Renevia, our lead facial aesthetics product candidate, is being developed as a potential treatment for facial lipoatrophy. “Lipoatrophy” means the loss of fat tissue which may be caused by several factors, including trauma, aging or drug side effects such as those that cause human immunodeficiency virus (HIV) treatment-associated lipoatrophy. As a potential alternative to traditional fat transfer procedures, Renevia is designed to mimic the naturally-occurring extracellular matrix in the body and provide a 3-D scaffold that supports effective cell transplant, retention, engraftment and metabolic support. Renevia is being developed with the goal of providing a natural looking and feeling, long-lasting option for facial volume restoration.
In 2017, Renevia met the primary endpoint of implanted volume retention in a pivotal clinical trial in Europe to assess its safety and effectiveness in restoring facial volume in patients whose subcutaneous fat, or adipose tissue, has been lost due to a side effect of certain drugs used to treat some patients with HIV. The 50-patient, HIV-Associated lipoatrophy study reported:
- Increase in hemifacial volume as measured by 3D image scan at 6 months
- No device or procedural-related serious adverse events reported
In March 2018 we filed for marketing authorization in the European Union (EU) for certain forms of facial lipoatrophy. We anticipate feedback from the regulatory agency in 2019. If approved, we intend to identify an external partner for commercialization of Renevia in Europe.