Nevisense View - a new product with great potential

Just before Christmas last year, we shipped the first Nevisense View from our office. Nevisense View is our new device for early detection of malignant melanoma, which we began to develop in early 2016. Nevisense View was born out of customer demand to have a version of Nevisense that also included the ability to manage images. As CEO, it is with great pride I can see what the organization and its employees succeeded with in such a short time.

Releasing a new medical device requires teamwork and a broad set of competences especially as we are working within a very demanding regulatory environment. Developing Nevisense View also required a more powerful Nevisense platform.  So not only are we releasing Nevisense View, but we are releasing an updated and improved version of Nevisense offering many new features.

Why one more product?

The idea behind Nevisense View is simple: we combine our Electrical Impedance Spectroscopy (EIS) method, which is a relatively new method, with clinical image documentation, an established diagnostic approach.

Nevisense View provides the opportunity to import standard and dermoscopic images of suspect lesions into Nevisense and store those images along with patient data and the lesion’s EIS evaluation - in one and the same place. That means a simple and straight-forward way to create complete documentation of lesions, and to follow the difficult-to-diagnose lesions over time.  With Nevisense more clinical capabilities are added and there is also an opportunity for a more streamlined workflow.

The benefits of Nevisense and the EIS method are now well documented. Studies show that besides help reducing unnecessary excisions[1], Nevisense can help physicians to detect melanoma at an earlier stage[2].

There are also major efficiency gains for Dermatology clinics. New Nevisense clinical data was presented for the first time at the World Congress of Cancer of the Skin in Vienna in September last year. The study2 was based around using Nevisense in parallel with short term digital dermoscopy (SDDI, i.e. the use of dermoscopic imaging to follow the development of a specific lesion over time). Utilizing this protocol many lesions could be classified as harmless at the first examination, while those lesions where Nevisense indicated a higher risk for melanoma could be surgically removed immediately, rather than waiting 3-6 months as is the normal process for these types of lesion. This approach detected 83% of melanomas earlier while reducing the need for performing SDDI by nearly 50%. Lowering cost levels is a crucial priority within healthcare today and these results combining Nevisense with imaging illustrate good potential for significant labour and cost savings.  

As mentioned above, Nevisense View can be a valuable and effective tool for dermatologists. The EIS measurement is the foundation of both Nevisense and Nevisense View and can not only reduce the need for SDDI but also reduce a number of unnecessary excisions. According to an article[3] by Johan Heilborn, former chief physician at the dermatology clinic at the Karolinska Institute, 150,000 nevi are being excised in order to capture 3,500 invasive melanoma at an estimated annual cost of SEK 300 million. If this is the cost level in Sweden, it can be interesting to reflect on the cost savings that might be made in other countries such as Germany and the US; markets with great potential for SciBase.

SciBase to co-operate with DermoScan

Earlier this week you may have seen the news that SciBase has started a co-operation with DermoScan, a supplier of digital dermoscopy systems from Germany. The agreement means that patient and Nevisense EIS information can be shared between Nevisense and DermoScan’s system, DermoGenius Ultra.

Like Nevisense View, the combination of EIS with patient information and images adds value for clinicians – both diagnostically, but also when it comes to patient flow.  We now have the possibility to reach out to hundreds of clinics that already have a digital dermoscopy system and may wish to add Nevisense in a fully integrated fashion. We are opening up a new world of opportunities for Nevisense.

The launch of Nevisense View is thereby not only a celebration of a new product, it also represents a direction where we combine with and improve the well-established methods. It is therefore I look forward to an exciting 2017 for SciBase and our products.

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

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

About Skin Cancer
Skin cancer is one of the world’s most common cancers, 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.

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 is awaiting 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. 

[1] Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multi-centre, prospective and blinded clinical trial on efficacy and safety. Malvehy J, Hauschild A, Curiel- Lewandrowski C, et al.  Br J Dermatol. 2014;171:1099-1107”

[2] Analysis of an electrical impedance spectroscopy system in short-term digital dermoscopy imaging of melanocytic lesions”, 

Rocha L, Guitera P, Khoury R, Avramidis M, Lo S, and Menzies SW, Posters presented at the 16th World Congress on Cancers of the Skin, Vienna, Aug 31th- Sep 3th, 2016

[3] ”Dermatoskopi vid pigmenterade lesioner – var står vi idag?” Johan Heilborn, MD, PhD, Överläkare Tumörsektionen, Hudkliniken Karolinska, Svensk Dermatologi och Venerologi. No.1 :2015

All-time high Sales for a quarter and the first shipment of our new product Nevisense View

The fourth quarter in figures

• Net sales amounted to TSEK 1,935 (1,181).
• The loss after tax amounted to TSEK 14,623 (11,154).
• The loss per share amounted to SEK 1.77 (1.35).
• The cash flow from current operations was negative in the amount of TSEK 13,032 (13,864).
• Significant margin improvement with gross margin increasing to 35.0% in Q4 (18.4%).

The full year in figures

• Net sales amounted to TSEK 6,436 (4,151).
• The loss after tax amounted to TSEK 53,086 (41,532).
• The loss per share amounted to SEK 6,41 (6.01).
• The cash flow from current operations was negative in the amount of TSEK 47,850 (46,588).
• Significant margin improvement with gross margin increasing to 34.5% (2.5%).

 Important events during the quarter

• Our primary market Germany continues to show good growth with sales in value up by 54% and electrode sales volume up by 93% in the quarter.
• Significant resources invested in the PMA process, with continued progress. Ongoing work to provide replies to feedback from the FDA within several areas.
• A nominating committee has been appointed for the AGM 2017.
• In the period the management team was strengthened with Niklas Jakobsson, responsible for QA and regulatory issues and with Anna Danström head of manufacturing and logistics.
• The semi-automated electrode production process now validated. 
• First delivery of Nevisense View in the period. 

 Important events after the end of the period

• DermoScan and SciBase agree to co-promote an integrated solution for digital dermoscopy and Nevisense.

Comment by CEO Simon Grant 

In the last quarter we were happy to see continued sales growth, driven by increased Nevisense usage. Compared to the same period 2015 our sales increased by 64 percent and reached MSEK 1.9, which is a new all-time high.  We also sold 5,600 electrodes, an increase of 106 percent. The sales for the full year 2016 amounted to over MSEK 6.4, which is an increase with 55 percent compared to 2015. The volume of sold electrodes (tests) increased by 87 percent to 15,200. Germany continues to be our growth engine and it is encouraging to see that we have a growing number of high-volume users there. As you know, our business model requires an initial device sale but the potential lies in the sale of single-patient electrodes when the device is used.

The first Nevisense View delivered

In December Nevisense View, a new device combining our EIS-method with the documentation of clinical images, became commercially available. With Nevisense View it is possible to import clinical and dermoscopic images of lesions and store them together with patient data and the EIS test results. For clinicians, this can have significant benefits. It can improve workflow, facilitate full documentation of suspicious lesions and help monitor difficult to diagnose lesions. In December we delivered the first Nevisense View to Belgium. Since then we have also sold units in Sweden and we see an increasing interest from these as well as from other markets, including Germany.

As part of the release of Nevisense View, we also released a major update of Nevisense itself. This included both an update in the Nevisense hardware but also significant improvements in the system software. We have, for example, added inbuilt network connectivity (Wi-Fi and Ethernet), improved patient data management and the body map, and added follow-up functionality.

Germany is the engine but there are other interesting markets

Germany is, as you know, our largest and most important market and we continue to grow at a rapid pace there. During the quarter sales increased by 54 percent and the volume of sold electrodes by 93 percent compared to the same period 2015. We see now over one thousand patients tested each month in Germany. We also see a growing number of clinics with more than one system, which is positive as it is a sign that they see the benefits of Nevisense. In total we now have fifteen customers in Germany with two, three or even four Nevisense systems. The German market success is driven by market conditions and our direct sales presence. There are many private dermatology clinics, there is reimbursement coverage for EIS-measurements and good acceptance for the method.

In January 2017 we entered into a co-promotion agreement with DermoScan GmbH. This co-operation provides an opportunity to reach Dermoscan’s customer base of several hundred clinics.  We will be able to offer an integrated solution for each other’s products and that will both improve workflow and save time for clinics. DermoScan will market Nevisense towards both their existing as well as new customers with Germany as the initial focus.

With Nevisense View we see improved opportunities for our offer on the Belgian and Swiss markets and we will subsequently increase our efforts there. We also see and increased interest in Nevisense View in Sweden.

In the USA the process to achieve a PMA approval continues to move forward. During the period we have provided additional complementary information, as is the normal process. We receive on-going feedback and we stand by our hope that we will receive an FDA approval by the end of the second quarter 2017.    

Moving forward in electrode production

In the period we finalized the validation of the semi-automated production process, which now is ready for implementation. We now have a short-term focus on increasing production capacity and yield.

We’re now looking forward to a spring where sales and the on-going PMA process will continue to be our main priorities. We will work to support the sales channels as they introduce Nevisense View and we are also looking forward to our cooperation with DermoScan. We believe that the cooperation offers good opportunities for us to reach new groups of customers and increase the knowledge of SciBase, Nevisense and the EIS-method.

Simon Grant, CEO

The Year-end report 2016 is found in its entirety below

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

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

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 February 17, 2017.

Contact person:

Michael Colérus, CFO
Tel: +46 70 341 34 72
E-mail: [email protected]

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.

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 is awaiting 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.

The shareholders of SciBase Holding AB (publ), reg. no. 556773-4768, (hereinafter the “Company”) are hereby invited to the Annual General Meeting to be held on 16 May 2017, at 5.00 PM at Setterwalls Advokatbyrå’s  offices with address at Sturegatan 10 in Stockholm.

Registration 

Shareholders who wish to attend the Annual General Meeting must be recorded in the share register held by Euroclear Sweden AB on May 10, 2017 and notify the Company of their intention to attend by no later than May 10, 2017, preferably before 3.00 p.m. CET. Notice of attendance is made in writing to SciBase Holding AB (publ), P.O. Box 3337, 103 67 Stockholm, Sweden, or by e-mail [email protected] or by phone +46-8-410 620 00. The notice of attendance shall include name, personal or corporate ID number, address and phone number. The same dates, addresses, and formal requirements apply for notifying the Company of any accompanying advisors. Powers of attorneys, certificates of incorporation and other documents of authorization must be presented at the Annual General Meeting, but can preferably be sent to the Company in connection with the notice of attendance.

Shareholders whose shares are registered in the names of nominees must temporarily register the shares in their own name in order to be entitled to attend the Annual General Meeting (so called voting registration). In order for such voting registration to be completed on May 10, 2017 the shareholders must inform their nominees well before this date.

A shareholder's rights at the meeting may be exercised by a proxy empowered by a power of attorney. The power of attorney shall be in writing, dated and signed and must not be older than five years. The original power of attorney must be presented at the meeting. Those representing a legal person must also present a certificate of registration or the similar showing the authorized signatories. A proxy form is available on the Company’s website, www.scibase.com.

Proposed agenda

1. 1.                  Opening of the meeting;  
2. 2.                  Election of chairman of the meeting; 
3. 3.                  Drawing up and approval of the voting list;
4. 4.                  Approval of the agenda; 
5. 5.                  Election of one or two persons to adjust the minutes; 
6. 6.                  Determination as to whether the meeting has been duly convened; 
7. 7.                  Presentation of the annual report and the auditor's report on the annual report and the consolidated annual report and the auditor’s report on the consolidated annual report; 
8. 8.                  Resolutions regarding: 
   1.                     i.          adoption of the income statement and balance sheet and the consolidated income statement and consolidated balance sheet;
   2.                         ii.     allocation of the Company's result according to the adopted balance sheet; and 
   3.                        iii.     discharge from liability for the members of the Board of Directors and the Managing Director; 
9. 9.                  Resolution regarding the number of members and deputies of the Board of Directors;
10. 10.               Resolution regarding the remuneration for the members of the Board of Directors and the auditor; 
11. 11.               Resolution on guidelines for determination of salary and other remuneration to senior management;
12. 12.               Election of members, deputies and Chairman of the Board of Directors and auditor; 
13. 13.               Resolution regarding appointment of Nomination  Committee; 
14. 14.               Resolution regarding authorisation for the Board of Directors to resolve upon issues of shares, warrants and convertibles; 
15. 15.               Closing of the meeting. 

Proposals 

Election of chairman of the meeting – item 2

The Nomination Committee proposes that Attorney-at-law Mattias Detterfelt is appointed chairman of the meeting.

Allocation of the Company's result – item 8 (ii) 

The Board of Directors and the Managing Director proposes that the result for the year is allocated so that SEK 189,237,244 is carried forward. No dividend to the shareholders is thus proposed.

Resolution regarding the number of members and deputies of the Board of Directors – item 9 

The Nomination Committee proposes that the Company's Board of Directors shall consist of six ordinary members and one deputy.

Resolution regarding the remuneration for the members of the Board of Directors and the auditor – item 10 

The Nomination Committee proposes that a fee of SEK 200,000 shall be paid to the Chairman of the Board of Directors and SEK 150,000 to external members of the Board of Directors who are not employed by a larger shareholder in the Company.  

Board members shall, provided that the circumstance so allow from a tax perspective and that no additional costs will be incurred by the Company, be allowed to invoice the fee.

Fees to the Company's auditor shall be paid in accordance with approved invoices.

Resolution on guidelines for determination of salary and other remuneration to senior management – item 11

The Board of Directors proposes that the Annual General Meeting resolve to adopt the following guidelines for the remuneration of senior management members for the period extending until the 2018 Annual General Meeting.

The remuneration of the senior management members shall comprise fixed salary, variable salary (if any), pension and other benefits. The total remuneration package should be based on market terms, be competitive and reflect the individual’s performance and responsibilities as well as the Group’s earnings trend.

The variable salary may comprise annual incentives in cash and long-term incentives in cash, shares and /or share-based instruments in the Company. Variable salary in cash is conditional upon the fulfillment of defined and measurable goals and should be maximized in relation to the fixed salary. Long-term incentives in the form of shares and /or share-based instruments in the Company may be provided through participation in long-term incentive programs approved by the Annual General Meeting. Terms and conditions for variable salary should be designed so that the Board of Directors, if exceptional economic circumstances prevail, has the option of limiting or refraining from payment of variable salary if such a measure is considered reasonable.

In specific cases, agreements may be reached regarding one-off remuneration amounts provided that such remuneration does not exceed an amount corresponding to the individual’s annual fixed salary and maximum variable salary in cash, and is not paid more than once per year and individual.

Pension benefits should either be defined benefit or defined contribution, or a combination there of. The retirement age for the Managing Director and for other senior management members is a minimum of 65. 

Members of the senior management generally have a period of notice of not more than 12 months. The Board of Directors shall have the right to depart from the guidelines resolved on by the Annual General Meeting if, in an individual case, there are special reasons for this. 

The sphere of senior executives encompassed by the guidelines comprises the Managing Director and other members of senior management.

Election of members, deputies and Chairman of the Board of Directors and auditor – item 12

The Nomination Committee proposes election of members, deputies and Chairman of the Board of Directors and auditor for the period until the end of the next Annual General Meeting, as follows:

Board members:

Tord Lendau (re-election)                                   

Thomas Taapken (new election)                                                   

Diana Ferro (new election)                                 

Per Aniansson (re-election)  

Renee Lucander (re-election)

Thomas Eklund (new election)                                                       

Chairman:

Tord Lendau (re-election)

Deputies: 

Per Nordgren (new election)

Auditor:

The chartered auditing firm PricewaterhouseCoopers AB (PwC), with Magnus Lagerberg as responible auditor (new election) 

Resolution regarding appointment of Nomination Committee – item 13 

The Nomination Committee proposes the following decision for election of a Nomination Committee for the Annual General Meeting 2018:

The Nomination Committee for the Annual General Meeting 2018, which shall comprise of four members, shall be appointed by way of that the Chairman of the Board of Directors will consult with the three largest shareholders of the Company at the end of the third quarter of 2017. These shareholders will be requested to each appoint one member who, together with the Chairman of the Board of Directors, will form the Nomination Committee. The composition of the Nomination Committee shall be publicly announced no later than six months prior to the Annual General Meeting. The Nomination Committee, whose mandate period applies until the time a new Nomination Committee has constituted itself, shall appoint a chairman among its members. The Nomination Committee shall prior to the Annual General Meeting 2018 prepare and submit proposals regarding the election of the chairman of the meeting, the number of board members and deputy members, the election of board members, chairman, deputy members and auditor, remuneration for the Board of Directors and the auditor, as well as guidelines for the appointment of the Nomination Committee for the following Annual General Meeting. The Nomination Committee’s proposals shall be presented in the notice to a general meeting where election of board members and auditor shall take place and on the Company’s website. Should a member of the Nomination Committee resign from its assignment, a replacement shall be sought from the shareholder that appointed the departing member. Should a shareholder that has appointed a member in the Nomination Committee substantially decrease its ownership in the Company, the next shareholder in size order shall, if the Nomination Committee so resolves, be requested to appoint a member to the Nomination Committee.

Resolution regarding authorisation for the Board of Directors to resolve upon issues of shares, warrants and convertibles – item 14

The Board of Directors proposes that the Annual General Meeting resolves to authorise the Board of Directors to, until the next Annual General Meeting, on one or more occasions, decide upon issuances of new shares, issuance of warrants and/or convertibles. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company, and  may be made either in cash and/or by way of set-off or contribution in kind or otherwise on specific terms. The number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall not exceed 820,000 (corresponding to approx. 10 percent of the number of shares in the Company at the date of the issuance of the notice).

Information at the Annual General Meeting

Upon request by any shareholder and where the Board of Directors believes that such may take place without significant harm to the Company, the Board of Directors and the Managing Director should provide information at the Annual General Meeting in respect of any circumstances which may affect the assessment of a matter on the agenda, and any circumstances which may affect the assessment of the Company’s or a subsidiary’s financial position and as regards the Company’s relationship to other group companies.

Majority Requirements 

For resolution in accordance with items 14 on the agenda, it is required that the general meeting’s resolution is supported by shareholders representing at least two thirds of the shares represented the votes cast at the general meeting.

Number of shares and votes

At the time of the issuance of this notice, the total number of shares and votes in the Company amounted to 8,284,768.

Documents

The financial statements and auditor's report will be available in the Company's offices and at the Company’s website www.scibase.com as of 25 April 2017. Copies of the aforementioned documents will also be sent by post to shareholders who so request and provide their postal addresses. The proposals of the Board of Directors and the Nomination Committee are set out in full in the notice. 

 * * * * * *

Stockholm in April 2017 

SciBase Holding AB (publ)

The Board of Directors

SciBase, who in June of this year took over the manufacturing of their single-use electrode from Ginolis, has appointed Anna Danström as Supply Chain & Production Manager. Anna Danström, who previously was responsible for electrode development at SciBase, has recently assumed her new role. As Supply Chain & Production Manager Anna becomes a member of the management team, where she replaces Marko Päivärinne. 

The insourcing of manufacturing has resulted in a number of advantages for SciBase, including better conditions to pursue the development of more cost-effective larger-scale manufacturing. With Anna as new Supply Chain & Production Manager the work to streamline and scale the production of electrodes in Uppsala will be intensified.   

- The manufacturing of electrodes is our most strategically important process and it is of utmost importance that we can both streamline and  increase production capacity going forward, a task which Anna is perfectly suited for. With the addition of Anna and also Niklas Jakobsson, who recently assumed responsibility for Quality Assurance and Regulatory issues, we are creating a very strong management team with the relevant competence and experience, says Simon Grant, CEO of SciBase.

Apart from being responsible for the development of electrodes at SciBase Anna has had long experience within medtech, working for a number of international companies such as St. Jude Medicals where she worked in a number of global technology transfer projects.   Anna also has experience in working with FDA-related processes, which will be a benefit given SciBase’s on-going PMA process and the forthcoming launch on the US market. Anna replaces Marko Päivärinne who has decided to pursue new challenges outside the company from early next year.

SciBase’s product Nevisense requires a new electrode for every patient examined. SciBase’s business model is based on selling instruments, but the major potential lies in the continuous use of the instruments, which generates revenues from the sale of the single-use electrodes. During the autumn SciBase passed a milestone of 10,000 electrodes sold during the year and increased sales of the electrodes by 77 percent for the first nine months of the year.

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

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail: [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 08.00 CET on December 1, 2016.

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.

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 is awaiting 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.

SciBase’s new instrument Nevisense View combines patented impedance measurement (EIS) for early detection of malignant melanoma with visual information from digital dermoscopy. Today the first Nevisense View instrument leaves SciBase for delivery to Belgium. 

The new instrument Nevisense View integrates images from digital dermoscopy with Nevisense’s EIS-technology.  The result is that all information from a skin examination is gathered in the same instrument, thus improving clinic workflow. To be able to track the development of a suspicious lesion, with the help of both EIS-values and images, helps prevent unnecessary excision of healthy lesions and minimises the risk of missing malignant melanoma.

Nevisense View is developed together with leading Dermatologists to improve workflow for clinical staff by providing the following functions:

• Wireless transfer of images to Nevisense
• Combination of EIS results, clinical and dermoscopy images, and patient information in one PDF-report for complete documentation of an examination.
• Easy-to-use follow-up functionality, such as split screen comparison of lesions over time.

- A new Australian study, presented in August of this year, showed that the utilisation of EIS can reduce the number of cases that need to undergo sequential digital dermoscopy monitoring by almost half while also detecting most malignant melanomas three months earlier than sequential digital dermoscopy alone.  The combination of digital dermoscopy and our unique EIS-measurement in the same instrument is therefore of both significant clinical benefit and can also potentially deliver significant health economic savings, says Simon Grant, CEO of SciBase.

Subscribe to SciBase’s monthly letter from the CEO here.

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

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

About Skin Cancer
Skin cancer is one of the world’s most common cancers, 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.

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 is awaiting 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.

To keep shareholders and other interested parties updated about SciBase progress we have we have decided to start sending out regular short newsletters regarding company activities and market information. In these letters we will explain important events in the Company’s development in a little more detail and touch upon current events within our industry or in the field of skin cancer. Please sign up for this newsletter here.

In this first letter we thought we’d outline our view on one of this autumn’s hot topics - teledermoscopy, and discuss how this method relates to our instrument.   

Teledermoscopy – good for increased awareness and access but is it good enough as a diagnostic method? 

Cancer is a disease that affects us all. It is estimated that a third of all Swedes will at some time in their lives receive a cancer diagnosis. One of the fastest growing cancers is skin cancer, of which malignant melanoma is the most dangerous type. Our instrument Nevisense, complements a traditional visual examination with a direct physical measurement of a lesion’s structure via its impedance. This helps physicians objectively assess suspicious lesions directly on the skin, i.e. without having to surgically excise the lesion of concern. With the help of Nevisense a physician can potentially detect melanoma at an earlier stage in its development, while decreasing the number of unnecessary surgeries to excise suspicious lesions. The earlier that cancer can be detected the higher the survival rate will be.

In recent times much has been written about teledermoscopy, a method to evaluate suspected skin cancer based on the remote evaluation of lesion images.  Teledermoscopy means taking a picture of a suspicious lesion then sending the image and patient’s clinical data to a specialist for interpretation.  The patient later receives advice on how to proceed, usually whether or not the patient needs to visit a physician for a ‘physical’ examination.

There are different variants of teledermoscopy. On the consumer (public) market there are apps that can be installed on your smartphone. Through the app you take a picture of a lesion and then send it for interpretation by (usually) a Dermatologist. The assessment usually costs from a few hundred crowns, and you usually receive a response within 24 hours to two weeks.

The healthcare sector has generally also embraced the method, which means that many primary care centers and General Practitioners have the possibility to send a picture to a specialist for assessment. This is something that takes place for example, in Stockholms Läns Landsting. Study results indicate that teledermoscopy results in shorter waiting times compared to the normal wait to see a Dermatologist. 

Teledermoscopy improves patient access to an examination and can result in the patient receiving care earlier, which is good. The earlier we detect malignant melanoma the better the chance to treat it successfully. When it comes to teledermoscopy for consumers there is however a risk with patients themselves selecting which lesion or lesions are to be assessed. The risk is that they choose benign lesion(s) for evaluation while missing the lesion that is a melanoma or other type of skin cancer. In addition a recent review published in JAMA Dermatology [1] showed that in general assessment by a Dermatologist during a face to face consultation results in a more accurate assessment than one done by teledermoscopy. It is therefore advantageous for patients to utilise face to face assessment by a physician who performs a full examination.

The products that cater to the consumer do however contribute with an important factor, to increase awareness which can lead to an increased patient flow into the health care system. To be able to handle the increased number of patients with lesions of concern, the health care system needs to be improved and streamlined. This is where SciBase comes in. As greater numbers of suspicious lesions are being evaluated, diagnosis needs to be as efficient and effective as possible. Diagnosis often involves excision of a suspected lesion, yet we know that 93-97 percent of all excisions are unnecessary as the excised tissue is not cancerous. Utilising Nevisense can reduce the number of unnecessary excisions by up to 40 percent. In addition to saving money for the healthcare system by performing fewer operations and pathology evaluations, we reduce patient anxiety and discomfort. Whereas Nevisense provides an immediate answer, excisions and biopsies must be analysed by a pathologist to determine if they are malignant or not. In the worst case it can take up to eight weeks to get an answer, a wait that can be hard on the patient.   

Nevisense is therefore a good complement to the diagnostic process both in situations with or without teledermoscopy. The challenge for Scibase is to demonstrate that Nevisense can help streamline the diagnostic process, save money and provide better care to patients. We are well on the way with a number of studies. A recent Australian study shows that Nevisense can halve the number of patients that need to undergo sequential monitoring i.e. that need to have a follow-up visit with digital dermoscopy. This is just one example of how Nevisense can lead to substantial cost-savings.  

Launch of Nevisense View

Finally, in response to our customers demand, we are expanding the functionality of Nevisense and launching an additional product – Nevisense View. With Nevisense View we have integrated clinical and dermoscopic images with our patented impedance technology. This new product was developed for clinicians that want to combine both methods and improve the management of patients. The first shipments to customers start now in December 2016. In the next CEO letter we will discuss Nevisense View and its application in more detail. 

Merry Christmas and a Happy New Year!

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

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

About Skin Cancer
Skin cancer is one of the world’s most common cancers, 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.

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 is awaiting 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. 

[1] Finnane A Soyer P et al. Teledermatology for the Diagnosis and Management of Skin Cancer. A Systematic Review. JAMA Dermatology. Dec. 2016 

David Sonnek (representing SEB Venture Capital and SEB pensionsstiftelse),

Per Nordberg (Fouriertransform),

Renee Aguiar-Lucander (Omega fund IV L.P.),

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, 2016.

The Annual General Meeting of SciBase Holding AB (publ) will be held on May 16, 2017 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 31, 2016

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

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 08.00 CET on October 31, 2016. 

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.

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 is awaiting 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. 

January 1 – September 30, 2016

The third quarter in figures

• Total net sales amounted to TSEK 1,580 (995).
• The loss after tax amounted to TSEK 12,395 (10,260).
• The loss per share amounted to SEK 1.50 (1.24).
• The cash flow from current operations was negative in the amount of TSEK 10,459 (9,669).
• Significant margin improvement with gross margin increasing to 44.6% in Q3 (17.6%).

The first nine months in figures

• Total net sales amounted to TSEK 4,501 (2,970).
• The loss after tax amounted to TSEK 38,463 (30,378).
• The loss per share amounted to SEK 4.64 (4.71).
• The cash flow from current operations was negative in the amount of TSEK 34,818 (32,724).
• Significant margin improvement with gross margin increasing to 34.3% (-3.8%).

Important events during the quarter

• A milestone was passed on the German market as the 100th customer bought and installed a Nevisense device. Our primary market Germany continues to show good growth with total sales up by 67% and electrode sales volume up by 118% in the quarter.
• In the period SciBase introduced its new product – Nevisense View – combining SciBase’s patented electrical impedance spectroscopy (EIS) for early detection of malignant melanoma with visual information from digital dermoscopy, creating a complete instrument that improves and simplifies the diagnostic process.
• In the period a new Australian study was presented, which showed that by using Nevisense, it is possible to reduce the number of cases that require digital dermoscopy follow-up by almost half. In addition Nevisense detected most melanoma three months earlier than traditional methods. The study consisted of 118 patients with 160 lesions, and the results were presented for the first time at the World Congress on Cancers of the Skin in Vienna on September 1.
• Significant resources allocated during the quarter on the PMA-process, with continued progress. Ongoing work to provide replies to feedback from the FDA within several areas. We have passed the inspection phase and no additional clinical data have been requested so far. 

Important events after the end of the period

• A nominating committee has been appointed for the AGM 2017.

Financial overview 

SciBase has recently taken over the production of its single use electrodes and is moving towards a launch of Nevisense on the US market. As part of this process, the Company has chosen to strengthen the management team with Niklas Jakobsson who is responsible for the Company’s Quality management system and Regulatory  issues.  

Niklas previously held the position of Quality manager at Ginolis AB in Uppsala where the electrode was manufactured before it was transferred to SciBase. This and his experience with the US market makes him a natural addition to the management team.

Niklas brings a wealth of other experience to SciBase with almost 20 years working in the MedTech industry. He has held positions within R&D, Production and Quality management for a number of different MedTech companies; many of which have been active on the US market.

For more information, please contact:
Simon Grant, CEO
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 08.00 CET on November 22, 2016.

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.

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 is awaiting 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.

January 1 – June 30, 2016

The second quarter in figures

• Total net sales amounted to TSEK 1,855 (918).
• The loss after tax amounted to TSEK 14,468 (10,939).
• The loss per share amounted to SEK 1.75 (1.80).
• The cash flow from current operations was negative in the amount of TSEK 13,112 (13,858).
• Significant margin improvement with gross margin increasing to 30.1% in Q2 (-34.5% Q2 15).

 The first half-year in figures

• Total net sales amounted to TSEK 2,921 (1,975).
• The loss after tax amounted to TSEK 26,068 (20,118).
• The loss per share amounted to SEK 3.15 (3.63).
• The cash flow from current operations was negative in the amount of TSEK 24,359 (23,055).
• Significant margin improvement with gross margin increasing to 28.7% (-14.6%).

 Important events during the quarter

• Record growth in key market Germany with total sales up 124% and electrode sales volume up 212%.
• SciBase will insource the strategically important production of the disposable electrode from Ginolis. The companies have mutually agreed to transfer the manufacturing to SciBase when Ginolis AB has completed the next milestone in the stepwise automation of the production process. 
• As part of the Nevisense PMA-process, a series of inspections were carried out by the US FDA with good results. 
• The AGM was held on May 16, 2016.
• SciBase participated in the Euromelanoma week May 9-13, a European initiative to highlight skin-cancer.  
• On April 25th, the Annual Report for 2015 was published.

Important events after the end of the period

A milestone was passed when the hundredth clinic in Germany installed a Nevisense device.

Financial overview