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MIAMI, Florida and NUREMBERG, Germany — September 28, 2026 / businesswire.com/ DermaSensor Inc., a leader in AI-powered skin cancer risk detection technology, today announced the commercial launch of DermaSensor in Germany through a distribution agreement with ContraCare GmbH. The launch represents a significant milestone in DermaSensor’s international expansion following its recent Class IIb CE Mark under the European Union Medical Device Regulation (MDR) and collaboration with the National Health Service (NHS) in the United Kingdom.

Under the agreement, DermaSensor Inc. will supply its medical devices to ContraCare GmbH, which will manage the commercial distribution of DermaSensor in Germany, Austria and Switzerland and enter into rental agreements with qualified healthcare professionals trained in skin lesion assessment and management. This first European commercial launch of DermaSensor is focused on leading dermatologists given their importance for validating new technologies and dermatology specialization, with the launch coinciding with this week’s EADV Congress 2026 and AI in Dermatology Summit 2026 (both in Vienna).

To establish a dedicated market presence for DermaSensor and support clear positioning among German physicians, ContraCare operates its DermaSensor business under the registered brand DERMALYTICA – a division of ContraCare GmbH. Through DERMALYTICA, ContraCare will lead physician engagement and commercialization of DermaSensor in the German, Austria and Swiss markets.

“Germany represents an important market in our European commercialization strategy and an opportunity to bring objective skin cancer risk assessment to more physicians at the point of care,” said Cody Simmons, Co-Founder and CEO of DermaSensor. “With our Class IIb CE Mark now in place, we are focused on working with strong commercial partners that understand their healthcare markets and can help expand access to our technology. ContraCare, through DERMALYTICA, provides that leading commercial presence in Germany.”

DermaSensor is a handheld, non-invasive medical device that uses optical spectroscopy and artificial intelligence to assess suspicious skin lesions for cancer. The device provides an objective result at the point of care to help inform the management of suspicious skin lesions. The spectroscopy technology scans lesions at a cellular level beneath the surface of the skin to non-invasively evaluate pathology features that can not be seen visually or with a dermatoscope. DermaSensor is designed to complement, not replace, clinical judgment. Nine published studies demonstrate DermaSensor’s strong performance and benefits, a publication in Nature described the importance of its FDA authorization creating a new medical device category, and the device has received various recognitions, including TIME Best Invention 2024 and Inc. Best in Business 2025. 

Building DermaSensor’s European Presence

“Skin cancer detection in Germany faces an important unmet need: dermatologists and general practitioners are not empowered with objective tools for skin cancer risk assessment that operate solely using harmless light and display the result within seconds,” said Dr. Torsten Kuehn, CEO of ContraCare GmbH. “DERMALYTICA is bringing DermaSensor to Germany to help address that gap since DermaSensor is the first and only FDA-authorized device that provides any form of risk assessment for all three common skin cancers. We are proud to now be the first company to offer this breakthrough technology to European physicians. Importantly, while the DermaSensor examination is not currently covered by statutory health insurance or billable through the EBM, medically indicated examinations of specifically documented skin lesions may be offered under a private medical treatment contract and billed analogously under the German Fee Schedule for Physicians (GOÄ). This provides a pathway for physicians to offer patients access to an innovative diagnostic service today.”

The German commercial launch follows DermaSensor’s receipt of a Class IIb CE Mark under the European Union Medical Device Regulation (MDR), an important regulatory milestone supporting the technology’s commercialization in Europe.

DermaSensor Inc. is also collaborating with the United Kingdom’s National Health Service (NHS) on a feasibility study evaluating the impact of AI-assisted skin cancer assessment when used by general practitioners within the NHS setting.

About DERMALYTICA – A division of ContraCare GmbH

DERMALYTICA is a registered brand of ContraCare GmbH focused on the commercialization of DermaSensor in Germany. Under its distribution agreement with DermaSensor Inc., ContraCare GmbH distributes DermaSensor medical devices to physicians in Germany. Through DERMALYTICA, ContraCare provides German physicians with information, access, and commercial support for DermaSensor technology.

For more information, visit dermalytica.com.

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is FDA Cleared (De Novo), CE Marked (Class IIb), and is currently available for sale in the U.S and Europe.

For more information, visit dermasensor.com.

Media Contact

DermaSensor Inc.
jacqueline.barberena@dermasensor.com
dermasensor.com

DERMALYTICA – Division of ContraCare GmbH

torsten.kuehn@dermalytica.com

dermalytica.com

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The community investment round comes just as DermaSensor announced four new US partnerships to widen access to DermaSensor’s device across primary care, enterprise healthcare, and federal health systems. These four new partnerships are 1) an approved supplier relationship with Henry Schein, Inc., the world’s largest provider of healthcare solutions to office-based dental and medical practitioners, 2) a new customer partnership with a major US healthcare institution that employs tens of thousands of providers, 3) a commercial partnership with MedTech MedCare (MTMC), the largest U.S. medical device contract sales company and 4) a partnership with Medical Place as DermaSensor’s exclusive reseller to the U.S. Department of Veterans Affairs (VA). Together, these partnerships establish a commercial infrastructure to scale access to DermaSensor nationwide and accelerate the Company’s growth.

Through the investment round now open on Wefunder, retail investors have a direct way to join DermaSensor’s mission, investing alongside the venture capital and other institutional investors who have supported the company since its earliest days.

“Our professional investor partners have supported us through every phase of building this new medical device category. Opening the financing on Wefunder is about extending that ownership to the physicians and patients who are living the problem we’re solving, given that 1 in 5 Americans are affected by skin cancer. We want the people closest to it to have a seat at the table.” said Cody Simmons, Co-Founder and CEO of DermaSensor. 

The company’s technology, originally developed at Boston University, uses Elastic Scattering Spectroscopy (ESS) and artificial intelligence to immediately deliver an objective risk result for suspicious lesions. In published studies, DermaSensor’s device has demonstrated 96% device sensitivity across the three most common skin cancers, melanoma, BCC, and SCC, while reducing missed skin cancer referrals by more than 50%.* Even though the device was just launched commercially two years ago, the device is already in use by hundreds of healthcare provider organizations and has been used to scan more than 45,000 suspicious lesions to date. 

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to check for skin cancer using elastic scattering spectroscopy and artificial intelligence. The DermaSensor™ device is a non-invasive, handheld system that delivers an immediate, objective result for skin cancer risk. DermaSensor is FDA cleared (Class II De Novo), CE Marked (Class IIb), and currently available for sale in the U.S. For more information, visit www.dermasensor.com. To invest in DermaSensor, visit wefunder.com/dermasensor. 

*Clinical evidence available upon request.

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The Company’s commercial expansion includes 1) an approved supplier relationship with Henry Schein, Inc., the world’s largest provider of healthcare solutions to office-based dental and medical practitioners, 2) a new customer partnership with a major healthcare institution that employs tens of thousands of providers across the U.S., 3) a commercial partnership with MedTech MedCare (MTMC), the largest U.S. medical device contract sales company and 4) a partnership with Medical Place as DermaSensor’s exclusive reseller to the U.S. Department of Veterans Affairs (VA). Together, these partnerships establish a scalable commercial infrastructure that significantly expands access to DermaSensor’s technology to further accelerate the Company’s growth.

“Our mission is to empower clinicians with data-driven, breakthrough technology that improves skin cancer care,” said Cody Simmons, Co-Founder & CEO of DermaSensor. “These partnerships represent an important milestone in our commercialization strategy. They greatly expand our reach across community practices, enterprise healthcare organizations, and federal healthcare systems, positioning us well to impact millions of patients in the years to come, with over 40,000 suspicious lesions already scanned to date.”

DermaSensor is the first and only device cleared by the FDA that provides any kind of risk assessment for the three common skin cancers. The AI-powered, non-invasive technology provides an immediate, objective skin cancer risk result to support physicians’ decision-making for lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma. The FDA pivotal studies demonstrated 96% device sensitivity¹ with over 1,000 patients and that device use reduces missed skin cancer referrals by more than 50%² with over 100 primary care physicians.

New Industry Partnerships

DermaSensor continues to execute against its commercialization strategy through several significant initiatives that expand access to its technology across enterprise healthcare, independent practices, and federal healthcare systems:

Henry Schein Approved Supplier: Launched as an approved supplier with Henry Schein Medical, the medical business of Henry Schein, Inc., a products, services, and technology platforms company serving more than 1 million customers globally. The relationship enables streamlined procurement of DermaSensor and expands access to the device for primary care practices and healthcare systems nationwide.

Major Healthcare Provider Institution Partnership: Completed a nationwide agreement with a major healthcare institution that employs tens of thousands of providers. Any of their divisions can now easily deploy DermaSensor devices, and two divisions are already in the processing of implementing DermaSensor devices at their facilities this year

MedTech MedCare (MTMC) Sales Partnership: MTMC is the largest medical device contract sales company in the US, with >150 sales team members across acute, post-acute, and ambulatory care markets. This partnership has already been implemented successfully in Texas and is now expanding several other states to strengthen provider awareness, expand field coverage, and accelerate commercial adoption of DermaSensor. “Our focus has always been on bringing innovative medical technologies to providers in a way that drives adoption and improves patient care,” said Jack Moran, CEO of MTMC. “DermaSensor represents a meaningful advancement in frontline skin cancer risk detection, and we’re excited to support its commercial expansion through our national sales organization.”

Exclusive U.S. Department of Veterans Affairs (VA) Reseller Partnership: Appointed Medical Place, a federal healthcare distributor with more than 43 years of experience serving VA medical centers and federal healthcare facilities, as DermaSensor’s exclusive reseller to the U.S. Department of Veterans Affairs. The agreement establishes a dedicated commercial pathway into one of the nation’s largest integrated healthcare systems and expands access to DermaSensor’s technology for veterans nationwide. “We believe DermaSensor has the potential to become an important technology within the VA healthcare system,” said Dr. Alfred Seawright, CEO, Medical Place. “This exclusive agreement reflects our confidence in the Company’s technology and our commitment to making skin cancer detection more accessible to our veterans, who have a three-hold higher prevalence of skin cancer.” ³

Together, these four major commercial partnerships significantly expand DermaSensor’s reach across the U.S. healthcare market and strengthen the infrastructure needed to support broad adoption. With expanded access secured across enterprise healthcare organizations, independent practices, national distribution channels, and federal healthcare systems, DermaSensor is well positioned to accelerate commercialization and advance its mission to save lives by improving early skin cancer detection.

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a non-invasive, handheld system that uses artificial intelligence and spectroscopy to immediately test skin lesions for cancer. By enabling quick and effective skin cancer checks, DermaSensor aims to improve skin cancer detection and save lives. DermaSensor is FDA cleared (Class II De Novo), CE Marked (Class IIb), and is currently available for sale in the U.S.

For more information, visit www.dermasensor.com.

References:

1. Merry SP et al. Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer. Journal of Primary Care & Community Health. 2025;16. doi:10.1177/21501319251344423

2. Ferris LK et al. DERM-SUCCESS FDA Pivotal Study: A Multi-Reader Multi-Case Evaluation of Primary Care Physicians’ Skin Cancer Detection Using AI-Enabled Elastic Scattering Spectroscopy. J Prim Care Community Health. 2025;16:21501319251342106. doi:10.1177/21501319251342106

3. Rezaei SJ et al. Skin Cancer and Other Dermatologic Conditions Among US Veterans. JAMA Dermatol. 2024 Oct 1;160(10):1107-1111. doi: 10.1001/jamadermatol.2024.3043.

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“This is a transformative milestone for DermaSensor and an important step in our mission to improve access to skin cancer detection globally,” said Cody Simmons, Co-Founder and CEO of DermaSensor. “We are the first and only automated device authorized by the FDA for detection of all three common skin cancers as well as the first and only automated skin cancer tool that can be used by physicians who are not already experts in dermatology. While many companies have tried, no such tools that are currently available in Europe have been able to achieve approval in the US, given the FDA’s high bar for clinical evidence. We are excited to now have the regulatory authorization to make our industry-leading product available to European Healthcare Providers (HCP’s) and their patients.”

DermaSensor’s handheld device uses spectroscopy and artificial intelligence to test suspicious skin lesions for cancer in real time at the point of care. The DermaSensor solution is CE marked for use by qualified healthcare professionals to inform whether suspicious lesions merit further clinical care (e.g. refer to dermatology, biopsy). The device’s performance and benefits have been consistently demonstrated across nine published studies conducted with over 40 clinical study sites and hundreds of clinicians in both the primary care and dermatology settings. The device has also recently received dozens of prestigious awards and recognitions, including TIME’s 2024 Best Invention List and Inc Magazine’s 2025 Best in Innovation alongside companies such as Anthropic and Nvidia.

Skin cancer remains one of the most common cancers worldwide, with growing demand for tech-enabled solutions that can help improve access to early detection. The CE Mark certification positions DermaSensor to pursue commercial opportunities with healthcare systems, physician networks, and distribution partners throughout Europe and other international markets that recognize CE Mark standards.

The company is also today announcing a feasibility study in collaboration with the National Health Service (NHS), focused on evaluating the impact of AI-assisted skin cancer assessment when used by GPs within the NHS setting. Additional details regarding the collaboration will be announced in the coming months.

DermaSensor also recently entered into a strategic commercial partnership with a large European distributor to support commercialization efforts and accelerate market access within certain of Europe’s largest healthcare markets. This commercial partner invested $5 million in DermaSensor’s recent Series B financing. The company is actively seeking additional commercial partners, leading healthcare systems, and physician thought leaders as the company aims to gain broad adoption in Europe as it has already done in the US with hundreds of healthcare provider institutions that are collectively using the devices on thousands of patients a month.

If you are interested in being a potential partner with DermaSensor, please provide information online through DermaSensor’s website. 

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is FDA Cleared (De Novo), CE Marked, and is currently available for sale in the U.S.

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Addressing a Growing Public Health Issue

Skin cancer remains the most common cancer in the U.S., affecting millions of Americans each year, with melanoma carrying the highest risk of mortality. Limited access to dermatologists increases PCPs’ responsibility to evaluate lesions suggestive of skin cancer [2,3].

“Primary care physicians are often the first to encounter suspicious skin lesions, yet many lack significant training and confidence in dermatologic assessment,” said Dr. Dan Siegel, Clinical Professor of Dermatology at SUNY Downstate and former President of the American Academy of Dermatology. “This study demonstrates how the non-invasive DermaSensor technology can significantly enhance diagnostic accuracy and empower clinicians to make more informed, confident decisions for their patients” [1,4].

Overview and Results of the Clinical Studies

The JAAD International study was conducted at UPMC and was the first investigator-initiated study ever conducted with DermaSensor in the United States. This independent, prospective study evaluated patients’ lesions of concern among 150 dermatology patients and found [8]:

• Sensitivity and specificity of the device were 100% and 9.4%, respectively, using Investigate Further vs Monitor as the cutpoint for positive vs negative. The publication also reported that sensitivity was 86.4% and specificity was 67.2% when considering 7-10 results as positive and 0-6 results as negative.
• 59.5% of the Investigate Further false positive results were still considered high risk lesions in that they were actively managed or treated by the study dermatologists.
• Overall diagnostic accuracy, i.e., Area Under the Curve (AUC), was 0.79, which was identical to the AUC in the FDA pivotal study with over 1,000 patients and 22 primary care study centers [8].

“These results further confirm that the DermaSensor device maintains consistent performance, in this case at a new health system and in the dermatology setting with patients’ suspicious lesions rather than primary care provider selected lesions,” said Dr. Laura K. Ferris, MD, PhD, who was the study’s Principal Investigator and is currently the Chair of Dermatology at UNC Chapel Hill. “This supports the device’s role as an important adjunctive tool for triage and clinical decision-making, helping non-dermatologists identify high-risk lesions with improved performance and confidence.”

The DERM-ASSESS III melanoma clinical utility study, published in JCAD, comprised of 118 PCPs that completed assessments of over 10,000 lesion cases. This study found that:

• Physician AUC improved significantly with the use of DermaSensor, from 0.630 to 0.671 (p = 0.036) [1].
• Melanoma detection increased from 70.2% to 79.1%, decreasing missed melanoma from 29.8% to 20.9% [1,5].
• 91.5% of the study physicians agreed the device added value to their clinical care [1].
• 75% agreed it would help detect more skin cancers [1,5].
• 71% reported increased confidence in evaluating skin lesions [1,8].

Clinical Significance

The DermaSensor solution offers rapid, objective assessment of skin lesions at the point of care, providing a 0-10 risk scale with “Investigate Further” or “Monitor” guidance within seconds for suspicious lesions [6,8]. Bridging gaps in dermatology access helps ensure timely evaluation of high-risk lesions while optimizing triage and resource allocation [1,3,5,8].

“By giving PCPs access to an AI-powered tool that objectively analyzes skin lesions in real time, we can help bridge the gap in dermatology access and ensure more patients receive timely, appropriate care,” said Dr. Falk, co-author and family medicine physician at Florida State University College of Medicine [1].

A Transformative Tool for the Future of Skin Cancer Detection

With rising skin cancer incidence nationwide, DermaSensor’s AI-powered, handheld device offers a scalable solution for improving detection, reducing unnecessary referrals, and enabling earlier intervention [2,5,8].

“This independent prospective UPMC study further reinforces that DermaSensor has strong and highly generalizable performance across different health systems and across the primary care and dermatology settings. Many published studies have shown that performance issues with generalizability and with skin of color are major shortcomings for image-based tools,” said Cody Simmons, CEO of DermaSensor. “Our spectroscopy-based system has already been used to test tens of thousands of lesions by several hundred doctors in the US, even though we just received FDA clearance last year. In the years to come, we look forward to our device helping tens of thousands of doctors to improve care for millions of patients.” [6,8]

About DermaSensor Inc.

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

References

1. Seiverling, E.V. (2025). JCAD MRMC Study. Journal of Clinical and Aesthetic Dermatology, October 2025, 58–65. Link
2. American Cancer Society. Cancer Facts & Figures 2025.
3. Ferris, L.K., et al. (2025). DERM-SUCCESS FDA Pivotal Study. JCAD, 2025.
4. Manolakos, D., et al. (2024). AI-Enabled ESS in Primary Care. JAAD International, 2024.
5. DermaSensor Inc. (2025). FDA Clearance and AI-Powered Device Overview.
6. DermaSensor Inc. (2025). Published FDA Pivotal Studies – Sensitivity/PPV.
7. DermaSensor Inc. (2023). Device Performance Across Skin Tones.
8. Jaklitsch, E., Chang, S., Bruno, S., D’Angelo, N., Tung, J.K., Ferris, L.K. (2025). Prospective evaluation of an AI-enabled ESS device for triage of patient-identified skin lesions in dermatology clinics. JAAD International, Dec 2025. Mendeley Supplementary Data

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