Lineage Cell Therapeutics Receives CE Mark Approval for Renevia®
Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that Renevia®, the Company’s facial aesthetics product, has been granted a Conformité Européenne (CE) Mark. 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.
"Obtaining CE Mark approval for Renevia is an important corporate accomplishment that demonstrates Lineage’s ability to generate positive data from clinical trials and direct a regulatory application through a successful review and registration process. I wish to congratulate our clinical/regulatory and technical operations teams on achieving this milestone,” stated Brian M. Culley, Chief Executive Officer. “As a next step, our Board of Directors has authorized us to engage a European business development representative to evaluate and negotiate partnership opportunities for Renevia. In light of our focus on advancing our three clinical-stage cell therapy programs, we believe it is in the best interests of our shareholders to seek an external partner with the commercial capabilities and know-how to launch Renevia in the European market and in return, provide Lineage with non-dilutive capital to support our novel cell therapy programs. We also will continue to invite and explore development and partnership opportunities for Renevia’s underlying hydrogel technology, HyStem®, which may hold potential as a supportive scaffold for cell therapy, including patient-derived organoid culture and bioprinting of new organs.”