Prospective study will evaluate a whole-body protocol designed to improve skin quality, elasticity and muscle preservation following significant GLP-1-associated weight loss
HUNTINGTON BEACH, Calif., September 21, 2026 — Lionheart Health, Inc. today announced plans to launch a 30-to-50-patient prospective clinical study evaluating its new SkinStim™ Post-GLP-1 Restoration Protocol, a comprehensive program designed to address changes in skin quality, tissue laxity and muscle mass that may accompany substantial weight loss.
The study will evaluate treatment of the face, neck, upper arms and thighs, together with a muscle-preservation program incorporating Lionheart Health’s bioelectric stimulation technologies, resistance exercise, protein optimization and clinician-directed supportive care.
“GLP-1 medications are helping millions of people achieve meaningful improvements in weight and metabolic health, but rapid or substantial weight loss can leave patients with facial volume loss, loose or crepey skin and reduced lean muscle mass,” said Howard J. Leonhardt, Executive Chairman and Co-CEO of Lionheart Health. “Our goal is to develop and scientifically evaluate a comprehensive restoration protocol that supports the full patient journey—not only losing weight, but maintaining strength, healthy-looking skin and long-term confidence.”
Allergan Aesthetics and AbbVie recently reported that, among GLP-1 patients evaluated in their research, 61% experienced midface volume loss, 50% experienced skin laxity and 35% experienced facial wrinkles or folds. The companies’ research also found that 67% of medical-weight-loss patients said their goals had expanded from weight reduction to improving their overall appearance.
Lionheart Health was the Dec 2023 winner of the Abbvie Allergan ULP Innovation Award in Regenerative Aesthetics.
“Patients completing major weight-loss journeys often feel healthier and more confident, yet may still be concerned about facial volume loss, loose or crepey skin and reduced muscle tone,” said Laura Bem, Lionheart Health’s Lead Aesthetician and Assistant Manager of the Lionheart Longevity Newport Beach Research Clinic. “This study will allow us to evaluate a personalized, whole-body approach—covering the face, neck, arms and thighs—using standardized measurements rather than relying only on visual impressions. Our goal is to help establish a responsible, evidence-based pathway for restoring skin quality, strength and confidence following GLP-1-associated weight loss.”
Prospective Study Design
The planned study will enroll approximately 30 to 50 qualified participants who have experienced significant GLP-1-associated weight loss and have reached a predefined period of weight stability.
Participants will undergo standardized assessments at baseline and scheduled follow-up visits. Planned measurements include:
- Standardized, repeatable photography of the face, neck, upper arms and thighs
- Blinded grading by independent qualified evaluators
- Cutometer measurements of skin elasticity, firmness and recovery
- Body-composition measurements, including lean mass and fat mass
- Body weight and documentation of weight stability
- Circumference and functional muscle measurements where appropriate
- Patient-reported outcomes addressing satisfaction, skin quality, confidence and quality of life
- Safety monitoring and documentation of adverse events
- Assessment of durability following completion of treatment
The core SkinStim™ protocol is expected to combine noninvasive bioelectric stimulation with clinician-directed skin-restoration and muscle-preservation strategies. Final treatment schedules, eligibility requirements and study arms will be defined in the completed protocol and reviewed by the appropriate Institutional Review Board.
Investigational Adjunct Arms
Subject to regulatory, ethical and clinical review, the research protocol may evaluate separate adjunct cohorts involving:
- Platelet-rich fibrin, or PRF
- Topically applied exosome or secretome preparations
- Amniotic-fluid-derived investigational preparations
- Placental extracts
- Autologous adipose tissue processed using the FDA 510(k)-cleared Synova WAVE™ Adipose Processing System
Each adjunct will be evaluated separately so its safety, feasibility and potential contribution can be distinguished from the core SkinStim™ protocol.
The FDA clearance of the Synova WAVE device applies to the device’s cleared function as a closed-loop lipoaspirate washing system for aesthetic body contouring. It does not, by itself, establish FDA approval of stromal vascular fraction or any resulting cellular preparation as a drug or biologic for skin restoration.
No exosome product is currently FDA-approved in the United States. Any human-cell-, tissue-, exosome-, secretome-, amniotic- or placental-derived investigational product will be used only if its proposed use is determined to be lawful and appropriately authorized, including an FDA Investigational New Drug application when required. Study enrollment will begin only after completion of the required regulatory and IRB reviews and informed-consent documentation.
Lionheart’s FACTS Supplier-Qualification Standard
Before any exosome or secretome supplier may be considered for marketing, procurement or clinical research, Lionheart Health will apply its FACTS checklist:
- F — Federal and state regulatory status: Written documentation of the product’s legal classification, manufacturing registration, intended use, applicable FDA submissions and any required IND authorization.
- A — Authenticity and source: Verified tissue or cell source, donor eligibility, informed consent, supplier identity and confirmation of whether the material contains actual extracellular vesicles, a secretome or an exosome-like cosmetic ingredient.
- C — Characterization and quality: Product-specific specifications and lot-specific certificates of analysis, including particle concentration and size distribution, identity markers, protein content, purity, potency methodology and contaminant testing.
- T — Traceability and handling: Complete chain of custody, lot traceability, manufacturing location, storage requirements, shipping validation, expiration dating and documented handling procedures.
- S — Sterility, safety and surveillance: Sterility, endotoxin, mycoplasma and relevant adventitious-agent testing, donor screening, adverse-event reporting, product-liability coverage and recall procedures.
“No supplier’s marketing claims will substitute for regulatory documentation, lot-specific testing and transparent manufacturing information,” Leonhardt said. “The FACTS standard is intended to place patient safety, scientific credibility and traceability at the center of every product decision.”
The SkinStim™ Post-GLP-1 Restoration Study is intended to generate prospective feasibility, safety and preliminary outcome data. No claim of safety or effectiveness should be inferred before the study is completed, analyzed and reported.
About Lionheart Health
Lionheart Health develops bioelectric and regenerative-health technologies intended to support healthspan longevity, tissue repair, muscle conditioning and aesthetic wellness. Its platform includes SkinStim™, BodStim™, HairCell™, OrthoStim™, Brain Band™ and other proprietary stimulation protocols delivered through clinic-based and portable systems.
For additional information, visit LionheartLongevity.com.
Media and Study Information:
Lionheart Health, Inc.
Huntington Beach, California
www.LionheartLongevity.com
Scientific and Regulatory References
- Allergan Aesthetics, an AbbVie company. “Medical Weight Loss Data and the Changing Profile of Patients.” March 4, 2026. Reports midface volume loss in 61%, skin laxity in 50% and facial wrinkles or folds in 35% of surveyed GLP-1 patients. AbbVie News Center.
- Allergan Aesthetics and AbbVie. “Survey of Facial Aesthetic Concerns and Treatment Trends Following GLP-1 Agonist-Associated Weight Loss” and “Survey of Body-Related Aesthetic Concerns and Nonsurgical Body Contouring Trends Following GLP-1 Agonist-Related Weight Loss.” Presented at the 2025 American Society for Dermatologic Surgery Annual Meeting. AbbVie announcement.
- Moradi A, et al. “Nonsurgical Aesthetic Treatment of the Face and Neck in GLP-1 Receptor Agonist Weight Loss Patients: Experience-Based Considerations.” Aesthetic Surgery Journal Open Forum. 2026. PubMed Central.
- Wilding JPH, et al. “Once-Weekly Semaglutide in Adults with Overweight or Obesity.” New England Journal of Medicine. 2021;384:989–1002. doi:10.1056/NEJMoa2032183.
- Wilding JPH, et al. “Effect of Semaglutide on Body Composition in Adults with Overweight or Obesity: Exploratory Analysis of the STEP 1 Study.” Journal of the Endocrine Society. 2021;5(Suppl 1):A16–A17. doi:10.1210/jendso/bvab048.
028. - Miron RJ, et al. “Use of Platelet-Rich Fibrin in Regenerative Dentistry: A Systematic Review.” Clinical Oral Investigations. 2017;21:1913–1927. doi:10.1007/s00784-017-2133-z.
- Dobrev H. “Use of Cutometer to Assess Epidermal Hydration and Skin Elasticity in Psoriasis Patients.” Skin Research and Technology. 2000;6(4):239–244. doi:10.1034/j.1600-0846.2000.
006004239.x. - U.S. Food and Drug Administration. “Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes.” The FDA states that there are currently no FDA-approved exosome products. FDA consumer alert.
- U.S. Food and Drug Administration. “Important Patient and Consumer Information About Regenerative Medicine Therapies.” Addresses exosomes, amniotic fluid, placental and adipose-derived products and the potential need for FDA-authorized clinical investigation. FDA information.
- U.S. Food and Drug Administration. Synova WAVE Adipose Processing System, 510(k) BK251268; substantially equivalent decision dated November 17, 2025. FDA clearance record.
Forward-Looking Statement: This release contains plans and expectations regarding a proposed clinical study. Final enrollment, treatment arms, study procedures and timing remain subject to protocol completion, regulatory review, IRB approval, investigator participation, supplier qualification and other conditions. SkinStim™ has not been demonstrated through this proposed study to restore skin or preserve muscle following GLP-1-associated weight loss.