Election of Board of Directors

The extraordinary general meeting resolved, with required majority, to elect Jvalini Dwarkasing as a new member of the Board. The Board has therefore the following composition: Tord Lendau (chairman), Diana Ferro, Thomas Taapken, Matt Leavitt and Jvalini Dwarkasing.

Jvalini Dwarkasing is entitled to remuneration for work in accordance with the renumeration fees resolved by the 2021 Annual General Meeting, in proportion to the actual time served as member of the Board.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: simon.grant@scibase.com

Certified Advisor:

Avanza

Tel: +46 8 409 421 20

Emailca@avanza.se

About SciBase och 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 nominating committee, consisting of Christer Jönsson (appointed by FourierTransorm), Iraj Arastoupour, Peter Elmvik and Tord Lendau Chairman of the Board, hereby proposes the election of Dr. Jvalini Dwarkasing as a new member of the Board to an EGM to be held later in 2021.

Dr Dwarkasing, proposed to the nominating committee by Van Herk Investments, is currently the Chief Scientific Officer at SkylineDx. She has over 10 years of life science experience with an international track record within oncology having held both research and management positions. Dr Dwarkasing has a strong academic background and a PhD in medical nutrition and pharmacology. Her driver for doing research is patient focus and how to bring science from bench to bedside. Her geographical areas of focus are the US, Europe and Australia.

The nominating committee believes that her knowledge and experience within the fields of Dermatology/Pathology, the international Dermatology industry and Dermatology networks are aligned with the future competence needs for the SciBase Board of Directors.

For more information please contact:
Tord Lendau, Chairman of the Board
Tel: +46 708 10 01 67
Email: 
tordlendau@hotmail.com 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: 
ca@avanza.se  

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

About SciBase and Nevisense
SciBase 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.

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

Certified Adviser:

Avanza

Tel: +46 409 421 20

Email: ca@avanza.se

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

About SciBase and Nevisense
SciBase 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.

Approval of the Board of Director's resolution on a directed share issue

The extraordinary general meeting resolved, with required majority, to approve the Board of Director's decision from 31 May 2021, on a directed issue of 239,000 shares to a subscription price of SEK 5.20, resulting in an increase of the share capital of SEK 11,950. The right to subscribe shares in the share issue was vested in the Company's Board of Director Dr. Matt Leavitt.

Following registration of the share issue the Company's share capital amounts to SEK 3,423,755.35 divided on 68,475,107 shares. The dilution for existing shareholders amounts to approximately 0.35 per cent.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: simon.grant@scibase.com

Certified Advisor:

Avanza

Tel: +46 8 409 421 20

Emailca@avanza.se

About SciBase och 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.

Approval of the Board of Director's resolution on a directed share issue

The extraordinary general meeting resolved, with required majority, to approve the Board of Director's decision from 31 May 2021, on a directed issue of 239,000 shares to a subscription price of SEK 5.20, resulting in an increase of the share capital of SEK 11,950. The right to subscribe shares in the share issue was vested in the Company's Board of Director Dr. Matt Leavitt.

Following registration of the share issue the Company's share capital amounts to SEK 3,423,755.35 divided on 68,475,107 shares. The dilution for existing shareholders amounts to approximately 0.35 per cent.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: simon.grant@scibase.com

Certified Advisor:

Avanza

Tel: +46 8 409 421 20

Emailca@avanza.se

About SciBase och 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 RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

The share issues have been carried out at a subscription price of SEK 5.20 per share and provides the Company with approximately SEK 71.2 million before transaction-related costs.“So far in 2021 we have received MDR certification, launched our NMSC (non-melanoma skin cancer) indication in Europe and filed an application for reimbursement coverage with CMS in Florida, US. With the share issues, we will further accelerate our strategic growth areas and our market penetration in the US by applying for reimbursement in additional regions. Furthermore, we will continue to develop our skin barrier application with a focus on securing additional partnerships. In summary, the share issues provide SciBase with the financing needed to achieve reimbursement in the US, while  also strengthening the shareholder base through welcoming new local and international institutional owners such as ÖstVäst Capital Management and the specialist investor Van Herk Investments B.V. Through its investments in BioInvent, Immunicum and Zealand Pharma, Van Herk has shown great success in life science and in addition they also have good knowledge  within the field of skin cancer.”, says Simon Grant, CEO of SciBase.

SciBase has carried out a capital raise of approximately SEK 71.2 million. The capital raise is divided into two directed share issues, one to a number of Swedish and international investors, including Van Herk Investments B.V. and ÖstVäst Capital Management, and the other to the Board member Dr. Matt Leavitt who was newly elected on the annual general meeting 2021.

The share issues have been carried out at a subscription price of SEK 5.20 per new share, corresponding to a discount of approximately 11.0 per cent in relation to the volume weighted average price during the previous five (5) trading days of the Company's shares on the Nasdaq First North Growth Market. The subscription price has been determined through negotiations at arm’s length with investors and is assessed to reflect current market conditions and demand.

In connection with the share issues, lock-up agreements with Board members and senior executives of the Company who own shares in the Company have been entered into, including customary terms and exemptions under the direction of Vator Securities.

The net proceeds from the share issues will primarily be used for penetration of the U.S. market, including reimbursement activities and strengthening of the local sales and customer support organization, and for the development of new applications.

The share issue directed to Swedish and international investors has been carried out based on the authorization granted at the annual general meeting on 18 May 2021. The share issue directed to the Board member Dr. Matt Leavitt (who was newly elected on the annual general meeting 2021) is covered by the so-called Leo Act (Chapter 16 of the Swedish Companies Act) and is thus subject to approval from a general shareholder meeting. Notice of an extraordinary general meeting will be announced through a separate press release.

The reasons for the deviation from shareholders’ preemption rights are to raise capital in a cost and time effective manner, diversify the ownership of the Company and to make it possible for the Board member Matt Leavitt to invest and thus achieving alignment with the Company’s shareholders.

To facilitate the completion of the share issue directed to Swedish and international investors, the new shares have been subscribed to by Vator Securities AB as issuing agent at an amount corresponding to the quota value of the shares, for subsequent transfer to the final investors at a price of SEK 5.20 per share, which is finally reported to the Company.

Through the share issues the number of shares in the Company will increase by 13,695,021, from 54,780,086 to 68,475,107 and the share capital will increase by SEK 684,751.05 from SEK 2,739,004.30 to SEK 3,423,755.35. The dilution for existing shareholders amounts to approximately 20 per cent.

Advisers

Vator Securities AB is sole global coordinator and bookrunner and Eversheds Sutherland Advokatbyrå AB is legal advisor to SciBase in connection with the share issues.

For more information, please contact:

Simon Grant, CEO SciBase

Tel: +46 72 887 43 99

Email: simon.grant@scibase.com

Certified Advisor:

Avanza Tel:

+46 8 409 421 20

Email: ca@avanza.se

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 persons set out above, at 8.55 CEST on 31 May 2021.

About SciBase och 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.

Important information

Release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions according to law and people in those jurisdictions, in which this press release has been announced or distributed, should inform themselves of and follow such legal restrictions. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in SciBase in any jurisdiction.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended. The information in this press release may not be announced, published or distributed to Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Afrika, the United States the United States, or in any other jurisdiction where the announcement, publication or distribution of the information would not comply with applicable laws and regulations.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of the United Kingdom version of the EU Prospectus Regulation (2017/1129/ EU) which is part of United Kingdom law by virtue of the European Union (Withdrawal) Act 2018) who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); (ii) high net worth entities etc. falling within Article 49(2)(a) to (d) of the Order; or (iii) such other persons to whom such investment or investment activity may lawfully be made available under the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

Forward-looking statements

This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. 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 Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is not required by law or Nasdaq First North Growth Market’s rule book for issuers.

We have achieved many exciting and important milestones recently at SciBase. After a long process we received our MDR-certification which enabled us to launch our NMSC (non-melanoma skin cancer) application in Europe, which is a key part of our growth strategy. We have also entered a new phase in the US by submitting our first application for reimbursement coverage – another very important milestone for the company. Within the skin barrier application two significant and groundbreaking clinical studies have recently been published. Barrier-related diseases are widespread, and using Nevisense as a tool for the assessment of the barrier can really help better understand and manage patients,” says Simon Grant, CEO SciBase.

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

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: 
ca@avanza.se  

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 annual general meeting resolved:

  • to adopt the profit and loss statement and the balance sheet and the group profit and loss statement and the group balance sheet for the financial year 2020;
  • that SEK 175,081,224 shall be carried forward in new account and that no dividend shall be paid;
  • to grant the board members and the CEO discharge from liability for the financial year 2020;
  • that the board of directors shall consist of four ordinary members without deputy members and that a registered accounting firm shall be elected as auditor;
  • that the fees payable to the board of directors for the period until the end of the next annual general meeting shall be SEK 200,000 for the chairman of the board and SEK 150,000 to each of the other ordinary board members (who are not employed by a larger shareholder in the Company)and that fees payable to the auditor is to be paid in accordance with approved invoices;
  • for the period until the end of the next annual general meeting, to re-elect Diana Ferro, Thomas Taapken and Tord Lendau and to new-elect Dr. Matt Leavitt as board members, to re-elect Tord Lendau as chairman of the board of directors and to re-elect the auditing firm PricewaterhouseCoopers AB (PwC) as auditor for the Company, with Magnus Lagerberg as auditor-in-charge;
  • to adopt principles for the appointment of a nomination committee (same principles as previous year); and
  • to authorize the board of directors to increase the share capital through issuance of new shares, warrants and/or convertible debentures through which the Company’s share capital may be increased by an amount corresponding to not more than 20 per cent of the share capital after such issue(s);

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

Certified Advisor (CA):

Avanza

Tel: +46 8 409 421 20

Email: corp@avanza.se

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

About SciBase and Nevisense
SciBase 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’s strategy is to leverage the Nevisense technology platform to launch additional clinical applications and products. The first clinical application or indication to be added is NMSC, initially for Nevisense 3.0.

There are two types of skin cancer: melanoma and non-melanoma skin cancer (NMSC). NMSC is more than ten times more prevalent than melanoma and comes itself in primarily two forms: basal cell carcinoma and squamous cell carcinoma. Although NMSC is less harmful and deadly than melanoma, it is still important that it is detected early and is managed with the most appropriate therapy. Because Dermatologists see many more patients with suspected non-melanoma skin cancer than suspected melanoma, there is potential for greatly increased use of Nevisense. SciBase estimates that the global potential for the use of diagnostic devices such as Nevisense for this indication could exceed 4 million tests annually. Adding the NMSC application to the current melanoma application potential of 5-7 million annual tests increases the market opportunity substantially for SciBase.

The development of the NMSC application has been driven by a demand from the German customer base and is an important part of our continued growth in Germany. Recent publications support the use of Nevisense in NMSC. A study published in November 2020 by Sarac, Garbe and others confirmed the ability of Nevisense to accurately identify non-melanoma skin cancers. In the study Nevisense showed good discriminative power to distinguish NMSC from benign lesions and concluded that Nevisense can support clinicians in the early diagnosis of NMSC.

The NMSC application is a software update and as such can be easily deployed to almost all existing Nevisense users. It also uses the same Nevisense electrode and business model as melanoma. The first step in the launch is to update the existing customer base, initially in Germany.

“The launch of the NMSC application is a key part of our growth strategy. The demand from our German customer base has been the driver behind the development. As the current melanoma reimbursement in Germany should also apply to NMSC we expect increased electrode usage by existing customers and increased appeal to new customers given they will be able to use the system on a larger patient base. 2021 looks to be an exciting year for SciBase with a number of milestones already reached, and plenty more to come” says Simon Grant, CEO of SciBase.  

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

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: 
ca@avanza.se  

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.

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: 
simon.grant@scibase.com 

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: 
ca@avanza.se  

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.