SciBase unveils growth strategy including plans for US launch of Nevisense

Following the Pre-Market Approval (PMA) of Nevisense in the US in June, SciBase today presents an update of their strategic growth plan. The focus of the plan is SciBase's entry into the US market, the continued growth in the core market Germany, and the utilization of the current product platform for additional clinical indications.  

The strategic plan has been developed together with the Company's Board and to support the above includes a reasonably aggressive investment strategy. It is the Board’s opinion that the current financial resources as of end-June of over 60MSEK, will be sufficient to cover the Company’s capital needs for at least the coming 12-month period. The new strategy and growth plan will over time however, entail increased capital requirements.  The Board is therefore currently evaluating a number of options for long-term funding of the Company. The Company believes that if the strategy is successfully implemented, both the US market and the new applications will drive rapid growth.  

- The launch of the new strategic plan represents a more aggressive approach to the market, both in key existing markets but also in the United States. Our focus going forward will be on driving sales, but also on new clinical applications for our technology. We have taken an important step with the July launch of new Nevisense software and electrodes that will be used in the development of new clinical applications for the dermatologist, says Simon Grant, CEO SciBase. 

US plan

With the FDA's approval of the SciBase PMA application in June, the Company is now able to start exploiting the world's largest market, the United States. SciBase intends to take a step-wise approach to the market initially focusing on servicing ‘self-pay’ clinics, where the patient pays healthcare costs directly and not through an insurance company. Focus will be on the highly populated New York metropolitan area/Tri-State Area, which also is one of the regions in the US with the highest number of cases of malignant melanoma.

SciBase will in parallel build awareness of Nevisense and further develop the existing network of Key Opinion Leaders (KOL) in the US which will assist in disseminating knowledge and experience of Electrical Impedance Spectroscopy (EIS) and Nevisense in the US.. Finally, as Nevisense gains traction and shows commercial success, the Company will approach selected local and regional insurance companies and seek local reimbursement for EIS testing. In order to achieve more general penetration across the US general reimbursement for Nevisense testing from insurance companies is required. This process is both time and resource intensive and will therefore be started on a selective basis as soon as practicable.

Following on from commercial traction in the North East, SciBase believes that further expansion through nationwide distribution partners could lead to a further acceleration of the sales growth trajectory in the medium term, which provides the opportunity to enable wider penetration of the US market.

- We have developed a well-balanced plan, which enables us to establish ourselves in the US while getting the most out of the resources we invest. We will start in a well-populated, high-profile region where many patients are used to paying for themselves - and also where several important Key Opinion Leaders are based.  With this approach we have a great opportunity to both lay the foundation for reimbursement and to create a successful case that in the future can attract interesting partners and distributors, says Simon Grant.

Continued development of the German market

In addition to the US market, SciBase will build on its growth in Germany; currently its largest market with a loyal user base of 150 private Dermatology clinics offering Nevisense. SciBase believes that it can now shift sales focus from these "early adopter" clinics to the mainstream private Dermatology market. The recently released Nevisense product improvements and enhancements will help drive this, as will the opportunity arising from the integration of Nevisense with DermoScan's product DermoGenius Ultra. DermoScan is the first digital dermoscopy company to include EIS as a standard parameter and DermoGenius is used in more than 400 clinics in Germany.

New Clinical applications for Electrical Impedance Spectroscopy

It has long been known that EIS can be useful in assessing other skin conditions. Before the Company decided to focus purely on melanoma, it published a number of studies within other clinical areas, including non-melanoma skin cancer and atopic dermatitis. Both of these disorders are common and involve significantly larger patient groups than malignant melanoma. SciBase’s plan is to utilise the current product Nevisense as a unique platform that can both investigate and support treatment modalities for these new clinical applications.

SciBase is currently conducting clinical trials with leading academic and clinical centers to investigate these new indications. The first published results are expected in the first half of 2018 and following this SciBase will start the commercialization of the first application. The new applications not only mean more value and utility for dermatologists, but would, if successful, open up new, complementary markets with significant sales potential. The concept of Nevisense as a dermatology platform means that dermatologists, regardless of their area of interest, can be approached with an integrated tool providing multiple software analyses and electrodes designed for a range of key clinical situations.

Finally, SciBase has successfully concluded a three year development project conducted together with the Royal Institute of Technology (KTH) to miniaturise the measurement electronics for Nevisense to a 5mm x 5mm Application Specific Integrated Circuit (ASIC). The project proves that the size and cost of Nevisense can be significantly reduced. This opens up the possibility of a new generation of Nevisense that is smaller and cheaper where the target group can be expanded to general practitioners and others.

In summary, SciBase believes this approach has great potential and can lead to significant growth for the Company. The key elements of the strategy are:

  • That the company plans the US introduction of Nevisense in the North-East, initially targeting self-pay clinics, while building a general reimbursement case  
  • That there will be a continued focus on growth in the German market, addressing more mainstream private Dermatologists with improved Nevisense features   
  • By leveraging Nevisense as a platform, SciBase can address unmet needs within other skin-conditions and be even more useful as a tool for Dermatologists.  
  • Long term, the Company hopes to utilise the ASIC project to both reduce cost and enable the development of smaller, simpler instruments potentially addressing new customer groups with new screening capabilities.

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

Simon Grant, CEO
Tel: +46 72 887 43 99
E-mail:
simon.grant@scibase.com 

This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on September 25, 2017. 

About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and now also a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com 

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About Us

SciBase is a Swedish medical technology company founded in 1998 that has developed Nevisense, a point-of-care device for the accurate detection of malignant melanoma. Nevisense has emerged from more than 20 years of research at Karolinska Institute in Stockholm and at SciBase. The device is designed to be provide additional information when evaluating lesions with a suspicion of melanoma. Nevisense is based on a technology called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. The CE-marked system consists of an electrode on a hand-held probe connected to a small portable device performing the analysis and displaying the result. A video describing the Nevisense method is available on: www.scibase.se/en/the-nevisenseproduct and further information is also available on www.scibase.com.

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