scibase-receives-increased-us-medicare-fee-schedules-for-the-nevisense-melanoma-test

SciBase receives increased US Medicare fee schedules for the Nevisense melanoma test

 

SciBase Holding AB (“SciBase”) (STO: SCIB), a leading developer of augmented intelligence-based solutions for skin disorders announced today that two Medicare Administrative Contractors (MACs): First Coast Service Options (First Coast) and Novitas Solutions (Novitas) have published updated fee schedules for SciBase’s early detection test for melanoma (0658T). First Coast covers the state of Florida and Novitas covers the central and mid-Atlantic US and together they cover about one-third of the US Medicare population. The updated fee schedules are valid retroactively from 1st January 2023 and are available on the MAC’s respective webpages.

We are very pleased with the new fee schedules and more importantly, the levels will be seen as appropriate by clinicians to support the expanded use of the Nevisense test for early melanoma detection at point of care. For SciBase this is a critical decision that paves the way for further US expansion – both within the two covered regions, but also into MACs that cover other parts of the US.

We are happy to know clinicians have found Nevisense clinically valuable and useful in the management of patients. For Medicare it can also result in savings due to earlier and more accurate melanoma detection. This has been a challenging process that has taken longer than anticipated and I applaud the patience of our users.  The decisions mean that Medicare patients in these regions will now have better access to the latest technology and improved accuracy when their atypical lesions are being evaluated for suspicion of melanoma,” said Simon Grant, Chief Executive Officer of SciBase.

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 April 4, 2023.

scibase-to-present-at-the-redeye-medtech-&-diagnostics-seminar-on-may-11,-2022

SciBase to present at the Redeye Medtech & Diagnostics Seminar on May 11, 2022

 

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 Redeye Medtech & Diagnostics seminar on May 11th at 10.55 pm. The presentation will be followed by a short Q&A. The presentations are live broadcasted at https://www.redeye.se/events/825143/redeye-theme-medtech-diagnostics . The presentation will also be available at www.redeye.se and on the Company’s website in Redeye Universe.

It has been a busy start to the year and we see an exciting year in front of us with US growth and progress with the skin barrier application.,” says Simon Grant, CEO SciBase.

scibase-receives-largest-electrode-order-from-a-single-clinic-valued-at-60ke

SciBase receives largest electrode order from a single clinic valued at 60k€

 

SciBase Holding AB (“SciBase”) [STO: SCIB], a leading developer of augmented intelligence-based solutions for skin disorders,  announced today that it has received its single largest order to date from a single clinic. The order for nearly 2,000 electrodes was received from an existing customer, a private Dermatology clinic in Germany. The order was valued at around 60k€ and will be delivered in April. The company has seen a significant increase in order volume following the announcement of an 8% increase in electrode prices from April 1.

“It is very pleasing to see one of our customers commit so strongly to utilising our product going forward. To me an order like this is the best indication that a customer believes in our technology and the value it can bring them and their patients,” says Simon Grant, CEO SciBase.

new-study-published-showing-nevisense-impact-on-clinician-confidence-and-accuracy

New Study published showing Nevisense impact on clinician confidence and accuracy

 

SciBase Holding AB (“SciBase”) (STO:SCIB), a leading developer of augmented intelligence-based solutions for skin disorders,  announced today that a new study supporting the use of Nevisense in diagnosing melanoma has been published in “SKIN – The journal of cutaneous medicine”. The article is authored by Avani Kolla, Prof David Polsky and others from The Ronald O. Perelman Department of Dermatology, NYU Grossman School of Medicine in New York. The study shows that Nevisense provides valuable diagnostic guidance when evaluating atypical pigmented skin lesions.

“Melanoma is a potentially deadly form of skin cancer and has an almost 100% cure rate if caught early. While the performance of Nevisense as a diagnostic aid in the management of atypical pigmented skin lesions suspicious for melanoma has been previously demonstrated, its impact on clinician confidence in their biopsy decisions has not been described. In this pilot study, we found that mean confidence for clinicians in correctly identifying the disease diagnosis significantly increased when we added Nevisense to the evaluation of clinical and dermoscopic images of skin lesions suspicious for melanoma. Adding Nevisense to these evaluations also significantly increased diagnostic accuracy and biopsy sensitivity for melanoma,” says David Polsky, MD, PhD Alfred W. Kopf, MD Professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, NYU Langone Health.

“This study further validates Nevisense as a valuable tool for the early detection of melanoma. The article presents additional evidence that Nevisense can help clinicians of all experience levels improve their ability to accurately identify lesions that require treatment and to be more confident in their clinical management decisions”, says Simon Grant, CEO of SciBase.

Publication details:

  • New clinical study suggests Nevisense has a positive impact on Clinicians confidence and diagnostic accuracy for early melanoma detection
  • The US based study data further supports Nevisense’s clinical value for clinicians of all levels

The article is titled “Impact of Electrical Impedance Spectroscopy on Clinician Confidence and Diagnostic Accuracy in Evaluating Melanocytic Skin Lesions Suspicious for Melanoma: A Pilot Study” and evaluates whether “clinician diagnostic confidence, sensitivity, specificity and accuracy can be increased by adding EIS measurement scores to clinical and dermoscopic images of lesions clinically suspicious for melanoma”. In the study Nevisense increased clinician’s sensitivity for melanoma and dysplastic nevi from 70% to 84%. The conclusion in the article states: ” EIS increased novice and expert diagnosticians’ confidence regarding dermoscopically equivocal melanocytic lesions.”

scibase:-interim-report

SciBase: Interim report

 

The second quarter in figures

  • Net sales amounted to TSEK 2,258 (1,683).
  • 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.

Apr 1 – June 30

Jan 1 – June 30

July 1 2020 –
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.

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.

scibase-raises-sek-71.2-million-through-two-directed-issues

SciBase raises SEK 71.2 million through two directed issues

 

The Board of Directors of SciBase Holding AB (publ.) (“SciBase” or the “Company”) has, with support of the authorization granted by the annual general meeting on 18 May 2021 decided on a directed issue of 13,456,021 shares to a number of Swedish and international investors, including Van Herk Investments B.V. and ÖstVäst Capital Management. Furthermore, the Board of Directors has, conditioned by the approval at the extra general meeting, decided on a directed issue of 239,000 shares to the newly elected Board of Director Dr. Matt Leavitt. Notice of the extraordinary general meeting for approval of the share issue to Dr. Matt Leavitt will be announced separately.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATESAUSTRALIAHONG KONGJAPANCANADANEW ZEALANDSWITZERLANDSINGAPORESOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

The share issues have been carried out at a subscription price of SEK 5.20 per share and provides the Company with approximately SEK 71.2 million before transaction-related costs.“So far in 2021 we have received MDR certification, launched our NMSC (non-melanoma skin cancer) indication in Europe and filed an application for reimbursement coverage with CMS in Florida, US. With the share issues, we will further accelerate our strategic growth areas and our market penetration in the US by applying for reimbursement in additional regions. Furthermore, we will continue to develop our skin barrier application with a focus on securing additional partnerships. In summary, the share issues provide SciBase with the financing needed to achieve reimbursement in the US, while  also strengthening the shareholder base through welcoming new local and international institutional owners such as ÖstVäst Capital Management and the specialist investor Van Herk Investments B.V. Through its investments in BioInvent, Immunicum and Zealand Pharma, Van Herk has shown great success in life science and in addition they also have good knowledge  within the field of skin cancer.”, says Simon Grant, CEO of SciBase.

SciBase has carried out a capital raise of approximately SEK 71.2 million. The capital raise is divided into two directed share issues, one to a number of Swedish and international investors, including Van Herk Investments B.V. and ÖstVäst Capital Management, and the other to the Board member Dr. Matt Leavitt who was newly elected on the annual general meeting 2021.

The share issues have been carried out at a subscription price of SEK 5.20 per new share, corresponding to a discount of approximately 11.0 per cent in relation to the volume weighted average price during the previous five (5) trading days of the Company’s shares on the Nasdaq First North Growth Market. The subscription price has been determined through negotiations at arm’s length with investors and is assessed to reflect current market conditions and demand.

In connection with the share issues, lock-up agreements with Board members and senior executives of the Company who own shares in the Company have been entered into, including customary terms and exemptions under the direction of Vator Securities.

The net proceeds from the share issues will primarily be used for penetration of the U.S. market, including reimbursement activities and strengthening of the local sales and customer support organization, and for the development of new applications.

The share issue directed to Swedish and international investors has been carried out based on the authorization granted at the annual general meeting on 18 May 2021. The share issue directed to the Board member Dr. Matt Leavitt (who was newly elected on the annual general meeting 2021) is covered by the so-called Leo Act (Chapter 16 of the Swedish Companies Act) and is thus subject to approval from a general shareholder meeting. Notice of an extraordinary general meeting will be announced through a separate press release.

The reasons for the deviation from shareholders’ preemption rights are to raise capital in a cost and time effective manner, diversify the ownership of the Company and to make it possible for the Board member Matt Leavitt to invest and thus achieving alignment with the Company’s shareholders.

To facilitate the completion of the share issue directed to Swedish and international investors, the new shares have been subscribed to by Vator Securities AB as issuing agent at an amount corresponding to the quota value of the shares, for subsequent transfer to the final investors at a price of SEK 5.20 per share, which is finally reported to the Company.

Through the share issues the number of shares in the Company will increase by 13,695,021, from 54,780,086 to 68,475,107 and the share capital will increase by SEK 684,751.05 from SEK 2,739,004.30 to SEK 3,423,755.35. The dilution for existing shareholders amounts to approximately 20 per cent.