Lineage Cell Therapeutics Receives CE Mark Approval for Renevia

Lineage Cell Therapeutic’s comparative clinical trial met its primary endpoint of change in hemifacial volume at six months (p<.001), which enabled its facial aesthetics product Renevia, a Conformite Europeanne Mark.

CARLSBAD, Calif.–(BUSINESS WIRE)–$LCTX #LineageCell—Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), 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.”

“Renevia, in combination with autologous adipose tissue, offers a new small-volume treatment for facial lipoatrophy,” Mr. Culley continued. “In Renevia’s pivotal trial in Europe, Lineage studied patients with human immunodeficiency virus (HIV) treatment-associated lipoatrophy, a severe form of lipoatrophy characterized by the pathological loss of body fat from under the skin. Renevia is designed to mimic the naturally occurring extracellular matrix in the body and provide a 3-D scaffold, which we believe supports effective adipose tissue transplant, retention, engraftment, and metabolic support. Renevia and Lineage’s other HyStem-associated hydrogel injectable matrices are designed to facilitate the survival and growth of transplanted cells. Data from the pivotal trial suggest that Renevia may be a stable long-term solution not only for people with HIV-associated lipoatrophy, but also for people with other forms of facial fat loss, such as those caused by pharmaceuticals or aging. Additionally, Renevia may be able to serve as a premium alternative to currently available dermal fillers, which we believe account for more than a million procedures each year in the European facial aesthetics market. Use of Renevia and autologous adipose tissue may have the potential to create a better, longer-lasting, and more natural outcome than other fillers used alone.”

As Lineage proceeds with its efforts to evaluate and negotiate partnership opportunities for Renevia, it expects to provide investors with additional information regarding commercial plans for the program.