Fredrik Goldkuhl, head of Product Development and member of the Group management team has decided to leave SciBase in August of this year. David Melin will replace Fredrik in the management team and as head of product development.
- During Fredrik’s 11 years at SciBase the Company has undergone major changes from a Company with an idea in an early development phase to now having Nevisense established on a number of European markets and in the final stages of a US approval process. I would like to take the opportunity to thank Fredrik for his great commitment to SciBase and wish him all the best in his new role, says Simon Grant, CEO SciBase.
David Melin has been appointed as his replacement and as new head of product development. David joined SciBase in 2013 and has worked primarily with product development within hardware and system design. David holds a degree of M.Sc. in Mechanical Engineering focusing on Mechatronics from the Royal Institute of Technology, Stockholm.
- David has been a key member of our product development team and has played a central role in the development of our core Nevisense product. He has also driven much of the ongoing development of our new applications and our next generation product platform. I congratulate David on his new role and look forward to working closely with him in the future, says Simon Grant.
For further information please visit www.scibase.com or contact:
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 13.00 CET on June 13, 2017.
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 has recently moved from its premises in downtown Stockholm to newly renovated premises in Sundbyberg, a part of greater Stockholm. The new address is Landsvägen 39, directly across from the Sundbyberg train station.
- When it was time to renegotiate our rental agreement we did a review of our situation and saw that our needs had changed. Through the relocation we now have an office that is more suited for our current activities, as well as being cost-efficient, says Simon Grant, CEO of SciBase.
The Company’s other contact information, such as postal address and telephone, remains unchanged. The new visiting address is Landsvägen 39, 172 63 Sundbyberg.
For further information please visit www.scibase.com or contact:
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.
May 2nd SciBase received patent approval for a further US patent.
On May 2nd 2017 SciBase received confirmation that US patent number 9,636,035 has been approved. The patent protects the unique shape of the microneedles that enable detection of malignant melanoma in the skin using electrical impedance as demonstrated with high precision in clinical trials. In total SciBase now has 3 patent families approved in the US and an additional family in process.
”Our electrode design is one of the key reasons for the success of our method. It is positive that we further strengthen our patent portfolio in the US, especially as we are in the final stages of our PMA-application.”, says Simon Grant CEO SciBase.
For further information please visit www.scibase.com or contact:
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 May 4, 2017.
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 loss after tax amounted to TSEK 11,612 (11,600).
The loss per share amounted to SEK 1.40 (1.40).
The cash flow from current operations was negative in the amount of TSEK 11,981 (11,247).
The gross margin in the period was 26.5% (26.3%).
Important events during the quarter
Our primary market Germany continues to show good growth with sales in value up by 99% and electrode sales volume up by 95% in the quarter.
Significant resources invested in the PMA process, with continued progress. During the period the Company has supplied FDA with feedback within several areas.
DermoScan and SciBase agree to co-promote an integrated solution for digital dermoscopy and Nevisense.
Important events after the end of the period
The notice to attend the AGM 2017 was published.
The annual report 2016 was published.
Australian clinical study published in British Journal of Dermatology presents further benefits with Nevisense.
SciBase receives US patent on the electrode design.
Apr 1 2016 -
Jan 1 - Mar 31
Mar 31 2017
Jan 1 - Dec 31
THE GROUP
2017
2016
Rolling-12
2016
Net sales, SEK ths
1 755
1 066
7 125
6 436
Gross margin, %
26,5%
26,3%
33,8%
34,5%
Equity/Asset ratio, %
90,7%
94,4%
90,7%
90,8%
Net indebtness, multiple
0,10
0,06
0,10
0,10
Cash equivalents, SEK ths
72 627
122 241
72 627
84 955
Cashflow from operating activities, SEK ths
-11 981
-11 247
-48 584
-47 850
Earnings per share (before and after dilution), SEK*
-1,40
-1,40
-6,41
-6,41
Shareholder's equity per share, SEK*
9,79
16,19
9,79
11,19
Average number of shares, 000'*
8 285
8 285
8 285
8 285
Number of shares at closing of period, 000'*
8 285
8 285
8 285
8 285
Share price at end of period, SEK
19,30
23,50
19,30
19,00
Average number of employees
22
18
22
21
*Adjusted for in May 2015 performed reversed split, 40:1
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 above, at 08.00 CET on May 10, 2017.
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.
At the annual general meeting of SciBase Holding AB (publ) on 16 May 2017 in Stockholm the shareholders adopted the below resolutions.
Resolution regarding adoption of the profit and loss account and balance sheet for the company and the group as well as resolutions in respect of appropriation of profits and discharge from liability
The meeting resolved to adopt the income statement and balance sheet and the consolidated income statement and consolidated balance sheet included in the annual report.
The meeting resolved to allocate the profit for the year in accordance with the board of directors’ proposal, i.e. SEK 189,273,244 was carried forward.
The meeting resolved to discharge the board members and managing director from liability for their management of the Company's affairs during the preceding financial year.
Resolution regarding the remuneration for the board of directors and the auditor
The meeting resolved to that remuneration for the Board of Directors and the auditor should be paid in accordance with the following:
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
The meeting resolved to adopt guidelines for determination of salary and other remuneration to senior management in accordance the board’s proposal.
Resolution regarding members of the board of directors and auditor
For the time until the end of the next annual general meeting, the meeting resolved to elect Tord Lendau (re-election), Per Aniansson (re-election), Renee Aguiar-Lucander (re-election), Thomas Taapken (new election), Diana Ferro (new election) and Thomas Eklund (new election) as ordinary members of the board of directors. Per Nordberg (new election) was elected as deputy member of the board of directors for the time until the end of the next annual general meeting.
PricewaterhouseCoopers AB (PwC) (new election) was elected as auditor with Magnus Lagerberg as responsible auditor for the time until the end of the next annual general meeting.
Resolution regarding appointment of nominating committee
The meeting resolved to adopt principles for the appointment the nominating committee for the annual general meeting 2018 in accordance with the nominating committee’s proposal.
Resolution regarding authorization of the board of directors to issue new shares, issuance of warrants and/or convertibles
The meeting resolved to authorize the board of directors to, during the time 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.
The information herein is such that shall be announced in accordance with the rules applied by Nasdaq First North. The information was submitted for publication at 7:00 pm on May 16, 2017.
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 age 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.
Following two recent industry events in March, one in the US and one on our main market Germany, it is always interesting to reflect on our industry, its trends and the areas that might be the focus in the future.
Of special interest is the annual meeting of the American Academy of Dermatology (AAD). Held in March, it is the largest and most influential meeting of the year in the US. The AAD has more than 19,000 members, which means that almost all US Dermatologists are members. Because Nevisense is not yet approved in the US, there are limitations on how actively we can market Nevisense at this meeting. Despite this, our presence helps us establish contacts and is a good opportunity to evaluate both new technologies and industry trends.
From these meetings I have chosen to highlight three topics that I believe may impact Dermatology and skin cancer diagnostics in one way of another in the future.
- Strong growth in specialised Electronic Medical Records
- The application of molecular diagnostics to melanoma
- The potential use of artificial intelligence within skin cancer diagnostics.
Specialised Electronic Medical Records systems
After promising so much for so long, it appears that the time is finally here for Electronic Medical Records to begin to fulfill a role in helping provide better clinicalcare. Whereas systems of the past have been mostly administrative and replacing existing paper-based systems, the newer systems are very specialty-driven and can really add clinical value.
It was very pleasing to see the number of EMR systems specialized for the needs of the dermatologist and a dermatology clinic. Having the right patient information and history, images and test results easily available helps clinicians make better decisions when diagnosing skin cancer and other skin-related diseases.
We see this as an important trend and earlier this year, SciBase announced its cooperation with the German manufacturer Dermoscan. The partnership means that we will integrate Nevisense with Dermoscan’s system allowing EIS data to be available to German EMR systems.
Molecular diagnostics show potential, but not for point-of-care use
One area where there is activity in terms of new developments is the area of molecular diagnostics. At AAD, there were two types of gene expression tests commercially available. Most interest centered on tests that can help identify tumors that have a high risk of spreading through metastasis. This is a gene expression profile test that may be appropriate for some patients after the lesion has already been removed. In general the test is managed by the pathologist, and is performed in specialized laboratories.
The second test is a method based on the detection of the expression of two specific genes (LINC and/or PRAME). Depending on the level of expression, the test indicates the likelihood of a lesion being melanoma. To collect a sample, tape is repeatedly placed onto the suspicious lesion and then torn away thus collecting a skin sample that can be sent to a laboratory and its RNA analyzed. Though not as sensitive as Nevisense, the early results are interesting. The gene expression results are however not available directly at the ‘point–of-care’. Doctors will still need to send the tape stripped sample to a laboratory for analysis, which takes time, and we believe that this, combined with the cost of the procedure, will limit its clinical utilization.
Artificial intelligence within skin cancer diagnosis
During AAD, a hot topic of discussion was the role of Artificial Intelligence or AI in Dermatology. In late January, several international media outlets such as The Guardian, CNN and Fortune reported the results of a new study using an AI based system to classify lesions and identify melanomas. The research system was developed at Stanford University and utilized ‘deep neural networks’ based on the analysis of 130,000 images.
The study illustrates once again the challenge for clinicians using visual methods for melanoma detection. Though still early, this was the most promising study of its kind to date and it will be interesting to see how AI might change the health care sector in the future. It is probably an understatement to say that there remain open regulatory questions regarding AI-based diagnostic tools, especially in the US. This type of technology might be very useful for channeling the right patients to Dermatologists. We believe however, that clinicians will continue to make the final diagnostic decisions - though more and more based on new tools such as Nevisense, digital dermoscopy and potentially AI.
There is no question that in the future healthcare will be more technology-intensive than it is today. SciBase follows with great interest all new efforts to detect melanoma especially when they, like our approach, involve a change in the way we work.
More exposure for EIS in Germany
In March, SciBase also exhibited at ‘Dermatologische Praxis’ in Frankenthal, a conference for private Dermatologists in Germany. Germany is SciBase’s most important market and this event is the busiest of the year for the SciBase team in Germany.
The conference program included an interesting lecture about Nevisense and the EIS method, presented by a private Dermatologist and Nevisense user from Kiel. The focus of the lecture was how EIS can help detect melanoma at an early stage, and how the method can be incorporated into the routine workflow of a clinic. The lecture was very well attended and resulted in several immediate sales.
For SciBase these events are very important. They provide a unique opportunity for us to present our product and to establish contact with potential customers. Moreover, they are an important opportunity to evaluate new trends and follow interesting developments in our industry such as those discussed above.
Best regards, Simon
For further information please visit www.scibase.com or contact:
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.
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 April 25, 2017.
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 age 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 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, has now been published in the British Journal of Dermatology (BJD). The BJD is one the world’s leading journals within dermatology research and this is the second time that they publish an article about Nevisense and the EIS method.
In the study, conducted by Dr Lilian Rocha, Associate Prof. Pascale Guitera, Prof. Scott W. Menzies et. al. at the Melanoma Institute of Australia and Royal Prince Alfred Hospital in Sydney, short term digital dermoscopy imaging (SDDI) was combined with Nevisense’s electrical impedance spectroscopy (EIS). In total, the use of Nevisense showed the potential to reduce the number of cases that needed to undergo SDDI by 47%. This could simplify diagnostics and lead to significant cost savings for health care while shortening many patients’ waiting time for a diagnosis with approximately three months.
Highlights from the study:
19% of all examined lesions showed a high positive Nevisense EIS score’ and were surgically removed immediately. 83.1% of the malignant melanomas in the study were discovered three months earlier than with standard SDDI by using Nevisense according to the study protocol.
28% showed a negative Nevisense EIS score indicating that the need for a patient follow-up visit would be unnecessary.
All melanomas were identified in the study by using the standard Nevisense cut-off for melanoma.
“The use of Nevisense in combination with dermoscopy monitoring reduced the need for follow-up by 47%, thus not only shortening patients’ waiting time for a diagnosis but avoiding a second consultation in nearly half of cases,” says Prof Scott W. Menzies at Sydney Medical School, University of Sydney.
“It is a significant step for SciBase to see these results published in the British Journal. The study was independently performed by two well-known centers and focussed on patients that traditionally require a three month process to manage. The results verify the potential for Nevisense to improve the diagnosis of melanoma and to provide clinicians with a clinically useful tool. We see the publication as very beneficial to us in our continued efforts to increase acceptance of the Nevisense EIS method around the world,” says Simon Grant, CEO of SciBase.
Malignant melanoma is often difficult to detect, and early detection is of crucial importance. Lesions suspected of being malignant melanoma, but which cannot be clearly determined during the initial examination, are often followed up using short term digital dermoscopy imaging (SDDI). This means that the lesion is photographed and compared over time. The use of SDDI and follow-up digital dermoscopy is increasing – especially in difficult-to-diagnose cases – but it is resource-intensive and can take three months or more for a final diagnosis. In addition, it can be challenging to get patients to return for follow-up visits.
The top line results of this study were previously presented as a poster at the World Congress of Cancers of the Skin in Vienna. The publication of the full study is initially in the BJD’s online journal and will be followed by publication in the physical journal. This publication is the second publication that demonstrates the benefits of Nevisense in the BJD. In May 2014 the results of the Nevisense pivotal trial were also published in the BJD.
The article can be accessed through the following link: http://onlinelibrary.wiley.com/doi/10.1111/bjd.15595/full
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 May 2, 2017.
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 has signed an agreement with the German medical device company DermoScan to link Nevisense with its EIS measurement for early detection of malignant melanoma, with DermoScan’s digital dermoscopy system DermoGenius Ultra. DermoScan’s systems are used by several hundred clinics in Germany and other markets.
DermoScan is one of Europe’s foremost manufacturers of digital dermoscopy systems. The agreement means that EIS measurements from Nevisense will be integrated as a standard option in DermoGenius Ultra. The result is that both patient data and Nevisense (EIS) measurements can be shared between the two systems. The solution improves both the clinic workflow and the diagnostic process for dermatology clinics.
- The partnership with DermoScan is an opportunity for SciBase for two reasons - it gives us a channel to reach out to a larger audience and it means that we can provide a better, more integrated solution for clinicians. We see the inclusion of Nevisense EIS as a parameter in the DermoGenius system as a sign of the growing interest in Nevisense and our method. We believe that DermoScan’s broad customer network will have a positive effect on the market penetration of Nevisense, says Simon Grant, CEO of SciBase.
SciBase and DermoScan will conduct joint marketing efforts of the integrated solution. Through DermoScan’s customer base, SciBase will have the possibility to reach additional key target groups and for DermoScan, they will be able to offer a unique integration with Nevisense.
- We are very happy to reach an agreement to cooperate with the team at SciBase. Nevisense is an exciting new technology that complements perfectly our digital dermatoscopy system DermoGenius Ultra. Integrating the products will help save time and improve patient flow for our customers. We are also looking forward to cooperating in the market with joint sales and marketing activities, says Johann Tillmann, President DermoScan.
Nevisense is a valuable complement to the visual assessment done with dermoscopy and so it is a clear advantage to integrate of Nevisense and the EIS score into DermoGenius Ultra. For the clinics, it will be easier to integrate Nevisense and the EIS score into their workflow. The integration with DermoGenius also makes it possible to link Nevisense to the most common Electronic Health Record systems in Germany.
For further information please visit www.scibase.com or contact:
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 January 31, 2017.
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.
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:
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
