Category: Uncategorized

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: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

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:

https://www.nwo.nl/onderzoeksprogrammas/nationale-wetenschapsagenda-nwa/onderzoek-op-routes-door-consortia-orc-2

Simon Grant CEO of SciBase comments:

"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: simon.grant@scibase.com

Certified Advisor (CA):.

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

"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: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

2022-02-23 08:00

January 1 – December 31, 2021

The fourth quarter in figures

  • Net sales amounted to TSEK 3,925 (3,055).
  • The loss after tax amounted to TSEK 13,852 (9,839).
  • The loss per share amounted to SEK 0.20 (0.20).
  • The cash flow from current operations was negative in the amount of TSEK 11,709 (10,290).
  • The gross margin reached 52.8% (49.4%).
  • Electrode sales volume increased by 7% and reached 8,024 (7,492) units. Repeat sales of electrodes to existing customers increased by 12%.

The full year in figures

  • Net sales amounted to TSEK 11,727 (9,521).
  • The loss after tax amounted to TSEK 41,778 (34,989).
  • The loss per share amounted to SEK 0.67 (1.12).
  • The cash flow from current operations was negative in the amount of TSEK 39,501 (33,861).
  • The gross margin reached 56.1% (52.5%).
  • Electrode sales volume increased by 16% and reached 29,792 (25,686) units. Repeat sales of electrodes to existing customers increased by 12%.

Important events during the quarter

  • Overall sales increased by 28% (+34%, 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. The sales in the important US market increased within the area of skin cancer by 395% (in local currency by 415%).  Sales in Germany decreased by 18% (-14% in local currency).
  • A request for a Medicare payment assignment for the Nevisense procedure was submitted to National Government Services (NGS), the Medicare Administrative Contractor with carrier jurisdiction responsibility for New York and several other states.
  • SciBase received an order of ten additional Nevisense systems and electrodes valued at approximately KUSD 100 from Advanced Dermatology, P.C. (AdvDermPC) in New York City.
  • A nominating committee for the AGM 2022 was appointed.

Important events after the end of the period

  • A new study from the US supporting the use of Nevisense in diagnosing melanoma was published in “SKIN – The journal of cutaneous medicine”. The study shows that Nevisense provides valuable diagnostic guidance when evaluating atypical pigmented skin lesions.
  • SciBase announced a change in the Management team and a new head of Quality and Regulatory Affairs.

Financial overview   

Oct 1 – Dec 31Jan 1 – Dec 31
THE GROUP2021202020212020
Net sales, SEK ths3 9253 05511 7279 521
Gross margin, %52,8%49,4%56,1%52,5%
Equity/Asset ratio, %82,8%79,1%82,8%79,1%
Net indebtness, multiple0,210,260,210,26
Cash equivalents, SEK ths65 60741 42765 60741 427
Cashflow from operating activities, SEK ths-11 709-10 290-39 501-33 861
Earnings per share (before and after dilution), SEK-0,20-0,20-0,67-1,12
Shareholder’s equity per share, SEK1,030,961,161,50
Average number of shares, 000′68 47548 70760 82731 287
Number of shares at closing of period, 000′68 47554 78068 47554 780
Share price at end of period, SEK5,524,625,524,62
Number of sold electrodes, pieces8 0247 49229 79225 686
Average number of employees18171716

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 February 23, 2022.

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: simon.grant@scibase.com

Certified Advisor:
Vator Securities
Tel: +46 8 580 065 99
Email: ca@vatorsec.se  

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.

Downloads

"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: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

 ”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: simon.grant@scibase.com

Certified Advisor (CA):

Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

Stockholm January 19, 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.

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: simon.grant@scibase.com 

Certified Advisor:
Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

AdvDermPC is one of the largest dermatology groups in the New York City tri-state area with 59 practices.  This order brings the total number of AdvDermPC practices utilizing Nevisense to seventeen. AdvDermPC has integrated Nevisense tests into routine skin cancer exams since 2019 and so can offer their patients the most advanced technology for the earliest possible detection of melanoma.  Melanoma is the deadliest and most aggressive form of skin cancer, but when detected early, treatment has a nearly 100% cure rate.

"This expansion in Nevisense use by Dr Fox and the AdvDermPC team is especially pleasing because it has been driven by the clinical value they experience in their day-to-day work.  AdvDermPC is a leader in adopting next-generation solutions to improve patient care and outcomes" said Simon Grant, Chief Executive Officer of SciBase. "Having renowned dermatology groups, such as AdvDermPC, expand the use of Nevisense and offer more and more patients our point-of-care diagnostic tests, will serve as a key driver for our US market growth."

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com 

Certified Advisor:
Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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 16, 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.

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: simon.grant@scibase.com 

Certified Advisor:
Vator Securities

Tel: +46 8 580 065 99

Email: ca@vatorsec.se

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.

"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: simon.grant@scibase.com 

Certified Advisor:
Vator Securities
Tel: +46 8 580 065 99
Email: ca@vatorsec.se  

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.

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