Press

PRESS RELEASES

March 4, 2024

Hugel Receives FDA Approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for Injection for the Treatment of Glabellar Lines

Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (FDA) approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown)
lines in adults.

November 28, 2022

Croma Australia Pty Ltd, a subsidiary of Hugel Aesthetics, Receives TGA Approval in Australia for LETYBO (letibotulinumtoxinA) for the Treatment of Glabellar Lines

Hugel Aesthetics announced it received Therapeutic Goods Administration (TGA) approval for LETYBO (letibotulinumtoxinA) to treat moderate-to-severe glabellar (frown) lines in adults.

October 25, 2022

Hugel Aesthetics Receives FDA Acceptance of BLA Resubmission for LetibotulinumtoxinA for Injection for Glabellar Lines

Hugel Aesthetics announced the acceptance of its Biologics License Application for letibotulinumtoxinA, by the U.S. Food and Drug Administration (“FDA”).

October 6, 2022

Hugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA

Hugel Aesthetics announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for letibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.

October 5, 2022

Hugel Aesthetics to Present Data from Phase 3 Clinical Trial At 2022 American Society of Dermatologic Surgery Annual Meeting

Hugel Aesthetics announced a presentation at the ASDS annual meeting highlighting data from its phase 3 clinical trial, BLESS III, assessing the efficacy of letibotulinumtoxinA in improving the psychosocial health-related QoL of subjects with moderate to severe glabellar lines.

July 27, 2022

New Published Data Supports the Safety and Efficacy of LetibotulinumtoxinA for the Treatment of Glabellar Lines Hugel Aesthetics announces the publication of the BLESS

III clinical trial in the Aesthetic Surgery Journal. The published data comes as Hugel is accelerating its efforts towards becoming a leading global medical aesthetics company.

June 23, 2022

Croma Aesthetics Canada Ltd. Receives Canadian Market Authorization for Letybo (LetibotulinumtoxinA for Injection) for the Treatment of Glabellar Lines

Croma Aesthetics Canada Ltd., doing business as Hugel Aesthetics, today announced it received a Notice of Compliance from Health Canada for Letybo (letibotulinumtoxinA for injection) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity (frown lines between the eyebrows) in adult patients under 65 years of age.

May 24, 2022

Global Aesthetics Brand Hugel Inc. Accelerates the Leap Forward as a Global Company Appointing ‘Brent Saunders’, a World-Class Expert in the Medical Aesthetic Industry

Hugel Inc. announced to convene an extraordinary general shareholders’ meeting to appoint Brent Saunders to the Board as a non-executive director.

January 27, 2022

Hugel America, Inc. Announces Successful Completion of Croma-Pharma’s Decentralized Procedure for Letybo® (LetibotulinumtoxinA for Injection) in Europe

Hugel America, Inc., a growth-focused joint venture between aesthetic market-leading partners Hugel Inc., and Croma-Pharma GmbH (Croma), announced that Croma has completed the decentralized procedure in Europe for Letybo® (LetibotulinumtoxinA for Injection) to treat glabellar (frown) lines.