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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: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

2022-05-18 14:15

Today, the annual general meeting of 2022 was held in SciBase Holding AB (publ) (the “Company” or “SciBase”). Below follows a summary of the resolutions passed at the annual general meeting.

The annual general meeting resolved:

to adopt the profit and loss statement and the balance sheet and the group profit and loss statement and the group balance sheet for the financial year 2021;
that SEK 202,229,730 shall be carried forward in new account and that no dividend shall be paid;
to grant the board members and the CEO discharge from liability for the financial year 2021;
that the board of directors shall consist of five ordinary members without deputy members and that a registered accounting firm shall be elected as auditor;
that the fees payable to the board of directors for the period until the end of the next annual general meeting shall be SEK 200,000 for the chairman of the board and SEK 150,000 to each of the other ordinary board members (who are not employed by a larger shareholder in the Company) and that fees payable to the auditor is to be paid in accordance with approved invoices;
for the period until the end of the next annual general meeting, to re-elect Jvalini Dwarkasing, Diana Ferro, Matt Leavitt, Thomas Taapken and Tord Lendau as board members, to re-elect Tord Lendau as chairman of the board of directors and to re-elect the auditing firm PricewaterhouseCoopers AB (PwC) as auditor for the Company, with Magnus Lagerberg as auditor-in-charge;
to adopt principles for the appointment of a nomination committee (same principles as previous year); and
to authorize the board of directors to increase the share capital through issuance of new shares, warrants and/or convertible debentures. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company and may be made either in cash and/or by way of set-off or contribution in kind or otherwise be conditional. Through issuances resolved upon with support from the authorization – with deviation from the shareholders’ preferential rights – the number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall correspond to not more than a 20 per cent dilution of the share capital and the number of shares and votes in the Company after such issue(s).

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

The information was submitted, through the agency of the contact person set out above, for publication at the time stated by SciBase’s news distributor Cision upon publication of this press release.

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.

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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: simon.grant@scibase.com Certified Advisor (CA):. Vator Securities Tel: +46 8 580 065 99 Email: ca@vatorsec.se 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 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: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

"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: simon.grant@scibase.com

Certified Advisor:
Vator Securities
Tel: +46 8 580 065 99
Email: ca@vatorsec.se

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: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

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: michael.colerus@scibase.com

Certified Advisor:

Vator Securities

Tel: +46 580 065 99

Email: ca@vatorsec.se

The information was submitted for publication, through the agency of the contact person set out above, at 09.00 CET on April 22, 2022.

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: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

Excerpt from the official consortium press release:

The Dutch Research Council (NWO) has, within the framework of Research along Routes by Consortia (NWA-ORC), awarded the research project Next Generation Immuno-Dermatology (NGID) with a prestigious grant of 11.7 MEuro. NGID is a nationwide, large-scale project to unravel novel biomarkers for six different skin diseases. These biomarkers will drive a high-tech, patient-centric approach in clinical practice.

In the Netherlands over 2.5 million patients suffer from chronic inflammatory skin diseases. Although not life-threatening, the personal impact and socio-economic costs of these chronic conditions are very high. The biggest problem is that many treatments are not suited for every patient and often do not work.

NGID will tackle this problem and will develop the right care for the right patient at the right time. Within this 6-year project six inflammatory skin diseases will be investigated in ultra-high detail. For this approach, a unique, international consortium consisting of scientific institutes, universities, high-tech companies, hospitals, patient associations and (bio)pharmaceutical industry has been setup. Dermatologists from all Dutch University Medical Centers will be connected to biologists, bio-informaticians, statisticians, behavioural scientists, communication researchers and of course to the patient. By means of a new data analysis and integration approach, NGID will make patient-specific fingerprints that will guide the best care for the individual patient in the future- Link to official webpage:

https://www.nwo.nl/onderzoeksprogrammas/nationale-wetenschapsagenda-nwa/onderzoek-op-routes-door-consortia-orc-2

Simon Grant CEO of SciBase comments:

"This project provides a concrete example of how SciBase is helping to advance the management of skin diseases. The importance of the skin barrier in diseases such as atopic dermatitis is well known, but until now it has not been possible to evaluate the barrier in routine clinical practice. SciBase's Nevisense and Nevisense Go were chosen for this project because of their ability to evaluate the skin barrier from an atopic dermatitis perspective in routine clinical and even home use. The inclusion of these SciBase products in this consortium is a testament to the robust diagnostic potential of the SciBase technology. Understanding the status of the barrier will in turn help steer therapy and patient management overall, and we are proud to contribute to this progress.

The goal of the NGID project is to improve the standard of care within Dermatology and to expand the personalization of disease management to each patient - in other words, to provide the right care to the right patient at the right time. The opportunity for SciBase is to become an integral part of personalized atopic dermatitis management, and with the very high numbers of patients affected, this is one of the most significant opportunities for SciBase to date", says Simon Grant CEO SciBase.

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

"It is very pleasing to see one of our customers commit so strongly to utilising our product going forward. To me an order like this is the best indication that a customer believes in our technology and the value it can bring them and their patients," says Simon Grant, CEO SciBase.

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se