Stockholm, Sweden and New York, US, - December 16, 2021 - SciBase Holding AB ("SciBase") [STO:SCIB], a leader of augmented intelligence-based solutions for skin disorders, announced today that it has 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.
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: [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 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.
SciBase a leading developer of augmented intelligence-based solutions for skin disorders, announced today that CEO Simon Grant will present an update on the latest developments from SciBase at the Vator Healthcare Innovation Summit on October 7th at 10.40 am. The presentation will be followed by a short Q&A. The Summit is a digital investor event with some of the most innovative and fast-growing Companies in healthcare represented. All presentations will be in English.
Register for the event at: https://vatorsecurities.se/event/vator-securities-healthcare-innovation-summit/
"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.
I trust that you have had a good summer. We have certainly been keeping busy here in Sweden during Q3 and expect to spend more time in the market now that US restrictions are being relaxed. Not only are we in the US reimbursement coverage process, but we've also welcomed specialist investor Van Herk. I think this is a good opportunity to provide a short update on recent events in SciBase, now that everything slowly starts to return to normal. First, let us do a short recap on what we have recently achieved.
Important milestones during 2020…
FDA Approval – Opening up the US market
Nevisense 3.0 approval from FDA, which was the trigger for us to begin our partnership with Advanced Dermatology and Cosmetic Surgery group (ADCS),
New Product launch opening new addressable markets
Launched our new handheld device Nevisense Go for research use, enabling the development of new clinical applications, firstly within skin barrier
US Reimbursement process begins Applied for and received a US CPT III code, the first step towards broad reimbursement coverage
…which paved the way for progress so far in 2021:
Reimbursement progress in first US state We filed our first application for reimbursement coverage with the Medicare contractor in Florida, First Coast. Reimbursement is a catalyst for broad adoption of our test. This is the first of many such applications and is important for clinicians, who need to be reimbursed financially for their time and materials when they utilize Nevisense on Medicare patients.
MDR Certification
We have been certified as a company according to MDR – one of the first companies within dermatology to do so.
New indication, NMSC
MDR certification allowed us to launch our Non-Melanoma Skin Cancer (NMSC) indication in Europe.
Continued scientific community validation
We saw the publication of key studies within the new skin barrier application
and
Attracted new specialist investors and Institutions
Carried out a successful directed issue where we welcomed Van Herk, ÖstVäst and Dr Matt Leavitt (founder of ADCS) amongst others.
So where do we stand now?
I am happy to report that we are now moving into the commercial phase in our partnership with ADCS. The pilot phase has been successful, though took longer than expected due to Covid-19. ADCS has been the cornerstone in our reimbursement process in Florida by submitting claims for reimbursement. This is a necessary part of the process, which is complex but is extremely important for widespread utilization and sales. The Medicare contractor in Florida, First Coast, has communicated that the procedure is covered and will be reimbursed when deemed medically necessary. This is a normal forward step in the process and the next phase is to work with users and First Coast to ensure the coverage ends up at the right fee level. Here we support providers and partners in their dialog with First Coast and other payers to help them make an informed and appropriate decision.
We are already underway with the process for the next Medicare area application, covering New York and the North-East area. Parallel with this we are preparing to approach private (commercial)payers. Securing payer coverage involves separate processes by region and insurance type and is an area where we are expanding our resources and focus. We are also expanding the sales team and collaborations with further practice groups.
In summary, the next steps for SciBase in the US are a strengthening of the sales team, a broader geographic and partner focus, and an acceleration of further reimbursement submissions.
Non-melanoma skin cancer in Germany MDR certification enabled us to launch our new clinical application non-melanoma skin cancer with Germany being the first market. Although still affected by Covid we have seen a positive uptake of the application both from our existing customer base as well as from new customers. We had our first “live” congress in Germany in over a year and a half where the application was presented by a key opinion leader. The Congress was smaller than in the past, but it is still a good sign that things are slowly returning to normal. As we hopefully leave Covid behind us, we believe that Germany will show good growth.
Progress in other strategic growth areas
In addition to US reimbursement and sales, new product and clinical application development is a strategic priority. The release of a research version of Nevisense Go for skin barrier and the NMSC indication for Nevisense were the first product milestones in this journey.
The recent publication of two articles supporting the new Skin Barrier application were additional milestones. The first groundbreaking article presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology and the second study from the Swiss institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of atopic dermatitis even on unaffected skin. These articles have really spurred interest among researchers within the area of the barrier function as well as from potential industry partners. We have already sold a number of Nevisense Go to major industry partners for the evaluation of the skin barrier.
Short term we are working on developing a more robust AI-algorithm for the assessment of the skin barrier and we will continue to collaborate with researchers and industry groups interested in skin barrier and to sell Nevisense and Nevisense Go. We are currently participating in several clinical studies collecting further scientific evidence supporting clinical applications within skin barrier. We see broad potential within this space for future growth and the potential to really revolutionize the way atopic disorders are being monitored; and help patients get the right treatment at the right time.
We are in a continuous dialog and evaluation process with potential partners for barrier. Our long-term vision is to, together with major partners, develop our technology into a standard of care and ultimately develop non-specialist and consumer products.
We expect to maintain a high level of activity during the rest of the year. Our focus remains on the development of US reimbursement and sales. I also hope to soon be able to communicate more regarding the research and industry collaborations within the barrier indication. With the milestones we have achieved and the effects of the pandemic soon behind us we expect to be able to deliver on our strategy and the sales growth that entails.
Thank you for your support and I look forward to the next steps on our journey!
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. Further information is available at www.scibase.com.
The appointments have been made in accordance with the instructions regarding principles for the appointment of the company nominating committee which were determined at the Annual General Meeting of SciBase Holding on May 18, 2020.
The Annual General Meeting of SciBase Holding AB (publ) will be held on May 18, 2022 in Stockholm.
Shareholders who wish to have an item considered at the Annual General Meeting can submit a request to the Board to this effect. Such a request for an item to be considered is to be sent to SciBase Holding AB (publ), Att: Chairman of the Board, Box 3337, 103 67 Stockholm, and must have been received by the Board no later than seven weeks before the Annual General Meeting, or otherwise in such good time that the matter, where necessary, can be included in the notice to attend the Annual General Meeting.
Stockholm, October 29, 2021
SciBase Holding AB (publ)
For more information, please contact: Tord Lendau, Chairmain of the board, phone +46 (0)70 810 01 67
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, — August 19, 2021 – SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that the Nominating Committee proposes the election of Dr. Jvalini Dwarkasing as a new Board member at an extraordinary general meeting to be proposed by the Board of Directors of SciBase.
The nominating committee, consisting of Christer Jönsson (appointed by FourierTransorm), Iraj Arastoupour, Peter Elmvik and Tord Lendau Chairman of the Board, hereby proposes the election of Dr. Jvalini Dwarkasing as a new member of the Board to an EGM to be held later in 2021.
Dr Dwarkasing, proposed to the nominating committee by Van Herk Investments, is currently the Chief Scientific Officer at SkylineDx. She has over 10 years of life science experience with an international track record within oncology having held both research and management positions. Dr Dwarkasing has a strong academic background and a PhD in medical nutrition and pharmacology. Her driver for doing research is patient focus and how to bring science from bench to bedside. Her geographical areas of focus are the US, Europe and Australia.
The nominating committee believes that her knowledge and experience within the fields ofDermatology/Pathology, the international Dermatology industry and Dermatology networks are aligned with the future competence needs for the SciBase Board of Directors.
For more information please contact: Tord Lendau, Chairman of the Board
Tel: +46 708 10 01 67
Email: [email protected]
The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The shareholders of SciBase (publ), reg.no 556773-4768 (the "Company") are hereby summoned to an extraordinary general meeting on Tuesday 7 September 2021.
The board of directors has, in light of continued spread of the coronavirus and in accordance with the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations, decided that the extraordinary general meeting shall be held without physical presence of shareholders, proxies and/or external parties and that the shareholders shall have only the opportunity to vote by mail prior to the meeting.
The Company welcomes all shareholders to exercise their voting rights at the annual general meeting through postal voting as described below. Information on the resolutions passed at the extraordinary general meeting will be published on Tuesday 7 September 2021, as soon as the result of the postal voting has been finally confirmed.
PARTICIPATION
A Shareholder wishing to attend the Meeting shall:
be recorded in the share register maintained by Euroclear Sweden AB on Monday 30 August 2021; and
notify the Company of its intention to attend the Meeting not later than on Monday 6 September 2021 by submitting a complete voting form and, where applicable, proxies, registration certificates and other corresponding authorization documents in accordance with the instructions under the heading “Information on postal voting” below.
To be entitled to attend the meeting, shareholders whose shares are nominee-registered must, in addition to giving notice of attendance to the Company by casting their postal vote, register such shares in their own names so that the shareholder is recorded in the share register as of Monday 30 August 2021. Such registration may be temporary (so called voting right registration) and request for such registration shall be made to the nominee in accordance with the nominee's routines in such time in advance as decided by the nominee. Voting rights registrations effected no later than the second banking day after 30 August 2021 will be considered in the preparation of the share register.
INFORMATION ON POSTAL VOTING
Postal voting
The shareholders may exercise their voting rights at the meeting only by voting in advance, so-called postal voting, in accordance with Section 22 of the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations.
A special form shall be used for postal voting. The form will be available on the Company's website, http://investors.scibase.se/.The postal voting form is considered as the notification of participation at the annual general meeting.
The completed voting form must be received by Eversheds Sutherland Advokatbyrå AB no later than Monday 6 September 2021. The form may be submitted by post to Eversheds Sutherland Advokatbyrå AB, Attn: Rasmus Nordfäldt Laws, Box 14055, 104 40 Stockholm or via e-mail to [email protected].
The shareholder may not provide special instructions or conditions in the voting form. If so, the vote (i.e. the postal vote in its entirety) is invalid. Further instructions and conditions are included in the form for postal voting.
The shareholders may request in the postal voting form that a resolution on one or several of the matters on the proposed agenda below should be deferred to a so-called continued general meeting, which cannot be conducted solely by way of postal voting. Such general meeting shall take place if the meeting so resolves or if shareholders with at least one tenth of all shares in the Company so requests.
Proxy voting
A shareholder represented by proxy shall issue a power of attorney which shall be dated and signed by the shareholder. If the shareholder postal votes by proxy, the power of attorney shall be enclosed to the form. If issued by a legal entity, the power of attorney shall also be accompanied by registration certificate or, if not applicable, equivalent documents of authority. Power of attorney forms for those shareholders wishing to postal vote by proxy will be available on the Company's website http://investors.scibase.se/.
PROPOSED AGENDA
The Board of Directors' proposed agenda for the meeting:
Opening of the Meeting
Appointment of chairman of the meeting
Preparation and approval of the voting list
Approval of the agenda for the meeting
Appointment of one or two persons to verify the minutes of the meeting
Determination of whether the meeting has been duly convened
Election of Board of Directors
Closing of the meeting
PROPOSED RESOLUTIONS
Appointment of chairman of the Meeting (item 2)
The Board of Directors proposes that Johan Engström (Eversheds Sutherland) is appointed as the chairman of the meeting.
Preparation and approval of voting list (item 3)
The voting list which is to be prepared based on the meeting's share register and postal votes received is pro-posed as voting list for the meeting.
Election of one or two persons to verify the minutes (item 5)
The Board of Directors proposes that Rasmus Nordfäldt Laws (Eversheds Sutherland), or, if unable to attend the meeting, any of the persons assigned by the Board of Directors, shall verify the minutes. The persons verifying the minutes shall also control the voting list and that received postal votes are correctly reflected in the minutes.
Election of Board of Directors (item 7)
The nominating committee proposes that the Board of Directors is to be composed of five directors.
The nominating committee proposes that Jvalini Dwarkasing is elected as a new member of the Board. Should the meeting resolve in accordance with the proposal, the Board of Directors will be: Tord Lendau (chairman), Diana Ferro, Thomas Taapken, Matt Leavitt, and Jvalini Dwarkasing
A new member of the Board is entitled to remuneration for work in accordance with the renumeration fees resolved by the 2021 Annual General Meeting, in proportion to the actual time served as member of the Board.
Dr Jvalini Dwarkasing
Dr Dwarkasing is currently the Chief Scientific Officer at SkylineDx. She has over 10 years of life science experience with an international track record within oncology having held both research and management positions. Dr Dwarkasing has a strong academic background and a PhD in medical nutrition and pharmacology. Her drive for doing research is patient focus and how to bring science from bench to bedside. Her geographical areas of focus are the US, Europe and Australia.
OTHER
Information
Shareholders have the right to request information from the Board of Directors and the CEO in accordance with Chapter 7 Section 32 of the Swedish Companies Act regarding conditions that may affect the assessment of a matter on the agenda and conditions that may affect the assessment of the Company's financial situation. The Board of Directors and the CEO shall disclose such information if the Board of Directors considers that this can be done without significant damage to the Company. The disclosure obligation also applies to the Company's relationship with another group company, the group accounts and such matters as mentioned above with regard to subsidiaries.
Requests for such information must be submitted in writing to the Company no later than ten days before the meeting, i.e. no later than 28 August 2021, to the Company's address SciBase Holding AB (publ), Box 3337, 103 67 Stockholm, Sverige, Sweden or by e-mail to [email protected]. The information is provided by the Company by keeping it available on the Company's website www.scibase.com and at the Company at the above address no later than five days prior to the meeting, i.e., 2 September 2021. The information is also sent to shareholders who have requested it and who have provided their address.
Processing of personal data
For information regarding how your personal data is processed in connection with the meeting, please refer to the privacy policy on Euroclear Sweden AB's website:
The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The extraordinary general meeting in SciBase Holding AB (publ) (the "Company") was held today on September 7, 2021. Due to the extraordinary situation following the COVID-19 pandemic, the extraordinary general meeting was carried out through postal voting only, without any physical attendance. The general meeting resolved, with the required majority, as follows:
Election of Board of Directors
The extraordinary general meeting resolved, with required majority, to elect Jvalini Dwarkasing 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.
Jvalini Dwarkasing is entitled to remuneration for work in accordance with the renumeration fees resolved by the 2021 Annual General Meeting, in proportion to the actual time served as member of the Board.
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
SciBase Holding (publ), Reg. No. 556773-4768 (the ”Company”), hereby announces that the Company has entered into an agreement with Vator Securities AB (”Vator Securities”) regarding the service as a Certified Adviser. Vator Securities will be appointed Certified Adviser (CA) on 28 September 2021. Up until then, Avanza Bank AB will continue to act as Certified Adviser for the Company.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.
About SciBase and Nevisense SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. 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 an FDA approval (PMA) 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 and abnormalities. SciBase is listed on First North Growth Market (“SCIB”). Further information is available at www.scibase.com.
I hope you are all enjoying the summer weather. For the team at SciBase, it has been an exceptionally interesting and busy half year, and we are looking forward to a similarly busy second half of 2021. Three highlights:
First, SciBase welcomes new institutional shareholders such as Van Herk, specialists within life science and melanoma, and ÖstVäst.
Second, as an important commercial leap, we have filed our first application for reimbursement coverage with CMS in Florida. Reimbursement is a catalyst for broad adoption of our test. This is the first of many such applications and is important because when approved, it means that Florida clinicians will be reimbursed financially for their time and materials when they utilize Nevisense on Medicare patients.
Third, we have received our MDR certification and have launched our Non-Melanoma Skin Cancer (NMSC) indication in Europe.
With the recent successful directed share issue of SEK 71 million, SciBase is now well-financed to further accelerate our market penetration in the US. More reimbursement applications for additional regions will follow. This funding will also support the further development of the Barrier applications where there is a lot already happening and we expect to be able to announce further updates in Q3 and Q4 of this year.
New Shareholders, and the capital increase
Last month’s directed share issue successfully strengthened our investor base and provided us with funding for our US initiatives. SciBase’s aim has been, and still is, to continue building a strong institutional and long-term investor base. Two of our new largest investors – Van Herk Investments from the Netherlands and ÖstVäst Capital Management, are seasoned in life science investments. We look forward to working with the team at Van Herk over the summer and believe that their knowledge within skin cancer and their clinical and commercial network can contribute significantly to SciBase’s development.
US Market – Important milestone reached
This year much of our focus has been on the US market, where our priorities are insurance coverage/reimbursement for our test and working with large practice groups. It was an important milestone for us to submit our first reimbursement application in Florida for Medicare patients in May. We are already underway with the process for the next application, covering New York and the North-East area. Securing coverage takes time and involves separate processes by region and insurance type. With the funds secured in the directed share issue, we are expanding our resources to handle these processes. Sales and Marketing resources will also be expanded following positive insurance decisions.
Over the last 12 months we have worked closely with the Advanced Dermatology and Cosmetic Surgery (ADCS) practice group. With over 20 systems now placed in Florida at ADCS sites, we have gained a good understanding of US market needs, and we will leverage this knowledge as we work our way across the US. It is really an honor to have Dr Matt Leavitt, the founder of ADCS join the Board of SciBase and become an investor. Matt has a unique and deep knowledge of the US Dermatology space both clinically and commercially, and we look forward to working closely with him as we penetrate the US market.
In summary, the next steps for SciBase in the US are a strengthening of the team and an acceleration of further reimbursement submissions.
Progress in other strategic growth areas
Our team in Germany led by Emanuel Von Kienlin, has been waiting patiently for the completion of our MDR certification process. We recently successfully completed our first audit under MDR and it feels very positive to have this major certification in place, when most all other companies within Dermatology are still working on this.
MDR was needed so that we can begin to sell and install our new Non-Melanoma Skin Cancer (NMSC) software module for Nevisense. This module uses the same Nevisense hardware and electrodes as the melanoma module, and as such is a reasonably simple addition for existing users. We have to date completed nearly 50 installations of this module with existing customers and have added a number of new customers. We look forward to reporting on the progress with this new indication, and we will continue to develop this module and add further functionality based on both clinical studies and development.
We continue to have new product and clinical application development as a strategic priority. The release of a research version of Nevisense Go and the NMSC indication for Nevisense were the first product milestones in this journey. Yet another milestone was the recent publication of two articles supporting the new Skin Barrier application. A groundbreaking article presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology. The article was written by Professor Cezmi Akdis at the Swiss institute of Allergy and Asthma Research (SIAF). Prof. Akdis is the key research collaborator in SciBase’s product development for skin barrier assessment. The article presents the background for the steep increase in allergic diseases over the last decades, and how this increase is connected to industrialization and modern lifestyle. This article really spurred interest among researchers within the area of the barrier function.
Another key study from the Swiss institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of atopic dermatitis even on unaffected skin. The Nevisense measurement also correlated with relevant biomarkers for atopic dermatitis. We are now working on fine-tuning the algorithm for the barrier application and in advanced discussions with potential industry partners to further develop this area through the initiation of clinical studies.
Short term our aim is to target researchers and industry groups interested in skin barrier to sell Nevisense and Nevisense Go and collaborate to further develop the scientific evidence supporting clinical applications. We see broad potential within this space for future growth and have a number of collaborations ongoing. We strongly believe that over time the barrier applications have the potential to become a real success story for SciBase.
We expect to maintain a high pace of activities over summer. We will continue to increase the level of activities in the US as we prepare for a first positive reimbursement decision. We hope to soon be able to communicate more regarding the research and industry collaborations within the barrier indication, and we look forward to returning to the levels of growth that we have previously had, as the effects from Covid subside.
Happy summer!
For more information, please contact: Simon Grant, CEO SciBase
Phone: +46 72 887 43 99
Email: [email protected]
About SciBase andNevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com..
The loss after tax amounted to TSEK 11,151 (8,864).
The loss per share amounted to SEK 0.19 (0.38).
The cash flow from current operations was negative in the amount of TSEK 9,162 (8,704).
The gross margin reached 56.3% (55.7%).
Electrode sales volume increased by 28% and reached 5,968 (4,672) units. Repeat sales of electrodes to existing customers increased by 23%.
January - June in figures
Net sales amounted to TSEK 4,821 (4,179).
The loss after tax amounted to TSEK 19,304 (17,800).
The loss per share amounted to SEK 0.34 (0.89).
The cash flow from current operations was negative in the amount of TSEK 18,635 (16,597).
The gross margin reached 54.4% (54.7%).
Electrode sales volume increased by 19% and reached 13,464 (11,270) units. Repeat sales of electrodes to existing customers increased by 20%.
Important events during the quarter
Overall sales increased by 34% (cleared for currency effects +43%). 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 13% (cleared for currency effects +19%).
SciBase performed two successful directed share issues which raised approximately MSEK 66.5 net, after issue costs.
SciBase submitted the first US reimbursement application to CMS’s Medicare Contractor in Florida, First Coast Service Options (FCSO). The application for Medicare coverage in Florida marks an important step in the reimbursement process for SciBase and is a necessary step towards broader penetration and usage of the Nevisense test.
SciBase received certification under the new Medical Device Regulation (MDR).
The new Non-Melanoma Skin Cancer (NMSC) clinical application was launched following the completion of the MDR certification process.
A groundbreaking article by key SciBase collaborator Professor Cezmi Akdis presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology. The article presented the background for the steep increase in allergic and other diseases over the last decades, and how this increase is connected to degradation in barrier function in the body.
A new clinical study from the Swiss Institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of barrier degradation in atopic patients, even in visually unaffected skin. Nevisense measurements also correlated with relevant biomarkers for atopic dermatitis.
The notice to attend the AGM 2021 was published as well as the nominating committees supplementary proposal to nominate Dr Matt Leavitt for the Board of Directors.
The AGM 2021 was held on May 18.
An EGM was held on June 16th.
The annual report 2020 was published on April 9th.
Important events after the end of the period
SciBase has entered into an agreement with Vator Securities AB (”Vator Securities”) regarding the service as a Certified Adviser. Vator Securities will take over as Certified Adviser on September 28, 2021. Until Vator Securities takes over, Avanza Bank AB will continue to act as Certified Adviser for the Company.
July 1 2020 -
Apr 1 - June 30
Jan 1 - June 30
June 30 2021
Jan 1 - Dec 31
THE GROUP
2021
2020
2021
2020
Rolling-12
2020
Net sales, SEK ths
2 258
1 683
4 821
4 179
10 163
9 521
Gross margin, %
56,3%
55,7%
54,4%
54,7%
52,5%
52,5%
Equity/Asset ratio, %
87,3%
69,2%
87,3%
69,2%
81,7%
79,1%
Net indebtness, multiple
0,15
0,44
0,15
0,44
0,22
0,26
Cash equivalents, SEK ths
88 192
30 450
88 192
30 450
88 192
41 427
Cashflow from operating activities, SEK ths
-9 162
-8 704
-18 635
-16 597
-35 899
-33 861
Earnings per share (before and after dilution), SEK
-0,19
-0,38
-0,34
-0,89
-0,72
-1,12
Shareholder's equity per share, SEK
1,59
1,44
1,65
1,68
1,25
1,50
Average number of shares, 000'
59 265
23 265
57 023
19 942
50 949
31 287
Number of shares at closing of period, 000'
68 236
36 560
68 236
36 560
68 236
54 780
Share price at end of period, SEK
5,52
2,44
5,52
2,44
5,52
4,62
Number of sold electrodes, pieces
5 968
4 672
13 464
11 270
27 880
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 August 19, 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 AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
