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 September 2019, Renevia received a Class III classification with an intended use in adults as a resorbable matrix for the delivery of autologous adipose tissue preparations to restore and/or augment facial volume after subcutaneous fat volume loss for the treatment of facial lipoatrophy. The CE Mark provides Lineage, or its authorized agent, the authority to market and distribute Renevia throughout the European Union (EU) and in other countries that recognize the CE Mark.
Lineage has engaged Sercader Ltd., a European based, life sciences advisory firm, to identify an external commercialization partner with the capabilities and infrastructure to launch and further develop Renevia in the European market.