STOCKHOLM, SWEDEN, — May 10, 2021 – SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that it has been granted certification under the new Medical Device Regulation (MDR).
MDR is a set of mandatory legal requirements central for all companies selling medical devices in the EU. The new regulation comes into effect on May 26th. SciBase is one of very few medical device manufacturers to have completed the MDR certification, after an intensive two year process. With the MDR Certification in place SciBase can release new products, indications and functionality such as their new Non-melanoma Skin cancer (NMSC) application.
The MDR was introduced by the European Union to establish a modernized and more robust legislative framework for medical devices. The aim is to ensure better protection of public health and patient safety by improving the quality, safety and performance of medical devices.
Until now, Medical devices have been CE-marked through the MDD (Medical Device Directive). Following various incidents such as the PIP breast implant scandal in France, the EU decided to improve safety and control by strengthening the regulation of medical devices. The result is the MDR industry regulations.
MDR tightens the control mechanisms for medical devices, including medical software and Apps and will have substantial impact on medical device manufacturers and distributors.
“Achieving MDR has been a strategically important goal for SciBase, because MDR is necessary for us to add new applications such as NMSC (Non-Melanoma Skin Cancer) to our platform – which is key to our strategy. For customers this will result in better products. For the industry this raises the bar in terms of what it takes to operate in this space. This has been a challenging project for SciBase, where parts of the process that were out of our hands didn’t progress as we expected; but we made it in the end. I believe many companies will struggle to achieve certification and so we believe MDR certification will be a competitive advantage going forward. Overall, it is another milestone as we execute our strategy to provide our customers with additional clinical applications using our unique technology platform” says Simon Grant, CEO of SciBase.
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 above, at 16.00 CET on May 10, 2021.
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
STOCKHOLM, SWEDEN, - April 15, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the publication of a groundbreaking article presenting the "epithelial barrier hypothesis" in Nature Reviews Immunology. The article was written by Professor Cezmi Akdis at the Swiss institute of Allergy and Asthma Research (SIAF). Prof. Akdis is the key research collaborator in SciBase's product development for skin barrier assessment. The article presents the background for the steep increase in allergic diseases over the last decades, and how this increase is connected to industrialization and modern lifestyle.
Simon Grant, CEO of SciBase commented "This article shows just how important the skin and epithelial barrier in general, are in the development of a range of diseases. It also illustrates the potential value of tools for epithelial barrier assessment. This week Prof Akdis and his team in Davos also published an article in Allergy on the use of Nevisense with perhaps the most common barrier-related disease, atopic dermatitis. The Nature article is impressive in its breadth and by extension what it can mean for SciBase's barrier assessment technology. I think this will help followers of SciBase understand why we have included barrier assessment as a key component of our strategy. The article is not just important from a scientific perspective; we also believe it will, together with the previously published article in Allergy, drive interest from researchers and potential industry partners. "
Professor Akdis provides some background. "There has been a steep increase in allergic and autoimmune diseases, reaching epidemic proportions and now affecting more than one billion people worldwide. These diseases are more common in industrialized countries, and their prevalence continues to rise in developing countries in parallel to urbanization and industrialization. Intact skin and mucosal barriers are crucial for the maintenance of tissue homeostasis as they protect host tissues from infections, environmental toxins, pollutants and allergens.
A defective epithelial barrier has been demonstrated in allergic and autoimmune conditions such as asthma, atopic dermatitis, allergic rhinitis, chronic rhinosinusitis, eosinophilic esophagitis, coeliac disease and inflammatory bowel disease. In addition, leakiness of the gut epithelium is also implicated in systemic autoimmune and metabolic conditions such as diabetes, obesity, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis and autoimmune hepatitis. Finally, distant inflammatory responses due to a `leaky gut' and microbiome changes are suspected in Alzheimer disease, Parkinson disease, chronic depression and autism spectrum disorders.
The article introduces the `epithelial barrier hypothesis', which proposes that the increase in epithelial barrier-damaging agents linked to industrialization, urbanization and modern life underlies the rise in allergic, autoimmune and other chronic conditions. Furthermore, it discusses how the immune responses to impaired microbiota, which normally acts as a barrier against pathogens, may be involved in the development of these diseases.
The research started in 1998 with the first studies showing mechanisms of eczema, mechanisms of epithelial cell death and continued with more than 60 publications, many major discoveries and one ready to use skin barrier detection instrument.
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
About SIAF-SFI
The Swiss Institute of Allergy and Asthma Research (SIAF) is a department of the foundation Swiss Research Institutes for High Altitude Climate and Medicine Davos (SFI), an affiliated institute of the University of Zurich, and member of the Life Science Zurich Graduate School. SIAF members play leading roles in national and international organizations, such as European Academy of Allergy and Clinical Immunology and in editorial boards and editorships of top Journals in the field of allergy asthma and clinical immunology. At the same time, SIAF fulfills teaching obligations in the University of Zurich. The research activities at SIAF are focused on patient-relevant translational research and the investigation of the immunological principles in the field of skin atopic dermatitis, allergies and asthma to develop approaches for new preventive and curative treatments for patients. SIAF also promotes personalized medicine to develop treatment approaches that are better tailored to the needs of individual patients. These personalized medicine research activities are expected to not only help to find tailor-made therapies but also to develop more precise diagnosis. The continuously growing SIAF is one of the most cited and leading institutes in its area worldwide with more than 50,000 citations and 1,000 original research articles in the last 20 years. SIAF organizes the internationally renowned World Immune Regulation Meeting (WIRM) in Davos every year. SIAF works in close collaboration with the Christine Kühne-Center for Allergy Research and Education (CK-CARE), Davos. Further information is available at www.siaf.uzh.ch.
The shareholders in SciBase Holding AB (publ), reg. no. 556773-4768 (the "Company"), are hereby given notice to attend the annual general meeting at 2:00 p.m. on Tuesday 18 May 2021. The meeting will be held through postal voting only (see below).
Special arrangements due to the risk for spread of the virus COVID-19 (coronavirus)
The board of directors has, in light of continued spread of the coronavirus and in accordance with the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations, decided that the annual general meeting shall be held without physical presence of shareholders, proxies and/or external parties and that the shareholders shall have only the opportunity to vote by mail prior to the annual general meeting.
The Company welcomes all shareholders to exercise their voting rights at the annual general meeting through postal voting as described below. Information on the resolutions passed at the annual general meeting will be published on Tuesday 18 May 2021, as soon as the result of the postal voting has been finally confirmed.
Notice
Shareholders wishing to participate at the annual general meeting must be entered in the shareholders' register, kept by Euroclear Sweden AB (the Swedish Central Securities Depository & Clearing Organisation), on the record day which is Friday 7 May 2021 and no later than on Monday 17 May 2021 notify the Company of their attendance by casting their postal vote in accordance with the instructions under the heading "Postal voting" below so that the postal voting form is received by Setterwalls Advokatbyrå AB no later than that day. Please note that a notification to attend the general meeting can only be done by a postal vote. A shareholder represented by proxy shall (as always) issue a power of attorney. Further instructions regarding this are available below under the heading "Proxy voting".
Nominee registered shares
Shareholders who have their shares registered in the name of a nominee must request temporary entry in the transcription of the share register kept by Euroclear Sweden AB (so-called voting rights registration) in order to be entitled to participate and vote for their shares at the meeting through postal voting. The shareholder must inform the nominee well in advance of Friday 7 May 2021, at which time the register entry must have been made. Voting rights registration that have been requested by the shareholder at such time that the registration has been completed by the nominee no later than Tuesday 11 May 2021, will, however, be taken into account in the preparation of the share register.
Postal voting
The shareholders may exercise their voting rights at the annual general meeting only by voting in advance, so-called postal voting, in accordance with Section 22 of the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations.
A special form shall be used for postal voting. The form will be available on the Company's website, http://investors.scibase.se/en/annual-general-meeting-2021.The postal voting form is considered as the notification of participation at the annual general meeting.
The completed voting form must be received by Setterwalls Advokatbyrå AB no later than Monday 17 May 2021. The form may be submitted by post to Setterwalls Advokatbyrå AB, Attn: Johan Tönnesen, Box 1050, 101 39 Stockholm or via e-mail to [email protected].
The shareholder may not provide special instructions or conditions in the voting form. If so, the vote (i.e. the postal vote in its entirety) is invalid. Further instructions and conditions are included in the form for postal voting. The shareholders may request in the postal voting form that a resolution on one or several of the matters on the proposed agenda below should be deferred to a so-called continued general meeting, which cannot be conducted solely by way of postal voting. Such general meeting shall take place if the annual general meeting so resolves or if shareholders with at least one tenth of all shares in the Company so requests.
Proxy voting
A shareholder represented by proxy shall issue a power of attorney which shall be dated and signed by the shareholder. If the shareholder postal votes by proxy, the power of attorney shall be enclosed to the form. If issued by a legal entity, the power of attorney shall also be accompanied by registration certificate or, if not applicable, equivalent documents of authority. Power of attorney forms for those shareholders wishing to postal vote by proxy will be available on the Company's website http://investors.scibase.se/en/annual-general-meeting-2021.
Processing of personal data
For information regarding how your personal data is processed in connection with the annual general meeting, please refer to the privacy policy on Euroclear Sweden AB's website, https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.
Proposed agenda
Opening of the meeting and election of chairman of the meeting.
Preparation and approval of the voting list.
Approval of the agenda.
Election of one person who shall approve the minutes of the meeting.
Determination of whether the meeting has been duly convened.
Submission of the annual report and the auditor's report as well as of the consolidated financial statements and the auditor's report on the group.
Resolution in respect of:
adoption of the profit and loss statement and the balance sheet as well as of the consolidated profit and loss statement and the consolidated balance sheet;
allocation of the Company's results according to the adopted balance sheet; and
the members of the board of directors' and the CEO's discharge from liability.
Resolution regarding the number of members and, where applicable, deputies of the board of directors and number of auditors and, where applicable, deputy auditors.
Determination of the fees payable to the members of the board of directors and the auditors.
Election of members of the board of directors and auditor.
Resolution on principles for the appointment of a nomination committee.
Resolution on an authorisation for the board of directors to resolve upon issues of shares, warrants and convertibles.
Closing of the meeting.
The nomination committee's proposed resolutions
The nomination committee is composed of the chairman of the board of directors of the Company (i.e. Tord Lendau), Christer Jönsson (appointed by Fouriertransform), Iraj Arastoupour and Peter Elmvik. The nomination committee has presented the following proposed resolutions in relation to items 1 and 8-11 in the proposed agenda.
Item 1 - Election of chairman
Olof Reinholdsson (lawyer at Setterwalls Advokatbyrå) is proposed as chairman of the meeting, or if he is unable to attend the meeting, any other person proposed by the board of directors.
Items 8-10 - Election of and remuneration to the board of directors and auditors
The board of directors today consists of the following four (4) ordinary members without deputy members: Tord Lendau (chairman), Diana Ferro, Barbro Fridén and Thomas Taapken. Barbro Fridén has declined re-election since she has received assignments abroad. In the light of the aforementioned, the nomination committee proposes that the board of directors, until the end of the next annual general meeting, shall consist of three (3) ordinary members without deputy members. Furthermore, it is proposed that a registered accounting firm shall be elected as auditor.
The nomination committee furthermore proposes 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). It is proposed that the Company's auditor shall be paid in accordance with approved invoices.
With the exception of Barbro Fridén, who has declined re-election as above, all current board members are proposed to be re-elected until the end of the next annual general meeting. Furthermore, Tord Lendau is proposed to be re-elected as chairman of the board of directors. The nomination committee reserves the right to propose election of an additional board member during the time period after issuance of this notice until the annual general meeting why the nomination committee's proposal under items 8-10 in the agenda may be changed.
The registered accounting firm PricewaterhouseCoopers AB (PwC) is proposed to be re-elected as auditor. The accounting firm has informed that Magnus Lagerberg will remain as principally responsible auditor.
Item 11 - Resolution on principles for the appointment of a nomination committee
The nomination committee proposes the following decision for election of a nomination committee for the annual general meeting 2022 (same principles as the previous year). The nomination committee for the annual general meeting 2022, which shall comprise of four members, shall be appointed by way of that the chairman of the board of directors will consult with the three largest shareholders of the Company at the end of the third quarter of 2021. These shareholders will be requested to each appoint one member who, together with the chairman of the board of directors, will form the nomination committee. The composition of the nomination committee shall be publicly announced no later than six months prior to the annual general meeting. The nomination committee, whose mandate period applies until the time a new nomination committee has constituted itself, shall appoint a chairman among its members. The nomination committee shall prior to the annual general meeting 2022 prepare and submit proposals regarding the election of the chairman of the annual general meeting, the number of board members and, where applicable, deputy members, the number of auditors and, where applicable, deputy auditors, the election of board members, chairman and, where applicable, deputy members, auditor and, where applicable, deputy auditors, remuneration for the board of directors and the auditor, as well as guidelines for the appointment of the nomination committee for the following annual general meeting. The nomination committee's proposals shall be presented in the notice to a general meeting where election of board members and auditor shall take place and on the Company's website. Should a member of the nomination committee resign from its assignment, a replacement shall be sought from the shareholder that appointed the departing member. Should a shareholder that has appointed a member of the nomination committee substantially decrease its ownership in the Company, the next shareholder in size order shall, if the nomination committee so resolves, be requested to appoint a member to the nomination committee.
The board of directors' proposed resolutions
The board of directors of the Company has presented the following proposed resolutions in relation to items 2, 4, 7(ii) and 12 in the proposed agenda.
Item 2. - Preparation and approval of the voting list
The voting list that is proposed for approval is the voting list to be prepared chairman of the general meeting, based on the shareholders' register for the general meeting kept by Euroclear Sweden AB, and postal votes received, and approved by the person appointed by the meeting to approve the minutes.
Item 4. - Election of one person who shall approve the minutes of the meeting
The board of directors' proposes that Christer Jönsson (Fouriertransform) is to be appointed as the person verifying the minutes together with the chairman of the general meeting, or in the event that he or she is prevented from doing so, the person the board of directors appoints instead. The person appointed to verify the minutes shall, apart from approving the minutes of the general meeting together with the chairman of the general meeting, check the voting list and that the result of received votes are correctly reflected in the minutes of the general meeting.
Item 7 (ii) - Allocation of the Company's results according to the adopted balance sheet
The board of directors proposes that SEK 175,081,224 shall be carried forward in new account. Accordingly, no dividend is proposed.
Item 12 - Resolution regarding authorisation for the board of directors to resolve upon issues of shares, warrants and convertibles
The board of directors proposes that the annual general meeting resolves to authorise the board of directors to, until the next annual general meeting, on one or more occasions, decide upon issuances of new shares, issuance of warrants and/or convertibles. 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. 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). The chairman of the board of directors, the managing director or a person appointed by the board of directors shall be authorised to make any minor adjustments required to register the resolution with the Swedish Companies Registration Office.
Shareholders' right to request information
The board of directors and the CEO shall, if any shareholder so requests and the board of directors believe that it can be done without material damage to the Company, provide information regarding circumstances that may affect the assessment of an item on the agenda or of the Company's, or a subsidiary's economic situation. Such duty to provide information also comprises the Company's relation to the other group companies. A request for such information shall be made to the Company in writing no later than on Saturday 8 May 2021. The information will be made available at the Company's office from Thursday 13 May 2021, at the latest. The information will, from the same date, also be available on the Company's website www.scibase.com. The information will also be sent, within the same period of time, to the shareholder who has requested it and stated its address.
Majority requirements
Resolution in accordance with the board of director's proposal in accordance with item 12 on the agenda requires that the general meeting's resolution is supported by shareholders representing at least two thirds of the shares represented at the general meeting as well as of the votes cast.
Number of shares and votes in the Company
The total number of shares in the Company at the time of issuance of this notice is 54,780,086. The Company does not hold any of its own shares.
Documentation
The financial accounts and auditor's report will be kept available at the Company's office and on the Company's website www.scibase.com. Copies of such documents will be sent free of charge to shareholders who so request and state their postal address. The proposals of the board of directors and the nomination committee are set out in full in the notice.
Stockholm, April 2021
SciBase Holding AB (publ)
The board of directors
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
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 AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
SciBase Holding AB (”SciBase” or the “Company”) has updated the Company’s financial calendar for 2021.
As the previous published date for the interim report for the first quarter, May 13th, is a national holiday, the date has now been changed to May 12th.
The updated financial calendar is set out as follows:
May 12 Interim report Q1 2021
May 18 Annual general meeting 2021
August 19 Interim report Q2 2021
November 11 Interim report Q3 2021
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
SciBase hereby announces that the Annual report for 2020 is available at the Company's website 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:
The information was submitted for publication, through the agency of the contact person set out above, at 09.00 CET on April 9, 2021.
About SciBase and Nevisense
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
STOCKHOLM, SWEDEN, - April 12, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the publication of a new clinical study supporting SciBase's strategy to develop multiple clinical applications for the Nevisense and Nevisense Go platforms.
The study is from the Swiss institute of Allergy and Asthma Research (SIAF) and has been published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of atopic dermatitis even on unaffected skin. The Nevisense measurement also correlated with relevant biomarkers for atopic dermatitis.
SIAF, based in Davos, is a world leader within applied allergy and asthma research. SIAF is headed by Director Cezmi Akdis, who is also Professor of the University of Zurich Medical Faculty and one of the directors of the Christine Kühne Center for Allergy Research and Education.
Professor Akdis said `Personalized and precision medicine is becoming one of the most exciting areas in all of medicine. Our research group has proposed the "epithelial barrier hypothesis", which asserts that defective epithelial skin barriers are the main reason for the initiation and increase of allergic and autoimmune conditions such as asthma, atopic dermatitis and inflammatory bowel disease. Furthermore, leakiness of the gut epithelium is also implicated in conditions such as diabetes, obesity, multiple sclerosis, rheumatoid arthritis and others. Moreover, distant microinflammatory responses due to a `leaky gut' and microbiome changes are suspected in Alzheimer's disease, Parkinson's disease, chronic depression and autism spectrum disorders.
Defective skin barrier is an important part of the "epithelial barrier hypothesis". Atopic dermatitis alone affects more than 10% of infants, and represents a huge health and socioeconomic burden. Skin barrier assessment shows potential to be clinically useful for early prediction of disease development, improved diagnosis, disease follow-up and therapy evaluation.
This study shows that the Nevisense method can directly assess the status of epithelial barrier using electrical impedance spectroscopy (EIS). EIS was able to assess epithelial skin barrier integrity, differentiate between patients and controls without AD and characterize lesional and non-lesional skin of patients. EIS also showed a significant correlation with biomarkers associated with inflammatory pathways that may affect the skin barrier. Furthermore, copy numbers of filaggrin, an essential skin barrier molecule significantly correlated with EIS on non-lesional skin of patients. These findings that are presented in the article strongly indicates that Nevisense and the EIS method is a useful tool to detect skin barrier dysfunction.'
SciBase CEO Simon Grant commented "This is an exciting new application area for SciBase, and one where we have unique advantages. Barrier-related diseases are widespread, and assessment of the barrier can help better understand and treat patients. The study illustrates the potential for Nevisense to become a valuable tool for clinicians within AD and other epithelial barrier-related diseases. We see a number of applications with broad market potential, and we are working with SIAF and others to develop clinical products. For SciBase this an important milestone in our strategy to develop multiple clinical applications using our unique technology platform."
The study can be found here : https://onlinelibrary.wiley.com/doi/10.1111/all.14842?af=R.
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
About SIAF-SFI
The Swiss Institute of Allergy and Asthma Research (SIAF) is a department of the foundation Swiss Research Institutes for High Altitude Climate and Medicine Davos (SFI), an affiliated institute of the University of Zurich, and member of the Life Science Zurich Graduate School. SIAF members play leading roles in national and international organizations, such as European Academy of Allergy and Clinical Immunology and in editorial boards and editorships of top Journals in the field of allergy asthma and clinical immunology. At the same time, SIAF fulfills teaching obligations in the University of Zurich. The research activities at SIAF are focused on patient-relevant translational research and the investigation of the immunological principles in the field of skin atopic dermatitis, allergies and asthma to develop approaches for new preventive and curative treatments for patients. SIAF also promotes personalized medicine to develop treatment approaches that are better tailored to the needs of individual patients. These personalized medicine research activities are expected to not only help to find tailor-made therapies but also to develop more precise diagnosis. The continuously growing SIAF is one of the most cited and leading institutes in its area worldwide with more than 50,000 citations and 1,000 original research articles in the last 20 years. SIAF organizes the internationally renowned World Immune Regulation Meeting (WIRM) in Davos every year. SIAF works in close collaboration with the Christine Kühne-Center for Allergy Research and Education (CK-CARE), Davos. Further information is available at www.siaf.uzh.ch.
STOCKHOLM, SWEDEN, - April 12, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that it has today received information that the certification process under the new Medical Device Regulation (MDR 2017/745) has been slightly delayed due to resource issues at the notified body.
As there are no outstanding questions, we expect that the internal process at the notified body will be finalized by the end of April thus delaying the certification process by two weeks from our expected date.
MDR is a set of mandatory legal requirements and central for all companies selling medical devices in the EU. The new regulation will come into force on the 26th of May this year.
"Unfortunately, Covid-19 and the extremely high pressure on all notified bodies from Companies has delayed our MDR certification by two weeks. This is both unexpected and highly frustrating after more than two years working on this project, but this part of the process is out of our hands. At this time we do not see a risk for further delay, but this final step lies with our notified body." says Simon Grant, CEO of SciBase.
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The loss after tax amounted to TSEK 9,839 (10,207).
The loss per share amounted to SEK 0.20 (0.61).
The cash flow from current operations was negative in the amount of TSEK 10,290 (8,842).
The gross margin reached 49.4% (58.0%).
Electrode sales volume increased by 4% and reached 7,492 (7,180) units. Repeat sales of electrodes to existing customers increased by 6%.
The full year in figures
Net sales amounted to TSEK 9,521 (9,276).
The loss after tax amounted to TSEK 34,989 (39,594).
The loss per share amounted to SEK 1.12 (2.38).
The cash flow from current operations was negative in the amount of TSEK 33,861 (37,956).
The gross margin reached 52.5% (54.5%).
Electrode sales volume increased by 8% and reached 25,686 (23,724) units. Repeat sales of electrodes to existing customers increased by 9%.
Important events during the quarter
The negative impact of Covid-19 seen in the first half of the year lessened in Q3 and in Q4 sales reached a new quarterly high. Sales in the company's key market Germany increased by 15% while overall sales increased by 9%. The market situation however remains difficult to predict going forward, due to ongoing lockdowns and reduced marketing activities.
SciBase announced the outcome of the exercise of warrants of series TO1. In total 91.4% of the warrants were subscribed for at a price of SEK 1.75, raising MSEK 30 net.
Nevisense Go, SciBase's next generation handheld platform, was released at the end of October. The first version of Nevisense Go will be used by researchers and industrial partners to assess skin barrier function.
SciBase was granted a Category III CPT® code for the Nevisense melanoma detection test in the US.
Two US studies showing improved detection of melanoma by clinicians with Nevisense were published in leading US journals. The studies compared the evaluation of atypical, pigmented skin lesions using visual evaluation alone to visual evaluation plus Nevisense.
The first study validating the use of Nevisense in Non-melanoma skin cancer was published.
Nevisense was included in infant study at Mount Sinai Hospital in New York. Nevisense will be used to measure skin properties including barrier function and evaluate whether these measurements can help predict the development of allergies or monitor their progress.
Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.
Important events after the end of the period
A further German study evaluating the value of using Nevisense on suspected Non-melanoma skin cancer (NMSC, also known as Keratinocyte cancer) in normal clinical practice was published.
A nominating committee was appointed.
July 1 - Sep 30
Jan 1 - Sep 30
THE GROUP
2020
2019
2020
2019
Net sales, SEK ths
3 055
2 800
9 521
9 276
Gross margin, %
49,4%
58,0%
52,5%
54,5%
Equity/Asset ratio, %
79,1%
69,4%
79,1%
69,4%
Net indebtness, multiple
0,26
0,44
0,26
0,44
Cash equivalents, SEK ths
41 427
26 456
41 427
26 456
Cashflow from operating activities, SEK ths
-10 290
-8 842
-33 861
-37 956
Earnings per share (before and after dilution), SEK
-0,20
-0,61
-1,12
-2,38
Shareholder's equity per share, SEK
0,96
1,93
1,50
1,93
Average number of shares, 000'
48 707
16 618
31 287
16 618
Number of shares at closing of period, 000'
54 780
16 618
54 780
16 618
Share price at end of period, SEK
4,62
4,36
4,62
4,36
Number of sold electrodes, pieces
7 492
7 180
25 686
23 724
Average number of employees
17
18
16
18
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 February 19, 2021.Contact person: Michael Colérus, CFO. +46 70 341 34 72
For more information, please contact:
Simon Grant, CEO SciBase
Phone: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
A new study published in the Journal of the American Academy of Dermatology (JAAD) shows that COVID-19 has materially delayed diagnosis for patients with skin cancer and a substantial backlog of undiagnosed cases remain. Rates of skin cancer detection in the study were down by 43-51%. These delays in initial diagnosis and treatment may lead to skin cancers presenting at more advanced stages, with potential increased morbidity and worse melanoma survival outcomes.
The study was based on data collected by the Advanced Dermatology and Cosmetic Surgery (ADCS) group of practices in the US. ADCS is a key partner for SciBase in the US, though SciBase was not directly involved in the study.
"This study shows that COVID-19 has had a significant negative effect on the rates of skin cancer diagnosis, primarily due to a reluctance from patients to visit clinics. This effect has been seen in Europe as well. We expect an increased focus on skin cancer and diagnosis once effects of the pandemic have subsided, and this represents a likely increase in demand for products such as ours", says Simon Grant, CEO of SciBase.
The article can be accessed through the following link: https://www.jaad.org/article/S0190-9622%2821%2900082-7/fulltext
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
SciBase's head of product development, David Melin, has resigned from his position and has accepted a role at another company. The company is reviewing options for the role going forward.
"I would like to take the opportunity to thank David for his exceptional work at SciBase, and especially his work with our Nevisense hardware platforms. David has managed a very well-functioning development team, and I wish him all the best in his future role", says Simon Grant CEO SciBase.
For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
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 AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and an FDA approval (PMA) in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
