STOCKHOLM, SWEDEN, - March 23, 2022 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that it has received its single largest order to date from a single clinic. The order for nearly 2,000 electrodes was received from an existing customer, a private Dermatology clinic in Germany. The order was valued at around 60k€ and will be delivered in April. The company has seen a significant increase in order volumefollowing the announcement of an 8% increase in electrode prices from April 1.
"It is very pleasing to see one of our customers commit so strongly to utilising our product going forward. To me an order like this is the best indication that a customer believes in our technology and the value it can bring them and their patients," says Simon Grant, CEO SciBase.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +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 March 23, 2022.
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
STOCKHOLM, SWEDEN, - March 23, 2022 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today its inclusion in the launch of a multidisciplinary research consortium focused on six different dermatological disorders. The Next Generation Immunodermatology (NGID) consortium is based in the Netherlands and will run over 6 years, leveraging the expertise from several different groups across academic, clinical, and industrial research settings. The consortium has received funding of 11.7m euros to stimulate and support innovative approaches to identify and develop novel diagnostic and therapeutic approaches within dermatology.
Excerpt from the official consortium press release:
The Dutch Research Council (NWO) has, within the framework of Research along Routes by Consortia (NWA-ORC), awarded the research project Next Generation Immuno-Dermatology (NGID) with a prestigious grant of 11.7 MEuro. NGID is a nationwide, large-scale project to unravel novel biomarkers for six different skin diseases. These biomarkers will drive a high-tech, patient-centric approach in clinical practice.
In the Netherlands over 2.5 million patients suffer from chronic inflammatory skin diseases. Although not life-threatening, the personal impact and socio-economic costs of these chronic conditions are very high. The biggest problem is that many treatments are not suited for every patient and often do not work.
NGID will tackle this problem and will develop the right care for the right patient at the right time. Within this 6-year project six inflammatory skin diseases will be investigated in ultra-high detail. For this approach, a unique, international consortium consisting of scientific institutes, universities, high-tech companies, hospitals, patient associations and (bio)pharmaceutical industry has been setup. Dermatologists from all Dutch University Medical Centers will be connected to biologists, bio-informaticians, statisticians, behavioural scientists, communication researchers and of course to the patient. By means of a new data analysis and integration approach, NGID will make patient-specific fingerprints that will guide the best care for the individual patient in the future- Link to official webpage:
"This project provides a concrete example of how SciBase is helping to advance the management of skin diseases. The importance of the skin barrier in diseases such as atopic dermatitis is well known, but until now it has not been possible to evaluate the barrier in routine clinical practice. SciBase's Nevisense and Nevisense Go were chosen for this project because of their ability to evaluate the skin barrier from an atopic dermatitis perspective in routine clinical and even home use. The inclusion of these SciBase products in this consortium is a testament to the robust diagnostic potential of the SciBase technology. Understanding the status of the barrier will in turn help steer therapy and patient management overall, and we are proud to contribute to this progress.
The goal of the NGID project is to improve the standard of care within Dermatology and to expand the personalization of disease management to each patient - in other words, to provide the right care to the right patient at the right time. The opportunity for SciBase is to become an integral part of personalized atopic dermatitis management, and with the very high numbers of patients affected, this is one of the most significant opportunities for SciBase to date", says Simon Grant CEO SciBase.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
STOCKHOLM, SWEDEN, — March 30, 2022 – SciBase Holding AB (“SciBase”) [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that its patent application : EP Application No. 18729063.0 has been granted by EPO in Europe. This patent is linked to the new measurement procedure instituted recently with the introduction of Nevisense 3.0.
In addition, SciBase was granted their first patent within the skin barrier area in Sweden in November. This patent named `Epithelial barrier function' with application no 1851376-2, was granted by the Swedish patent authority and is seen as a positive indication that an EPO patent will also eventually be granted.
"An early focus on intellectual property from the SciBase founders provided the platform for our broad patent portfolio that now includes eight families and 69 granted patents. These two patents further strengthen our IP portfolio. The Swedish patent is also an important step in the process towards an EPO patent for the barrier application", says Simon Grant CEO SciBase.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
STOCKHOLM, SWEDEN, - December 22, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that a request for an appropriate Medicare payment assignment for the Nevisense procedure has been submitted to "National Government Services" (NGS), the Medicare Administrative Contractor with carrier jurisdiction responsibility for New York and several other states.
In July 2021, the American Medical Association (AMA) assigned a Category III CPT® code for the Nevisense melanoma detection test that has been used by providers to report the use since then.
The request was submitted to NGS based on provider usage in the New York region. NGS holds the Medicare contract for New York, Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, Illinois, Minnesota and Wisconsin. A decision regarding rate assignment within NGS may be implemented in one or more of NGS jurisdictions.
"Coverage and payment from CMS are important for new procedures and technology such as ours, so this submission is an important milestone for SciBase and for Nevisense in the U.S.," said Simon Grant, CEO of SciBase. "Establishing a payment rate with NGS represents a significant opportunity for SciBase as they cover several regions with significant potential, which would allow providers to utilize this medically necessary technology in these regions. We believe that Nevisense can play a central role in improving skin cancer detection in the U.S., and especially for the important patient demographic covered by Medicare."
For more information please contact: Simon Grant, CEO SciBase
Tel: +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 December 22, 2021.
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
SciBase has appointed Alf Laurell as Director of Quality Assurance and Regulatory Affairs and Person for Regulatory Compliance (PRRC) for SciBase. Alf joins SciBase from Elekta in Stockholm. The previous head of Quality and Regulatory and PRRC, Niklas Jakobsson has decided to pursue a new opportunity outside the company and as such leaves the SciBase Management team.
”I would like to warmly welcome Alf to SciBase, and look forward to working with him. I would also like to take the opportunity to thank Niklas for his exceptional work at SciBase, and especially his work with the new Medical Device Regulation (MDR). Niklas was key in our effort to secure our MDR-approval and I wish him all the best in his new role.”, says Simon Grant CEO SciBase.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
As we start 2022, I thought it a good opportunity to review some of the important events of 2021 and discuss our most recent progress.
The pandemic has during 2021 continued to play a role but even with the effects of Covid, it has still been a year including many milestones for SciBase.
SciBase Strategy, MDR and NMSC
SciBase's strategy is based on gaining traction for our melanoma detection test in key markets and leveraging our core technology Electrical Impedance Spectroscopy (EIS) in additional clinical applications. Each new application uses the same core EIS technology but utilizes a different Artificial Intelligence (AI) -based analysis that must be approved by regulatory authorities before it can be released. This year the EU introduced a new set of regulations called the Medical Device Regulation or MDR. SciBase was one of the first companies in Sweden, and within Dermatology in general, to be certificated under MDR. This was completed in May and meant that we could release our first new application module, Non-melanoma Skin Cancer (NMSC).
Today more than 100 sites have the NMSC module installed. Feedback from customers has been good and the module has been one of the key drivers to increase the number of system sales in Germany. We will continue to build on this module and improve it by incorporating clinical data from new studies as they happen.
Skin Barrier and Nevisense Go
SciBase's other `new application' is the Skin Barrier application, and 2021 has also seen significant progress within this application. Like NMSC, it is based on the same EIS method and proprietary electrode but using barrier-specific AI algorithms. Because it is a relatively new method and application, the focus within barrier has been the research market and Industry collaborations. The goal over time is to develop multiple clinical applications that can be used by non-specialists and even eventually by patients in the home.
Two key articles published this year helped drive the interest in this area, and we have seen a steady increase in sales in this segment. Skin Barrier can be measured both on the Nevisense platform, and also with our new handheld device, Nevisense Go. Nevisense Go is a technological first - it is a hand-held device based on SciBase's own integrated circuit for EIS, and it includes an embedded neural network that performs AI analyses at the point-of-care. It promises to be a powerful platform for diagnostic barrier-related testing and eventually other applications.
While a lot has happened within Skin Barrier in 2021, we are excited about what 2022 will bring. Barrier has significant potential within many areas, especially atopic dermatitis and other atopic disorders. Be sure to watch this space in 2022.
US Strategy and reimbursement progress
The US system for reimbursing physicians and their practices for their work is highly complex and introducing a new technology into this system takes time and resources. SciBase made significant progress during 2021 year on this front.
Our US strategy revolves around partnering with the large practice groups and together rolling out the technology across the group while simultaneously securing payment for the Nevisense test. Our key partner during 2021 has been the Advanced Dermatology and Cosmetic Surgery group (ADCS), which has its base (and 70 practices) in Florida. Based on the usage from more than 20 ADCS clinics in Florida, we submitted an application in May to the Medicare Contractor (MAC) for Florida, First Coast Service Organization (FCSO). On July 1st our CPT code become active and is now in use across the US.
The very good news is that First Coast is paying for the Nevisense test using our new code. This will help us with our applications to other regions or MACs and to private payers. There is however work remaining to raise the payment level our customers receive from First Coast. This cost level is based on customer's actual costs and our customers assist us in this process. This work is going on right now and we hope to see results early this year.
At the same time, we are working with our submissions to other MACs. Our second submission was made in December to NGS who cover the New York and North-Eastern US region (and several other states across the US). We will work our way through the different MACs until we have coverage across the major regions in the US. This process is based on building a customer base first in each region, so it takes time and resources. Finally, over the coming quarters, we will increase our activity addressing private payers (insurance companies) to cover Nevisense. We believe we have a good strategy and `demand momentum' from clinicians for the product.
We expect 2022 to be a year of many milestones in the US, where we roll out Nevisense to more areas and clinicians in co-ordination with reimbursement applications. We will continue to strengthen the team in the US, expanding on the excellent work done so far.
Strengthened ownership base and Board
During the spring we carried out a successful directed issue where we welcomed new specialist investors such as Van Herk, ÖstVäst as well as Dr Matt Leavitt (founder of ADCS) amongst others. To attract strong, long-term specialist investors has been and will continue to be of strategic importance for SciBase so therefore this was an important milestone for us. We also strengthened the Board through the addition of Dr Matt Leavitt and Dr Jvalini Dwarkasing, and both are already helping drive the US strategy.
Though SciBase achieved several key milestones in 2021, the year was still significantly affected by the Covid-19 pandemic. Our customers' practices were for the most part open, but many had opening hours affected or periods of lockdown, and overall patient numbers are down compared to pre-Covid levels. In addition, sales and marketing activities remained (and still remain) at a reduced level for in-person contacts such as Congresses.
Now we look forward to 2022 and expect it to be a year when we show good sales growth. While German sales for melanoma have been the vast majority of our sales until now, we see rapid growth in the US and the new applications in the near future. So, we are working to transform the company from a single application, single market company - to a multiple market multiple product company. This is an exciting phase for the SciBase team that will present both opportunities and challenges, and we very much look forward to both.
I'd also like to take the opportunity to welcome two new members to the SciBase team. Fabio Munroe will drive the development of the Florida region and in Stockholm Alf Laurell assumes the role of Director Quality Assurance and Regulatory Affairs.
On behalf of the SciBase team I would like to thank you all for your interest in SciBase and wish you all the best for 2022!
Simon
For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
STOCKHOLM, SWEDEN, - January 26, 2022 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that a new study supporting the use of Nevisense in diagnosing melanoma has been published in "SKIN - The journal of cutaneous medicine". The article is authored by Avani Kolla, Prof David Polsky and others from The Ronald O. Perelman Department of Dermatology, NYU Grossman School of Medicine in New York. The study shows that Nevisense provides valuable diagnostic guidance when evaluating atypical pigmented skin lesions.
"Melanoma is a potentially deadly form of skin cancer and has an almost 100% cure rate if caught early. While the performance of Nevisense as a diagnostic aid in the management of atypical pigmented skin lesions suspicious for melanoma has been previously demonstrated, its impact on clinician confidence in their biopsy decisions has not been described. In this pilot study, we found that mean confidence for clinicians in correctly identifying the disease diagnosis significantly increased when we added Nevisense to the evaluation of clinical and dermoscopic images of skin lesions suspicious for melanoma. Adding Nevisense to these evaluations also significantly increased diagnostic accuracy and biopsy sensitivity for melanoma," says David Polsky, MD, PhD Alfred W. Kopf, MD Professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, NYU Langone Health.
"This study further validates Nevisense as a valuable tool for the early detection of melanoma. The article presents additional evidence that Nevisense can help clinicians of all experience levels improve their ability to accurately identify lesions that require treatment and to be more confident in their clinical management decisions", says Simon Grant, CEO of SciBase.
Publication details:
New clinical study suggests Nevisense has a positive impact on Clinicians confidence and diagnostic accuracy for early melanoma detection
The US based study data further supports Nevisense's clinical value for clinicians of all levels
The article is titled "Impact of Electrical Impedance Spectroscopy on Clinician Confidence and Diagnostic Accuracy in Evaluating Melanocytic Skin Lesions Suspicious for Melanoma: A Pilot Study" and evaluates whether "clinician diagnostic confidence, sensitivity, specificity and accuracy can be increased by adding EIS measurement scores to clinical and dermoscopic images of lesions clinically suspicious for melanoma". In the study Nevisense increased clinician's sensitivity for melanoma and dysplastic nevi from 70% to 84%. The conclusion in the article states: " EIS increased novice and expert diagnosticians' confidence regarding dermoscopically equivocal melanocytic lesions."
The article is now available online at SKIN - The journal of cutaneous medicine's website (https://jofskin.org/index.php/skin/article/view/1463/pdf ).
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
SciBase a leading developer of augmented intelligence-based solutions for skin disorders, announced today that CFO Michael Colérus will present an update on the latest developments from SciBase at the Redeye Life Science day on November11th at 16.10 pm. The presentation will be followed by a short Q&A. The presentation will be broadcasted live and can be followed at https://www.redeye.se/events/815899/redeye-life-science-day-2021 The presentation will also be available at www.redeye.se and on the Company's website i n Redeye Universe.
"We have achieved many exciting and important milestones recently at SciBase. After a long process we received our MDR-certification which enabled us to launch our NMSC (non-melanoma skin cancer) application in Europe, which is a key part of our growth strategy. We have also entered a new phase in the US by submitting our first application for reimbursement coverage - another very important milestone for the company. Within the skin barrier application two significant and groundbreaking clinical studies have recently been published. The skin barrier is an exciting new application area for SciBase and one where we have unique advantages. Barrier-related diseases are widespread and using Nevisense as a tool for the assessment of the barrier can really help better understand and manage patients," says Simon Grant, CEO SciBase.
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
The loss after tax amounted to TSEK 8,622 (7,350).
The loss per share amounted to SEK 0.13 (0.20).
The cash flow from current operations was negative in the amount of TSEK 9,156 (6,974).
The gross margin reached 63.3% (52.7%).
Electrode sales volume increased by 20% and reached 8,304 (6,924) units. Repeat sales of electrodes to existing customers increased by 4%.
January - September in figures
Net sales amounted to TSEK 7,802 (6,466).
The loss after tax amounted to TSEK 27,926 (25,150).
The loss per share amounted to SEK 0.46 (0.99).
The cash flow from current operations was negative in the amount of TSEK 27,792 (23,571).
The gross margin reached 57.8% (54.0%).
Electrode sales volume increased by 20% and reached 21,768 (18,194) units. Repeat sales of electrodes to existing customers increased by 14%.
Important events during the quarter
Overall sales increased by 30% (+36%, before currency effects).Covid-19 continues to affect sales and the market situation remains difficult to predict going forward, due to ongoing lockdowns and reduced marketing activities. Sales in the company’s key market Germany increased by 9% (+11% in local currency).
SciBase has entered into an agreement with Vator Securities AB (”Vator Securities”) regarding the service as a Certified Adviser. Vator Securities took over as Certified Adviser on September 28, 2021. Until Vator Securities took over, Avanza Bank AB continued to act as Certified Adviser for the Company.
At an extraordinary general meeting held on September 7, 2021, Jvalini Dwarkasing was elected as a new member of the Board. The Board has therefore the following composition: Tord Lendau (chairman), Diana Ferro, Thomas Taapken, Matt Leavitt and Jvalini Dwarkasing.
Important events after the end of the period
A nominating committee was appointed.
Financial overview
Oct 1 2020 -
July 1 - Sep 30
Jan 1 - Sep 30
Sep 30 2021
Jan 1 - Dec 31
THE GROUP
2021
2020
2021
2020
Rolling-12
2020
Net sales, SEK ths
2 982
2 287
7 802
6 466
10 857
9 521
Gross margin, %
63,3%
52,7%
57,8%
54,0%
55,4%
52,5%
Equity/Asset ratio, %
86,8%
67,0%
86,8%
67,0%
81,2%
79,1%
Net indebtness, multiple
0,15
0,49
0,15
0,49
0,23
0,26
Cash equivalents, SEK ths
78 270
21 724
78 270
21 724
78 270
41 427
Cashflow from operating activities, SEK ths
-9 156
-6 974
-27 792
-23 571
-38 081
-33 861
Earnings per share (before and after dilution), SEK
-0,13
-0,20
-0,46
-0,99
-0,65
-1,12
Shareholder's equity per share, SEK
1,24
0,71
1,40
1,02
0,96
1,50
Average number of shares, 000'
68 475
36 560
60 827
25 481
57 797
31 287
Number of shares at closing of period, 000'
68 475
36 560
68 475
36 560
68 475
54 780
Share price at end of period, SEK
4,88
4,00
4,88
4,00
4,88
4,62
Number of sold electrodes, pieces
8 304
6 924
21 768
18 194
29 260
25 686
Average number of employees
17
16
17
16
17
16
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on November 11, 2021.
Contact person: Michael Colérus, CFO. +46 70 341 34 72
For more information, please contact:
Simon Grant, CEO SciBase
Phone: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase’s products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase’s technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
STOCKHOLM, SWEDEN, - November 29, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today, that an article describing the consequences of the new medical device regulation (MDR) in the EU has been published in the journal "Journal of the European Academy of Dermatology and Venereology" (JEADV).
The new MDR regulation that came into force on May 26 2021 will have significant effects for the medical device industry and for clinicians, including Dermatologists. Firstly, many more products, especially software or app-based products require regulatory approval and control. This affects many products within Dermatology that previously were not regulated. There are also more stringent requirements within clinical evidence and the approval of product changes.
MDR will most likely have positive effects on the quality of devices, to the benefit of patients, but may also have effect on the availability of new and existing devices and methods. SciBase is one of very few companies in the field of dermatology that is certified according to the new more stringent MDR regulation.
"We believe this article will help the Dermatology field understand the implications of this new regulation and how it will affect their access and use of products, which in turn can affect the care they give their patients. I think this will affect the buying decisions of clinicians, and that they will be much more likely to purchase from MDR-certified companies." says Simon Grant, CEO of SciBase
The article was a collaboration between Dermatology clinicians and regulatory experts with input from SciBase and can be found at the JEADV journals homepage: https://onlinelibrary.wiley.com/doi/abs/10.1111/jdv.17830
For more information please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
About SciBase and Nevisense SciBase is a global medical technology company headquartered in Stockholm, Sweden, that has developed a unique point of care platform for the non-invasive detection of skin cancer and other skin conditions. SciBase is a pioneer within augmented intelligence, combining artificial intelligence with Electrical Impedance Spectroscopy (EIS) to provide objective information that assists dermatologists and others in clinical decision-making. SciBase's products include Nevisense and Nevisense Go and to date the platform addresses the areas of melanoma detection, non-melanoma skin cancer detection and skin barrier assessment. Nevisense is the only FDA-approved device for the detection of melanoma and the only MDR-approved technology for skin cancer detection in Europe. SciBase's technology is based on more than 20 years of academic research at the Karolinska Institute in Stockholm, Sweden. For more information please visit www.scibase.com.
