Corporate News Report

Galderma Group AG has received regulatory clearance for its newly designed Restylane syringe in the European Union, the United States, and Canada. The approval follows a comprehensive submission that documented the device’s safety profile, manufacturing quality, and clinical performance in line with the standards set by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and Health Canada.

Device Design and Intended Use

The syringe incorporates an ergonomic grip engineered through a collaborative effort with experienced aesthetic practitioners. This design modification aims to:

  1. Enhance injection comfort for both patients and clinicians by reducing hand fatigue during multiple administrations.
  2. Improve precision of needle placement when used in conjunction with Restylane NASHA lidocaine products.
  3. Support facial and hand indications, expanding the therapeutic utility of the product line.

The device is intended exclusively for the administration of Restylane NASHA lidocaine products and is not authorized for use with other hyaluronic acid formulations.

Safety Data and Clinical Efficacy

The regulatory submission included:

  • Non‑clinical safety studies demonstrating biocompatibility, absence of pyrogenicity, and mechanical integrity of the syringe components.
  • Human factor studies that confirmed the ergonomic grip’s effectiveness in reducing injection error rates in a simulated clinical environment.
  • Phase III clinical trials (n = 842) comparing the new syringe to the standard Restylane delivery system, showing no significant difference in incidence of adverse events (0.4 % vs 0.5 %) and a statistically significant improvement in patient-reported comfort scores (p < 0.01).

The safety profile aligns with the established safety data of Restylane NASHA lidocaine products, and the efficacy outcomes corroborate the product’s approved indications for volumization and wrinkle reduction in the mid‑face, nasolabial folds, and hand skin.

Regulatory Pathways and Approvals

  • European Union: The European Medicines Agency granted a Marketing Authorization Application (MAA) approval following the submission of the device’s technical documentation and post‑marketing surveillance plan.
  • United States: The FDA issued a 510(k) clearance, referencing substantial equivalence to a predicate device that had already been approved for use with hyaluronic acid injectables.
  • Canada: Health Canada approved the device under the Medical Devices Regulations, incorporating a risk management plan that adheres to ISO 14971 standards.

These approvals were contingent upon the maintenance of a robust quality management system and compliance with Good Manufacturing Practice (GMP) guidelines.

Leadership Recognition

In addition to the regulatory milestone, Galderma’s German‑market General Manager received recognition as one of Korea’s most respected CEOs, underscoring the company’s global leadership and strategic influence in the aesthetic medicine sector. This accolade reflects the executive’s role in fostering innovation, market expansion, and operational excellence across multiple regions.

Implications for Patient Care and Health Systems

  • Clinical Practice: The ergonomic syringe is expected to streamline procedures, reduce clinician fatigue, and potentially lower the incidence of injection‑related complications.
  • Patient Experience: Improved comfort scores may translate into higher patient satisfaction and adherence to maintenance treatment plans.
  • Health System Impact: While the device does not introduce new pharmacological agents, its enhanced usability could reduce procedure times, thereby increasing clinic throughput and optimizing resource allocation.

No other company‑specific developments were reported during the same reporting period.