaking, women’s health is stuck in the 1980s. Treatments for infertility, for example, have seen little progress and innovation. Many women rely on painful, daily progesterone injections that must be administered by another person. However, change is on the horizon.
Rahima Benhabbour, PhD, a tenured associate professor of biomedical engineering at the Lampe Joint Department of Biomedical Engineering at NC State University and UNC-Chapel Hill and adjunct associate professor at the UNC Eshelman School of Pharmacy, is hoping to improve the future of women’s health by bringing a new 3D printed drug delivery system from the labs of University of North Carolina-Chapel Hill to the homes of women in need.
Growing up in Algeria, Benhabbour has deep ties to Africa that have inspired her to develop women-controlled prevention and empower women in sub-Saharan Africa, where HIV prevalence is high amongst women. Since starting her lab at Carolina in 2017, she has focused all of her research on inventing cost-effective drug delivery systems to help women across the world get better prevention or treatment, faster, and more comfortably.
“Women's health is an underserved area of research,” said Benhabbour. “My research has centered around women's health for three main reasons: empowerment, access, and choice. If we can get away from how women’s health was administrated traditionally, we can improve healthcare, prevention, and save the lives of many women.”
Benhabbour’s lab has investigated ultra-long-acting injectable formulations for HIV, thin film technology for the treatment of chronic pain in the vulva, and even biodegradable implants that can release multiple drugs at once. But one of her most successful feats is called AnelleO PRO, a 3D-printed, self-administered intravaginal ring that helps treat infertility.
The AnelleO PRO Device
With generous support from a KickStart Venture Services Commercialization Award, the Eshelman Institute for Innovation, and other entities at UNC, she was able to translate years of hard work into a real, tangible product. Benhabbour founded a startup, AnelleO, in 2016 alongside Rima Janusziewicz, PhD, an alumnus of the DeSimone lab (PhD, Analytical Chemistry, ‘17) and a former postdoctoral researcher in the Benhabbour lab.
Their premier product, AnelleO PRO, releases progesterone, a hormone important in beginning a pregnancy and maintaining it. A single ring delivers progesterone (PRO) over 28 days. Two or three rings can be used in conjunction with other drugs used in IVF and covers the entire treatment period required for assisted reproductive technology to be successful (8–10 weeks). Keeping in mind that every body is different and requires different needs, the rings have been developed as a “one-size-one-dose-fits-all” model.
In January, Benhabbour wrote about their 3D printed intravaginal rings and how it can be expanded in Nature Reviews Biomedical Engineering.
The ring is created through continuous liquid interface production (CLIP™), a 3D printing technology developed by Carbon and pioneered by the AnelleO team for women’s health. Unlike other 3D printing technologies that print layer by layer, CLIP uses liquid resin solidified through ultraviolet rays to print rings in high resolution. The 3D printer draws data from a computer to print the rings, including the product and indication-specific designs that are important in releasing the drug from the device.
Their CLIP manufactured designs stand out among current intravaginal rings on the market based on their sustained, controlled drug release and smooth, comfortable design.
“With an injection molded ring, the best you could achieve for infertility treatment is a week worth of release,” said Benhabbour. “With CLIP, we are able to overcome the limitations of traditional intravaginal drug delivery systems. AnelleO PRO puts out a months-worth of release, fits everyone, and can be easily administered and adhered to.”
The Future of AnelleO PRO
The AnelleO team is now focused on translating their technology to human clinical trials and gaining FDA approval. Because this is the first 3D printed intravaginal ring to come across the desk of the FDA, the team is working directly with regulatory experts to pave a new regulatory path and determine the required studies for regulation and approval.
Clinically-speaking, the toolbox for women’s health is incredibly small, often requiring women to seek out medications for off-label use. Using AnelleO PRO design as a framework, Benhabbour is interested in expanding beyond assisted reproductive technology to treat other conditions affecting women, including endometrial and cervical cancers and menopausal hormone replacement therapy.
In an editorial for the Journal of Controlled Release, Benhabbour highlighted how far technologies, like AnelleO PRO, have come and the collaborations needed to be formed to address unmet needs in women’s health.
“The road ahead is clear: researchers, clinicians, policymakers, philanthropic organizations, and industry stakeholders must work together to sustain and accelerate this momentum,” wrote Benhabbour. “With continued investment and interdisciplinary collaborations, we can move closer to a world where every woman has access to the healthcare she deserves, guided by science that is innovative, diverse, and inclusive to achieve bespoke and effective therapies.”
Technology Created by Women, for Women
Once you step inside of Innovate Carolina’s Kickstarter Incubator space in the Genome Science Building on UNC-Chapel Hill’s campus, you’ll notice that this lab is run predominantly by women. Janusziewicz, who oversees other research scientists in the group, says that the makeup of the group speaks to the passion for improving unmet needs in women's health.
“AnelleO's team, which is predominately female, but also has men in key roles, is a testament to the idea that addressing an unmet need is both a noble and fundable endeavor, regardless of gender,” said Janusziewicz. “The other key aspect of the team is that we have members at nearly every career level and stage, which allows for an organic transfer of knowledge, mentorship, and guidance.”
For Benhabbour, the most enjoyable and fulfilling part of her career is witnessing the enthusiasm with which her undergraduate and graduate students, postdoctoral fellows, and fellow scientists at AnelleO aspire to change the world.
“There's a strong community here at UNC of wonderful women who are working on pioneering technologies and research, and it is something to celebrate,” said Benhabbour. “Women’s health requires more women to actually work in this field, especially women in STEM that understand engineering, that understand the biology of women, that understand what women need.”