Our Commitment to Microtia
Developing life-like, life-long solutions for children and families facing the challenges of microtia
Our therapeutic ear replacement, AUR-201, is designed to replace missing, damaged, or partially-formed ears for people with microtia and is currently in clinical trials; AUR-201 received Rare Pediatric Disease Designation (RPDD) and Orphan Disease Designation (ODD) by the FDA in March 2019.
The Challenges of Microtia
Microtia is an ultra-rare condition where the ear is small, or not fully formed—even completely missing—causing hearing loss for many people. It occurs in approximately 800 infants every year in the US, which is over 6 infants for every 100,000 live births. Microtia can result in serious, life-long physical, psychological, and emotional challenges, especially during childhood.
Current Microtia Care
Existing treatments for microtia can involve repeat surgeries and result in negative outcomes which may not be reversible.
- Rib Carving – A multistage surgery that could cause scarring, damage to the chest wall, and can fail.
- Polymer Implant – May not look natural and/or could cause immune responses; can break or fail.
AUR-201: Exploring a New Approach to Microtia
AUR-201 is an ear built from a patient's own cells and is designed to look and feel like a natural, human ear. For people with microtia, AUR-201 takes the place of a missing, damaged, or incomplete ear.
Designed Like Nature
AUR-201 is built from a patient's own cells to look and feel like a real ear. It can even grow collagen once it's placed, just like in nature.
Shape, Angle, and Location
AUR-201 is customized to look and feel human, mirroring the ear's complex shape; when placed, its collagen form allows it to be placed at the best angle, in the right location on the head.
Because AUR-201 is built from a patient's own cells, there is less potential for the body to reject it.
How is AUR-201 Made?
Decades of research have allowed us to better understand how our cells function—and how they may be used to create lost or missing parts of our bodies. We begin by taking a sample of a person's own cells, and using special processes to guide their growth, we use bioprinters to create the shape of an ear that is biologically and functionally similar to a natural ear. Over a period of time, the cells grow to form a life-like ear, which is then implanted by an experienced surgeon.
Is the AUR-201 Clinical Trial for Me or My Child?
For children and families facing the challenges of microtia, participating in the AUR-201 may be an option. To learn more about eligibility criteria required for participation, visit ClinicalTrials.gov, talk to your healthcare professional, or contact us.
We are actively developing clinical trial sites and clinical partnerships with leading physicians including those with specialties in ENT, plastic surgery, craniofacial surgery, OB/GYN, pediatrics, and other areas of focus.
At Auregen, we intend to change the way serious conditions are addressed through human tissue origination. We believe our first product, AUR-201, has the potential to transform microtia treatment, with potential follow-on indications in other vital therapeutic spaces. To help develop a clinical trial site, become a clinical trial investigator, or to learn more about our approach, please contact Auregen medical information.