First Insights on the Upcoming Role of Next-Generation PLLA-LASYNPRO in Aesthetic and Regenerative Medicine: A Survey of Experts—the PLLA-LASYNPRO Rationale

Introduction: Injectable collagen stimulators have traditionally been linked to inflammatory foreign-body reactions (FBR) as a mechanism of action. However, the next-generation PLLA-LASYNPRO microspheres, contained in the CE-marked JULÄINE medical device, may represent a paradigm shift. Preclinical data suggest these microspheres can promote collagen and extracellular matrix (ECM) regeneration with minimal inflammatory response. Objectives and Hypotheses: This study aimed to evaluate the scientific soundness and clinical relevance of a non-inflammatory mechanism of action for PLLA-LASYNPRO. The central hypothesis was that design and manufacturing innovations could enable effective biostimulation while reducing inflammation and long-term tissue reactions. Study Design: A structured expert board meeting was convened to assess the rationale and implications of this emerging mechanism. The process included a preliminary survey and an in-person consensus meeting involving multidisciplinary specialists in aesthetic and regenerative medicine. Methods: On January 24, 2025, 13 experts in aesthetic medicine, dermatology, and plastic surgery participated in a board meeting held in Milan, Italy. Scientific literature and preclinical data were reviewed in advance. Discussions were organized around biophysical characteristics, tissue integration, inflammatory profile, and safety considerations. Results: The board considered the non-inflammatory mechanism of PLLA-LASYNPRO both biologically plausible and clinically promising. Key differentiating features included particle morphology, lack of excipients, and manufacturing purity. The panel highlighted the potential to reduce chronic inflammation, a known limitation of traditional collagen stimulators. Early clinical impressions supported this hypothesis, although prospective data are still forthcoming. Conclusion: This manuscript presents the consensus of a multidisciplinary board on the rationale for PLLA-LASYNPRO in aesthetic and regenerative medicine. It forms the first part of a two-paper series. The second manuscript will provide practical clinical guidance for the deep dermal administration of PLLA-LASYNPRO and real-world use of JULÄINE.