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

AV Access Presents eShare W90: A 4K Wireless Conferencing System for Smarter Hybrid Meetings at ISE 2026 in Barcelona28.1.2026 09:00:00 CET | Press release

AV Access proudly announces its participation in ISE 2026, one of the world’s leading AV and systems integration exhibitions. From February 3-6 at the Fira de Barcelona, Gran Via, the company will showcase its latest solutions designed to improve collaboration, enhance entertainment, and boost workplace productivity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128178621/en/ The eShare W90 wireless presentation and conferencing system makes hybrid meetings more secure, more collaborative, and far easier to manage. At Booth 1F110, AV Access will highlight its flagship innovations, including the eShare W90 wireless conferencing system, the plug-and-play 4KIP200 HDMI over IP solution, and the complete iDock series of KVM docking stations—demonstrating its dedication to versatile, high-performance AV technology. Stream, Charge and Share with a Single USB-C Cable At the heart of the booth is the eShare W90 wireless presentat

SES Extends EGNOS GEO-1 Satellite Service to Power Precise Navigation Across Europe28.1.2026 08:50:00 CET | Press release

The agreement ensures Europe’s satellite-based augmentation continues enhancing navigation for aviation and other critical users and lowering emissions SES, a leading space solutions company, and the European Union Agency for the Space Programme (EUSPA) today announced an extension of the European Geostationary Navigation Overlay Service (EGNOS) GEO-1 satellite service agreement through 2030, with an option to extend until 2032, helping maintain high-precision navigation services for aviation and other critical users across Europe. By improving the accuracy and integrity of satellite positioning signals, EGNOS supports aircraft in landing in low-visibility conditions, as well as planning more efficient routes, reducing fuel burn and CO₂ emissions. At the core of the EGNOS service is Europe’s regional Satellite-Based Augmentation System (SBAS) that improves the accuracy and reliability of Global Navigation Satellite System (GNSS) signals, such as GPS. Beyond aviation, EGNOS supports mar

LTTS Secures Strategic Engineering and R&D Agreement from Global Automotive OEM28.1.2026 08:30:00 CET | Press release

Key win in LTTS’ Mobility Segment across multiple vehicle technology domains L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & ER&D Consulting Services, announced that it has secured a significant multi-year engagement in its Mobility segment from a leading automotive OEM. The strategic win further strengthens LTTS’ long-standing partnership with the premium automotive manufacturer and underscores its growing role in supporting next-generation mobility engineering. The engagement encompasses advanced software, connectivity and digital engineering services across multiple vehicle technology domains. LTTS will draw on its global engineering expertise, strong domain knowledge and proven delivery frameworks to support the customer’s evolving product and technology roadmap. This win reinforces LTTS’ comprehensive mobility engineering capabilities, spanning embedded systems, digital platforms, verification and validation, cloud integration, cybersecurity, and

SFI Health™ EMEA Announces the Launch in Poland of Equazen® Forte, Marking a New Chapter in Cognitive Support for Young Adults and Adults28.1.2026 08:00:00 CET | Press release

Equazen® Forte represents a strategic evolution of the brand, extending its clinically researched omega-3 based cognitive support product formulation beyond children to young adults and adults through pharmacies across Poland. SFI Health™ EMEA, the regional entity of SFI Health™, a global leader in natural healthcare, today is pleased to announce the launch of Equazen® Forte in Poland, a new concentrated omega 3 product formulation to be added to the Equazen® range designed to support the normal cognitive performance for young adults and adults. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260127646023/en/ Equazen® Forte: a key milestone in the brand’s long-term development strategy. Equazen® Forte represents a key milestone in the brand’s long-term development strategy. Traditionally recognized as a pediatric brain health expert, Equazen® is now evolving to support consumers across different life stages, addressing changi

Fujirebio Expands Its Neuro Testing Portfolio With the Launch of the Fully Automated Lumipulse® G pTau 217 CSF Assay for Research Use Only28.1.2026 07:07:00 CET | Press release

H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 CSF assay for the fully automated LUMIPULSE® G immunoassay analyzers. This CLEIA (chemiluminescent enzyme immunoassay) assay is available for Research Use Only (RUO) and allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human cerebrospinal fluid (CSF) within just 35 minutes. Alzheimer’s disease (AD) is characterized by the accumulation of neurofibrillary tangles in the brain, composed of hyperphosphorylated tau, and amyloid plaques, consisting of distinct β-amyloid peptides. CSF pTau217 has emerged as an early biomarker for neuropathological changes associated with AD. This new immunoassay further strengthens Fujirebio’s growing portfolio of neurological biomarkers and reinforces the company’s leading position in the advancement of associated research tools and diagnostics. “By adding pTau 217 CSF to our neuro portfol

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