Business Wire

GALDERMA

22.1.2024 07:01:31 CET | Business Wire | Press release

Share
Galderma Announces Regulatory Approval for Restylane® SHAYPE™, a New Hyaluronic Acid Injectable Designed for Augmenting the Chin Region

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

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Vultr, SUSE & Supermicro Debut Unified Cloud-to-Edge Architecture for Global AI Scaling6.5.2026 14:00:00 CEST | Press release

The strategic partnership bridges the gap between regional cloud and the far edge, combining ruggedized hardware and GitOps-driven Kubernetes to streamline large-scale AI deployments Vultr, the world's largest privately-held cloud infrastructure company, in collaboration with SUSE and Supermicro, today announces a strategic architectural framework designed to solve the complexities of deploying and operating AI workloads across distributed environments. As AI moves closer to the point of data creation - from manufacturing floors to retail storefronts - organizations face significant challenges in latency, cost and operational consistency. This joint initiative provides a seamless, Cloud-to-Edge pipeline that integrates high-performance hardware, localized cloud infrastructure, and unified Kubernetes management. The partnership addresses the reality that sending all data back to a central cloud is no longer viable for real-time AI. The solution breaks down the infrastructure into three

Waiv Enters Collaboration with Daiichi Sankyo to Deliver AI-Derived Biomarkers for ADC Program6.5.2026 14:00:00 CEST | Press release

Waiv, formerly Owkin Dx, to leverage its digital pathology platform encompassing foundation models and AI methodology for ADC biomarker discovery program Waiv, formerly Owkin Dx, a Paris-based company catalyzing AI precision testing, today announced it has entered a collaboration with Daiichi Sankyo (TSE: 4568) to lead digital pathology biomarker discovery for an antibody-drug conjugate (ADC) program. With deep expertise across diverse pathology and multimodal data, and a global data network spanning academic institutions, hospitals, and laboratories, Waiv has a proven track record delivering AI-powered biomarker solutions across the full drug development lifecycle. Under the collaboration, Waiv will apply its end-to-end computational pathology platform to early phase data. This includes tumor microenvironment (TME) analysis across both hematoxylin and eosin (H&E) and immunohistochemistry (IHC) stained samples, as well as biomarker discovery and outcome prediction capabilities aimed at

Elisa Expands PON Deployment with Vecima’s All-PON™ Shelf, Delivering 10G Fiber Services in Estonia6.5.2026 13:30:00 CEST | Press release

Elisa plans to install Vecima’s EXS1610 All-PON shelf across its footprint in Estonia, building on its existing Vecima PON deployment16-port EXS1610 All-PON Shelf supports a variety of PON standards, including GPON, XGS-PON, and 10G-EPON Vecima Networks Inc. (TSX: VCM) announced today that leading telecommunications operator Elisa has deployed Vecima’s Entra EXS1610 All-PON™ Shelf for 10G Fiber-to-the-Home (FTTH) services for its subscribers in Estonia. In Estonia’s competitive broadband market, Elisa brings highly innovative solutions to its subscribers. Vecima’s EXS1610 supports multiple deployment use cases, including greenfield, targeted brownfields, rural edge-outs, hybrid fiber-coax (HFC) overbuilds, footprint extensions, and hub collapses. Its compact shelf footprint can help reduce operating costs and allow operators to deploy anywhere – for maximum flexibility, including data centers, remote cabinets, the headend, and multi-dwelling units. The Entra EXS1610 All-PON Shelf featu

Vertex Announces CASGEVY® Reimbursement Agreement for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia in Germany6.5.2026 13:01:00 CEST | Press release

-The agreement ensures sustainable access to this innovative therapy for eligible patients ages 12 years and older in Germany- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that a reimbursement agreement was signed with the GKV-Spitzenverband for its CRISPR/Cas9 gene-edited therapy, CASGEVY® (exagamglogene autotemcel). This agreement secures sustainable access to this innovative one-time treatment for eligible patients in Germany ages 12 years and older living with severe sickle cell disease or transfusion-dependent beta thalassemia. “For the first time in Germany, a long-term, sustainable access agreement to a gene therapy has been established for people living with sickle cell disease and transfusion-dependent beta thalassemia,” said Ludovic Fenaux, Senior Vice President, Vertex International. “This agreement represents significant progress for people living with these two devastating and life-shortening diseases. We are pleased to collaborate across the health c

Suzano Connects an Area the Size of Over 200,000 Soccer Fields Through Ecological Corridors in Just Four Years6.5.2026 13:00:00 CEST | Press release

Initiative integrates fragments of native forests in the Atlantic Forest, Cerrado and Amazon biomes, stimulating wildlife movement, the expansion of vegetation cover and the restoration of ecosystems Suzano, the world's largest pulp supplier, has connected 214,368 hectares of native forest in the Atlantic Forest, Cerrado, and Amazon biomes in Brazil by establishing ecological corridors, restoring an area larger than 200,000 soccer fields within four years. In 2025 alone, 55,366 hectares of native forest were connected, advancing Suzano’s public goal of connecting 500,000 hectares by 2030, as outlined in the Company’s recently published Sustainability Report. The implementation of ecological corridors is guided by decades of research and monitoring by Suzano and its partners. The aim is to connect larger fragments of land that host greater biodiversity, as well as those already monitored by experts, with sites where wildlife is limited or threatened. These corridors are designed to foll

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye