| Scibase

Nov 07 2017

SciBase receives order of up to 1 million SEK within a new customer segment in Italy

SciBase has signed a new distribution agreement in Italy with International Health and Fitness Organisation AB (IHFO), a Swedish distributor active in Italy, within a completely new customer segment. As part of the signing, SciBase received an initial order of approx. 0.5 million SEK consisting of Nevisense systems and single use electrodes for delivery during the fourth quarter 2017. In addition IHFO has an option to place a follow-up order of more Nevisense and electrodes of an additional 0.5 million SEK to be delivered during 2018. The Nevisense systems ordered by IHFO will be placed at a number of pharmacies and non-specialist clinics in Italy that will perform melanoma screening tests.

-This is a very interesting co-operation for us, as it is a customer segment that we previously haven’t sold to. The Nevisense test will be combined with visual screening and be performed by the staff at the pharmacies or clinics. This could potentially be a huge opportunity for us, partly as it is a new customer segment but also if it is successful this could be rolled out in other markets together with IHFO, says Simon Grant, CEO SciBase.

Within the framework of the agreement IHFO will market Nevisense towards non-specialists. Nevisense will be used as part of a screening evaluation and complement traditional visual evaluation. These Nevisense systems will primarily be placed at pharmacies and non-specialist clinics and IHFO will train the staff in how to use Nevisense and how to integrate it into the screening process.

The distribution agreement is split into two phases and together the total potential order value is close to 1 million SEK. The first phase, at a value of 0.5 million SEK, will be delivered during the fourth quarter 2017. If the initial implementation is successful the rest of the order will be delivered during 2018. Initially the agreement applies to Italy, but there is the possibility to roll out this model to at least three additional markets in Europe adding additional sales potential.

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

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 16.15 CET on November 7, 2017.

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. 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 now also a FDA clearance 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. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.

Nov 09 2017

SciBase receives first commercial order in the US from private clinic in New York

SciBase has received the first commercial order in the US - from a private clinic with a focus on self-pay patients in Manhattan, New York. The order, consisting of a Nevisense system and single-use electrodes, is strategically important as it can be seen as an early sign that our launch strategy is the right approach. SciBase’s strategy focuses initially on marketing Nevisense to private clinics with self-pay patients in the New York Metropolitan Area.

-We are very pleased to have sold our first Nevisense in the US and take it as an early confirmation that our US strategy is the right one. This is a great clinic to start with and we will be gearing up our efforts going forward, says Simon Grant, CEO SciBase.

The private clinic is led by a prominent and well-known dermatologist working within both the clinical as well as the cosmetic field, including skin cancer, eczema, acne and other skin orders.

Focused growth plan for the US market
The launch strategy communicated in September includes an initial focus on so-called self-pay clinics where the patient pays the health care cost directly and not through an insurance company. SciBase will focus on the highly populated New York metropolitan area/Tri-State Area, which also is one of the regions in the US with the highest number of cases of malignant melanoma. SciBase will in parallel build awareness of Nevisense and further develop the existing network of Key Opinion Leaders (KOL) in the Northeast region of the US. The next step will then be to approach selected local and regional insurance companies and seek local reimbursement for EIS testing. In order to achieve more general penetration across the US general reimbursement for Nevisense testing from insurance companies is required. This process is both time and resource intensive and will therefore be started on a selective basis as soon as practicable. Following commercial traction in the Northeast, SciBase believes that further expansion through nationwide distribution partners could lead to a further acceleration of the sales growth.

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

Sep 25 2017

SciBase unveils growth strategy including plans for US launch of Nevisense

Following the Pre-Market Approval (PMA) of Nevisense in the US in June, SciBase today presents an update of their strategic growth plan. The focus of the plan is SciBase's entry into the US market, the continued growth in the core market Germany, and the utilization of the current product platform for additional clinical indications.

The strategic plan has been developed together with the Company's Board and to support the above includes a reasonably aggressive investment strategy. It is the Board’s opinion that the current financial resources as of end-June of over 60MSEK, will be sufficient to cover the Company’s capital needs for at least the coming 12-month period. The new strategy and growth plan will over time however, entail increased capital requirements. The Board is therefore currently evaluating a number of options for long-term funding of the Company. The Company believes that if the strategy is successfully implemented, both the US market and the new applications will drive rapid growth.

- The launch of the new strategic plan represents a more aggressive approach to the market, both in key existing markets but also in the United States. Our focus going forward will be on driving sales, but also on new clinical applications for our technology. We have taken an important step with the July launch of new Nevisense software and electrodes that will be used in the development of new clinical applications for the dermatologist, says Simon Grant, CEO SciBase.

US plan

With the FDA's approval of the SciBase PMA application in June, the Company is now able to start exploiting the world's largest market, the United States. SciBase intends to take a step-wise approach to the market initially focusing on servicing ‘self-pay’ clinics, where the patient pays healthcare costs directly and not through an insurance company. Focus will be on the highly populated New York metropolitan area/Tri-State Area, which also is one of the regions in the US with the highest number of cases of malignant melanoma.

SciBase will in parallel build awareness of Nevisense and further develop the existing network of Key Opinion Leaders (KOL) in the US which will assist in disseminating knowledge and experience of Electrical Impedance Spectroscopy (EIS) and Nevisense in the US.. Finally, as Nevisense gains traction and shows commercial success, the Company will approach selected local and regional insurance companies and seek local reimbursement for EIS testing. In order to achieve more general penetration across the US general reimbursement for Nevisense testing from insurance companies is required. This process is both time and resource intensive and will therefore be started on a selective basis as soon as practicable.

Following on from commercial traction in the North East, SciBase believes that further expansion through nationwide distribution partners could lead to a further acceleration of the sales growth trajectory in the medium term, which provides the opportunity to enable wider penetration of the US market.

- We have developed a well-balanced plan, which enables us to establish ourselves in the US while getting the most out of the resources we invest. We will start in a well-populated, high-profile region where many patients are used to paying for themselves - and also where several important Key Opinion Leaders are based. With this approach we have a great opportunity to both lay the foundation for reimbursement and to create a successful case that in the future can attract interesting partners and distributors, says Simon Grant.

Continued development of the German market

In addition to the US market, SciBase will build on its growth in Germany; currently its largest market with a loyal user base of 150 private Dermatology clinics offering Nevisense. SciBase believes that it can now shift sales focus from these "early adopter" clinics to the mainstream private Dermatology market. The recently released Nevisense product improvements and enhancements will help drive this, as will the opportunity arising from the integration of Nevisense with DermoScan's product DermoGenius Ultra. DermoScan is the first digital dermoscopy company to include EIS as a standard parameter and DermoGenius is used in more than 400 clinics in Germany.

New Clinical applications for Electrical Impedance Spectroscopy

It has long been known that EIS can be useful in assessing other skin conditions. Before the Company decided to focus purely on melanoma, it published a number of studies within other clinical areas, including non-melanoma skin cancer and atopic dermatitis. Both of these disorders are common and involve significantly larger patient groups than malignant melanoma. SciBase’s plan is to utilise the current product Nevisense as a unique platform that can both investigate and support treatment modalities for these new clinical applications.

SciBase is currently conducting clinical trials with leading academic and clinical centers to investigate these new indications. The first published results are expected in the first half of 2018 and following this SciBase will start the commercialization of the first application. The new applications not only mean more value and utility for dermatologists, but would, if successful, open up new, complementary markets with significant sales potential. The concept of Nevisense as a dermatology platform means that dermatologists, regardless of their area of interest, can be approached with an integrated tool providing multiple software analyses and electrodes designed for a range of key clinical situations.

Finally, SciBase has successfully concluded a three year development project conducted together with the Royal Institute of Technology (KTH) to miniaturise the measurement electronics for Nevisense to a 5mm x 5mm Application Specific Integrated Circuit (ASIC). The project proves that the size and cost of Nevisense can be significantly reduced. This opens up the possibility of a new generation of Nevisense that is smaller and cheaper where the target group can be expanded to general practitioners and others.

In summary, SciBase believes this approach has great potential and can lead to significant growth for the Company. The key elements of the strategy are:

That the company plans the US introduction of Nevisense in the North-East, initially targeting self-pay clinics, while building a general reimbursement case
That there will be a continued focus on growth in the German market, addressing more mainstream private Dermatologists with improved Nevisense features
By leveraging Nevisense as a platform, SciBase can address unmet needs within other skin-conditions and be even more useful as a tool for Dermatologists.
Long term, the Company hopes to utilise the ASIC project to both reduce cost and enable the development of smaller, simpler instruments potentially addressing new customer groups with new screening capabilities.

For further information please visit www.scibase.com or contact:

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail: [email protected]

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. 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 now also a FDA clearance 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. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.

Oct 16 2017

Nevisense presented as one of the top ten most important news stories within skin cancer for dermatologists at US congress

SciBase has participated in, exhibited and demonstrated their product Nevisense, for early detection of malignant melanoma at the Fall Clinical Dermatology Conference in Las Vegas. The congress was held between 12th and 15 of October and is one of the largest and important national congresses within dermatology. At the congress Darrel S. Rigel, MD and Clinical Professor of Dermatology at the New York University Medical Center presented Nevisense as one of the top ten most important news stories within skin cancer. Nevisense was also presented in a scientific poster by Dr Ryan Svoboda. The poster illustrated the clinical performance of Nevisense and the EIS-method. The first installation and clinical use of Nevisense with patients in the US will be at Dr Rigel’s clinic in New York.

- This is the first time we participate in a congress in the US after our FDA approval and our aim has been to introduce Nevisense and build relationships with US dermatologists. We were pleased to establish many contacts during the congress and these will be valuable as we launch our product and method in the US market. It is also pleasing to be able to announce that we now have the first US clinic ready to soon start using Nevisense, says Simon Grant, CEO SciBase.

Professor Rigel is a well-known Key Opinion Leader within dermatology and especially within skin cancer. During one of his congress presentations he listed Nevisense as one of the top ten most important happenings within skin cancer that dermatologists need to know about.

Dr Rigel has presented over 600 times at different congresses, both medical and political, around the world. He is the architect of the so-called ABCDE criteria for melanoma, which are used to help determine if a lesion is benign or malignant. He is also frequently interviewed as an expert on nationwide television channels such as CNN, ABC, FOX, NBC and CBS and his research and opinions are regularly mentioned in the New York Times, Wall Street Journal and many other nationwide newspapers and magazines. Dr Rigel’s clinic in New York will be the first clinical installation of Nevisense and will help SciBase understand how to best incorporate Nevisense into the US clinical environment.

The Fall Clinical Dermatology Conference aims to give practicing dermatologists a thorough update regarding diagnostics and treatments of different disorders related to medical, surgical and cosmetic dermatology, including malignant melanoma. The congress is held annually in Las Vegas and attracts about 700-800 dermatologists.

For further information please visit www.scibase.com or contact:

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail: [email protected]

Oct 20 2017

The following people have been appointed as members of SciBase Holding's election committee for the Annual General Meeting in 2018:

David Sonnek chairman (representing SEB Venture Capital,

Andreas Pennervall (SEB pensionsstiftelse),

Åsa Knutsson (Fouriertransform),

Tord Lendau (Chairman of the Board).

The appointments have been made in accordance with the instructions regarding principles for the appointment of the company election committee which were determined at the Annual General Meeting of SciBase Holding on May 16, 2017.

The Annual General Meeting of SciBase Holding AB (publ) will be held on May 16, 2018 in Stockholm.

Shareholders who wish to have an item considered at the Annual General Meeting can submit a request to the Board to this effect. Such a request for an item to be considered is to be sent to SciBase Holding AB (publ), Att: Chairman of the Board, Box 3337, 103 67 Stockholm, and must have been received by the Board no later than seven weeks before the Annual General Meeting, or otherwise in such good time that the matter, where necessary, can be included in the notice to attend the Annual General Meeting.

Stockholm, October 20, 2017

SciBase Holding AB (publ)

For more information, please contact:
Tord Lendau, Chairmain of the board, phone +46 (0)70 810 01 67

Michael Colérus, CFO, phone +46 70 341 34 72

About Skin Cancer
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to the age of 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.

Oct 26 2017

SciBase Holding AB (publ) proposes a preferential rights issue of SEK 85 million, secured to SEK 75 million

Summary

The board of directors of SciBase Holding AB (publ) ("SciBase" or "The Company") has decided to propose a new share issue of approximately SEK 85 million with preferential rights for the Company's existing shareholders (the "Rights Issue").
The subscription price in the Rights Issue is set to SEK 9.00.
The Rights Issue is subject to approval at the Extraordinary General Meeting to be held on 15 November 2017. The Company has today issued a notice to the Extraordinary General Meeting.
The proceeds from the Rights Issue will be primarily used for the launch of Nevisense in the US, to develop and market new applications for Nevisense and development of the next generation products based on an application specific integrated circuit platform.
The Company's three largest shareholders, SEB Pensionsstiftelse, Fouriertransform Aktiebolag and SEB Venture Capital have expressed their support for the Rights Issue and have undertaken to subscribe for a total of SEK 16.0 million. In addition, a guarantee consortium procured by Pareto Securities AB has, subject to certain conditions, committed to subscribe for new shares for up to SEK 59 million. Together, these subscription undertakings and guarantee commitments amount to SEK 75 million or approximately 88 percent of the new shares offered in the Rights Issue. Members of the board of directors and management have also undertaken to subscribe for shares for a total of approximately SEK 0.6 million.

Background and rationale

SciBase is a medical technology company headquartered in Stockholm developing and selling instruments for skin cancer detection and the investigation of skin diseases. The Company’s main product, Nevisense, has been developed for doctors and nurses to facilitate detection of malignant melanoma, the most dangerous form of skin cancer. Since the Company was founded in 1998, more than SEK 600 million has been invested into the Company and the technology which has resulted in a technologically advanced product ready for an accelerated commercialisation. The technology is patented and has been validated by several clinical studies with good results. Nevisense has been granted approval to sell the device in the EU (CE marking), Australia (TGA approval) and, since June 2017, in the US (PMA approval).

The work to obtain a PMA approval was initiated in 2008 and has been an important and resource-intensive process for the Company. Following the approval of the PMA-application by the US Food and Drug Administration, SciBase can now market and sell Nevisense on the US market. The Company’s management and board of directors have together developed an updated business strategy covering SciBase's entry into the US market, the continued growth on the core market Germany and the development of the current product platform for use within additional clinical applications.

The Company assesses that the US market is the largest and most profitable market for medical devices and that a successful launch of Nevisense on the US market would constitute a major commercial opportunity for the Company. The US is therefore considered to be a natural next step for SciBase. In addition to the launch in the US, the updated growth strategy aims to broaden the mode of use of Nevisense from being a pure melanoma detection tool to becoming a unique platform product that dermatologists and general practitioners can use to detect and investigate various skin conditions. SciBase will primarily focus on indications within non-melanoma skin cancer and atopic dermatitis, both of which comprise significantly larger patient groups than the current indication malignant melanoma.

SciBase recently successfully completed a three-year development project with the Royal Institute of Technology in Stockholm to miniaturise the measurement electronics in Nevisense through an application-specific integrated circuit (ASIC). The ASIC enables the future development of a significantly smaller, cheaper and simpler device which will in turn make it possible to approach new customer groups.

The planned US launch and the Company’s updated growth strategy will over time entail increased capital requirements. SciBase’s management and board of directors have resolved to propose the Rights Issue of up to approximately SEK 85 million in order to provide the capital needed. The Rights Issue is secured up to approximately SEK 75 million through subscription undertakings and guarantee commitments.

Of the SEK 85 million expected to be raised through the Rights Issue, the Company intends to distribute the secured SEK 75 million in proceeds as follows: 50–60 percent to finance the launch and marketing of Nevisense in the US, 15–20 percent to develop and market new applications for Nevisense and 15–20 percent for development of next generation products based on the ASIC platform. About 10–15 percent of the issue proceeds will be allocated to general corporate purposes, including transaction costs. The Company is further continuously looking into acquisition opportunities that might supplement current product offerings and distribution channels. The remaining and unsecured part of the proceeds corresponding to approximately SEK 10 million will be used to accelerate the launch of Nevisense in the US and to finance potential acquisitions.

As of the end of the second quarter of 2017, the Company had a cash position of approximately SEK 61 million. The board of director’s assessment is that the current cash position together with the proceeds from the secured part of the Rights Issue will be sufficient to implement the Company’s current business plan.

The Rights Issue

On 26 October 2017, the board of directors of SciBase proposed to the Extraordinary General Meeting to resolve on a preferential rights issue of approximately SEK 85 million.

For each share held on the record date, the shareholder will receive one (1) subscription right. Seven (7) subscription rights entitle the holder to subscribe for eight (8) new shares. The subscription price has been set to SEK 9.00 per share. At full subscription, the Rights Issue will provide SciBase with approximately SEK 85 million, before deduction of transaction costs, by issuing no more than 9,468,306 new shares, resulting in an increase in the share capital of up to approximately SEK 35,032,732.20. Following the Rights Issue, the number of outstanding shares in SciBase will amount to no more than 17,753,074.

Subscription undertakings and guarantee commitments

The Company's three largest shareholders, SEB Pensionsstiftelse, Fouriertransform and SEB Venture Capital, (the “Main Owners”) who together represent approximately 53.4 percent of the capital and voting rights of the Company, have through subscription undertakings undertaken to subscribe for a total of SEK 16.0 million, corresponding to 18.8 percent of the gross proceeds in the Rights Issue, at full subscription. The Main Owners have undertaken not to exercise or sell the remaining subscription rights they will be assigned in connection with the Rights Issue. Moreover, a consortium of Swedish and international investors have, through guarantee commitments, committed to guarantee subscription of new shares in the Rights Issue up to a total amount of SEK 59 million, corresponding to approximately 69 percent of the Rights Issue, at full subscription. Subscription undertakings and guarantee commitments amount to a total amount of SEK 75 million, which means that the Rights Issue is approximately 88 percent covered by subscription undertakings and guarantee commitments. In addition, members of the board and management have undertaken to subscribe for shares corresponding to a total amount of approximately SEK 0.6 million, or 0.8 percent of the Rights Issue.

Extraordinary General Meeting

The Rights Issue is proposed to be resolved at the Extraordinary General Meeting that will be held on 15 November 2017.

For the complete notice to the Extraordinary General Meeting, please see separate press release.

Indicative timetable

10 November 2017 Q3-report is published

15 November 2017 Extraordinary General Meeting

20 November 2017 Expected date for publication of the prospectus

22 November 2017 Record date. Shareholders who are registered in the Company’s share ledger kept by Euroclear Sweden AB on this day will be assigned subscription rights carrying the right to participate in the Rights Issue

27 November – 7 December 2017 Trading in subscription rights

27 November – 11 December 2017 Subscription period

On or about 14 December 2017 The outcome of the Rights Issue is announced

On or about 27 December 2017 The Rights Issue is completed and registered

Adviser

Pareto Securities AB is financial adviser to SciBase and Setterwalls Advokatbyrå AB is legal adviser to SciBase and Pareto Securities AB in connection with the Rights Issue. Avanza Bank is the Company’s certified adviser.

IMPORTANT INFORMATION

This press release is not an offer or solicitation to acquire shares in SciBase. A prospectus relating to the Rights Issue referred to in this press release will be filed with the Swedish Financial Supervisory Authority. After approval and registration of the prospectus by the Swedish Financial Supervisory Authority, the prospectus will be published and made available, inter alia, on SciBase’s website.

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. SciBase does not intend to register any portion of the offering of the securities in the United States or to conduct a public offering of the securities in the United States. The information in this press release may not be announced, published or distributed, directly or indirectly, to the United States, Canada, Australia, New Zealand, Singapore, South Africa, Japan or Hong Kong or in any other jurisdiction where the announcement, publication or distribution of the information would not comply with applicable laws and regulations.

For further information, please contact:

Simon Grant, CEO, Tel +46 72 887 43 99

Michael Colérus, CFO, Tel +46 70 341 34 72

This information is information that SciBase Holding AB (publ) 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 21:00 CET on 26 October, 2017.

Jun 29 2017

SciBase receives US approval for Nevisense

SciBase today announces that the US Food and Drug Administration (FDA) has approved the Scibase Pre-Market Approval (PMA) for its product Nevisense. Nevisense is SciBase’s device for the early detection of malignant melanoma. With the approval, SciBase can now market and sell Nevisense in the US.

SciBase has now received confirmation from the FDA that the Nevisense PMA has been approved. According to the letter from the FDA the device is:

‘intended for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologists chooses to obtain additional information when considering a biopsy.’

The approval means that SciBase now can start the commercial distribution and marketing of Nevisense on the US market. This means that Nevisense is now effectively the only device of its kind available on the US market for the detection of malignant melanoma.

- The Approval is a massive achievement and the result of eight years of hard work. The US Pre-Market Approval process is globally the most demanding regulatory process there is. As part of the Nevisense approval process SciBase were asked to perform the largest clinical trial of its kind ever performed within melanoma detection. The FDA also spent nearly a year reviewing SciBase’s operations and processes. The approval is thereby a validation of us as a Company as well as of our product Nevisense.

Most employees in the company have been working directly or indirectly on the Approval for many years, and this really is a remarkable and nearly unique achievement given the size of our Company, says Simon Grant CEO SciBase.

For SciBase the approval means that the Company now can accelerate activities in preparation for the US introduction. The Company has been doing groundwork for some time and will present the strategy for the US introduction after summer.

- It’s no secret that the US market is the world’s largest and most profitable market for medical devices and in the long term, it represents a huge growth potential for us, says Simon Grant.

SciBase’s device Nevisense is a tool to detect malignant melanoma directly on the skin. Skin cancer is the most common form of cancer and accounts for almost half of all cancer cases. There are estimates that show that half of all Americans that reaches 65 years of age will get skin cancer at least once during their lifetime. During 2017 over 87,000 Americans will be diagnosed with malignant melanoma. Malignant melanoma is the deadliest form of skin cancer and accounts for 75 percent of all the deaths related to skin cancer.

Briefly about the PMA-process

Pre-Market Approval (PMA) is the strictest process for approval for new medical devices in the US market and is required for most so-called Class III devices. Class III devices are often based on new methods that have previously not been approved by the FDA, which means that a number of clinical trials within the field needs to be performed over a long period. Development, clinical trials, preparation of the actual application and the process within the FDA has taken SciBase over eight years, which is normal. Due to the complex and resource demanding process it is only about 30 Companies annually that receive a PMA-approval. SciBase is one of only a handful of Swedish Companies that have successfully has completed a PMA-process.

A PMA application contains detailed information covering the device’s development, manufacturing as well as the clinical trials that confirm the device’s safety and effectiveness in use. In dialogue with the FDA, SciBase has developed and conducted the world’s largest clinical study on detection of malignant melanoma as well as completed a so-called Reader study.

For further information please visit www.scibase.com or contact:

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail: [email protected]

Jul 10 2017

New Study: Nevisense shows potential to help clinics detect melanomas they might otherwise miss

Current methods for melanoma detection strive to detect melanomas at as early a stage as possible. Malignant melanoma is often difficult to detect and early detection is of crucial importance.

In a study at the Skin Cancer Clinic at Southampton University Hospital conducted by Dr Catriona Henderson and Dr Birgit Pees, Nevisense was evaluated as an adjunct to existing methods used for melanoma detection on 48 patients.

The results of the study reinforce what has been seen in other studies - that sometimes even innocuous-looking lesions can be melanoma, and that adding Nevisense can help clinicians detect these, when otherwise they might be missed.

The study concludes that using Nevisense “could help reduce unnecessary excisions and help detect subtle melanomas earlier. In a pigmented lesion clinic Nevisense can be used as an adjunct to macroscopic, dermoscopic and clinical history, to identify subtle early melanomas which might otherwise be missed. Nevisense can also be used to reassure that an otherwise mildly suspicious lesion does not need excision.”

The study was presented as a poster at the 97th Annual Meeting of the British Association of Dermatologists in Liverpool July 4-6 2017.

“We now have yet another study that shows the value of Nevisense, this time in a busy Skin Cancer Clinic in the UK. Missing a melanoma is perhaps the issue that concerns Dermatologists most, so any tools that can help them reduce this risk are very welcome” says Simon Grant, CEO at SciBase.

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

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. 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, as well as FDA clearance 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. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.

Aug 18 2017

Interim Report

January 1 – June 30, 2017

The second quarter in figures

Net sales amounted to TSEK 2,046 (1,855).
The loss after tax amounted to TSEK 11,746 (14,468).
The loss per share amounted to SEK 1.42 (1.75).
The cash flow from current operations was negative in the amount of TSEK 11,044 (13,112).
The gross margin in the period was 34.2% (30.1%).

The first 6 months in figures

Net sales amounted to TSEK 3,801 (2,921).
The loss after tax amounted to TSEK 23,358 (26,068).
The loss per share amounted to SEK 2.82 (3.15).
The cash flow from current operations was negative in the amount of TSEK 23,025 (24,359).
The gross margin in the period was 30.6% (28.7%).

Important events during the quarter

In June the Company announced that the US Food and Drug Administration (FDA) had approved SciBase’s Pre-market Approval (PMA) for its product Nevisense.
The Australian study previously presented at the World Congress of Cancers of the Skin showing that Nevisense can detect malignant melanoma three months earlier in follow-up cases and reduce the need for follow-up by nearly half, was published in the British Journal of Dermatology (BJD).
At the 2017 AGM held on May 16th, three new members of the Board were elected strengthening the commercial experience of the Board in Germany and the US.
SciBase was granted a US patent for the electrode design.
David Melin was appointed as new Head of Product Development.
SciBase relocated from central Stockholm to Sundbyberg (a suburb to Stockholm).

Important events after the end of the period

At the British Association of Dermatologist’s annual meeting in July a new study from Southampton University Hospital was presented showing Nevisense’s potential to help clinicians detect melanomas that otherwise could have been missed.

					July 1 2016 -
	Apr 1 - Jun 30		Jan 1 - Jun 30		June 30 2017	Jan 1 - Dec 31
THE GROUP	2017	2016	2017	2016	Rolling-12	2016
Net sales, SEK ths	2 046	1 855	3 801	2 921	7 316	6 436
Gross margin, %	34,2%	30,1%	30,6%	28,7%	34,8%	34,5%
Equity/Asset ratio, %	87,2%	92,7%	87,2%	92,7%	87,2%	90,8%
Net indebtness, multiple	0,15	0,08	0,15	0,08	0,15	0,10
Cash equivalents, SEK ths	60 974	108 786	60 974	108 786	60 974	84 955
Cashflow from operating activities, SEK ths	-11 044	-13 112	-23 025	-24 359	-46 516	-47 850
Earnings per share (before and after dilution), SEK	-1,42	-1,75	-2,82	-3,15	-6,08	-6,41
Shareholder's equity per share, SEK	8,38	14,45	8,38	14,45	8,38	11,19
Average number of shares, 000'	8 285	8 285	8 285	8 285	8 285	8 285
Number of shares at closing of period, 000'	8 285	8 285	8 285	8 285	8 285	8 285
Share price at end of period, SEK	23,40	17,20	23,40	17,20	23,40	19,00
Average number of employees	21	19	22	19	22	21

This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on August18, 2017.

Simon Grant, CEO, tel: +46 72 887 43 99 , [email protected]

Michael Colérus, CFO, tel: +46 70 341 34 72, michael.colé[email protected]

Sep 06 2017

SciBase presents the next generation Nevisense and a new type of electrode for the evaluation of New Applications

SciBase presents a new generation of its Nevisense device for early detection of malignant melanoma. The new Nevisense includes improvements in both software and hardware with the aim of streamlining the EIS measurement process. In addition, SciBase presents software and a new type of electrode which transform Nevisense into an impedance measurement platform for the evaluation of new clinical indications such as non-melanoma skin cancer.

The new Nevisense contains a number of new features aimed at improving the user experience and better integrating Nevisense into daily clinical workflow.

The next generation Nevisense includes the following:

Intelligent guidance and user feedback built into the device based on AI (artificial intelligence), an improved patient archive and a storage capacity increased to over 1,000 patients
New hardware with image management functionality, wifi connectivity and import of digital dermoscopy images
Integration with Dermoscan’s new EIS-compatible software for DermoGenius Ultra, which simplifies workflow with the aim of increasing usage of Nevisense

New electrodes open up the potential of new applications

In addition to the upgrades of the Nevisense software and hardware, SciBase presents a new type of electrode. The new ‘flat’ electrode does not have the same type of pins as the Nevisense electrode for melanoma, making it more suitable for the investigation of other skin disorders using electrical impedance. These include, for example, other types of skin cancer or atopic dermatitis.

- This product update is a major step for SciBase because we are expanding the market we can address in the future. We are redefining Nevisense from being an instrument used solely to detect melanoma to a platform that can potentially be used in several areas within Dermatology, "says Simon Grant, CEO of SciBase.

The update consists of three important parts. Firstly, SciBase have improved the Nevisense software so that it is optimised for the newly upgraded hardware. The main aim is to provide better guidance throughout the measurement process. The updates also improve overall user-friendliness, which is especially important for new or non-frequent users. The second area is a number of features for evaluating new clinical indications. This means that Nevisense becomes a platform for impedance measurement with different electrode and measurement options. Finally, SciBase have completed the integration with DermoGenius Ultra and the complete solution will be launched at two congresses in Germany during September.

For further information please visit www.scibase.com or contact:

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail: [email protected]

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