Elevai Labs Inc. Subsidiary, Elevai Skincare Inc., Announces Launch of Clinical Study Combining Its Flagship Topical Exosome Skincare Products with a Medical Aesthetic Energy Device

Rhea-AI Summary

Elevai Labs, Inc. (NASDAQ: ELAB) has announced the launch of a clinical study to evaluate the efficacy of its topical exosome products, Elevai empower™ and Elevai enfinity™, in combination with energy device treatments for facial skin rejuvenation. The study, conducted in collaboration with Dr. Jennifer Pearlman, aims to enroll up to 20 subjects aged 35-75 with various skin conditions.

The 12-week study will assess the products' efficacy as standalone treatments and in conjunction with energy devices, measuring tolerability, safety, and improvements in overall facial appearance. Elevai expects to announce topline data by Q1 2025 and publish results in a peer-reviewed journal.

This initiative aligns with the growing energy-based aesthetic device market, projected to reach $5.60 billion by 2030. Elevai is actively seeking partnerships with energy device companies to explore synergistic opportunities in the field of non-invasive skin rejuvenation.

Positive

• Launch of clinical study to evaluate efficacy of topical exosome products with energy device treatments
• Collaboration with renowned aesthetic medicine expert Dr. Jennifer Pearlman
• Potential to enhance facial rejuvenation treatments by combining exosome skincare with energy-based devices
• Aligns with growing energy-based aesthetic device market, projected to reach $5.60 billion by 2030
• Actively seeking partnerships with leading energy device companies for synergistic opportunities

Negative

• Results of the clinical study are not yet available, with topline data expected by Q1 2025

• In Collaboration with Renowned Aesthetic Medicine Expert Dr. Jennifer Pearlman, Elevai’s Study Will Investigate the Impact of Combining Exosome Skincare with Advanced Energy-Based Treatments for Optimal Skin Rejuvenation
  

• As the Global Energy-Based Aesthetic Device Market Is Projected to Reach $5.60 Billion by 2030, Elevai’s Study Seeks to Unlock the Full Potential of Combining Exosome Skincare Products with These Technologies for Enhanced Facial Rejuvenation
  

NEWPORT BEACH, Calif., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Elevai Labs, Inc. (NASDAQ: ELAB) (“Elevai” or the “Company”), a pioneering force in medical aesthetics, today announced the initiation of a clinical study to assess the efficacy of a topical exosome product in conjunction with an energy device treatment on facial skin appearance.

The clinical study will assess the efficacy of Elevai’s topical exosomes Elevai empower™, a topical exosome serum designed specifically for in-office application, and Elevai enfinity™, a daily topical exosome product for at home use, as standalone treatments and in conjunction with an energy device treatment on facial skin appearance. The objective of the study is to investigate the efficacy of a topical exosome product on facial appearance after daily use for up to 12 weeks.

Elevai is collaborating with Dr. Jennifer Pearlman, an internationally recognized leader in regenerative and aesthetic medicine, and Medical Director of the PearlMD Rejuvenation clinic in Toronto, Canada. She is a board-certified Fellow of Regenerative Medicine (FAARM) by the American Academy of Anti-Aging Medicine (A4M), an expert in Menopause credentialed by NAMS attending physician at Mount Sinai Hospital in Toronto and serves as Faculty teaching at the major international functional medicine meetings. She is faculty and Director of Women’s Health at Geneva College of Longevity Science, and a Global Ambassador for the Aesthetic Multispecialty Society, the largest network of cosmetic physicians in the world. Dr. Pearlman is co-founder of Healthspan Digital an AI powered Longevity platform enabling networks to offer leading edge longevity services and practices medicine as a board-certified medical doctor licensed in the Canadian province of Ontario and in the United States in both New York and Florida.

“This study represents an exciting step forward in aesthetic medicine. By examining the synergy between Elevai’s advanced exosome technology and proven energy device treatments, we aim to push the boundaries of what’s possible in non-invasive skin rejuvenation, ultimately delivering safer, more effective solutions to our patients,” said Dr. Pearlman.

The study will enroll up to 20 healthy subjects between the ages of 35-75 years of age of Fitzpatrick skin types I-VI with mild to moderate facial photoaging and sensitive skin, including those with acne, rosacea, pigmentation issues, eczema, atopic dermatitis, dry skin, or cosmetic intolerance syndrome. Endpoints will measure tolerability for absence of skin irritation, safety, and statistically significant improvement in overall facial appearance 12 weeks as compared to baseline.

“Partnering with a renowned investigator like Dr. Pearlman was a key milestone for us, as we prioritize clinical studies and scientific data as a key point of differentiation for our products,” remarked Jordan R. Plews, PhD, Chief Executive Officer of Elevai Skincare Inc. “Elevai expects to announce topline data from this study by Q1 2025 and to publish the results in a peer-reviewed scientific journal shortly after.”

Energy-based aesthetic devices are used to address a wide range of aesthetic applications such as skin resurfacing and skin tightening, among others. These devices are based on minimally invasive and non-invasive technology and are experiencing rising adoption due to the increasing popularity of cosmetic procedures. According to Research and Markets, the energy-based aesthetic devices market was valued at $3.36 billion in 2023, growing at a CAGR of 8.93% during the forecast period from 2024 to 2030, and is expected to reach $5.60 billion by 2030¹.

As part of Elevai’s commitment to advancing the science of skincare, this study aims to gather critical data to support the enhanced performance of Elevai’s exosomes alongside popular energy-based treatments like radiofrequency microneedling and non-ablative laser rejuvenation therapy. Elevai is actively seeking partnerships with leading energy device companies to explore synergistic opportunities and further validate the power of combining our innovative skincare formulations with energy-based treatments.

About Elevai Labs Inc.

Elevai Labs Inc. (NASDAQ: ELAB) specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. The Company operates a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors, Elevai Skincare Inc., Elevai Biosciences Inc., and Elevai Research Inc. For more information please visit www.elevailabs.com.

About Elevai Skincare Inc.

Elevai Skincare Inc., a subsidiary of Elevai Labs Inc., is a medical aesthetics company developing and commercializing cutting-edge physician-dispensed skin and hair care applications. Elevai Skincare Inc. develops cosmetic products for the physician-dispensed market, with a focus on leveraging novel proprietary science-backed technologies, including its stem cell exosome technology. For more information, please visit www.elevaiskincare.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. These forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. These risks and uncertainties include, among others: Elevai’s limited operating history and historical losses; Elevai’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai’s dependence on the success of its product candidates EL-22 and EL-32; that Elevai may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Elevai’s ability to obtain, maintain and protect its intellectual property; Elevai’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and Elevai’s expectations regarding its growth, strategy, progress and the design, objectives and timing of its studies.

These and other risks are described more fully in Elevai Labs’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:
IR@elevailabs.com

¹Energy based Aesthetic Devices (EAD) - Market Insights, Competitive Landscape, and Market Forecast – 2030 - https://www.researchandmarkets.com/reports/5188079/energy-based-aesthetic-devices-ead-market

FAQ

What is the purpose of Elevai Labs' new clinical study for ELAB stock?

The clinical study aims to assess the efficacy of Elevai's topical exosome products (Elevai empower™ and Elevai enfinity™) in combination with energy device treatments for facial skin rejuvenation, potentially enhancing the company's product offerings and market position.

When will the results of Elevai Labs' (ELAB) clinical study be available?

Elevai Labs expects to announce topline data from the clinical study by Q1 2025 and publish the results in a peer-reviewed scientific journal shortly after.

How many subjects will be enrolled in Elevai Labs' (ELAB) clinical study?

The clinical study will enroll up to 20 healthy subjects between the ages of 35-75 years with various skin conditions, including mild to moderate facial photoaging and sensitive skin.

What is the projected market size for energy-based aesthetic devices by 2030, relevant to ELAB?

According to the press release, the energy-based aesthetic devices market is projected to reach $5.60 billion by 2030, growing at a CAGR of 8.93% from 2024 to 2030.

Who is collaborating with Elevai Labs (ELAB) on the clinical study?

Elevai Labs is collaborating with Dr. Jennifer Pearlman, an internationally recognized leader in regenerative and aesthetic medicine, and Medical Director of the PearlMD Rejuvenation clinic in Toronto, Canada.