Bashar Bizrah, MD, FRCS, a facial plastic surgeon practicing in Dubai and London, has introduced a facelift technique in the MENA region that combines deep plane surgery with real-time nerve monitoring to enhance precision and patient safety.

At the core of the approach is the deep plane facelift, a method that targets not only the skin but also the deeper layers of facial structure, including muscles and connective tissue. According to Bizrah, this technique aims to deliver more natural and longer-lasting results compared to conventional facelifts, which often rely solely on skin tightening.

What distinguishes Bizrah’s facelift method is the use of facial nerve monitoring during surgery. The technology allows the surgical team to track nerve activity in real time, aiming to reduce the risk of nerve injury and allowing for immediate adjustments during the procedure. This, he says, helps maintain the patient’s natural facial expressions and minimizes complications.

“We don’t just create beauty—we protect human identity,” says Bizrah in a release. “A smile, a glance, a subtle expression—all are part of a person’s essence. It’s our responsibility as surgeons to preserve them with the utmost precision. This technology allows us to do just that.”

One patient who has undergone the updated facelift procedure described the results as exceeding expectations, noting a sharper jawline, tighter skin, and a more youthful appearance—all without visible signs of surgery, according to a release from Bizrah’s clinic.

Bizrah’s clinic reports that Bizrah has performed more than 45,000 facial plastic surgeries.

ID 358577856 © Anatolii Savitskii | Dreamstime.com

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GetHairMD won first place in the “Best in Show” award at The Aesthetic Innovation Summit held March 19 at the Austin Convention Center, recognizing the company’s approach to non-invasive hair restoration technology and business model.

The award was presented to GetHairMD CEO Paul Herchman by summit co-chairs Dr W. Grant Stevens, chairman of the board at Clarity Technologies and former president of The Aesthetics Society, and Philippe Schaison, CEO of SOLTÉGO, following Herchman’s presentation at the “Hair Restoration for Men & Women Showcase.”

GetHairMD is a clinically proven, non-invasive hair growth solution for patients that equips physicians with technologies and business models to enhance their practices.

“We’re honored to receive this recognition from leaders in the aesthetic industry,” says Herchman in a release. “This award validates our unique approach of partnering with top physicians nationwide to make advanced hair restoration accessible to the growing number of patients seeking results-driven solutions. What makes our model powerful is the territorial exclusivity we provide our physician partners, ensuring they become the go-to destination for hair restoration in their communities.”

The award comes at a time when hair loss solutions are increasingly in demand. Studies show that between 33% and 50% of women experience hair loss at some point in their lives, often with significant emotional and psychological impacts.

During the award presentation, Stevens noted that GetHairMD “exemplifies the innovation we aim to celebrate at this summit. Their multi-modality approach to hair restoration and unique business model represent the future of aesthetic medicine—combining state-of-the-art technology with physician expertise to deliver superior patient outcomes,” according to a release from GetHairMD

The GetHairMD Difference

GetHairMD consists of a territorial exclusivity model. This model provides partner physicians with a protected market area where they are the exclusive providers of GetHairMD solutions. 

“Our physician partners appreciate that when they join the GetHairMD network, they’re not just adding a service—they’re securing an exclusive offering that differentiates their practice,” says Herchman in a release. “This exclusivity, combined with our 90% success rate in treating various forms of hair loss, makes GetHairMD a powerful addition to aesthetic and medical practices nationwide.”

The company’s multimodality approach includes personalized treatment plans that may incorporate laser therapy, prescription topicals, TransDermal Infusion technology, and at-home products, all supervised by board-certified physicians.

Photo caption: GetHairMD CEO Paul Herchman presented with the Best in Show award.

Photo credit: GetHairMD

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The hair restoration practice of board-certified plastic surgeon Jeffrey Epstein, MD, FACS, FISHRS, has been rebranded as Foundation Aesthetic Hair Restoration, coinciding with the official launch of the Foundation Aesthetic Hair Restoration Method by Dr. J. Epstein. This method will be introduced across several practices within the Inspire Aesthetics Group, a management services organization (MSO) supporting plastic surgery and aesthetic clinics.

Practice Locations and Providers

The Foundation method will initially be offered at the following locations:

• Inspire Aesthetics (Delray Beach and Fort Lauderdale, Fla) – Dr Daniel Crane
• Garramone Plastic Surgery (Fort Myers, Fla) – Dr Ralph Garramone and Dr Nick Garcia
• Marietta Plastic Surgery (Woodstock and Marietta, Ga) – Dr Atanu Biswas
• McCollough Plastic Surgery (Gulf Shores, Ala) – Dr Carrie L. Morris

The rollout is expected to continue at additional locations across the United States.

Strategic Integration Within MSO

Chanda Fulgium, CEO of Inspire Aesthetics Group, stated the move is part of a broader strategy to diversify service offerings across affiliated practices and attract a wider patient demographic, including more male patients. The group anticipates that providing hair restoration services will offer both clinical and business growth opportunities.

Training and Technique

The method, developed by Epstein includes techniques such as No-Shave FUE, body hair transplantation, and specialized procedures for female patients. Surgeons offering the service are board-certified and hand-selected by Epstein. Training focuses on advanced aesthetic outcomes, minimally invasive techniques, and personalized treatment planning.

Background on the Method

Epstein, a facial plastic surgeon with decades of experience in hair restoration, designed the Foundation method to emphasize individualized care, natural-looking outcomes, and continuity in surgical excellence. The approach is intended to standardize quality and expand access to high-level hair restoration services across a network of qualified providers.

Photo: ID 355712512 | Ai © Tatsiana Kuryanovich | Dreamstime.com

With the entry of Letybo (letibotulinumtoxinA), from Hugel Aesthetics, into the U.S. aesthetic market, physicians and patients alike are beginning to evaluate how this botulinum toxin, which received FDA approval last year, stacks up against long-established brands. Plastic Surgery Practice spoke with Donald Yoo, MD, a double board certified facial plastic surgeon based in Beverly Hills, Calif, about his clinical experience with the product. Yoo also discusses Persana, a tech platform aimed at streamlining access to injectables by simplifying ordering, inventory management, and patient engagement. Having gained significant traction in Asia and Europe, Letybo now faces the challenge of earning trust in a brand-saturated American market.

Plastic Surgery Practice: Letybo is being positioned as a high-purity, smooth-diffusing botulinum toxin with long-lasting results. Based on your expertise and experience, how does it compare to established brands in terms of efficacy and patient outcomes?

Donald Yoo, MD: Letybo has been the number one neuromodulator in the Korean cosmetic market for the past 7 years, and has sold over 26 million vials in Asia, Europe, and Australia, and during that time has demonstrated an outstanding safety profile. Its positioning as a high-purity, smooth-diffusing botulinum toxin aligns with clinical observations of a natural, soft finish. In my experience, it performs on par with more established neurotoxins in terms of duration—around 3 to 4 months. Onset appears slightly quicker than Botox, with observable effects within a few days rather than the one-to-two-week timeline with Botox. This is in line with competitors such as Dysport.

PSP: With Letybo’s growing presence in Europe and China, but relatively low awareness in the United States, what challenges and opportunities do you see for its adoption in the American aesthetic market?

Yoo: The U.S. neuromodulator market is extremely competitive and heavily brand-driven, so Letybo’s biggest challenge will be building trust, name-recognition and awareness among both providers and patients. However, the opportunity lies in its already established and continually growing international credibility—especially in markets like Korea and Asia, where innovation in aesthetics is often ahead of the curve. If supported by solid clinical data, transparent education, and competitive pricing, Letybo could become a strong alternative for providers seeking to diversify or optimize results.

PSP: Every botulinum toxin has unique properties that influence how it spreads, how quickly it takes effect, and how long it lasts. Have you observed any distinct differences with Letybo that could make it particularly suited—or unsuited—for certain patient needs?

Yoo: Yes. Every neurotoxin has its own diffusion profile and onset characteristics due to the differential accessory proteins they carry surrounding the botulinum core protein they all share in common. Letybo seems to diffuse smoothly and evenly, making it well-suited for fine-line work or areas where precision and subtlety matter, like the forehead or crow’s feet. In the three FDA clinical trials it underwent with over 1200 patients, it showed itself to be just as effective as Botox for the glabella or frown lines. Due to its effectiveness and outstanding safety profile it certainly earns its place in a well-rounded injectable portfolio. Some patients who have developed Botox resistance or developed neutralizing antibodies to other neuromodulators may benefit from trying a slightly different formulation like Letybo.

PSP: Pricing and accessibility often play a role in product adoption. Given the rise of platforms like Persana that are streamlining access to injectables, how do you see tech-driven beauty services influencing the neurotoxin landscape? 

Yoo: As a Persana-verified physician, I’ve seen firsthand how innovative tech platforms like Persana are transforming the industry by making access to injectables more seamless. By streamlining ordering, optimizing inventory management, and enhancing patient engagement, these platforms reduce friction and empower providers to deliver more efficient, accessible care.

PSP: Many patients are brand loyal when it comes to injectables. What would you say to doctors who are hesitant to add a new option to their offerings? Are there any specific cases where you might recommend it over other options?

Yoo: Skepticism is natural, especially in a market where patient trust and outcomes are everything. That said, innovation always starts with curiosity and careful observation. I’d encourage providers to try Letybo in controlled, low-risk cases—perhaps with patients seeking a softer or more natural aesthetic, or cases of Botox resistance—and compare results firsthand. The more options we have, the better we can personalize care. In some cases, Letybo may offer a better fit for a patient’s goals, and being able to offer that option is a strength, not a risk. PSP

Main image photo credit: ID 182830119 © Viacheslav Iacobchuk | Dreamstime.com

Shanghai Moyom Biotechnology has obtained a Class III Medical Device Certificate from the China National Medical Products Administration (NMPA 20253130390) for its Aphranel MagiCCrystal CaHA filler.

The company says this makes it the first calcium hydroxylapatite microsphere (CaHA) injectable product approved in China for facial soft tissue augmentation. CaHA microspheres have become a core material in the global biostimulating injection field due to their biocompatibility and biodegradability, the company notes in a release. 

Leveraging proprietary technology, Moyom has controlled CaHA microsphere size (30-35μm), through-hole structure, and degradation rate to develop the Aphranel MagiCCrystal CaHA filler. “Its raspberry-like through-hole design increases porosity by 40%, with the number of microspheres per unit volume exceeding six times that of competing product. The viscoelastic modulus (G’ value) reaches 5500Pa, enabling long-lasting 3D supporting effect,” according to a release from the company.

The product employs a pre-mixing technology combining CaHA and carboxymethyl cellulose to ensure uniform particle suspension and a smoother injection push force. Validated by 31 biochemical tests, its inflammation rate is 30% lower than leading standards, and it is fully biodegradable. Its safety has been certified by Notified bodies in the EU, Brazil, Russia, Saudi Arabia, Mexico, and other countries.

“We are committed to providing safer and more accessible products for the global medical aesthetics market through technological innovation and promoting the sustainable development of the industry,” according to a release from the company.

Photo caption: Aphranel MagiCCrystal CaHA filler

Photo credit: Shanghai Moyom Biotechnology

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Galderma will present new data from across its portfolio, including Relfydess, Sculptra, and Restalyne, while also presenting results from a survey on facial changes caused by medication-driven weight loss at the 23rd Aesthetic & Anti-Aging Medicine World Congress in Monaco from March 27-29, 2025.

In total, Galderma will present 11 e-posters, host two symposia, four Masterclass sessions, five Meet-the-Expert sessions, and host an experiential lounge and interactive booth.  

“Through our data presentations and expert-led sessions, we reaffirm our commitment to being a leading force in advancing the field of Injectable Aesthetics and equipping healthcare professionals with the innovative solutions they need to fulfill the needs of patients, today and tomorrow,” says Baldo Scassellati Sforzolini, MD, PhD, head of global research and development at Galderma, in a release.  

Impact of Medication-driven Weight Loss

Rates of medication-driven weight loss have increased rapidly in recent years and can be associated with alterations in facial aesthetic appearance of variable magnitude. In a study investigating facial changes in medication-driven weight loss to date, Galderma surveyed more than 1,300 people across five countries. Findings from this study will be presented, showing 93% of those undergoing weight loss treatment noticed some degree of facial changes during their treatment, and many patients are considering aesthetic treatments to address these, with biostimulators and dermal fillers being the most frequently considered treatments.

The Galderma-sponsored “Medication-Driven Weight Loss: The Algorithms” symposium taking place on Thursday, March 27, as well as a dedicated Masterclass session on Friday, March 28, will explore the effects medication-driven weight loss can have on the face and dive into the ways aesthetic procedures can help restore facial volume and structure. 

New Data on Relfydess, Sculptra, and Restylane Shaype

Relfydess

Galderma will present new data from the phase IIIb EXPRESSION and RELAX studies, showing Relfydess achieved rapid onset of action and significant aesthetic improvement in frown lines and crow’s feet. 

In the EXPRESSION study, more than 50% of patients reported visible effects as early as day one and, in the RELAX study, effects were sustained through six months, confirming results seen in the READY trial program, and more than a third saw improvement beyond six months in frown lines.

Both studies re-confirmed high patient satisfaction with Relfydess, with 70% of patients in the RELAX study reporting that they preferred treatment with Relfydess versus prior treatments received. Encore data from a post-hoc analysis of the phase III READY program will show that, regardless of baseline wrinkle severity (moderate/severe), subjects treated with Relfydess achieved high rates of improvement in frown lines and crow’s feet, along with improved well-being, and a sustained effect through six months.

Sculptra

Galderma will also present new data on Sculptra (PLLA-SCA), a regenerative biostimulator, reinforcing its formulation, efficacy, and safety. New in vivo comparative data will demonstrate its favorable tissue response and slower, controlled product degradation profile at 52 weeks, as well as lower inflammation, compared to PLLA-GA. The lower inflammation is consistent with Sculptra’s safety profile. Differences in formulation can significantly impact local tissue response and product degradation, affecting potential clinical outcomes such as efficacy and duration.

An expert consensus also confirms Sculptra’s key role in the regenerative aesthetic field, and additional data will show its synergistic effect when paired with Alastin, underscoring its effect across all three skin layers.

Restylane Shaype

Encore data to be presented on Restylane Shaype, powered by Galderma’s proprietary NASHA HD Technology and approved in Canada and most recently in Brazil, will show that it constitutes an innovation in hyaluronic acid fillers as the firmest hyaluronic acid injectable available and displaying the highest G-prime (indicating superior gel strength and firmness) on the market providing a unique bone mimicking effect. 

Additional pooled and pivotal phase IV data to be presented will show that Restylane fillers preserve or enhance the natural expressions of 98% of patients while achieving desired aesthetic improvements in attractiveness and youthfulness. This naturalness, combined with high patient satisfaction, represents long-lasting aesthetic improvement. 

These e-posters, along with others presented on Dysport and Alastin, will be available. 

ID 24863104 © Robert Kneschke | Dreamstime.com

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A report in The Journal of Craniofacial Surgery highlights anatomy-based techniques designed to reduce the risk of complications and side effects of facial thread lifting, a technique that has become increasingly popular as a minimally invasive alternative to surgical facelifting. 

“Careful consideration of anatomical factors and potential complications, coupled with appropriate techniques, can assist practitioners in minimizing risks and optimizing outcomes,” according to the report by Kyu-Ho Yi, MD, PhD, of Yonsei University College of Dentistry, Seoul, Korea, and colleagues.

Focus on Anatomy for Optimal Outcomes of Thread Lifting

Facial thread lifting is a minimally invasive technique for facial rejuvenation. In this procedure, special absorbable, barbed sutures are placed to tighten sagging skin in the face and neck. Because it is a non-surgical procedure that can be performed quickly and with minimal recovery time, it has sometimes been called a “lunchtime lift.”

However, side effects and complications of thread lifting may occur. Some common side effects lead to cosmetic issues, such as skin dimpling or bulging or thread migration or extrusion. Other potential risks include damage to the facial nerve, resulting in asymmetrical facial movement, or inadvertent injury to the salivary (parotid) gland.

Most of these issues can be corrected with relatively simple procedures. Less commonly, more serious complications may occur—such as infections, inflammatory reactions (granulomas), or excessive scar tissue (fibrosis)—sometimes requiring thread removal.

Yi and coauthors emphasize that understanding the underlying anatomy can prevent many of these issues. They outline anatomically based techniques that can achieve excellent results of thread lifting while avoiding complications.

Key Techniques to Improve Outcomes

A simple but effective approach is called the reticular cutis gathering technique. In this approach, the patient’s head is tilted slightly downward and backward – letting gravity do the work of shifting the soft tissues upward. Taking advantage of this “natural repositioning” effect, thread placement targets not the superficial skin but the underlying connective tissue (retinacular cutis) and fascial layers (the superficial musculoaponeurotic system, or SMAS).

“By highlighting the importance of aligning threads with natural tissue movement and the SMAS, our research underlines key strategies for enhancing procedural safety and outcomes,” the researchers write. 

A related “pinching” technique can also help to ensure a stable, natural-appearing correction of loose or lax tissues, while also protecting the facial nerve and other underlying structures.

“Techniques like the reticular cutis gathering and pinching method can mitigate side effects and ensure safe thread placement,” Yi and coauthors conclude. Noting the many interrelated factors that contribute to patient outcomes, they add: “Continuous research, education, and advancements in thread materials and understanding of facial anatomy are critical for enhancing the safety and efficacy of thread lifting.”

Summary:

Research by Kyu-Ho Yi, MD, PhD, and colleagues reveals critical anatomical techniques to reduce complications in facial thread lifting, a minimally invasive cosmetic procedure that uses absorbable sutures to tighten facial skin. By carefully positioning threads in deeper tissue layers and using gravity-assisted methods, practitioners can minimize risks like skin dimpling, nerve damage, and thread migration while achieving more natural-looking results.

Key Takeaways:

1. Anatomical Precision is Crucial: Understanding facial anatomy is essential for reducing complications in thread lifting procedures. By targeting deeper tissue layers like the superficial musculoaponeurotic system, practitioners can achieve more natural and safer results, the authors write.
2. Technique Matters More Than Technology: Techniques like slight head positioning and careful tissue manipulation can improve outcomes and reduce side effects.
3. Ongoing Research is Key: The researchers stress the importance of continuous education and advancement in thread lifting techniques.

ID 361695115 © Ruslan Malysh | Dreamstime.com

Key Takeaways:

• PACE Academy offers hands-on training with digital cadaver technology and evidence-based courses on injectables.
• The initiative provides Harley Academy students with specialized instruction on Prollenium’s Revanesse dermal fillers.

Prollenium, a medical technology company, announced the launch of PACE Academy (Prollenium Advanced Clinical Education), a 5,000-square-foot facility dedicated to advanced training and education in medical aesthetics. According to the company, this initiative marks a first-of-its-kind partnership with Harley Academy, a world leader in higher education for aesthetic medicine.

Situated on Prollenium’s campus in Richmond Hill, Ontario, PACE aims to foster collaboration among key opinion leaders, medical injectors, and industry professionals. The academy is equipped with innovative learning tools, including an Anatomage table with digitized cadavers—the first interactive technology of its kind available outside universities and hospitals, according to the company. PACE also offers exclusive access to Prollenium’s manufacturing facility, the only site in North America producing hyaluronic acid (HA) dermal fillers.

In a press release, Prollenium states that Harley Academy brings unparalleled expertise to PACE with evidence-based courses on injectables and cosmetic dermatology. The curriculum blends their training model—physician-led instruction, personalized mentoring, and a mix of online and hands-on sessions—with PACE’s advanced tech environment. This partnership also features dedicated training sessions for Harley Academy students on Prollenium’s Revanesse range of dermal fillers.

“The opening of PACE marks a significant milestone for Prollenium, bridging a crucial gap in the industry where professionals can engage with groundbreaking technology and elevate their expertise,” said Ario Khoshbin, founder of Prollenium.

“PACE is designed to integrate with the technology and science we’ve developed and provide unprecedented access to advanced tools,” Khoshbin added.

Photo: Business Wire

Key Takeaways

• The approval of Evolysse Form and Evolysse Smooth transitions Evolus from a single-product company to a multi-product aesthetics innovator.
• In head-to-head trials, Evolysse fillers showed statistically significant advantages over Restylane-L in longevity and effectiveness.
• Evolus is expanding beyond the U.S. with a European launch of the Estyme dermal filler line set for late 2025.

Evolus Inc, a beauty company focused on building an aesthetic portfolio, announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse collection. These approvals mark Evolus’ entry into the U.S. HA dermal filler market and expansion as a mutli-product aesthetics company. 

Company Leadership Highlights Market Impact

“This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty,” said David Moatazedi, president and CEO of Evolus. “Evolysse Form and Evolysse Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation. The launch of these products is a catalyst in our growth as we are focused on achieving at least $700 million in net revenue and non-GAAP operating income margin of at least 20% by 2028.”

U.S. Market Launch Planned for 2025

Evolus plans to launch Evolysse Form and Evolysse Smooth in the U.S. market in Q2 2025. According to a press release from the company, this launch will leverage Evolus’ scalable cash-pay business model and existing digital infrastructure, creating tremendous synergy with the company’s fast-growing neurotoxin business and driving significant value for both customers and consumers. 

Cold-X Technology

Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes Cold-X technology that reportedly is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. The commercial launch of these first two injectable HA gels in 2025 will be followed by Evolysse Sculpt in 2026, and Evolysse Lips in 2027.

Industry Partnerships and Clinical Validation

“We are proud to partner with Evolus in bringing the Evolysse collection of injectable HA gels to the U.S. market. With decades of experience in biomaterial science and aesthetics, Symatese has a strong legacy of developing innovative aesthetic products that meet the evolving needs of practitioners and their patients. With one of the largest clinical trial programs undertaken for an injectable HA technology, Evolysse products are being evaluated for safety and effectiveness in over 2,000 patients globally,” said Jean-Paul Gérardin, CEO of Symatese.

FDA Approval and Clinical Outcomes

Dr Rui Avelar, Evolus chief  medical officer and head of R&D, added, “The FDA approval of Evolysse Form and Evolysse Smooth reflects our commitment to bringing high-quality, innovative aesthetic products to market. These additions to our portfolio reinforce Evolus’ dedication to the highest standards of patient safety and efficacy. With the introduction of Cold-X technology, Evolysse offers a differentiated approach to the dermal filler category, providing healthcare practitioners with new options to address the unique needs of their patients with precision and confidence.”

U.S. NLF Pivotal Study

Michael Kaminer, MD, lead investigator for the U.S. NLF pivotal study and an internationally recognized expert in cosmetic surgery, commented, “The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results, while delivering high patient satisfaction with their effectiveness and longevity.” 

The U.S. Nasolabial Fold (NLF) pivotal study for Evolysse Form and Evolysse Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. According to the company, 70 patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

Head-to-Head Study

Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority.

As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured timepoints for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at 6 and 9 months—even though 20% more Restylane-L was used.

According to the company, in the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.

Global Expansion Plans: Estyme in Europe

Evolus previously announced that EU Medical Device Regulation (MDR) approval was received for four unique injectable hyaluronic acid (HA) gels under the brand name Estyme. Evolus is also introducing Estyme through a limited experience program with select physician partners in Europe, to continue to expand global experience with the product’s performance. A broader European launch remains on track for the second half of 2025, further expanding Evolus’ footprint into the global dermal filler market and reinforcing its position as a leader in performance beauty.

Photo: ID 354157505 © Dmytro Dudchenko | Dreamstime.com

Summary

The FDA has approved Evolysse Form and Evolysse Smooth, marking Evolus’ entry into the US HA filler market. These injectable hyaluronic acid (HA) gels, developed by Symatese, utilize Cold-X technology to better preserve the HA molecule’s natural structure for longer-lasting, natural-looking results. A head-to-head clinical trial compared Evolysse Form and Evolysse Smooth to Restylane-L, finding that Evolysse Form was statistically superior at all measured time points over 12 months, while Evolysse Smooth was superior at six and nine months, even though 20% more Restylane-L was used. The safety profile of both fillers was comparable to Restylane-L, with no treatment-related serious adverse events or delayed-onset nodules. Evolus plans to launch the products in Q2 2025.

Key Takeaways

1. FDA Approves Evolysse Form and Evolysse Smooth – Evolus has received FDA approval for its first HA dermal fillers, developed in partnership with Symatese and featuring Cold-X technology for enhanced longevity.
2. Head-to-Head Trial Shows Superiority Over Restylane-L – Evolysse Form demonstrated statistical superiority at all time points over 12 months, while Evolysse Smooth was superior at six and nine months, even with less product used.
3. Evolysse Collection Set to Launch in Q2 2025 – Evolus will introduce its HA filler line to the US market later this year.

Evolus Inc announced that the US Food and Drug Administration (FDA) has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse collection, marking the company’s entry into the US HA dermal filler market.

Evolysse Form and Evolysse Smooth are part of a collection of injectable HA gels designed by Symatese, which utilizes innovative Cold-X technology that is designed to better preserve the natural structure of the HA molecule for long-lasting, natural-looking results. 

“Evolysse Form and Evolysse Smooth represent the first major technological breakthrough in HA dermal fillers in a decade, offering our customers and consumers a new standard in performance and innovation,” says David Moatazedi, president and chief executive officer of Evolus, in a release.

Head-to-Head Study With Restylane-L

The US Nasolabial Fold pivotal study for Evolysse Form and Evolysse Smooth included 140 patients in a double-blind, prospective, randomized, active-control split-face trial. Seventy patients were treated with each product, with investigators performing the procedures, evaluating outcomes, and following a rigorous clinical protocol.

Evolysse Form and Evolysse Smooth were evaluated in a head-to-head study with Restylane-L. Both products met the primary endpoint of non-inferiority, and both the confidence intervals as well as the corresponding p-values (<0.001) demonstrated statistical superiority.

As assessed by the live, blinded investigators, Evolysse Form showed statistically significant differences compared to Restylane-L at all measured time points for the entire 12-month study period. Evolysse Smooth showed statistically significant differences compared to Restylane-L at six and nine months, even though 20% more Restylane-L was used.

In the head-to-head clinical study versus Restylane-L, the safety profile of Evolysse Form and Evolysse Smooth was similar to the control, with most adverse events being mild to moderate. There were no treatment-related serious adverse events, and no delayed-onset nodules were observed.

Michael Kaminer, MD, lead investigator for the US NLF pivotal study, says in a release, “The Evolysse Form and Evolysse Smooth injectable HA gels demonstrated impressive safety, efficacy, and versatility, with the unique property of being injectable at various depths in the skin. These products allow practitioners to achieve precise, natural-looking results while delivering high patient satisfaction with their effectiveness and longevity.”

Evolus plans to launch Evolysse Form and Evolysse Smooth in the US market in Q2 2025.

Photo caption: Evolysse Form and Evolysse Smooth

Photo credit: Evolus