STOCKHOLM, SWEDEN, - November 2, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that they have been granted a Category III CPT®(CPT III) code from the American Medical Association (AMA) for their Nevisense melanoma detection test.

SciBase is therefore very pleased to announce that their CPT III code application for the Nevisense melanoma detection test was approved at the AMA's October meeting without opposition, according to the CPT Editorial Summary of Panel Action October 2020 which was released on October 30th.  The code will be published on the 1st January 2021 and be accessible to providers and payers across the US from the 1st July 2021.

As yet, the code does not have a payment attached to it, and the company will now focus on securing a suitable payment level and coverage with selected payors. Importantly, when the code is "effective" customers will be able to easily submit claims for reimbursement through existing billing systems. This will help track utilization which will support our efforts to achieve coverage, and our first objective is to achieve local coverage by CMS (Center for Medicare and Medicaid services) in selected states in 2021.

"This approval is an important milestone in our process to secure payment and coverage for our procedure" says Simon Grant, CEO of SciBase "We are very pleased to have secured the approval; very few companies achieve this level of success. The fact that Medicare's local organisations (Medicare Administrative Contractors  or MACs) have recently changed their policies means they are now open to consider procedures with CPT III codes for coverage. Our goal is for the Nevisense procedure to achieve coverage under Medicare, which would be an important step towards commercial success. We have further work to do in our discussions with payors, but this decision and our inroads in key markets mean we have a good foundation for the remainder of the process".

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.

Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.  

 "Our manufacturing of single use electrodes is of strategic importance to the Company and one of our more important projects going forward is to streamline the manufacturing process and increase the production capacity. Therefore, it is only natural that Linn, who started at SciBase in August, now becomes a member of the management team. With Linn on the team we get important strategic competence into the management team", says Simon Grant CEO SciBase.

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Asdvisor:
Avanza
Tel: +46 8 409 421 20
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 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.

January 1 - September 30, 2020

The third quarter in figures

• Net sales amounted to TSEK 2,287 (1,940).
• The loss after tax amounted to TSEK 7,350 (9,868).
• The loss per share amounted to SEK 0.20 (0.59).
• The cash flow from current operations was negative in the amount of TSEK 6,974 (10,264).
• The gross margin reached 52.7% (53.4%).
• Electrode sales volume increased by 46% and reached 6,924 (4,752) units. Repeat sales of electrodes to existing customers increased by 57%.

The first nine months in figures

• Net sales amounted to TSEK 6,466 (6,476).
• The loss after tax amounted to TSEK 25,150 (29,387).
• The loss per share amounted to SEK 0.99 (1.77).
• The cash flow from current operations was negative in the amount of TSEK 23,571 (29,114).
• The gross margin reached 54.0% (53.1%).
• Electrode sales volume increased by 10% and reached 18,194 (16,544) units. Repeat sales of electrodes to existing customers increased by 10%.

Important events during the quarter

• The Covid-19 pandemic has affected SciBase from the end of Q1. There was a recovery in sales levels in Q3 due to good electrode sales to existing customers, but system sales remain affected. Sales in the company's key market Germany increased by 23% while overall sales increased by 18% in the quarter. It is however difficult to predict how Covid-19 will affect sales and Group activities going forward.
• Nevisense was selected for `SpotCheck' remote melanoma detection evaluation study by The Ronald O. Perelman Department of Dermatology at NYU Langone Health in New York

Important events after the end of the period

• SciBase announced the outcome of the exercise of warrants of series TO1. In total, 91.4% of the warrants were subscribed for to the set subscription price of SEK 1.75.
• Nevisense Go, SciBase's next generation handheld device, was released at the end of October. The first version of Nevisense Go will be used to assess skin barrier function by researchers and industrial partners.
• SciBase was granted a Category III CTP® 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.
• 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.

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 November 12, 2020.

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]

Certified Advisor: 
Avanza AB 
Phone: +46 8 409 421 20 
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.

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

The subscription period regarding the warrants of series TO1 which was issued in connection with SciBase Holding AB's (publ) ("SciBase" or the "Company") issue of 19,941,721 units on 26 March 2020 commence on 5 October 2020. The exercise price for exercise of warrants has been determined to SEK 1,75.

The board of directors of SciBase resolved, on 26 March 2020, to carry out a fully guaranteed rights issue of up to 19,941,721 units with a subscription price of SEK 1.25 per unit. Each unit consisted of one (1) share and one (1) warrant free of charge, and every warrant entitles the holder to subscribe for one (1) new share in the Company. The warrants (ISIN SE0014399689) may be exercised for subscription of new shares during the period 5 October -16 October 2020 and the last day of trading in the warrants is 14 October 2020.

According to the terms of the warrants, the exercise price shall correspond to 70 percent of the volume-weighted average price of the Company's share on Nasdaq First North Growth Market during a period of ten (10) trading days immediately preceding 30 September 2020 (including 30 September 2020), but not less than SEK 1 and not more than SEK 1.75 per share. The volume-weighted average price for the Company's share amounted to approximately SEK 4.06 during this period, and hence, the exercise price has been determined to SEK 1.75 pursuant to the terms of the warrants.

If all warrants are exercised for subscription of new shares, the number of shares and votes in the Company will increase by a maximum of 19,941,721, from 36,559,822 to a maximum of 56,501,543 shares and votes. The share capital will increase by a maximum of SEK 997,086.05, from SEK 1,827,991.10 to a maximum of SEK 2,825,077.15 if all warrants are exercised. Provided that all warrants are exercised for subscription of new shares, the capital contribution to the Company will amount to approximately SEK 34.9 million before issue costs.

The warrants that are not sold on 14 October 2020 at the latest, alternatively exercised on 16 October 2020 at the latest, will become void. In order for the warrants of series TO1 not to become void, a holder must actively subscribe for shares, alternatively sell warrants.

Full terms and conditions regarding the warrants and information about the Company is available in the prospectus which was approved by the Swedish Financial Supervisory Authority (the "SFSA") and published by the Company on 8 May 2020. The prospectus is available on the Company's website http://investors.scibase.se/sv as well as the SFSA's website www.fi.se.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: [email protected]

Certified Advisor (CA):

Avanza

Tel: +46 8 409 421 20

Email: [email protected]

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.

Important information

Publication, distribution or release of this release can in some jurisdictions be subject to restrictions by law and persons in those jurisdictions where this release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this release is responsible to use this release and information herein in accordance with applicable rules in respective jurisdiction. This release does not contain or constitute an offer, nor an invitation, to acquire or subscribe for shares or other securities in the Company in any jurisdiction, either from the Company or from any others.

The information in this release may not be distributed or sent into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa the United States or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. Acts in contrary to this instruction can constitute a crime according to applicable securities laws. This release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exemption from registration, according to the applicable U.S. Securities Act from 1933 ("Securities Act"), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States.

This release is not a prospectus in accordance with the definition in the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). Complete information regarding the rights issue and the warrants can only be obtained through the prospectus approved by the Swedish Financial Supervisory Authority on 8 May 2020 which is available on the Company's website. Pursuant to article 2 k of the Prospectus Regulation, this press release constitutes an advertisement.

This information is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). This information must not be acted on or relied upon by persons who are not Relevant Persons. An investment or an investment activity referred to in this release is only available in the United Kingdom for Relevant Persons and will only be conducted with Relevant Persons.

This release may include forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and beyond the Company's control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

Information to distributors

For the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) national implementing measures, (together the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the offered shares have been subject to a product approval process, who have established that these shares are: (i) suitable for a target marked consisting of non-professional investors and investors who fulfil the criteria for professional clients and eligible counterparties, each as defined in MiFID II, and (ii) suitable for distribution through all distribution channels that has been approved in MiFID II ("Target Market Assessment"). Irrespective of the Target Market Assessment, distributors should note that: the price of the shares in the Company may decline and investors could lose all or part of their investment; the Company's shares offer no guaranteed income and no capital protection; and an investment in the Company's shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The target market assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the issues.

The target market assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, purchase, or take any other action whatsoever with respect to the Company's shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Company's shares and determining appropriate distribution channels.

SciBase Holding AB (publ) ("SciBase" or the "Company") today announces the outcome of the exercise of warrants of series TO1 which were issued in connection with the Company's 19,941,721 units issue on 26 March 2020. The outcome shows that a total of 18,220,264 warrants were exercised for subscription of 18,220,264 new shares in the Company, corresponding to 91.4 percent of the total number of warrants issued in series TO1.

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.
 

The board of directors of SciBase resolved, on 26 March 2020, to carry out a fully guaranteed rights issue of up to 19,941,721 units at a subscription price of SEK 1.25 per unit. Each unit consisted of one (1) share and one (1) warrant free of charge, and every warrant entitled the holder to subscribe for one (1) new share in the Company.

In total, 18,220,264 warrants of series TO1 have been used for subscription of 18,220,264 shares, meaning that approximately 91.4 percent of the total number of warrants issued in series TO1 were used for subscription of shares. SciBase is hereby provided with a total of approximately SEK 31.9 million before deduction of issue costs.

Through the exercise of 18,220,264 warrants of series TO1, the number of shares and votes in the Company will increase by 18,220,264, from 36,559,822 to 54,780,086 shares and votes. The share capital hereby increases with SEK 911,013.20, from SEK 1,827,991.10 to SEK 2,739,004.30. The dilution for shareholders' who did not exercise any warrants for subscription of new shares amounts to a total of approximately 33.3 percent based on the total number of shares in the Company following the completion of the rights issue and the exercise of the warrants.

The new shares subscribed for by exercise of warrants series TO1 are expected to be admitted for trading on First North Growth Market around October 29, 2020.

Full terms and conditions regarding the warrants and information about the Company is available in the prospectus which was approved by the Swedish Financial Supervisory Authority (the "SFSA") and published by the Company on 8 May 2020. The prospectus is available on the Company's website http://investors.scibase.se/sv as well as the SFSA's website www.fi.se.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: [email protected]

Certified Advisor (CA):

Avanza

Tel: +46 8 409 421 20

Email: [email protected]

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.

Important information

Publication, distribution or release of this release can in some jurisdictions be subject to restrictions by law and persons in those jurisdictions where this release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this release is responsible to use this release and information herein in accordance with applicable rules in respective jurisdiction. This release does not contain or constitute an offer, nor an invitation, to acquire or subscribe for shares or other securities in the Company in any jurisdiction, either from the Company or from any others.

The information in this release may not be distributed or sent into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa the United States or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. Acts in contrary to this instruction can constitute a crime according to applicable securities laws. This release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exemption from registration, according to the applicable U.S. Securities Act from 1933 ("Securities Act"), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States.

This release is not a prospectus in accordance with the definition in the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). Complete information regarding the rights issue and the warrants can only be obtained through the prospectus approved by the Swedish Financial Supervisory Authority on 8 May 2020 which is available on the Company's website.

This information is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). This information must not be acted on or relied upon by persons who are not Relevant Persons. An investment or an investment activity referred to in this release is only available in the United Kingdom for Relevant Persons and will only be conducted with Relevant Persons.

This release may include forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and beyond the Company's control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

Information to distributors

For the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) national implementing measures, (together the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the offered shares have been subject to a product approval process, who have established that these shares are: (i) suitable for a target marked consisting of non-professional investors and investors who fulfil the criteria for professional clients and eligible counterparties, each as defined in MiFID II, and (ii) suitable for distribution through all distribution channels that has been approved in MiFID II ("Target Market Assessment"). Irrespective of the Target Market Assessment, distributors should note that: the price of the shares in the Company may decline and investors could lose all or part of their investment; the Company's shares offer no guaranteed income and no capital protection; and an investment in the Company's shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The target market assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the issues.

The target market assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, purchase, or take any other action whatsoever with respect to the Company's shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Company's shares and determining appropriate distribution channels.

STOCKHOLM, SWEDEN, - October 30, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the release of the first device based on their new platform, Nevisense Go.

Nevisense Go is a handheld and fully portable device the size of a large Pen. It combines the company's core Electrical Impedance Spectroscopy (EIS) measurement technology with a new AI-based analysis platform embedded in the device. The result is a flexible platform that will be significantly easier to both collect data and develop applications on. It will also mean products that are easier for clinicians to use and to integrate into a clinic, and better acceptance by patients.

As previously communicated, the first Nevisense Go version is released for skin barrier assessment and is targeted at researchers and Industry Partners. One of the first sales of the product is to one of the largest global industrial players, and it is this type of customer that we are initially focused on. The first release is for research and does not include a clinical indication (i.e. is released as a non-medical device), but there is significant potential within the research market, and we believe it will lead to many new applications for the technology.  From this base, SciBase will continue to develop the platform, add indications and work through the regulatory processes to deliver the next generation of new products.

 `Nevisense Go represents an important milestone for SciBase. We have spent several years gaining acceptance for our methodology and we have developed a platform that builds on what we have learned but adds many advantages for our customers and broadens considerably the potential size of our market' says Simon Grant, CEO of SciBase `Today's release is the first step with our new platform and as we deliver clinical indications from next year, we expect this to drive revenue, especially when it comes to electrode sales. In the medium term we hope to expand the use of Nevisense Go into broad new areas and to broader customer groups - expending from specialists to GPs and even potentially to use in the home.'

SciBase's product Nevisense for melanoma detection was one of the first AI-based products approved within medicine. Nevisense Go is the next generation of that product platform and builds on the experience that SciBase has gained in over 100,000 clinical patient tests. Nevisense Go is the culmination of 5 years of work and 20+ years of diagnostic experience. Together with the KTH Royal Institute of Technology, SciBase has miniaturized their EIS measurement technology onto a single `chip' or application specific integrated circuit (ASIC). Together with our AI partner Peltarion SciBase has developed an agile environment for AI algorithm development and together with the Swiss Institute of Allergy and Asthma Research (SIAF), our research partner in Davos, SciBase has developed the world's first AI-algorithms for assessment of the skin barrier. Studies in SIAF demonstrated the correlation of EIS measurements with skin barrier defects caused by enzymes, toxins and environmental agents such as detergents in mouse models and in skin barrier defective patients.   

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
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 and New York, USA - August 26, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that they will participate in a clinical study to run parallel to the ACTIVATE study (sponsored by the Immune Tolerance Network and the NIAID/NIH), which is being conducted by the Department of Pediatric Allergy at Mount Sinai Hospital in New York.

The goal of the ACTIVATE study is to explore how differences in the gut microbiome of an infant affect its susceptibility to allergies. The study will compare groups born vaginally with those born by Cesarean section with and without so-called "vaginal seeding" of the infant microbiome. The study will examine whether vaginal seeding lowers the risk that infants test positive for allergies at one year of age. ACTIVATE will enroll 120 pregnant women and their babies, and will focus on those babies that are at higher-risk for developing allergies.

The infants will be followed for the first year of life, and SciBase's product 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.

"We look forward to adding Nevisense to the study and together with SciBase identify opportunities where these measurements can help clinicians manage these patients" says Dr. Hugh Sampson, Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and Director Emeritus of the Jaffe Food Allergy Institute.

"We are excited to participate in this clinical study which may help provide important guidance on how to reduce the risk that an infant will develop allergies. We look forward to seeing how our unique measurement methodology can help clinicians gain new insight into the skin of these infants and in doing so hopefully help this patient group" says Simon Grant, CEO of SciBase.

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected] 

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.

STOCKHOLM, SWEDEN, - September 16, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that both the Journal of the American Academy of Dermatology (JAAD) and SKIN, The Journal of Cutaneous Medicine (SKIN), have published studies assessing the clinical impact of Nevisense. The studies compared the results of US clinicians evaluating atypical pigmented skin lesions (atypical moles) using visual evaluation only compared to visual evaluation and the Nevisense result combined.

The JAAD publication titled "Impact of Electrical Impedance Spectroscopy on Dermatologists' Number-Needed-to-Biopsy Metric and Biopsy Decisions for Pigmented Skin Lesions"  sought to evaluate improvements in clinical accuracy in melanoma detection, while the SKIN publication titled "Integrating Electrical Impedance Spectroscopy into Clinical Decisions for Pigmented Skin Lesions Improves Diagnostic Accuracy: A Multitiered Study" sought to evaluate the differences between practicing dermatologists, physician's assistants, nurses and residents. All clinician types (dermatologists, physician's assistants, nurses and residents) improved by similar amounts, and the clinicians with the lowest number of correct evaluations improved the most. The publications are based on clinical evaluations of lesions in reader studies. The JAAD publication included 267 dermatologists while the SKIN publication included 591 clinicians (dermatologists, physician's assistants, nurses and residents). All clinicians evaluated lesions using visual evaluation only, and then they added the Nevisense information in over 25,000 evaluations.The key study takeaways were:

• The number of `missed melanomas' fell from ~7% to < 1%
• Overall sensitivity (ability to correctly identify melanoma) increased on average across the groups by 14% and specificity (ability to accurately identify benign moles) by 10.2%
• In total, clinicians identified 1,343 more melanomas with Nevisense compared to visual evaluation alone. 
• All clinician types (dermatologists, nurses and residents) improved a similar amount, and the clinicians with the lowest number of correct evaluations improved the most.
• In the JAAD study, dermatologists improved their sensitivity from 84 to 98%, their specificity from 34% to 44% and their NNB (Number Needed to Biopsy) from 6.3 to 5.3.

"Melanoma is the deadliest form of skin cancer, but when detected early, treatment has a nearly 100% cure rate making early detection critical to survival. These studies show a significant reduction of missed melanomas from ~7% to less than 1%, a further indication of the clinical value Nevisense can bring by helping clinicians identify melanomas and improve performance across the board. This is the first time this type of study has been performed and we are pleased with the results," stated Dr. Darrell S. Rigel, Clinical Professor, Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. "These results further demonstrate the benefits of early melanoma detection with Nevisense, and I am pleased that we are able to share our findings with the clinical community demonstrating the benefits of this technology for patients."

"Clinicians face difficult decisions every day when they evaluate moles, so it was very positive to see that Nevisense could so significantly improve their accuracy. Nevisense was able to help clinicians of all levels of experience, and especially those who were most in need of support," said Simon Grant, CEO of SciBase.  "Dr. Rigel's studies confirmed what we see from our users in the field - significant clinical benefit for both clinicians and patients. This is further proof of the potential for Nevisense to improve the standard of care of melanoma detection in the United States and will provide timely support to our ongoing reimbursement process."

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected] 

Certified Advisor (CA):
Avanza
Tel: +46 8 409 421 20
Email: [email protected] 

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.

I trust that you have all had a safe and enjoyable summer. Given the high level of interest we have seen from you, our shareholders, I felt it time I update you on where we are as a Company and our plans for the near future.We are making considerable progress in transforming SciBase from a single application Company built around melanoma detection to a platform Company with applications in several different clinical areas. We believe this will build significant shareholder value. With our unique platform and AI-based applications we are expanding our product line to address new markets with a large potential. Though there are many challenges in the current Covid-19 environment, I am very proud of the progress the team is making on this journey.

The summer has been extremely busy for SciBase. We have seen a return of the market for Nevisense tests in both Germany and the US after the negative effects we saw due to Covid-19 earlier this year. In addition to this return of base business, we have made real progress with our growth projects - our new clinical applications and our new platform, Nevisense Go. All this has been under the backdrop of a massive effort to secure certification under the new European medical device regulations, `MDR' (Medical Device Regulation).

I will take you through each of these points, starting with Nevisense Go, as this is by far the topic we receive the most questions about from shareholders.

Nevisense Go - Release and next steps

I am very pleased to announce that we expect to release the first version of the Nevisense Go platform on October 29th 2020. It has taken us a little longer than expected because of the pandemic and the very resource intensive MDR process, which we will discuss below. As previously communicated, this first version will be for the assessment of the skin barrier using inbuilt AI software. It will be fully functional as an impedance measurement device like Nevisense and utilize the same electrode and business model. It will however be simpler, easier to use and significantly less expensive.

This release of Nevisense Go is aimed at Industry partners and researchers within the area of skin barrier, though our aim is for Nevisense Go to eventually support all our clinical applications. Our activities so far lead us to believe that the market potential for research and Industry partners is significant and is a good first step for the product. The product can be used to investigate the skin barrier but is not as of yet linked to any clinical indications (such as eczema or melanoma).

Nevisense Go is the culmination of more than four years of work together with KTH Royal Institute of Technology and our clinical partners SIAF in Davos, but on the other hand is just the very first step for the platform. Our focus is now to continue to develop the platform and to collect clinical data so that we can perform the regulatory work needed to release indications starting next year.

COVID-19 and the Market

The pandemic had a significant effect on our customers in Germany and New York during the second quarter, and also slowed our rollout with Advanced Dermatology and Cosmetic Surgery (ADCS) somewhat. We saw however, increased interest in our products from the beginning of June and the return of orders from existing customers. This is very positive, though in general for the industry, customers have remained hesitant to invest in new devices. Overall, the third quarter appears back on track, and this is driving our hope that we will achieve one of our goals for 2020 - profitability in the Germany market on a local basis.

The bottom line is that after a very tough period the market, customers and patients are returning.

New applications and MDR

SciBase is entering a phase where we move from a single indication (melanoma) to multiple indications by adding non-melanoma skin cancer (NMSC) and skin barrier assessment. All indications are based on the same base Electrical Impedance Spectroscopy (EIS) + AI technology, the same electrode technology, and the same business model.

The release of new applications covering these indications is closely intertwined with the introduction of the new EU medical industry regulations, MDR. A company wanting to sell in Europe must have MDR in place if they wish to approve new indications, even if MDR only becomes mandatory from May 2021.

Our NMSC application is an add-on software module for Nevisense and as such will be targeted at the same customer group as melanoma. The product is complete and is awaiting approval under MDR. The initial clinical data evaluation has been positive. When released, we expect many customers to add this functionality and hope that the combination also helps us attract new customers. Though NMSC usually has a lower risk profile than melanoma, there are many more patients with NMSC than with suspected melanoma - in Sweden for example the ratio is at least 10 to 1.

Skin Barrier assessment is actually a group of applications that are linked to diseases connected to the skin barrier. We see uses for our technology in the prediction, improved diagnosis, and management of atopic diseases such as atopic dermatitis (eczema) and food allergies. These are very common diseases, and we see a large potential. The first step as discussed above is the release of Nevisense Go for barrier measurement and we are targeting Industry partners and researchers where we are collecting data to support new barrier applications.

US progress

It was very pleasing to see the publication of two new studies in JAAD and SKIN last week from Professor Darrel Rigel's team in New York. The reader studies evaluated the impact of Nevisense information on clinicians' decision-making. Nearly 600 US clinicians performed over 25,000 evaluations comparing management decisions first using visual evaluation only, and then with the addition of Nevisense information. The results were impressive - an average improvement in sensitivity of 14% (ability to detect melanoma) and an average improvement in specificity (ability to correctly classify as benign) of over 10%.

We have installed 6 systems in clinics in Florida and Michigan with our partner Advanced Dermatology and Cosmetic Surgery. We have several further installations planned and our hope is that we can move this first phase forward over the coming weeks.

We see the current period as the beginning of the next phase in the development of SciBase as a company. We will continue to build on our melanoma business not only in Germany, but also in the US. We will start the transition from Nevisense to Nevisense Go and in doing so broaden our customer focus. And finally, we will start the transformation from a `single product company' to a company with multiple legs to stand on with the addition of NMSC and Barrier. We are making considerable progress and have laid the foundation for accelerated future growth.

Best Regards

Simon Grant, CEO

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: [email protected]

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

Anna Danström, SciBase's head of production and supply chain, has chosen to leave her position and accept a role at another company. Linn Olsen will replace Anna as production and supply chain manager. Linn has a broad background within production, QA and Medtech, and comes from Trimble.

 "I would like to take the opportunity to thank Anna for her exceptional work at SciBase, and especially at our Uppsala facility. Anna has ensured that we have a well-functioning electrode manufacturing process and team and has also played a key role in improving our electrode gross margin. I wish Anna all the best in her future role, and welcome Linn to the team", says Simon Grant CEO SciBase.

For more information, please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
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.