SciBase Holding AB (publ)

https://www.scibase.com

SciBase is a global medical technology company specializing in the early detection and prevention of skin disorders. Headquartered in Stockholm, Sweden, the company's mission is to ensure proactive skin health management and early detection of skin cancer and other skin conditions, thereby minimizing patient suffering and empowering clinicians to improve and save lives.

SciBase develops and commercializes Nevisense, a unique point-of-care platform that combines artificial intelligence (AI) and advanced Electrical Impedance Spectroscopy (EIS) technology to enhance diagnostic accuracy. The Nevisense platform addresses melanoma detection, non-melanoma skin cancer detection, and skin barrier assessment. Its product line also includes Nevisense Go, a handheld and portable device primarily used for skin barrier assessment in research and industrial applications. Nevisense is FDA-approved for melanoma detection in the United States and MDR-approved for skin cancer detection in Europe.

Built on over 20 years of research from the Karolinska Institute, SciBase is positioned as a leader in dermatological advancements. Recent developments include reaching a milestone of over 400,000 Nevisense tests sold and receiving FDA approval in April 2026 to expand Nevisense labeling to include other healthcare professionals beyond dermatologists in the U.S. The company also published its Annual Report for 2025 in April 2026 and expanded its collaboration with Castle Biosciences in November 2025, which included a SEK 20 million loan facility. SciBase is currently the sole company with approved products utilizing EIS and AI for skin cancer and skin barrier function assessment, and Nevisense remains the only point-of-care product available for melanoma detection in the U.S. Pia Renaudin serves as CEO, and Michael Colérus is the CFO.

Latest updates

SciBase Passes 400,000 Nevisense Tests, Eyes Expansion Beyond Melanoma

Event summary

  • SciBase has sold over 400,000 Nevisense tests globally.
  • Nevisense is the only FDA-approved and CE-marked non-invasive diagnostic for melanoma risk assessment.
  • A late-2025 clinical study demonstrated Nevisense's ability to predict atopic dermatitis in newborns.
  • SciBase entered a collaboration with Castle Biosciences in 2025 to explore new diagnostic applications.

The big picture

SciBase's milestone underscores the growing demand for AI-powered, non-invasive diagnostic tools in dermatology. The company's strategic pivot beyond melanoma detection, particularly into preventative care for conditions like atopic dermatitis, represents a significant expansion of its addressable market. The partnership with Castle Biosciences suggests a broader strategy of leveraging Nevisense's platform for a wider range of dermatological applications, but also introduces integration and execution risks.

What we're watching

Clinical Validation
The success of Nevisense's expansion into atopic dermatitis diagnosis hinges on the results of the larger clinical studies currently underway, which will determine its utility and potential reimbursement pathways.
Partnership Impact
The collaboration with Castle Biosciences will likely shape SciBase's future product pipeline and market reach, and its effectiveness will depend on the integration of their respective technologies and commercial capabilities.
Market Adoption
Continued growth in Nevisense sales will require sustained adoption by dermatologists, which is contingent on demonstrating clear clinical and economic benefits compared to existing diagnostic methods.

SciBase Secures Funding, Expands Collaboration Amidst Margin Pressure

Event summary

  • SciBase reported a 45% increase in net sales for the full year 2025 (TSEK 40,461), with a 57% increase when adjusted for currency effects.
  • The company incurred a loss after tax of TSEK 87,063 in 2025, and negative cash flow from operations of TSEK 84,578.
  • SciBase completed a rights issue of approximately SEK 83 million and saw 96.4% subscription rates.
  • The company received FDA approval for extended labeling in the US and its Nevisense technology was included in US NCCN Guidelines for Melanoma.

The big picture

SciBase's rapid revenue growth is being offset by substantial losses and negative cash flow, necessitating the recent capital raise. The company's reliance on partnerships like Castle Biosciences and regulatory approvals like the FDA expansion highlight the risks associated with its growth strategy. The rights issue provides a short-term lifeline, but sustained profitability will depend on operational efficiencies and successful market penetration.

What we're watching

Margin Resilience
The gross margin decline, attributed to currency effects, gold prices, and production investments, warrants close monitoring to determine if these pressures are transitory or indicative of a longer-term trend impacting profitability.
Castle Partnership
The expanded collaboration and loan agreement with Castle Biosciences represents a significant dependency; the success of their joint clinical studies will be crucial for SciBase's future revenue and market penetration.
US Adoption
While US sales showed strong growth, the pace at which Nevisense adoption expands within the US market, particularly beyond the NCCN guidelines inclusion, will dictate the sustainability of this momentum.

SciBase Study Validates Nevisense EIS as Superior Skin Barrier Assessment Tool

Event summary

  • SciBase published a study in *Contact Dermatitis* comparing Nevisense EIS to TEWL and Corneometry for assessing skin barrier integrity.
  • The study found Nevisense EIS detected subtle structural changes not captured by TEWL measurements.
  • Researchers suggest EIS could serve as an early biomarker for skin barrier damage due to its dependence on cell cohesion and lipid composition.
  • The study was published in April 2026, Volume 94, Issue 4 of *Contact Dermatitis*.
  • SciBase is listed on the Nasdaq First North Growth Market since June 2, 2015.

The big picture

The validation of Nevisense EIS strengthens SciBase's position in the growing market for AI-powered diagnostic solutions in dermatology. The study's findings suggest a shift towards more sensitive and early detection methods for skin disorders, potentially impacting the development of new treatments and preventative measures. This could be particularly valuable in addressing the increasing prevalence of skin conditions linked to environmental factors and aging populations.

What we're watching

Adoption Rate
The pace at which dermatologists and researchers integrate Nevisense EIS into their workflows will determine the technology's commercial success, particularly given the established use of TEWL and Corneometry.
Clinical Utility
How the early biomarker potential of EIS translates into improved patient outcomes and reduced healthcare costs will be crucial for securing broader clinical adoption and reimbursement.
Competitive Landscape
Whether competitors develop alternative or improved skin barrier assessment technologies will impact SciBase's market share and pricing power in the long term.

Nevisense Validation Boosts SciBase's Diagnostic Platform

Event summary

  • SciBase announced publication of a clinical article in *The Dermatologist* detailing Dr. Stephen Hess's experience using Nevisense for melanoma detection.
  • The article highlights Nevisense's ability to provide objective data complementing visual examination and dermoscopy.
  • Dr. Hess emphasizes Nevisense's role in risk stratification for challenging diagnostic cases.
  • SciBase's Nevisense platform combines AI and electrical impedance spectroscopy (EIS) technology.

The big picture

Rising melanoma incidence is driving demand for improved diagnostic tools, creating a market opportunity for SciBase’s Nevisense platform. The publication in *The Dermatologist* provides validation for the technology, but broader adoption hinges on clinical acceptance and reimbursement. SciBase’s reliance on a single product, Nevisense, exposes it to concentration risk if competing technologies emerge.

What we're watching

Adoption Rate
The pace at which US clinicians integrate Nevisense into routine practice will determine the platform’s near-term revenue trajectory, given the US market’s significance.
Clinical Validation
Further clinical validation and peer-reviewed publications will be critical to solidify Nevisense's position and secure reimbursement pathways.
Competitive Landscape
The emergence of competing AI-powered diagnostic tools will likely intensify pressure on SciBase to demonstrate continued technological differentiation and clinical efficacy.

SciBase Gains FDA Nod to Broaden Nevisense User Base

Event summary

  • SciBase received FDA approval to expand the labeling for its Nevisense procedure to include physician assistants and medical assistants, in addition to dermatologists.
  • The updated labeling allows these healthcare professionals to perform the Nevisense measurement, while a dermatologist still initiates the test.
  • SciBase CEO Pia Renaudin stated the change will facilitate integration into clinic workflows and expand access for patients.
  • The approval, combined with recent NCCN guidelines and ongoing reimbursement efforts, is cited as bolstering SciBase’s US growth potential.

The big picture

SciBase’s FDA approval represents a strategic move to broaden the reach of its Nevisense platform, addressing a key bottleneck in clinic workflows. By enabling non-dermatologists to perform measurements, SciBase aims to increase utilization and patient access, a common strategy in the medical device space to scale adoption. This move aligns with the broader trend of leveraging AI and point-of-care diagnostics to improve early detection and reduce healthcare costs, but hinges on successful reimbursement and integration.

What we're watching

Adoption Rate
The actual uptake of Nevisense by clinics utilizing the expanded user base will be a key indicator of the approval’s impact on revenue and market penetration, and may be constrained by training and workflow integration challenges.
Reimbursement
The success of SciBase’s ongoing reimbursement efforts will be crucial to driving utilization, as broader adoption is unlikely without favorable coverage decisions from payers.
Competitive Landscape
The expanded accessibility of Nevisense may accelerate competition within the skin cancer diagnostics market, potentially requiring SciBase to differentiate its offering further.

SciBase's Nevisense Gains NCCN Guideline Inclusion, Boosting Adoption Prospects

Event summary

  • SciBase's Nevisense (EIS) has been included in the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for melanoma.
  • The NCCN Guidelines refer to EIS as a diagnostic support technology for melanoma detection.
  • Dr. Alexander Meves and Dr. Darrell Rigel, prominent dermatologists, have endorsed the inclusion, citing improved detection rates.
  • The inclusion is expected to enhance clinician understanding and adoption of Nevisense within established clinical strategies.

The big picture

The inclusion of Nevisense in the NCCN guidelines represents a significant validation of the company’s technology and positions it to benefit from the rising incidence of melanoma and the increasing emphasis on early detection. This endorsement is likely to accelerate adoption among clinicians who rely on NCCN guidelines for best practices, potentially driving revenue growth for SciBase. However, the company will need to demonstrate continued clinical utility and cost-effectiveness to maintain its position in a competitive diagnostic market.

What we're watching

Adoption Rate
The speed at which clinicians integrate Nevisense into their workflows, following NCCN guideline inclusion, will be a key indicator of commercial success and revenue generation.
Clinical Validation
Further clinical research demonstrating the long-term impact of Nevisense on patient outcomes and healthcare costs will be crucial for sustained adoption and reimbursement.
Competitive Landscape
How competing diagnostic technologies respond to Nevisense’s increased visibility and adoption within the NCCN guidelines will shape the overall market dynamics.

Nevisense Newborn Study Signals Potential Expansion for SciBase

Event summary

  • A study by Icahn School of Medicine at Mount Sinai demonstrated Nevisense's ability to predict atopic dermatitis in newborns at risk due to family history.
  • The study involved 19 infants, with eight developing atopic dermatitis within the first year, exhibiting significantly higher Nevisense scores at birth.
  • The findings, to be presented at the AAAAI conference, suggest a correlation between early skin barrier impairment (indicated by Nevisense scores) and the development of atopic dermatitis.
  • SciBase is concurrently conducting larger studies to predict atopic dermatitis in children, building on these initial findings.

The big picture

This study represents a potential expansion of SciBase's Nevisense platform beyond its current focus on melanoma detection. Early diagnosis of atopic dermatitis, a common and costly condition, could create a significant new market opportunity, but the company faces the challenge of demonstrating robust clinical and economic value. The findings also highlight the growing trend towards AI-powered diagnostics in dermatology and the potential for preventative interventions based on early biomarker detection.

What we're watching

Clinical Validation
The success of Nevisense's predictive capabilities will hinge on replication of these findings in larger, more diverse patient cohorts, particularly given the small sample size of the initial study.
Commercial Adoption
Widespread adoption of Nevisense for newborn screening will depend on demonstrating clear clinical utility and cost-effectiveness to healthcare providers and payers.
Regulatory Pathway
The regulatory pathway for a newborn screening test based on Nevisense remains unclear and will significantly impact the timeline for commercialization and market access.

SciBase Delays Year-End Report Amid Rights Issue

Event summary

  • SciBase has postponed the publication of its year-end report for the financial year 2025 to March 13, 2026.
  • The postponement is directly linked to an ongoing rights issue, with the subscription period concluding January 26, 2026.
  • The delay aims to align the trading restriction period with the rights issue.
  • Jesper Høiland (Chairman of the Board) and Michael Colérus (CFO) are listed as contacts for inquiries.

The big picture

SciBase's decision to delay its year-end report highlights the complexities of managing capital raises in the public market. The rights issue itself suggests a need for additional funding, potentially reflecting challenges in commercializing Nevisense or meeting growth expectations. Aligning the trading restriction period is standard practice, but the delay underscores the importance of investor relations during critical fundraising events.

What we're watching

Capital Structure
The success of the rights issue will be a key indicator of investor confidence and SciBase’s ability to secure necessary funding for its operations and growth initiatives.
Trading Dynamics
The extended trading restriction period following the rights issue could create volatility and impact the stock's performance in the short term.
Financial Transparency
The delay in reporting raises questions about the underlying financial performance and whether any unforeseen issues prompted the postponement.

SciBase Share Dilution as Warrant Repurchase Concludes

Event summary

  • SciBase's offer to repurchase outstanding warrants of series TO 2 concluded with 83.9% of warrants tendered.
  • The repurchase will result in the issuance of 209,075,476 new shares, representing approximately a 33.5% dilution.
  • The acceptance period ran from December 8, 2025, to January 8, 2026.
  • A group of investors had previously committed to tendering 74% of the warrants.

The big picture

SciBase's decision to repurchase the warrants and issue new shares highlights a strategic move to simplify its capital structure and potentially reduce future financial obligations. The substantial dilution, however, raises questions about the company's ability to generate sufficient returns to offset the increased share base. The concurrent rights issue suggests a need for additional capital, potentially signaling challenges in achieving profitability or funding expansion plans.

What we're watching

Shareholder Reaction
The market's response to the significant share dilution will be a key indicator of investor sentiment towards SciBase's growth strategy and the perceived value of the warrants program.
Rights Issue Impact
The interplay between the warrant repurchase and the upcoming SEK 83 million rights issue will determine if the company can successfully raise the intended capital without further depressing the share price.
Set-off Issue
The timing and execution of the directed set-off issue to warrant holders will be crucial to ensure a smooth transition and minimize any potential disruption to trading.
CID: 394