Kategorie: Allgemein

STOCKHOLM, SWEDEN, – October 26, 2022 – SciBase Holding AB (“SciBase”) [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that a new clinical study has been published presenting the improvement that the Nevisense test provides over standard of care visual and dermoscopic evaluation. The article named “Electrical impedance spectroscopy significantly enhances correct biopsy choice for pigmented skin lesions beyond clinical evaluation and dermoscopy” has been published in the journal “Melanoma Research”. The study included 231 US Dermatologists making a total of 33.957 biopsy decisions. The study participants showed a statistically significant improvement in correct biopsy decisions beyond their dermoscopic evaluation when integrating the Nevisense result. With Nevisense, Dermatologists identified more melanomas for biopsy; their sensitivity increasing from 85.2% to 91.1%. The article is available through the following link: https://journals.lww.com/melanomaresearch/Abstract/9900/Electrical_impedance_spectroscopy_significantly.42.aspx Prof Darrell Rigel, Icahn School of Medicine at Mount Sinai, New York and author of the study commented: “The overall findings from this study demonstrate that the integration of EIS technology into PSL biopsy decisions has the potential to significantly improve the accuracy of lesion selection for biopsy beyond clinical and dermoscopic evaluation alone.” “This is a very important study and result for SciBase as it quantifies the improvement in clinical decision-making possible with Nevisense compared to visual methods that are today considered the standard of care. As expected, the study showed that dermoscopy improved decision making over naked eye assessment, but more importantly it showed that using Nevisense further improved clinician performance by at least as much again. Adding Nevisense clearly resulted in the best clinical management decisions.  This is one of several publications that shows that Nevisense has a significant role in the challenging process for clinicians to identify malignancies”, says Simon Grant, CEO of SciBase. For more information, please contact:Simon Grant, CEO SciBaseTel: +46 72 887 43 99Email:  Certified Advisor (CA): Vator Securities Tel: +46 8 580 065 99 Email:  About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.  All press-releases and financial reports can be found here : http://investors.scibase.se/en/pressreleases The post New study shows Nevisense significantly improves US clinician’s decision-making beyond dermoscopy first appeared on Scibase.

The appointments have been made in accordance with the instructions regarding principles for the appointment of the company nominating committee which were determined at the Annual General Meeting of SciBase Holding on May 18, 2022. The Annual General Meeting of SciBase Holding AB (publ) will be held on May 18, 2023 in Stockholm. Shareholders who wish to have an item considered at the Annual General Meeting can submit a request to the Board to this effect. Such a request for an item to be considered is to be sent to SciBase Holding AB (publ), Att: Chairman of the Board, Box 3337, 103 67 Stockholm, and must have been received by the Board no later than seven weeks before the Annual General Meeting, or otherwise in such good time that the matter, where necessary, can be included in the notice to attend the Annual General Meeting. Stockholm, October 7, 2022 SciBase Holding AB (publ)  For more information, please contact:Tord Lendau, Chairmain of the board, phone +46 (0)70 810 01 67 Michael Colérus, CFO, phone +46 70 341 34 72 Certified Advisor (CA): Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.  All press-releases and financial reports can be found here : http://investors.scibase.se/en/pressreleases The post The following people have been appointed as members of SciBase Holding’s nominating committee for the Annual General Meeting in 2023: first appeared on Scibase.

The use of professional and household cleaning agents is associated with an increased risk of developing allergic disorders. In line with this, impairment of the epithelial barrier is also associated with the development of allergic disorders. The aim of the study was to utilize Nevisense and Electrical Impedance Spectroscopy (EIS) to assess the effect of commercially available detergents on the skin barrier of mice. The top line results of the study indicated that: Even at very low concentrations household detergents can impact the epidermis integrity, leading to an impaired skin barrier. Prolonged exposure to detergent residue in clothes could progressively impair the barrier, leading to a higher risk of allergen sensitization. Detergents could also aggravate already existing allergic disorders such as atopic dermatitis, increasing disease severity. EIS is a fast and reliable tool for in vivo detection of barrier function with possible applications in dermatological and cosmetic studies. „Since the 1960’s we have seen a pandemic-scale increase in the prevalence of allergic diseases, affecting one billion individuals. This study highlights the risk that laundry detergents are contributing to this development, as further described in our „epithelial barrier hypothesis“. We are very encouraged to see that EIS measurements could identify skin barrier impairment at such an early stage and at such low detergent concentrations. EIS provides an increasingly useful tool for such evaluations“ said Professor Cezmi Akdis at SIAF (Swiss Institute of Asthma and Allergy Research). „This is a fascinating study that shows the negative effect of common household detergents on the skin barrier, and though a mouse study, there are clearly implications for the general population. Skin barrier integrity is an important factor in many allergic diseases and EIS measurements of the skin barrier can provide unique and valuable insights in the prevention and management of these diseases. Studies have already shown that Nevisense can discriminate between patients with and without atopic dermatitis through non-lesional skin measurements and has the potential to track improvement after therapy. We believe that Nevisense and EIS have the potential to become a standard of care in this space and a very significant opportunity for SciBase.“, says Simon Grant CEO SciBase. For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.  All press-releases and financial reports can be found here : http://investors.scibase.se/en/pressreleases The post Nevisense detects skin barrier damage in mice caused by household detergents first appeared on Scibase.

Panel members urged caution for skin cancer detection SLAs and Apps and stressed the need for more high quality research to validate these technologies. „The standards would have to be set very high for new products, especially those intended for consumers,“ said FDA panelist Murad Alam, MD, a dermatologist from Northwestern University, Chicago, Illinois. The panel also considered the FDA’s proposal to change the classification status of Nevisense and any new products that assist dermatologists in melanoma detection from the most stringent regulatory category, class III, to the less restrictive class II. The Panel underscored the potential risks of reclassifying these technologies and strongly recommended keeping them in the class III category. SciBase shared the same opinion as panel experts through written submissions and oral presentations. SciBase believes the current process where FDA sets very high standards and is closely involved in clinical validation study design is the most appropriate. „We very much agree with the Panel’s recommendation. Nevisense is currently the only SLA available on the market and we have gone through the very rigorous Class III PMA (Pre Market Approval) process with it’s extremely high safety demands. Reclassifying this type of product to Class II would reduce the level of FDA oversight for new products entering into this space; something we believe could potentially compromise patient safety. While the FDA is not legally bound to follow the Panel’s recommendation, we believe that such an overwhelming recommendation will be difficult for the FDA to ignore. A final decision from FDA could take months or years, though it is our belief that even in the medium term a decision would not practically affect Nevisense or the market itself as stringent requirements on clinical study data would still apply.“, says Simon Grant CEO SciBase. For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post FDA expert panel in line with SciBase position to keep stringent approval level for all new skin lesion analyzers first appeared on Scibase.

The aim of the study was to investigate the impact Electrical Impedance Spectroscopy (EIS) has on clinical decision-making for atypical pigmented skin lesions (PSLs) when compared to other diagnostic tools such as dermoscopy. Dermatologists, dermatology residents, and medical students completed an online survey eliciting their biopsy decisions for 24 atypical PSLs of varying histopathological diagnosis. Half of the lesions from each diagnosis group were presented as a clinical image with associated dermoscopic image and the other half as a clinical image with the corresponding EIS (Nevisense) score. The study showed a significant increase in diagnostic accuracy with Nevisense, especially for respondents who reported rarely using dermoscopy. This group showed the greatest improvement in sensitivity and specificity when using EIS compared to dermoscopy.   “The study results showed that EIS may complement dermoscopy by helping a broader range of providers make improved PSL diagnostic decisions. This will ultimately improve patient care and reduce the morbidity and mortality associated with melanoma.” says Dr Ungar at Icahn School of Medicine at Mount Sinai. „The study further demonstrates the positive impact Nevisense has in the diagnostic process for clinicians when evaluating atypical pigmented skin lesions. The study showed that the addition of the Nevisense EIS data significantly increased the accuracy of clinicians. Clinician sensitivity increased from 66% to 75% and specificity from 40% to 70% which is a significant improvement. This further supports our market development efforts for the Nevisense EIS technology in the US”, says Simon Grant CEO SciBase. The full article can be found here: https://www.jofskin.org/index.php/skin/article/view/1568/pdf For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post US study shows that EIS and Nevisense significantly improves clinicians’ diagnostic accuracy first appeared on Scibase.

The first quarter in figures Net sales amounted to TSEK 4,260 (2,562). The loss after tax amounted to TSEK 9,736 (8,153). The loss per share amounted to SEK 0.14 (0.15). The cash flow from current operations was negative in the amount of TSEK 10,512 (9,473). The gross margin reached 62.8% (52.7%). Electrode sales volume increased by 33% and reached 9,982 (7,496) units. Repeat sales of electrodes to existing customers increased by 34%. Important events during the quarter Overall sales increased by 66% (+58%, before currency effects). The sales in the important US market increased within the area of skin cancer by 541% (in local currency by 475%). Sales in Germany increased by 54% (49% in local currency). SciBase Barrier technology part of major immunodermatology project – Next Generation Immunodermatology. The NGID consortium is based in the Netherlands and will run over 6 years, leveraging the expertise from several different groups across academic, clinical, and industrial research settings. A new study from the US supporting the use of Nevisense in diagnosing melanoma was published in „SKIN – The journal of cutaneous medicine“. The study shows that Nevisense provides valuable diagnostic guidance when evaluating atypical pigmented skin lesions. SciBase further strengthened the patent portfolio as patent application: EP Application No. 18729063.0 was granted by EPO in Europe. SciBase announced a change in the Management team and a new head of Quality and Regulatory Affairs Important events after the end of the     period A new study performed in Germany and published online in the journal Dermato demonstrated the clinical benefits of Nevisense in day-to-day practice Financial overview    Apr 1 2021 –  Jan 1 – Mar 31 Mar 31 2022 Jan 1 – Dec 31 THE GROUP 2022 2021 Rolling-12 2021 Net sales, SEK ths 4 260 2 562 13 425 11 727 Gross margin, % 62,8% 52,7% 58,9% 56,1% Equity/Asset ratio, % 79,3% 79,6% 79,4% 82,8% Net indebtness, multiple 0,26 0,26 0,26 0,21 Cash equivalents, SEK ths 54 621 31 403 54 621 65 607 Cashflow from operating activities, SEK ths -10 512 -9 473 -40 540 -39 501 Earnings per share (before and after dilution), SEK -0,14 -0,15 -0,66 -0,67 Shareholder’s equity per share, SEK 0,88 0,70 0,75 1,13 Average number of shares, 000′ 68 475 54 780 66 183 62 739 Number of shares at closing of period, 000′ 68 475 54 780 68 475 68 475 Share price at end of period, SEK 4,70 4,78 4,70 5,52 Number of sold electrodes, pieces 9 982 7 496 32 278 29 792 Average number of employees 18 18 18 17 This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on May 12, 2022. Contact person: Michael Colérus, CFO. +46 70 341 34 72 For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA): Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post Interim Report Q1 2022 first appeared on Scibase.

„It has been a busy start to the year and we see an exciting year in front of us with US growth and progress with the skin barrier application.,“ says Simon Grant, CEO SciBase. For more information please contact:Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email:   Certified Advisor:Vator Securities Tel: +46 8 580 065 99 Email:    About SciBase and NevisenseSciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post SciBase to present at the Redeye Medtech & Diagnostics Seminar on May 11, 2022 first appeared on Scibase.

The study looked at the real-life clinical effectiveness of Electrical Impedance Spectroscopy (EIS) when using Nevisense to detect malignancies in an everyday clinical setting. In summary, the study clinic showed a reduction in the number of unnecessary excisions of 47%, while still detecting 100% of melanomas. Clinicians combine Nevisense with visual and dermatoscopic examinations to identify atypia in the cell structure of lesions that normally cannot be seen.  The result provides better identification of which lesions to biopsy or excise and which lesions to leave. “For several years, electrical impedance spectroscopy has been an essential part of the skin check procedure in my practice, so I can offer the best possible quality to my patients, with very high sensitivity on Skin Cancer, and less burden caused by unnecessary surgery. Nevisense and EIS is supporting me in making the right clinical decision and ensuring that we excise the right suspicious lesions and that we don’t miss any melanomas,” says Dr Christoph Liebich. „This is a very positive study illustrating the clinical benefits of Nevisense in a real-life practice setting. What we see is that with the help of Nevisense close to 50% of unnecessary excisions were avoided. For some time we have seen that results in routine clinical practice are even better than in our pivotal trial, so it is encouraging to see this demonstrated in this publication.”, says Simon Grant CEO SciBase. The full article can be found here: https://www.mdpi.com/2673-6179/2/2/4/htm For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post German study shows clinical benefit of Nevisense first appeared on Scibase.

A pdf-version of the annual report is enclosed to this press-release. A printed version of the Annual report will only be distributed to shareholders who actively request a printed copy. For more information, please contact: Michael Colérus, CFO Tel: +46 70 341 34 72 E-mail: Certified Advisor: Vator Securities Tel: +46 580 065 99 Email: The information was submitted for publication, through the agency of the contact person set out above, at 09.00 CET on April 22, 2022. About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post SciBase publishes the Annual report for 2021 first appeared on Scibase.

In addition, SciBase was granted their first patent within the skin barrier area in Sweden in November. This patent named `Epithelial barrier function‘ with application no 1851376-2, was granted by the Swedish patent authority and is seen as a positive indication that an EPO patent will also eventually be granted. „An early focus on intellectual property from the SciBase founders provided the platform for our broad patent portfolio that now includes eight families and 69 granted patents. These two patents further strengthen our IP portfolio. The Swedish patent is also an important step in the process towards an EPO patent for the barrier application„, says Simon Grant CEO SciBase. For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com. The post SciBase further strengthens patent portfolio first appeared on Scibase.