GALDERMA
22.1.2024 07:01:31 CET | Business Wire | Press release
Galderma, the emerging pure-play dermatology category leader, announced today it has received approval from Health Canada for Restylane® SHAYPE™, a hyaluronic acid (HA) injectable designed for temporary augmentation of the chin region.2 Engineered to build and shape on bone with deep injection for a bone-mimicking effect,1,2,3,4† Restylane® SHAYPE™ will be available in Canada as of February 2024.
The chin is a critical component of overall appearance that influences the balance of facial proportions, profile, and shape.5,6,7,8 Genetics and age can impact overall chin definition,6,9 which may cause the appearance of a double chin, or “weak chin.” For decades, there has been heavy reliance on implants to create structure in the lower face, with no non-surgical options available offering qualities close to an implant.
Powered by new NASHA HD™ technology from Galderma,4 Restylane® SHAYPE™ has the highest G’ (“G prime”) of the Restylane® range.1,11 The firmest HA gel available on the market,1,2* Restylane® SHAYPE™ allows aesthetic injectors to shape, project and elongate the chin2,3 for natural-looking results from any angle.3‡ As a minimally modified and particularly firm HA gel,10 Restylane® SHAYPE™ is the injectable closest to the HA naturally found in skin10 and can be readily reversed.2,12,13
“Restylane® SHAYPE™ is the next generation in HA, going beyond currently available options for chin augmentation. Developed with leading experts, this innovative breakthrough has a unique ability to create the strength and support needed for a bone-mimicking effect. This makes Restylane® SHAYPE™ an ideal choice for lower face shaping, offering durable, natural-looking results for up to 12 months without retreatment.”
BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA
In a pivotal 12-month study conducted at nine sites across Canada, 91% of patients agreed they still had aesthetic improvements at 12 months, and 84% of patients would agree to be treated with Restylane® SHAYPE™ again. Furthermore, up to 97% of patients would recommend treatment with Restylane® SHAYPE™ to a friend and 95% of patients felt their results looked natural.3
“A product with a significant ability to create a bone-mimicking effect without the downtime of surgery has long been an unmet need, highlighted by the community of plastic surgeons, dermatologists, and aesthetic injectors all over the world. The development of the ideal gel required a significant increase in firmness to create the strength and support needed to shape the lower face. Now, through meticulous clinical evaluation, Galderma has achieved the development of a safe and effective HA injectable for chin remodeling.”
DR. ANDREAS NIKOLIS, M.D., Ph.D., FRCSC, BOARD-CERTIFIED PLASTIC SURGEON
PRINCIPAL INVESTIGATOR, RESTYLANE® SHAYPE™ PIVOTAL STUDY
MONTREAL, CANADA
Other regulatory reviews around the world are ongoing, and Galderma is working to bring this latest innovation to as many countries as possible.
About Galderma’s RESTYLANE® portfolio
RESTYLANE® is produced using the NASHA HD™ technology and is the original hyaluronic acid filler, with over 27 years of clinical experience and over 65 million treatments worldwide. NASHA® and OBT™ are complementary technologies that make RESTYLANE® the world’s most diverse range of fillers, for any and every look.
About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.
References |
1 Galderma. Data on file. MA-56724. 2023. Global rheology data (xStrain and G' including Restylane® SHAYPE™). |
2 Restylane® SHAYPE™ IFU. IFU-0103. August 2023. |
3 Galderma. Data on file. MA-53870. 2023. Restylane® SHAYPE™ 43BBJ2001 Clinical Study Report. |
4 Galderma. Data on file. MA-56848. 2023. Technical data for Restylane® SHAYPE™. |
5 Braz A, Eduardo CCP. Indian J Plast Surg. 2020;53(2):207–18. |
6 Schmid PM. Advances in Cosmetic Surgery. 2019;2(1):11–21. |
7 Gewargis J, Swaminathan V. J Aesthet Nurse; 2021:10(8);1–9. |
8 Galderma. Data on file. 2022. AART Methodology Comprehensive Training Deck. |
9 Sykes JM, Fitzgerald R. Facial Plast Surg. 2016;32(5):507–12. |
10 Galderma. Data on file. MA-58650. 2023. Degree of modification of HA fillers. |
11 Galderma. Data on file. MA-34483. 2023. xStrain and G' (US). |
12 Paap MK, Silkiss RZ. Plast Aesthet Res. 2020;7:36. |
13 Jung H. Arch Plast Surg. 2020;47(4):297–300. |
† The highest G' of the Restylane® range, a deep (supraperiosteal) injection depth and indication for chin augmentation together mean Restylane® SHAYPE™ can achieve a bone-mimicking effect. |
‡ Patients could receive a touch-up at Month 1. |
* Based on the products marketed in Canada as of December 2023. |
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240121172418/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
PMCOrganometallix Announces Price Increase on All Products24.4.2026 22:55:00 CEST | Press release
Due to significant changes in market conditions, PMC Organometallix, Inc. announces that effective May 1, 2026, or as contracts permit, prices across all product lines globally will increase by 10-25%. This adjustment is driven by sustained cost pressures from key inputs including rising raw material costs and escalating freight and logistics expenses. While the company has been absorbing these increases, the current economic environment brought on by the geopolitical crisis of the Iran conflict requires this adjustment to continue providing the high-quality, consistent materials and supply reliability that customers expect. PMC Organometallix will implement these changes in a transparent, collaborative manner and values your partnership while navigating these economic challenges. Customers with questions or to discuss a specific situation should contact their account representative. About PMC Group PMC Group is a growth-oriented, diversified, global chemicals and plastics company deli
Frankfurt Higher Regional Court upholds BESREMi® arbitral award in favor of AOP Health24.4.2026 18:52:00 CEST | Press release
Today, the Higher Regional Court of Frankfurt upheld the February 20251 partial final ICC arbitral award in favor of AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in its dispute with PharmaEssentia Corp. (“PharmaEssentia”). The ruling confirms the award which found the Taiwanese company to be liable for certain damages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424005227/en/ Portrait Dr. Rudolf Widmann, Founder AOP Health Credit: AOP Health/Daniel Ospelt Dr. Rudolf Widmann, one of the two founders of AOP Health, explains: “We very much welcome the Frankfurt Higher Regional Court’s decision that confirms our position. In the interest of our patients, we are dedicated to maintaining stable and sustainable access to BESREMi® and to responsibly navigating future challenges.” The Product in Dispute The conflict centers around BESREMi® (ropeginterferon alfa-2b), a product launched in 2019 and developed by AOP Health into
Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher24.4.2026 16:37:00 CEST | Press release
Compass is the most advanced company in classic psychedelics and has generated positive data from two ongoing large, well controlled Phase 3 clinical trials, designed to uphold the highest regulatory standardsFDA grants Compass NDA rolling submission and review request, based on Phase 3 dataCNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin, for treatment-resistant depression (TRD)CNPV further accelerates momentum and Compass is confident and ready to deliver for patients Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be en
Banma Intelligence and Alipay Launch AI Cockpit Solution Powered by Alipay AI Pay, Enabling Seamless and Secure In-Car Transactions by Voice24.4.2026 16:04:00 CEST | Press release
At the 2026 Beijing International Automotive Exhibition (“Auto China 2026”), OS and AI technology company Banma Intelligence and Alipay today launched a new AI cockpit solution integrating Alipay AI Pay, enabling drivers to complete purchases by voice command directly from their vehicle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260424618328/en/ Industry-first AI Cockpit Solution with Alipay AI Pay Unveiled “In the past two years, smart cockpits have achieved rapid advances in perception and decision-making,” said Ming Cai, Banma Intelligence Chief Product Officer. “With large models onboard, vehicles can understand user intent and make recommendations. By integrating Alipay AI Pay into our AI cockpit solution, we are removing the last friction point in the in-car smart cockpit experience - drivers simply speak to pay, no phone required.” The new AI cockpit solution initially covers two high-frequency use cases: enterta
Spatial Announces the Release 2026 1.0.1: New Enhancements Across 3D InterOp, Data Prep, Meshing, and 3D Modeling SDKs24.4.2026 15:21:00 CEST | Press release
Spatial Corp., the leading software development kit provider for design, manufacturing and engineering solutions and a subsidiary of Dassault Systèmes, today announced new enhancements across several of its product lines. These updates further strengthen Spatial’s commitment to delivering high-performance solutions that optimize interoperability, data preparation, and advanced modeling workflows. Designed to improve efficiency and robustness across CAD translation, modeling, meshing, and simulation processes, the latest updates introduce expanded format support, enhanced PMI handling, and new capabilities for complex geometry processing. 3D InterOp NX Reader Enhancement for 2D Drawings The NX reader imports 2D drawings as visualization data from NX 2412 and later versions. glTF Writer Supports Draco Compression glTF export incorporates Draco compression for meshes and point-clouds to significantly reduce output file sizes. Enhanced Support for Reading Product Manufacturing Information
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom