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.

As many of us head into a holiday break, I thought I would send out a short update, especially aimed at keeping our newer shareholders in the loop. On the whole things are progressing well, though we have several challenges due to the pandemic.

US activity

Nevisense 3.0 has been very well received by our US customers. We continue with two main focus areas in the US: our partnership with practice groups like Advanced Dermatology and Cosmetic Surgery (ADCS) and the reimbursement process. While the situation in New York is improving all the time, the high number of COVID-19 cases in Florida is a cause for some concern as we are establishing our first pilot cluster with ADCS in central Florida. Things are going well so far, and we expect to have four sites around Orlando up and running by the end of this week, which is great to see and a good indication that we are delivering value. Working with dermatology practice groups such as ADCS is a key part of our US strategy as this allows us to reach many sites through a single channel. The reimbursement application process is progressing, and we hope to receive feedback on our application in the coming months.

We saw some good development in Q1, with repeat orders of electrodes from our New York based dermatology practice group, Advanced Dermatology, P.C. (similar name but no connection to ADCS), and we just now see the return of such orders.  COVID-19 hit all New York clinics hard, but interest is clearly coming back.

New Indications, Products and MDR

Our focus internally at SciBase in Stockholm is on our new products and indications, and as part of these activities the company is working to finalize Medical Device Regulation (MDR) certification.  This is mandatory from May of 2021 after being delayed a year due to the pandemic and for approval of new indications such as Non-Melanoma Skin Cancer (NMSC), MDR is a necessity. Overall things are progressing well. The product is complete and the clinical data was submitted in April, but the regulatory process has been affected by Covid. We see some delays during the second half of the year, including a one-month delay in our MDR audit due to travel restrictions.  This is a somewhat fluid situation, and we will do our best to keep you informed.

Nevisense Go is our next generation platform, a hand-held version of Nevisense that uses the same electrodes and business model as the regular Nevisense. Our strategy with Nevisense Go is to start with the Barrier application and over time also add support for further and more specific applications, utilizing different AI models. Our first priority is Industry partners, and we see the potential to utilise Nevisense Go outside the specialist clinic and eventually in retail or even in the home. The first release of Nevisense Go is delayed somewhat into Q3 due to delays with MDR and at our contract manufacturer, but we are making significant progress.

Progress with Barrier

When it comes to the skin barrier application overall, things are also progressing. The method and some our clinical results were presented by Prof Cezmi Akdis in his presentation `Epithelial cell barrier and allergic diseases' at the recent digital EAACI meeting. Our methodology was also discussed by Kazunari Sugita in a review paper titled `Outside-in hypothesis revisited' published in May in the Annals of Allergy, Asthma and Immunology. The article abstract is available at https://doi.org/10.1016/j.anai.2020.05.016.

We continue to see good levels of industry interest in the combination of Nevisense Go and the barrier application. The ability to embed a neural network model into the stand-alone Nevisense Go is a unique accomplishment and I will be presenting this and other progress at the upcoming Redeye Artificial Intelligence Seminar 2020 on September 17th - see https://www.redeye.se/events/788494/artificial-intelligence-seminar-2020 for more details.

COVID-19 and the Market

The pandemic had a significant effect on our customers in Germany and New York during the second quarter. We have seen increased interest in our products in June and the beginning of July, but it is difficult to estimate how Q3 will be affected. The bottom line is that after a very tough period the market, customers and patients are coming back.

Increased interest and new Share Issue, and next steps

We were happy with the result of the share issue. The issue was considerably oversubscribed. We also saw an increased interest in the Company and our share during the second quarter with increased volumes traded resulting in us welcoming an additional ~ 1,000 shareholders and we want to thank them for their confidence in SciBase. As a result of the issue and the increased volumes traded there have been a couple of changes in our ownership. Petter Stordalen (Strawberry) has sold their shares in SciBase and we believe this is because of the pressure COVID-19 has put on their core business.

Phase 2 of our share issue involves the conversion of warrants. These warrants are currently traded using the ticker SCIB TO 1 and warrant-owners will be given the option to convert warrants to shares between October 5 - October 16 2020 at a value based on the average share price over the ten days preceding September 30th. The subscription price for a share will be from a minimum of SEK 1.00 to a maximum of SEK1.75.

We have been very busy, and we expect our high level of activity to continue through the rest of the year. Overall it feels like we are making considerable progress. The pandemic's effects remain a factor in our plans - and though we do our best to mitigate those effects, they may affect the timing of some of our activities. Internally our focus is very much on the new products and externally we are heartened by a return of our core Private Dermatologist market.

Best Regards and enjoy your holiday

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

Stockholm, Sweden and New York, USA - August 18, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that Nevisense will be included in a large clinical study initiated by The Ronald O. Perelman Department of Dermatology clinic at NYU Langone Health.  

The SpotCheck study will investigate the use of Nevisense as a point-of-care diagnostic tool to assist with skin cancer detection in a remote setting such as a non-specialist practice or pharmacy. The study will evaluate how Nevisense can help providers assess patients' irregular moles in such locations, and if successful will help improve access for patients to technology for the early detection of melanoma.

David Polsky, MD, PhD., the Alfred W. Kopf, M.D. Professor of Dermatologic Oncology at NYU Langone Health and Perlmutter Cancer Center will serve as the Primary Investigator for the study. "We are very interested in developing new methods to extend expert skin cancer diagnostic services to communities lacking access to in-person specialist care. We believe that Nevisense can help improve the accuracy of visual diagnosis in a telemedicine-based system", says Dr. Polsky who is also Director of its Pigmented Lesion Section in the Ronald O. Perelman Department of Dermatology and a professor in the  Department of Pathology at NYU Langone.

Simon Grant, CEO of SciBase, stated, "We are delighted that NYU has selected Nevisense for this very important study. There is clearly a need for improved tools for non-specialists to assess atypical pigmented lesions. The objective data Nevisense provides may effectively help in remote settings such as pharmacies, and not only provide much needed support for clinicians and patients but open up a significant new opportunity for SciBase."

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

For more information, please contact:
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.

January 1 - June 30, 2020

The second quarter in figures

• Net sales amounted to TSEK 1,683 (2,168).
• The loss after tax amounted to TSEK 8,864 (10,613).
• The loss per share amounted to SEK 0.38 (0.64).
• The cash flow from current operations was negative in the amount of TSEK 8,704 (9,900).
• The gross margin reached 55.7% (53.3%).
• Electrode sales volume decreased by 18% and reached 4,672 (5,712) units. Repeat sales of electrodes to existing customers decreased by 22%.

The first half-year in figures

• Net sales amounted to TSEK 4,179 (4,536).
• The loss after tax amounted to TSEK 17,800 (19,520).
• The loss per share amounted to SEK 0.89 (1.17).
• The cash flow from current operations was negative in the amount of TSEK 16,597 (18,850).
• The gross margin reached 54.7% (52.9%).
• Electrode sales volume decreased by 4% and reached 11,270 (11,792) units. Repeat sales of electrodes to existing customers decreased by 8%.

Important events during the quarter

• The Covid-19 pandemic started to affect SciBase from mid-March and continued through the second quarter. Sales in the company's key market Germany were affected and decreased by 25% in the quarter, and overall sales decreased by 23%. Customer interest and sales seems to be returning to normal from the end of Q2.
• SciBase received FDA approval for Nevisense 3.0.
• SciBase entered into a partnership agreement with the Advanced Dermatology and Cosmetic Surgery group (ADCS), the single largest dermatology network in the US with over 150 practices. The first systems were installed in Florida in June.
• SciBase rights offer was heavily oversubscribed raising net MSEK 19.3 (after issue costs).
• SciBase submitted a reimbursement code application in the US.
• Anna Danström, SciBase's head of production and supply chain chose to leave her position and accept a role at another company.
• Extraordinary general shareholders' meeting was held on April 29th approving the Boards decision regarding the rights offering.
• The AGM was held on June 17th, 2020.
• The annual report for 2019 was published on April 5th.

Important events after the end of the     period

• Nevisense selected for `SpotCheck' remote melanoma detection evaluation study by The Ronald O. Perelman Department of Dermatology at NYU Langone Health in New York.

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 August 20, 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 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, June 15th, 2020 - SciBase, a global healthcare company with a platform technology enabling innovative products for skin disorders such as skin cancer and atopic dermatitis, today announces that the company has submitted a reimbursement code application for its melanoma application to the Centers for Medicare & Medicaid Services (CMS) in the US.

CMS oversees the administration of medical procedures within Medicare and Medicaid, and their codes are also utilized by third-party payers. Medicare covers healthcare for the elderly and Medicaid covers uninsured patients.

 "The SciBase team has delivered another important milestone and made significant progress in the US, positioning us for long-term sustainable growth. We are pleased that we have been able to submit our reimbursement code application to CMS without any delays given the challenges with the Covid-19 situation. The Medicare population is of particular interest to SciBase, given the higher rates of melanoma in the elderly. We continue to target 2021 for the first regional reimbursement coverage in the US.", says Simon Grant CEO SciBase.

SciBase has recently accelerated its activities delivering on significant milestones for its shareholders marking a step change in the speed in which the Nevisense 3.0 is capturing market acceptance and share in our focus markets, Germany and the US.

• Nevisense 3.0 was launched in Germany in late 2018 and delivered greatly improved clinical workflow, test throughput and customer satisfaction.

• In November of the same year, new clinical guidelines were published supporting the use of Nevisense in the evaluation of atypical lesions by Onkoderm (a German dermatology organization for skin cancer prevention and therapy). The launch of Nevisense 3.0, together with inclusion in German guidelines, contributed to sales growth of more than 30% in 2019 in Germany, driven by a 50% increase in the number patients tested.

• Following the launch of Nevisense 3.0 in Germany, the Company's sales increased six quarters in a row (compared with corresponding period the previous year).

• SciBase received FDA approval for Nevisense 3.0 in April 2020, and the Company now offers the third generation of Nevisense on the US market.

• In May 2020, a collaboration agreement between SciBase and the US largest dermatology chain, Advanced Dermatology and Cosmetic Surgery group (ADCS), was also initiated.

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

Certified Advisoer (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.

Today, the annual general meeting of 2020 was held in SciBase Holding AB (publ) (the "Company" or "SciBase"). Below follows a summary of the resolutions passed at the annual general meeting (all in accordance with the proposals presented in the notice to attend the meeting kept available at the Company's website 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 2019;

• that the Company's accumulated profits amounting to SEK 98,878,721 should be carried forward in new account and that no dividend shall be paid for the financial year 2019;

• to grant the board members, including the board member who resigned during the financial year, and the CEO discharge from liability for the financial year 2019;

• 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 amount to SEK 200,000 to the chairman and SEK 150,000 to each external board member who is not employed by a major shareholder of 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 re-elect Diana Ferro, Thomas Taapken and Tord Lendau and to new-elect Barbro Fridén 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);

• on an authorization for 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); and

• on changes to the Company's articles of association (i) regarding the prerequisites for participating in general meetings and (ii) by introducing a provision on the collection of proxy forms and postal voting.

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.

The nation's premier dermatology group begins rollout of Nevisense technology to examine patients with irregular moles suspicious of melanoma

Stockholm, Sweden and Maitland, Florida, - June 23, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that it has installed the first two Nevisense Systems at Advanced Dermatology and Cosmetics Surgery ("ADCS") - the nation's premier dermatology group. The Nevisense systems are now operational at ADCS' Windermere, Florida location led by Dr. Bill Steffes. This is the first of several sites planned to offer Nevisense as part of a joint-partnership rollout this year.

Based in Maitland, Florida, Advanced Dermatology and Cosmetic Surgery is the nation's leading providers of dermatological services with over 150 sites of care located across 14 states.  "We take pride in providing our patients with access to the most advanced technology for the earliest detection of melanoma, when the disease is at its most curable stage.  "Technological advances like Nevisense will not only improve outcomes for our patients, but also change the landscape for the future of skin cancer detection and we are thrilled to be a part of this advancement," said Dr. Matt Leavitt, founder and CEO of Advanced Dermatology and Cosmetic Surgery.

"This is a terrific first step in our collaboration with ADCS after their decision to adopt our advanced skin cancer detection solutions. Offering ADCS providers such as Dr. Bill Steffes state-of-the art technology means they will have more management options, helping them improve patient care and outcomes," said Simon Grant, Chief Executive Officer of SciBase. "Having the nation's leading dermatology group, such as ADCS, adopt Nevisense, is a reflection of the increasing level of interest we see for SciBase's skin disorders solutions" added Grant.

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.

About Advanced Dermatology and Cosmetic Surgery

Advanced Dermatology and Cosmetic Surgery is the largest dermatology practice in the country. We are committed to providing comprehensive and unparalleled dermatologic and aesthetic care in a welcoming and engaging environment, seeking to make each patient experience unique. We strive to combine the best of the art of medicine with the latest advances in research and technology in formulating individualized treatment plans to achieve the desired result with superior patient safety and privacy standards.

To learn more about Advanced Dermatology, visit www.advancedderm.com or call 1-866-400-DERM.

I trust and hope that you are all well in these trying times. I'm very thankful that the team at SciBase has come through this unscathed so far. At the same time the landscape of our family life and our work life has undergone real changes in the recent months and I expect some of these changes are here to stay.

I, perhaps foolishly, thought that the activity levels would come down somewhat due to Covid-19. How wrong I was! We have been, and continue to be, very busy with a number of exciting projects.

But first a bit about our customers. Our two focus markets are Germany and the US - and in the US we have been until now concentrated in the Northeast and especially the New York area. Both have been significantly affected by the pandemic, and New York especially so. Many practices are opening now, but with reduced hours and reduced patient numbers. Aesthetic procedures such as botox are for the most part halted, but medical procedures such as skin cancer checks are returning.  It will take some time to return to a new normal, but the process to restart business is underway.

So what has kept us so busy? I'd like to run through some of the recent milestones and key projects we are working on.

Germany

Even though Covid-19 significantly affected the Q1 sales in Germany, we were extremely close to breakeven in Germany in Q1. This is due to a continuation of increased electrode use and sales we saw in 2019 and customer support cost savings. Nevisense 3.0 has dramatically improved usability for customers so that the test is easier to integrate into their patient workflow and this has driven test usage. On the other hand, Nevisense 3.0 requires much less training and support which has resulted in reduced staff costs. Breaking even in Germany is important because it means we can concentrate our investments on the other two parts of our strategy - the US and our new applications.

Progress in the US (finally!)

Within medtech there is a saying that `if you haven't made it in the US, you haven't made it'. It is a fantastic market once a product is established, but it is a notoriously tough market to penetrate and the reimbursement system is by far the most important and complex I have encountered. It has taken much longer than we had hoped, but we have reached a few key milestones.

Firstly, after an intensive 11 month process, the FDA has approved Nevisense 3.0. That it takes so long is to do with the fact that melanoma is considered a high -risk application and therefore the controls are stringent. So stringent in fact that we are the only device approved on the US market for melanoma detection. We think that Nevisense 3.0 is essential for our success in the US where patient throughput and efficiency are even more critical than Europe.

We were also very pleased to announce our collaboration partnership with the Advanced Dermatology and Cosmetic Surgery group (ADCS) last week. As the largest US network with over 150 clinics across the US, ADCS is a great partner and this is a significant opportunity for both companies. The driver for ADCS was best expressed by Matt Leavitt the CEO when he said `I want to bring more science into Dermatology'. They also have a company-wide focus on the early detection of skin cancer, so the fit with SciBase is excellent. More news will follow as we roll out the pilot phase in the coming weeks and months.

Otherwise, we saw sales traction and a good increase in usage from our US customers in Q4 and the beginning of Q1. With the effect of Covid, sales activities are reduced, so we have taken the opportunity to focus on our reimbursement process which continues to move forward, albeit more slowly than we would want.

Same technology, new products

The core of our products is combination of Electrical Impedance spectroscopy (EIS) and Artificial Intelligence (AI). Many companies talk about AI, but we are the first company within Dermatology and one of only a handful of companies globally to actually launch an AI-driven medical product into the market.  Around 100,000 patients have been successfully tested with our EIS and AI combination.

Development-wise we are working on two new product areas. Firstly, we are taking the same core electrode technology and EIS methodology and developing new AI algorithms that support new and exciting clinical applications. In other words, we are reusing the same basic measurement technology we have developed over the last 15 years and building new software analyses that provide clinical value in new clinical areas. Those two areas are non-melanoma skin cancer and skin barrier assessment. Both these applications have potential at least as large as melanoma and I see the skin barrier application especially as an exciting product. If you are interested in learning more about these areas I recommend that you visit our website or take a look at the following link from our AI partner Peltarion [https://peltarion.com/blog/applied-ai/scibase].

Secondly, we are very nearly complete with a revolutionary new product called Nevisense Go. Nevisense Go is a miniaturized, handheld version of Nevisense. The product provides completely self-contained measurement of EIS and AI-based evaluation of those measurements. The first application for Nevisense Go is the measurement of skin barrier function, but eventually all applications can be supported. The possibilities for this product are many. Being smaller, much less expensive and easier to use, Nevisense Go has real potential outside the dermatology clinic. We have a promising level of interest from industry for this product, and that will be our initial focus. I look forward to sharing more news on this as we near product completion.

So as you can see, there is a lot going on. Our goal is to do as much as we can now so that when the market comes back we are `firing on all cylinders'. We have a good team and I am really proud of what they continue to achieve under difficult circumstances.  Stay safe and I look forward to seeing you virtually or otherwise during the upcoming presentations of the company to support our new financing round. More information is available at [http://investors.scibase.se/en] if you are interested in becoming a shareholder.

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.