SciBase today announces the results from their Reader Study in the US. The results from the study show that the addition of Nevisense significantly improved the ability of US dermatologists to accurately detect melanoma. The Reader Study is an important requirement of the application process to the US Food and Drug Administration (FDA). With the results from the study, SciBase can now compile their complete application.
“We are very pleased with the result of the study. This was the last requirement from the US FDA for our Pre-Market Approval (PMA) application for Nevisense on the US market. Now that the Reader study is successfully completed, we can finalize and submit our application”, says Simon Grant, CEO of SciBase.
41 US dermatologists reviewed online 141 randomly selected potential melanoma lesions; first with an image of each lesion together with patient information, and then with Nevisense information added.
The results showed that the use of Nevisense significantly improves physicians’ ability to detect melanoma, whilst also satisfying the goal set for accuracy. This meant the study met both primary endpoints agreed with the FDA.
“The study results are in addition to the results from the SciBase pivotal study published last year, but with a different approach and with a broad group of US dermatologists. This shows that Nevisense has the potential to provide additional valuable information to clinicians in the difficult task of accurately detecting malignant melanomas”, says Simon Grant, CEO of SciBase.
Approval from the FDA is required for SciBase to be able to market and sell Nevisense in the US, the world’s largest medical device market. By meeting the FDA’s requirements for the study, SciBase can now finalize its pre-market approval (PMA) application, which is scheduled for submission before the end of 2015.
SciBase’s point-of-care device 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 AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL.
SciBase Holding AB (publ) (“SciBase” or the “Company”) today announces the outcome of its offering to subscribe for new shares in SciBase (the “Offering”) in connection with the planned listing on Nasdaq First North.
The interest for the Offering has been strong, both among the general public in Sweden and among institutional investors in Sweden and abroad, and the Offering was significantly oversubscribed.
The Offering in brief
As previously announced, the price in the Offering is SEK 50 per share, implying a pre-money market capitalization of SEK 249 million, based on SciBase’s 4,984,768 shares outstanding prior to the Offering.
The Offering originally comprised 3,000,000 new shares, but has, in accordance with the terms of the Offering, been increased by 300,000 additional new shares to comprise a total of 3,300,000 new shares, corresponding to approximately 40% of the shares and votes in SciBase after completion of the Offering (excluding the Over-allotment option).
SciBase has granted an over-allotment option to Pareto Securities of up to 495,000 additional new shares, corresponding to up to 15% of the total number of shares in the Offering (the “Over-allotment option”). If the Over-allotment option is fully exercised, the Offering comprises in total 3,795,000 new shares, corresponding to approximately 43% of the shares and votes in SciBase after completion of the Offering.
The Over-allotment option can, according to the terms of the Offering, be exercised, at one or more occasions, whole or in parts, by Pareto Securities up until and including July 1, 2015.
The total value of, and gross proceeds from, the Offering is SEK 165 million (excluding the Over-allotment option).
If the Over-allotment option is fully exercised, the total value of, and gross proceeds from, the Offering is SEK 190 million.
The existing shareholders SEB Venture Capital, SEB Pensionsstiftelse, Fouriertransform and Omega Fund IV, L. P. (the “Cornerstone Investors”) participated in the Offering with SEK 19.4 million, SEK 13.5 million, SEK 12.6 million and SEK 4.5 million, respectively – in aggregate SEK 50 million. The Cornerstone Investors will jointly hold approximately 57% of the shares and votes in SciBase if the Over-allotment option is fully exercised.
Existing investors other than the Cornerstone Investors participated in the IPO with an aggregate amount of approximately SEK 14 million.
As a result of the Offering, around 4,000 new investors have been allocated shares in SciBase.
The new investors include both specialist and generalist institutional investors from Sweden and abroad, as well as Swedish retail investors.
Trading in SciBase’s shares on Nasdaq First North is planned to commence on Tuesday, June 2, 2015, under the ticker “SCIB”.
Simon Grant, CEO, comments:
We are very pleased to see such a high level of interest from such a varied group of investors. The high demand has allowed us to fully increase the size of the offering, bringing the company additional capital to further increase sales efforts in new and existing markets. This is an important step for SciBase and I would like to welcome the new investors in our fight against skin cancer.
Tord Lendau, Chairman, comments:
We welcome our new shareholders and look forward to take the next step in the company’s development together with you. With the world’s best objective detection device for malignant melanoma, a strong management team, and backing from new capital, we will continue on-track towards profitability.
Viktor Drvota, board member by the mandate of SEB Venture Capital and SEB Pensionsstiftelse, comments:
As one of SciBase’s first and largest shareholders, it means a lot to see this considerable interest from both new institutional investors and private individuals. We participated significantly in the offering and as long-term shareholders we look forward to working with you to support the company in its commercial expansion.
Advisors
Pareto Securities is Sole Manager and Bookrunner in connection with the Offering. Hamilton Advokatbyrå is legal advisor to SciBase and Gernandt & Danielsson is legal advisor to Pareto Securities. Avanza is Selling Agent and Certified Adviser.
For further information please visit www.scibase.com or contact:
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense
SciBase 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 The Karolinska Institute in Stockholm and at SciBase. The device is designed to 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: http://scibase.se/en/the-nevisense-product and further information is also available on www.scibase.com.
IMPORTANT NOTICE
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, South Africa or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL.
SciBase, a Swedish medtech company that has developed a unique instrument for the detection of malignant melanoma, announces that trading in the company’s shares on Nasdaq First North commences today with the ticker “SCIB”. The outcome of the Offering was announced on May 29. The level of interest in the IPO was high from both Swedish and international institutional investors as well as the general public, resulting in around 4 000 new shareholders. The Offering was oversubscribed several times.
Simon Grant, CEO, comments:
“I am especially pleased with the tremendous interest from a wide range of new private investors and institutional generalists and specialists. With the additional capital and the superior data we have from the world’s largest trial of its kind, we will expand our efforts in prioritized markets. I look forward to continuing the fight against skin cancer and at the same time becoming a profitable listed company.”
Advisors
Pareto Securities is Sole Manager and Bookrunner in connection with the Offering. Hamilton Advokatbyrå is legal advisor to SciBase and Gernandt & Danielsson is legal advisor to Pareto Securities. Avanza is Selling Agent and Certified Adviser.
For further information please visit www.scibase.com or contact:
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense
SciBase 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 The Karolinska Institute in Stockholm and at SciBase. The device is designed to 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: http://scibase.se/en/the-nevisense-product and further information is also available on www.scibase.com.
IMPORTANT NOTICE
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, South Africa or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
SciBase, a Swedish medtech company that develops and markets a new technology for early detection of malignant melanoma, together with its partner KTH Royal Institute of Technology, have been granted 3.9 MSEK from Vinnova’s ‘Smarter Electronic Systems’ program fund. The project is for the development of a minimized and modular next generation of SciBase’s product Nevisense.
The project’s objective is to minimize the size of measurement electronics, which is essential to the next generation of Nevisense.
Vinnova’s explanatory statement for approving SciBase’s application:
”The project strengthens SciBase’s competitiveness and the niche market for embedded systems in medical technology. The project received especially good marks in regards to the main criteria Potential and Practicability.”
“The development of minimized measuring electronics is key for the next generation of Nevisense. We are very pleased with Vinnova’s support and the funding allows us to start working on the project in the next quarter,” says Fredrik Goldkuhl, Head of Research and Development at SciBase.
SciBase’s partner in the project is the Integrated Circuits and Systems Group at KTH Royal Institute of Technology in Kista, Stockholm.
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North ("SCIB"). Avanza is Certified Adviser. Further information is available on www.scibase.com.
SciBase, a Swedish medtech company that develops and markets a new technology for early detection of malignant melanoma, continues to expand. The Company has contracted an additional selling agent and recruited a further Sales Representative in Germany, the Companies main market, bringing the total number of local representatives to five. The Company is also expanding in Sweden and has recruited Maria Näslund as Product Manager.
- We grow at a faster rate than expected in the German market. We see both an increased demand for Nevisense and an increased test usage. To be able to manage this demand we have expanded our presence from three to five persons covering the German market, says Simon Grant, CEO SciBase.
SciBase has signed an agreement with a new agent with long experience working with Dermatologists, who will focus on building the Nevisense customer base in South-West Germany. This is in addition to SciBase’s existing agent and employees and means that a larger part of Germany now can be covered.
A further new recruitment in Germany will focus on supporting customers as they incorporate Nevisense into the daily workflow of their clinics - thus increasing the usage of Nevisense. In practice this means introducing and helping implement processes that integrate Nevisense into routine clinical care for patients.
- With our business model the bulk of our income comes from the daily use of our instrument - and that is from the single patient use of electrodes. Therefore it is important that clinics integrate Nevisense into their daily way of working and that is something our new sales representatives can support them with, says Simon Grant
The increased sales resources in Germany are expected to have a positive impact on the third quarter 2015 and onwards.
SciBase also expands on the home front and has recently recruited Maria Näslund as the Nevisense Product Manager. Maria will focus on product management and market support for Nevisense, but will also help drive the development of the next generation of Nevisense. Maria worked previously at St Jude Medical in Uppsala.
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and is awaiting FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North ("SCIB"). Avanza is Certified Adviser. Further information is available on www.scibase.com.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION IS UNLAWFUL.
On Wednesday May 13, SciBase Holding AB (publ) (“SciBase”) published the prospectus and the terms of its initial public offering, with planned listing on Nasdaq First North. The application period starts today. SciBase will present the company on several occasions during the application period.
Today, Monday May 18, marks the start of the application period for SciBase’s initial public offering, with planned listing on Nasdaq First North. The application period continues until and including May 27 for the Swedish general public and until and including May 28 for institutional investors in Sweden and abroad. Prospectus and application forms are available on SciBase’s website.
Several opportunities to meet SciBase’s CEO Simon Grant will be offered during the application period where he will present the company and answer questions.
A presentation will be given at Avanza Bank's “Börsdag” at the Opera Terrace in Stockholm on May 20 at 10:45. The invitation can be downloaded on SciBase’s website. A video of the presentation will also be available on SciBase’s website after the event.
Furthermore, Pareto Securities has planned the following lunch presentations: In Stockholm on Wednesday May 20, in Malmö on Monday May 25, and in Stockholm on Tuesday May 26. Please contact Anna Nilsson for more information: [email protected].
Advisors
Pareto Securities is Sole Manager and Bookrunner in connection with the Offering. Hamilton Advokatbyrå is legal advisor to SciBase and Gernandt & Danielsson is legal advisor to Pareto Securities. Avanza is Selling Agent and Certified Adviser.
For further information please visit www.scibase.com or contact:
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly.
About SciBase and Nevisense
SciBase 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 The Karolinska Institute in Stockholm and at SciBase. The device is designed to 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: http://scibase.se/en/the-nevisense-product and further information is also available on www.scibase.com.
IMPORTANT NOTICE
This announcement is not and does not form a part of any offer for sale of securities.
Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, New Zealand, Hong Kong, Japan, Switzerland, South Africa or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.
Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.
In any EEA Member State other than Sweden that has implemented the Prospectus Directive, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
This communication is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). This communication must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this communication relates is available only to relevant persons and will be engaged in only with relevant persons. Persons distributing this communication must satisfy themselves that it is lawful to do so.
Matters discussed in this announcement may constitute forward-looking statements. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
SciBase, that develops and markets a new method for the early detection of malignant melanoma, will today be present on-site at the Karolinska University Hospital to support the physicians in the detection of malignant melanoma.
The Karolinska University Hospital is a participant in the Euromelanoma Week, a European initiative to increase the awareness of skin cancer and especially malignant melanoma, it’s most dangerous form. The Karolinska University Hospital is one of 45 organizations in Sweden that will accept patients without a referral to examine suspicious skin lesions.
Nevisense, which has been developed by SciBase, is an aid in the detection of malignant melanoma. The cancer is often hard to detect and the current diagnostic methods are based on visual detection, which is dependent upon the individual physicians experience and knowledge. Nevisense is the first non-visual method and as such an important objective complement to the current methods.
- Our clinical studies have demonstrated that Nevisense has a very high sensitivity to detect malignant melanoma but can also help to reduce the number of unnecessary biopsies. We hope that many patients will visit Karolinska during Euromelanoma week to have their lesions examined and that we, with Nevisense, can be of assistance in the difficult task to correctly identify the lesions that are melanoma, says Simon Grant, CEO of SciBase.
Skin cancer is one of the most common cancers in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75%) of deaths related to skin cancer. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly and the key to a successful treatment is early detection.
About Euromelanoma 2015
Euromelanoma 2015 is an European investment in the prevention and early detection of malignant melanoma and other forms of skin cancer. In Sweden the Euromelanoma week runs from May 18 to May 22. Dermatology clinics, spread through the country, offer together more than 5,000 examinations without referrals. All the clinics utilise appointments (no drop-ins). Ordinary patient-fees and cost ceilings apply. You can find all the participating clinics in Sweden at www.euromelanoma.com/sweden.
For further information please visit www.scibase.com or contact:
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 The Karolinska Institute in Stockholm and at SciBase. The device is designed to 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: http://scibase.se/en/the-nevisense-product and further information is also available on www.scibase.com.
SciBase, a Swedish medtech company that develops and markets a new technology for early detection of malignant melanoma, has received approval from the United States Patent and Trademark Office (USPTO) for its patent on micro-needle electrodes. This technology is already patented in 12 European countries, Australia and Canada. The patent expires 2023.
SciBase’s point-of-care device 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. Malignant melanoma is a fast growing type of skin cancer, which appears in the epidermis right under the cornified layer. Nevisense’s electrodes utilise microscopic needles that permit measurement of the electrical impedance in the skin layers, where malignant melanoma can appear. The technique is essential for detecting the early stages of skin cancer.
”Right now, Nevisense is in the regulatory approval process in theUnited States, and we see theUSas a future key market for us. The approval of this US patent is thus an important step in our comingUSexpansion. Electrodes with micro-needles can potentially be used to detect other types of cancer as well,” says Simon Grant, CEO of SciBase.
SciBase holds a total of 49 registered patents and currently have another 12 active patent applications pending in six patent families.
Skin cancer is the most common cancer in the world, accounting for nearly half of all cancers. It has been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once. Malignant melanoma is the most fatal form of skin cancer causing the majority (75 percent) of deaths related to skin cancer, although it only accounts for 4 percent of all skin cancer cases. Worldwide, doctors diagnose about 230,000 new cases of melanoma yearly. The key to management is early detection.
SciBase, a Swedish medical technology company that has developed a unique point-of-care device for the accurate detection of malignant melanoma, today announces the establishment of a Scientific Advisory Board. The Board, which is composed of world-leading dermatology experts, will advise SciBase as they develop the company.
SciBase’s Scientific Advisory Board has already held its first meeting and the Board’s main function will be to advise the company on how to improve and increase acceptance of the method and the product, Nevisense. Additionally, the Board will assist in the development of the next generation of Nevisense and provide guidance in regards to upcoming clinical studies.
The board is composed of five world-leading physicians:
Dr Allan C. Halpern
Chief of Dermatology Service at Memorial Sloan-Kettering Cancer Center in New York
Dr David E. Elder
Professor of Pathology and Laboratory Medicine at the Hospital of the University of Pennsylvania
Dr Scott W. Menzies
Professor of Medicine, Discipline of Dermatology and Director of Sydney Melanoma Diagnostic Centre
Dr Josep Malvehy
Director of the Melanoma Unit at University Hospital Clinic of Barcelona
Dr Holger Hänßle
Senior Physician at Heidelberg University Clinic
IPO on Nasdaq OMX First North in June
On April 23 SciBase announced its upcoming IPO and listing on Nasdaq First North in June 2015. The main purpose of the IPO is to finance Scibase’s continued expansion and commercialization, which is the company focus for 2015. Further announcements relating to the Initial Public Offering will be made in due course.
“With the development of our product Nevisense now completed, our focus is on building a solid base for the future. Our Scientific Advisory Board’s leading expertise and experience will be invaluable in driving our product and company forward and we are excited to have their support. With our IPO, we will raise the capital needed to expand sales and marketing of Nevisense. Nevisense is contributing to a safer and more effective detection of skin cancer, which benefits both health care systems and patients”, says Simon Grant, CEO at SciBase.
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.
The loss after tax amounted to TSEK 9,179 (9,012).
The loss per share amounted to SEK 0.05 (0.05).
The cash flow from current operations was negative in the amount of TSEK 9,197(10,250).
Important events during the quarter
The wholly owned subsidiary SciBase GmbH was formed with the aim of strengthening the Group’s sales and marketing focus in Germany.
Tobias Bergenblad was appointed as the new Global Sales Manager.
Patents granted in Australia and Japan.
Important events after the end of the period
In April, SciBase established a Scientific Advisory Board consisting of international experts in the field of skin cancer.
In April, an exclusive distributor agreement for the Austrian market was signed with Intramed Handels GesmbH.
In April, SciBase announced its intention to launch an Initial Public Offering and listing on Nasdaq First North.
At an Extraordinary General Meeting on April 28, resolutions were taken to:
- introduce a share-based incentive program,
- consolidate shares and reduce the share capital,
- authorize the Board to make decisions regarding new share issues.
”During the first quarter of 2015, we have started to see the results of SciBase’s transformation into a more sales-focused company. Our sales have increased significantly during the first quarter and this is mainly due to a growing usage in our key market Germany. An important driver for the increased acceptance of Nevisense has been the publication of our pivotal clinical trial in the British Journal of Dermatology, which validated our product, and was the largest study of its kind. With Nevisense, we address many of the challenges within health care related to the detection of malignant melanoma,” says Simon Grant CEO of SciBase.
Financial overview
Jan 1 - Mar 31
Jan 1 - Dec 31
THE GROUP
2015
2014
Apr 1 2014 - Mar 31 2015 Rolling-12
2014
Net sales, SEK 000'
1 057
64
2 593
1 600
Gross margin, %
2,6%
-15,6%
-20,8%
-36,0%
Equity/Asset ratio, %
73,0%
91,7%
73,0%
78,5%
Net indebtness, multiple
0,37
0,09
0,37
0,27
Cash equivalents, SEK 000'
17 313
55 906
17 313
27 566
Cashflow from operating activities, SEK 000'
-9 197
-10 250
-36 024
-37 077
Earnings per share (before and after dilution), SEK
-0,05
-0,05
-0,20
-0,19
Shaeholder's equity per share, SEK
0,12
0,32
0,12
0,16
Average number of shares, 000' (before and after dilution)
