SkinHealth Systems Receives FDA Clearance for SkinStylus Microneedling Device
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20 hours ago
0mins
SkinHealth Systems announced that the FDA has cleared the SkinStylus microneedling device for the improvement of the appearance of periorbital wrinkles in adults aged 22 years and older for all Fitzpatrick skin types.
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Analyst Views on SKIN
Wall Street analysts forecast SKIN stock price to rise
2 Analyst Rating
0 Buy
2 Hold
0 Sell
Hold
Current: 0.755
Low
1.60
Averages
1.63
High
1.65
Current: 0.755
Low
1.60
Averages
1.63
High
1.65
About SKIN
SkinHealth Systems Inc., formerly The Beauty Health Company, is a global medical aesthetics company. The Company, anchored by Hydrafacial, a professional skincare treatment, and supported by complementary offerings including SkinStylus microneedling and HydraScalp with Keravive, combines advanced device technology, proprietary consumables, and clinical validation to deliver treatment experiences through an omnichannel network of providers worldwide. Hydrafacial specializes in the category of hydradermabrasion with its patented delivery system that cleanses, extracts and hydrates the skin with proprietary solutions and serums. The treatment extends to the scalp through its HydraScalp powered by Keravive treatment, which is designed to support the hair's natural growth. SkinStylus specializes in nano-channeling and microneedling where its products are designed to provide either a non-invasive (nano-channeling) or minimally-invasive (microneedling) skin treatment to individuals.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
SkinHealth Systems Receives FDA Clearance for New Device
- FDA Clearance: SkinHealth Systems Inc.'s SkinStylus microneedling device has received FDA clearance for improving periorbital wrinkles in adults aged 22 and older, making it the only microneedling device cleared for facial acne scars, periorbital wrinkles, and abdominal scars, thereby strengthening its competitive position in the rapidly growing microneedling market.
- Rising Market Demand: With U.S. consumer spending on microneedling projected to reach approximately $330 million by 2025, reflecting a 33% year-over-year increase, the FDA clearance for SkinStylus will help meet the growing market demand, potentially driving revenue growth for the company.
- Commitment to Scientific Innovation: The company emphasizes that this FDA clearance reinforces its commitment to science-backed innovation in professional aesthetics, indicating SkinHealth Systems' dedication to providing scientifically-based beauty solutions that enhance brand image and market recognition.
- Stock Price Fluctuations: SKIN's stock has traded between $0.55 and $2.69 over the past year, closing at $1.11 on Tuesday with a 47.04% increase, although it fell 8.11% in after-hours trading, reflecting both positive market reactions to the new product approval and short-term volatility.
See More
SkinStylus Receives FDA Clearance for Multiple Skin Indications
- FDA Clearance for New Indications: The SkinStylus microneedling device has received FDA clearance for improving periorbital wrinkles in adults aged 22 and older, reinforcing SkinHealth Systems' competitive position in the microneedling market and is expected to drive sales growth.
- Surging Market Demand: In 2025, consumer spending on microneedling in U.S. medical aesthetics grew by 33% year-over-year, reaching approximately $330 million, reflecting a consumer preference for clinically driven skin treatments, and the multiple indications of SkinStylus will further meet this demand.
- Clinical Validation Results: SkinStylus demonstrated statistically significant improvements in periorbital wrinkles across all Fitzpatrick skin types in clinical studies, with physicians noting the device's comfort and ease of use, which is expected to attract more medical practices to adopt it.
- Combination Treatment Trend: The pairing of Hydrafacial and microneedling treatments is gaining popularity, with 90% of Hydrafacial consumers expressing interest in combining it with microneedling in the future to maximize outcomes, and the integration of SkinStylus will further drive this trend.
See More
Beauty Health (SKIN) Q1 2026 Earnings Transcript
See More
SkinHealth Systems Inc. Reports Q1 2026 Earnings with Cautious Outlook
- Revenue and EBITDA Performance: SkinHealth Systems reported Q1 net sales of $64.9 million, a 6.7% decline year-over-year, while adjusted EBITDA reached $8.5 million, up 17%, exceeding expectations and demonstrating the company's resilience in profitability.
- Device Placement Pressure: Management noted that device placements fell below expectations and anticipates continued softness in Q2, with CEO Malha highlighting macroeconomic factors and intensified competition impacting capital equipment demand, indicating a challenging near-term growth outlook.
- Leadership Changes and Strategic Adjustments: The company made key leadership changes within its commercial organization, with CEO Malha taking a more direct role in global sales, aiming to enhance sales execution through more structured processes and better account prioritization to improve device utilization.
- Full-Year Revenue Outlook Revision: The company revised its full-year revenue outlook to a range of $280 million to $295 million, reflecting a cautious view on capital equipment demand, while maintaining adjusted EBITDA guidance between $35 million and $45 million, indicating confidence in future growth despite current challenges.
See More
SkinHealth Systems to Report Q1 2026 Financial Results on May 7
- Earnings Release Schedule: SkinHealth Systems will report its Q1 2026 financial results after market close on May 7, 2026, providing key financial metrics to assess the company's performance.
- Investor Conference Call: Following the earnings release, the company will host an investor conference call at 4:30 p.m. Eastern Time, aimed at sharing financial results and addressing investor inquiries to enhance transparency.
- Disclosure Channels: SkinHealth Systems discloses material information to the public through various means, including SEC filings, press releases, and conference calls, ensuring compliance with Regulation FD and enhancing corporate transparency.
- Company Overview: SkinHealth Systems is a global medical aesthetics company delivering clinically proven solutions, anchored by its leading Hydrafacial™ brand, committed to improving consumer skin health and providing quality treatment experiences.
See More
Beauty Health Company Q4 2025 Earnings Call Insights
- Revenue Performance: In Q4 2025, total revenue reached $82.4 million, reflecting a 1.3% year-over-year decline, yet showing significant improvement from the previous quarter's double-digit drop, with consumables revenue rising to $57.7 million, indicating resilience and potential in the market.
- Margin Improvement: The CFO reported an increase in adjusted gross margins from 62% to over 68%, while GAAP gross margins rose from 54.5% to 65.3%, demonstrating substantial progress in cost control and profitability.
- Future Outlook: For 2026, the company anticipates revenue between $285 million and $305 million, with expectations that the first half may be slightly below last year, but a recovery is expected in the second half, reflecting management's confidence in future growth.
- Strategic Focus: The CEO emphasized that 2026 will be an execution year, concentrating on sales force excellence, marketing discipline, and innovation, particularly the early development of the next-generation Hydrafacial system targeted for launch in 2028, aimed at enhancing market competitiveness.
See More
SkinHealth Systems Receives FDA Clearance for New Device
- FDA Clearance: SkinHealth Systems Inc.'s SkinStylus microneedling device has received FDA clearance for improving periorbital wrinkles in adults aged 22 and older, making it the only microneedling device cleared for facial acne scars, periorbital wrinkles, and abdominal scars, thereby strengthening its competitive position in the rapidly growing microneedling market.
- Rising Market Demand: With U.S. consumer spending on microneedling projected to reach approximately $330 million by 2025, reflecting a 33% year-over-year increase, the FDA clearance for SkinStylus will help meet the growing market demand, potentially driving revenue growth for the company.
- Commitment to Scientific Innovation: The company emphasizes that this FDA clearance reinforces its commitment to science-backed innovation in professional aesthetics, indicating SkinHealth Systems' dedication to providing scientifically-based beauty solutions that enhance brand image and market recognition.
- Stock Price Fluctuations: SKIN's stock has traded between $0.55 and $2.69 over the past year, closing at $1.11 on Tuesday with a 47.04% increase, although it fell 8.11% in after-hours trading, reflecting both positive market reactions to the new product approval and short-term volatility.
See More
SkinStylus Receives FDA Clearance for Multiple Skin Indications
- FDA Clearance for New Indications: The SkinStylus microneedling device has received FDA clearance for improving periorbital wrinkles in adults aged 22 and older, reinforcing SkinHealth Systems' competitive position in the microneedling market and is expected to drive sales growth.
- Surging Market Demand: In 2025, consumer spending on microneedling in U.S. medical aesthetics grew by 33% year-over-year, reaching approximately $330 million, reflecting a consumer preference for clinically driven skin treatments, and the multiple indications of SkinStylus will further meet this demand.
- Clinical Validation Results: SkinStylus demonstrated statistically significant improvements in periorbital wrinkles across all Fitzpatrick skin types in clinical studies, with physicians noting the device's comfort and ease of use, which is expected to attract more medical practices to adopt it.
- Combination Treatment Trend: The pairing of Hydrafacial and microneedling treatments is gaining popularity, with 90% of Hydrafacial consumers expressing interest in combining it with microneedling in the future to maximize outcomes, and the integration of SkinStylus will further drive this trend.
See More
Beauty Health (SKIN) Q1 2026 Earnings Transcript
See More
SkinHealth Systems Inc. Reports Q1 2026 Earnings with Cautious Outlook
- Revenue and EBITDA Performance: SkinHealth Systems reported Q1 net sales of $64.9 million, a 6.7% decline year-over-year, while adjusted EBITDA reached $8.5 million, up 17%, exceeding expectations and demonstrating the company's resilience in profitability.
- Device Placement Pressure: Management noted that device placements fell below expectations and anticipates continued softness in Q2, with CEO Malha highlighting macroeconomic factors and intensified competition impacting capital equipment demand, indicating a challenging near-term growth outlook.
- Leadership Changes and Strategic Adjustments: The company made key leadership changes within its commercial organization, with CEO Malha taking a more direct role in global sales, aiming to enhance sales execution through more structured processes and better account prioritization to improve device utilization.
- Full-Year Revenue Outlook Revision: The company revised its full-year revenue outlook to a range of $280 million to $295 million, reflecting a cautious view on capital equipment demand, while maintaining adjusted EBITDA guidance between $35 million and $45 million, indicating confidence in future growth despite current challenges.
See More
SkinHealth Systems to Report Q1 2026 Financial Results on May 7
- Earnings Release Schedule: SkinHealth Systems will report its Q1 2026 financial results after market close on May 7, 2026, providing key financial metrics to assess the company's performance.
- Investor Conference Call: Following the earnings release, the company will host an investor conference call at 4:30 p.m. Eastern Time, aimed at sharing financial results and addressing investor inquiries to enhance transparency.
- Disclosure Channels: SkinHealth Systems discloses material information to the public through various means, including SEC filings, press releases, and conference calls, ensuring compliance with Regulation FD and enhancing corporate transparency.
- Company Overview: SkinHealth Systems is a global medical aesthetics company delivering clinically proven solutions, anchored by its leading Hydrafacial™ brand, committed to improving consumer skin health and providing quality treatment experiences.
See More
Beauty Health Company Q4 2025 Earnings Call Insights
- Revenue Performance: In Q4 2025, total revenue reached $82.4 million, reflecting a 1.3% year-over-year decline, yet showing significant improvement from the previous quarter's double-digit drop, with consumables revenue rising to $57.7 million, indicating resilience and potential in the market.
- Margin Improvement: The CFO reported an increase in adjusted gross margins from 62% to over 68%, while GAAP gross margins rose from 54.5% to 65.3%, demonstrating substantial progress in cost control and profitability.
- Future Outlook: For 2026, the company anticipates revenue between $285 million and $305 million, with expectations that the first half may be slightly below last year, but a recovery is expected in the second half, reflecting management's confidence in future growth.
- Strategic Focus: The CEO emphasized that 2026 will be an execution year, concentrating on sales force excellence, marketing discipline, and innovation, particularly the early development of the next-generation Hydrafacial system targeted for launch in 2028, aimed at enhancing market competitiveness.
See More
