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Episurf — Interim / Quarterly Report 2018
Oct 26, 2018
3157_10-q_2018-10-26_cec03315-d9b1-487e-b07a-ecea295d5339.pdf
Interim / Quarterly Report
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Q3 Interim Report,
1 July–30 September 2018
CLINICAL RESULTS OF AN INDIVIDUALISED MINI-METAL IMPLANT FOR FOCAL CARTILAGE LESIONS IN THE KNEE.
OUTCOME SCORES
Pain Sym ADL Sport QoL
Pre-OP 3 Months 12 Months 24 months
Fig. 2 Mean KOOS-average by domain n=65 (24mth n=35)
Pain Sym ADL Sport QoL Pre-OP 3 Months 12 Months 24 months
Fig. 3 VAS Pain - average
Fig 1. KOOS subscales: preop, 3, 12, 24 months
Results from International Multicentre Outcome Study on Episealer T. Spalding, C. Stevenson, J. Holz, T. Jung, C. Kösters, M. Lind, L. Konradsen, M. Polacek, P. Verdonk, P. Emans, K. Eriksson, M. Högström.
INTRODUCTION
Patients in the "gap age" 35-60 years old, with focal cartilage lesions are often considered too young for an arthroplasty and too old for biologic repair. Many may have already had failed prior surgery.
Mini-Metal implants are a novel option to treat joint surface lesions, and require careful evaluation to determine results expectations and thereby indications.
EPISEALER IMPLANT Detailed specific MRI data was used to
manufacture patient specific implants and guide instruments by a CAD/CAM process, to fit the unique anatomy of each individual knee.
Implants were uncemented and made of chrome-cobalt, double coated with hydroxyapatite on top of titanium. (Episurf, Stockholm, Sweden).
GROUP DEMOGRAPHICS
92 patients (46 men, 46 women) with focal cartilage lesions ICRS grade 3 or 4 underwent partial resurfacing.
75 on medial condyle, 6 lateral condyle and 11 on trochlea. Mean age 49 (27-69) years, and mean
BMI 29 (21-41). 30% had failed previous cartilage surgery.
RESULTS: STUDY GROUP
- 12 month results in 65 patients:
- Female 38, Male 27. • MFC 52, LFC 5, trochlea 8.
- 24 month results in 35 patients.
- 2 patients (4.5%) underwent revision:
- 9 months for infection
- 30 months for arthritis progression
All mean KOOS domain scores were significantly improved at 1 and 2 years (p<0.05) (Fig. 1 & 2).
Mean VAS score improved from 65 preoperatively to 35 at 24 months (Fig. 3).
PROCESS FOR EPISEALER IMPLANTATION
Patients undergo detailed MRI resulting in Damage Marking report detailing location of defect and proposed solution. 3D printed patient individualised guide instrumentations are produced to allow accurate implantation.
Conflicts of Interest: TS, JH & KE are Consultant Advisors to Episurf Medical
CONCLUSION
and low early revision rate.
The study shows excellent early clinical results in the treatment of focal full thickness symptomatic cartilage lesions on the femoral condyles or trochlea with a second-generation patient specific metal implant and cutting guides. Adherence to strict indications has allowed for high patient reported scores
AIM
We report prospective detailed results of patients undergoing treatment for chondral defects using a patient specific 2nd generation individualized mini-metal implant.
METHODS
This study consists of the prospective analysis of sequential patients from 11 surgeons.
Patients had focal chondral or osteochondral lesions on femoral condyle or trochlea that had failed to improve on non operative treatment or who had previously undergone repair surgery that had failed.
Demographic, operative and clinical scores (VAS and KOOS) were collected preop and at 6, 12 and 24 months postoperatively.
Patients with minimum 12 months follow up were analysed.
AUTHORS
Tim Spalding: Coventry, UK Ciara Stevenson: Coventry, UK Johannes Holz: Hamburg, Germany Martin Lind: Aarhus, Denmark Karl Eriksson: Stockholm, Sweden Peter Verdonk: Antwerp, Belgium Pieter Emans: Maastricht, The Netherlands Tobias Jung: Berlin, Germany Clemens Kösters: Greven, Germany Lars Konradsen: Copenhagen, Denmark Martin Polacek: Drammen, Norway Magnus Högström: Umeå, Sweden
Contact: [email protected]
Episealer® Trochlea surgery in Zurich with PD Dr. Kessler, October 2018
Third quarter 2018 compared to 2017, Group
- » Group net sales increased by 86.7% compared to last year and amounted to SEK 1.0m (0.5)
- » Gross order intake amounted to SEK 0.7m (0.9), a decrease of 15.5%. The number of approved orders amounted to 35 (42)
- » Order backlog amounted to SEK 0.6m (0.8)
- » Loss before tax amounted to SEK –12.9m (–13.5)
- » Earnings per share amounted to SEK –0.42 (–0.44)
Significant events during the third quarter
- » Episurf Medical released new CE-marked joint visualisation tool based on Al
- » Episurf Medical has received initial feedback from the US FDA on the IDE application for the Episealer® knee Implant
- » Episurf Medical expanded into the Polish Market
- » Promising clinical results from use of Episealer® was accepted for presentation at the annual meeting of the Australian Knee Society in October
- » Clinical outcome for Episealer® was presented at the annual meeting of the European Orthopaedic Research Society (EORS) In Galway, Irland In September
- » Patent approvals in Japan, US, Canada and Australia for Episurf Medical
Revenues and gross order intake
Significant events after the third quarter
- » Clinical outcome for Episealer® to be presented at the annual meeting of the Danish Orthoaedic Society (DOS) In Copenhagen in October
- » New Chinese patent approval for Episurf Medical
Pål Ryfors, CEO
Message from the CEO Dear shareholders,
We are concluding yet another intense quarter for Episurf Medical. We are continuing to deliver on our strategy, and the activity level is high across our business. We are approaching the completion of two of our most important milestones ever, namely the approval to start a clinical trial in the US and the launch of an individualised ankle implant. We are improving our results during the quarter, driven both by increased revenues and lowered operating expenses.
Continued preparations for the US market
Our preparations for the initiation of a clinical trial in the US continued with full force during the quarter. The US project is the largest project that the company has ever engaged in, and we want to ensure that the preparatory work is carried out in the best possible manner. In line with our communication at the end of July, we have received
feedback from the FDA on our original application, and we are now providing final answers to such feedback. In addition to the dialogue with the FDA, we have engaged in preliminary site recruitment. In our opinion, there is a great interest in participating in the study, and we look forward to communicating more once details are set, and we can formalise the site recruitment.
Our ankle implant
We have not yet received CE-mark of the ankle implant. We have to admit that we had hoped for a quicker process, but we are nevertheless hopeful to achieve this in the coming weeks. We have noticed a demand for this product among our group of existing and potential customers, and we hope to be able to offer the product shortly. In the meantime, our preparations for a clinical trial with the Talus implant continued during the quarter.
| Key strategy | Key activities during the third quarter | ||||
|---|---|---|---|---|---|
| Produce clinical and health economic data supporting the Episealer® technology |
» Preparation of the IDE clinical trial » Presentation of clinical results from a European multicenter study at several clinical congresses » Preparation of clinical trial of the Episealer Talus implant |
||||
| Establish the Episealer® technology with a large user base of orthopaedic surgeons and Key Opinion Leaders globally |
» Preparation of the IDE clinical trial » Entered into the Polish market » Continued work in the Indian market » First consultation meeting with the regulatory authority in Japan » Continued progress in Europe with Germany showing excellent commercial progress |
||||
| Secure production and reimbursement enabling high margins |
» CE-approval of Epioscopy 3D-visualisation procuct » Continued reimbursement work in the UK market |
||||
| Continue our record of innovation to ensure technological relevance |
» CE-approval of Epioscopy 3D-visualisation procuct » Development of ankle implant |
"We have now treated close to 400 patients in Europe, and the reported results show excellent patient improvements."
Strong clinical results
Recently, it was announced that clinical data from the large European multicenter study that is ongoing was accepted for presentation at no less than three important clinical congresses. At the annual meeting of the Australian Knee Society, data was presented by Associate Professor Karl Erikson from the Stockholm South General Hospital. At the annual meeting of the Danish Orthopaedic Society, Professor Martin Lind presented clinical results from the study, and at the annual meeting of the European Orthopaedic Research Society in Galway, Ireland, an abstract from the study was accepted as a poster presentation. The study shows excellent early clinical results, and we can conclude that our technology is helping patients in the "gap age" (35– 60). We know that there is a significant number of potential patients out there in the treatment gap in need of a viable treatment option. The results clearly show that Episealer® could be a solution for them.
Delivering on our strategy for a global establishment
We continued to deliver on our strategy of broadening our geographic reach. We are carefully and cost consciously reviewing new geographies as we know that achievement on our long-term targets is dependent upon full market access for the Episealer® technology in several global geographies. In Japan, we participated in a first consultation meeting with the regulatory authority for designing a regulatory strategy leading to market access in Japan. We also decided to enter the Polish market through a co-operation with a local partner. Our work to establish Episurf in India continued during the quarter, and we will communicate more once progress is made in each of these regions. In this context, it is also important to mention that our IP portfolio was strengthened during the quarter by new patent approvals in Japan, the US, Australia and Canada.
Epioscopy®
The Episealer® process is based on a detailed analysis of a patient's MR images. These images are converted to a transparent and dynamic 3D-visualisation of the knee joint. At the end of the third quarter, we took a significant step in the continuous development of our proprietary software platform by the CE-marking of a new knee joint visualisation tool. The tool, named Epioscopy®, is a web-based application based on artificial intelligence (AI), providing an overview of a knee joint's clinical condition. The product is intended to assist healthcare professionals in their planning of optimal treatments for patients' knees by interactive 3D visualisation of structures and possible structural deviations. In addition to great benefit for our customers, this product is also essential from the perspective of longterm profitability as increased efficiency on our software platform will decrease costs and enable higher margins going forward.
Financials
In the third quarter, our revenues grew by 87% to SEK 1,0m and the operating expenses decreased by 7% compared to the same quarter previous year. I am pleased to conclude that despite a very high level of activity with investments in the US clinical trial, our new ankle implant and to some extent in new markets, we are continuing to improve the result. At the end of Q3, we had SEK 29,9m in available liquidity and SEK 63.0m of un-used funds on a credit facility, bringing the total available financing to SEK 92.9m.
Concluding remarks
We have now treated close to 400 patients in Europe, and the reported results show excellent patient improvements. We have come this far with a minimal amount of clinical evidence available, with published peer-reviewed results from only one multicenter study available with ten patients. The ongoing European multicenter study is fully recruited, and the size of this study is ten times the first Episealer study, i.e. 100 patients. Interim results have been presented, and we look forward to the publication of these results. Such publication will be of critical importance to us. We are also looking forward towards expanding our business into the ankle business, as well as geographically into the US market. While doing this, we are also expecting revenues in Europe to continue to grow. In summary, we are confident about the strength and uniqueness of our technology, and we know that this technology is addressing an unmet clinical need of significant size. The strategy is clear, and we are entirely focused on the execution of our strategy.
Stockholm, October 2018
Pål Ryfors, CEO
Business update and forward–looking statements
By the reporting date on October 26 2018, Episurf Medical's implants had been used in 383 surgeries. Another 51 orders are approved for surgery in the coming weeks. Episurf Medical's patients are experiencing significant improvements in pain and mobility. Furthermore, they are also experiencing a short recovery time. Out of the total implant portfolio of 383 implants, we now have 19 patients who have had their implants for more than 4 years and 130 patients have now had their implants for more than 2 years since the surgery date. During the third quarter, 37 surgeries were performed with the Episealer® knee implant. 35 orders were approved for surgery during the third quarter. We continue to note a demand for the Episealer® Femoral Twin implant as 73% of the surgeries performed in the third quarter were of this product. This clearly shows that there is a demand for treating the more elongated lesions and the Episurf technology and the Episealer® Femoral Twin implant meets this demand in a very good way.
Implant surgeries in quarter
Approved orders in quarter
As of the reporting day, 383 surgeries have been performed with the Episealer® implant and 58 patients have had their implant for more than 3 years, and 130 patients have had the implant for more than 2 years since surgery.
Financial information
Group
Net sales and operating profit/loss
Group net sales amounted to SEK 1.0m (0.5) in the quarter and to SEK 2.9m (1.6) for the first nine months. Loss before tax amounted to SEK –12.9m (–13.5) for the quarter and SEK –42.5m (–45.5) for the first nine months. Initial costs for entering the US market amounts to 2.1m SEK (0.3) during the quarter.
Financial position
Group cash and cash equivalents at end of period amounted to SEK 29.9m (87.5). To assure financing of continued operations, a financing agreement with European Select Growth Opportunities Fund was entered into in February and decided on the Annual General Meeting in April 2018. The agreement provides the company with access to SEK 70m over a 36month period of which SEK 7m was acquired during the second quarter 2018. See more information about the financing agreement below and on the Company's website. The Board of Directors is continuously reviewing the company's financial need and financial position, as well as the optimal capital structure for the company. Should there be additional capital needs, the Board is of the opinion that the company is in a good position to secure future financing either within the existing credit facility or by way of a directed issue of common equity.
The equity ratio was 82.4% (93.6). Group investments in intangible assets amounted to SEK 2.1m (1.3) for the quarter of which SEK 0.6m (0.6) are related to capitalised development costs and for the first nine months investments in intangible assets amounted to SEK 7.5m (5.2) of which SEK 3.6m (2.4) are related to capitalised development costs, remaining investments relates to patents. Investments in tangible assets amounted to SEK – (0.0) for the quarter and the first nine months.
Human resources
Number of employees in the Group at end of the period was 24 (27).
Parent Company
Net sales and operating profit/loss
Net sales amounted to SEK 0.1m (–) in the quarter and for the first nine months to SEK 0.3m (–). Loss before tax amounted to SEK –6.9m (–5.7) for the quarter and SEK –21.8m (–22.7) for the first nine months.
Financial position
Cash and cash equivalents at the end of period for the Parent Company amounted to SEK 19.9m (78.9). The equity ratio was 95.4% (98.0). Investments in intangible assets, capitalised development costs, amounted to SEK 0.6m (0.6) for the quarter and SEK 3.6m (2.4) for the first nine months. Investments in tangible assets amounted to SEK –m (–) for the quarter and the first nine months.
Human resources
Number of employees in the Parent Company at end of the period was 13 (13).
Transactions with closely related parties
Shareholder and Board member Leif Ryd has received consulting fees for ongoing work as well as work for the Clinical Advisory Board during the period of SEK 0.4m (0.5).
As a technical measure in order to meet the Investor's demand for immediate access to its shares, certain shareholders, during a transitional period, lend shares to the issuing agent engaged for this agreement.
Rounding
Due to rounding, the sum of numbers may differ.
Episurf Medical's strategy rests on four key pillars:
Clinical and health economical data supporting the Episealer® technology
Large user base of orthopaedic surgeons and KOL's
Secure reimbursement and production enabling high margins
Technological and clinical relevance through a high degree of innovation
Financing Agreement
To assure financing of continued operations, a financing agreement with European Select Growth Opportunities Fund ("ESGOF") was entered into in February and decided on the Annual General Meeting in April 2018. The agreement provides the company with access to SEK 70m over a 36month period in form of convertible debt securities divided into a number of tranches.
In connection with each tranche of convertibles, warrants are also issued to ESGOF.
When convertibles and warrants are issued to ESGOF, warrants are also issued free of charge to existing shareholders. Full utilization of these warrants would entail an additional SEK 70 million being added to the company.
Key terms in the convertible agreement
- » The notes have a principal amount of SEK 50,000 each. they bear no interest and have a maturity of 12 months from the date of the registration of their issuance with the Swedish Companies Registration Office. During their term, the investor may request to convert some or all of the notes at a variable conversion price representing an 8% discount to the lowest daily volume weighted average price over the last 15 trading days during which the investor has not sold any share on the market prior to the conversion date.
- » Upon such conversion request, Episurf Medical has the option to remit, at its discretion, cash, shares in Episurf Medical or a combination of both. This characteristic will enable Episurf Medical to manage the potential dilution resulting from the notes.
- » Episurf Medical pay to the investor a commitment fee equal to 4% of the aggregate principal amount of the notes issued under the requested tranche.
- » In case of an event of default, each outstanding note will accrue interest at a rate of 15%.
Follow-up table, financing agreement
Main characteristics of the warrants issued to ESGOF
- » ESGOF receives warrants without further remuneration in connection with the issuance of a tranche of convertibles. The number is determined based on the current stock price in connection with the execution of the tranche.
- » The warrants have a term of five (5) years from the date of the registration of their issuance with the Swedish Companies Registration Office and will immediately be detached from the notes. Each warrant gives right to subscribe for one (1) new share (subject to standard adjustments in accordance with the terms and conditions of the warrants) in Episurf Medical at a fixed strike price representing a 120 % premium to the reference price on the date of the request from Episurf Medical to issue a new tranche.
Key terms of warrants issued to existing shareholders
- » In connection with the issue of convertible bonds and warrants to ESGOF, warrants are also issued free of charge to existing shareholders, the number is determined on the basis of the current share price in connection with the completion of the tranche.
- » The shareholder options have the same characteristics as the warrants and are admitted to public trading.
Use of convertibles and warrants
» The first tranche was conducted in the second quarter of 2018 as a targeted issue of SEK 7m through the issuance of 140 convertibles of 1,147,540 associated warrants to ESGOF. In connection with this, 1,131,462 warrants were also issued to the shareholders. All warrants have a redeeming price of SEK 6.10. See table below for follow-up of number of outstanding and utilised convertibles and warrants.
| Financing, SEKm | Total | Used | Remaining | ||
|---|---|---|---|---|---|
| European Select Growth Opportunities Fund | 70.0 | 7.0 | 63.0 | ||
| Convertibles | |||||
| Tranch | Amount before costs |
Date | Number of notes |
Number utilised |
Number of outstanding notes |
| KV1 | SEK 7m | 2018-05-23 | 140 | 48 | 92 |
| Summary of transactions | |||||
| Received cash from issue of convertible debentures | 7.0 | ||||
| Transaction costs | –0.3 | ||||
| Net proceeds | 6.7 | ||||
| Amount classified as equity | –0.5 | ||||
| Converted debentures | –2.4 | ||||
| Accrued interest | 0.5 | ||||
| Reported value of debt as at September 30, 2018 | 4.3 |
Warrants
| Tranch | Registration date |
Term to maturity |
Strike price | Number of warrants outstanding |
Number of utilised |
Number of outstanding |
|---|---|---|---|---|---|---|
| KV1/TO4B | 2018-05-23 | 5 year | 6,10 | 2,279,002 | 0 | 2,279,002 |
Share information
There are two types of shares in the Company. Each Class A-share carries three votes, and entitles the holder to three votes at the General Meeting and each class B-share carries one vote and entitles the holder to one vote at the General Meeting. Class B shares have traded on Nasdaq Stockholm's Small Cap segment since 11 June 2014 with the ticker EPIS B.
30 September 2018 A-shares 5,257,078 B-shares 25,869,831 Total number of shares 31,126,909 Total number of votes 41,641,065
The ten largest shareholders in Episurf Medical AB at September 30 2018
| No. of A-shares |
No. of B-shares |
Share capital in % |
Voting rights, % |
|
|---|---|---|---|---|
| Serendipity Ixora AB | 4,601,519 | 0 | 14.8 | 33.2 |
| JP Morgan Bank, Luxemburg | 112,066 | 2,162,916 | 7.3 | 6.0 |
| Försäkringsaktiebolaget, Avanza Pension | 0 | 1,506,224 | 4.8 | 3.6 |
| Skandinaviska Enskilda Banken, W8IMY | 0 | 1,376,356 | 4.4 | 3.3 |
| AMF Aktiefond småbolag | 0 | 1,164,448 | 3.7 | 2.8 |
| Gile Medicinkonsult AB | 279,945 | 142,954 | 1.4 | 2.4 |
| LMK Forward AB | 0 | 938,000 | 3.0 | 2.3 |
| Swedbank Försäkring AB | 0 | 720,533 | 2.3 | 1.7 |
| Nordnet Pensionsförsäkring AB | 0 | 674,251 | 2.2 | 1.6 |
| Pål Ryfors* | 0 | 666,393 | 2.1 | 1.6 |
| Total, 10 largets shareholders | 4,993,530 | 9,352,075 | 46.1 | 58.4 |
| Summary, other | 263,548 | 16,517,756 | 53.9 | 41.6 |
| Total | 5,257,078 | 25,869,831 | 100.0 | 100.0 |
* Pål Ryfors has lent out 350,000 shares to the European Select Growth Opportunities Fund and owns a total of 1,016,393 shares. No interest expires.
Other information
Significant risks and uncertainty factors
Episurf Medical's material business risks, for the Group as well as for the Parent Company, are to obtain regulatory approval and market acceptance, the outcome of clinical studies, the ability to protect intellectual property rights, the possibility to obtain the correct reimbursement for the Group's products and dependence on key personnel and partners. The Company does not see any new material risks for the upcoming three months. For a more detailed description of significant risks and uncertainties, refer to Episurf Medical's annual report.
The Board of Directors and the CEO hereby give their assurance that the Interim Report gives a true and fair view of the business activities, financial position and results of operations for the Group and Parent Company, and describes significant risks and uncertainty factors to which the Parent Company and the companies included in the Group are exposed.
Stockholm, 25 October 2018
Dennis D. Stripe Wilder Fulford Board chairman Board member
Christian Krüeger Leif Ryd Laura Shunk Board member Board member Board member
Pål Ryfors CEO
Review report
To the Board of Directors ofEpisurf Medical AB (publ) Corp. id. 556767-0541
Introduction
We have reviewed the summary interim financial information (interim report) of Episurf Medical AB (publ) as of 30 September 2018 and the nine-month period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
Scope of review
We conducted our review in accordance with International Standard on Review Engagements ISRE 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and
other generally accepted auditing practices and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the Group in accordance with IAS 34 and the Annual Accounts Act, and for the Parent Company in accordance with the Annual Accounts Act.
Stockholm, 25 October 2018 KPMG AB
Duane Swanson Authorized Public Accountant
Consolidated income statement
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Operating income | |||||
| Net sales | 1.0 | 0.5 | 2.9 | 1.6 | 2.5 |
| Other operating income | 0.1 | 0.1 | 0.3 | 0.2 | 0.6 |
| Total operating income | 1.1 | 0.6 | 3.2 | 1.8 | 3.1 |
| Operation expenses | |||||
| Merchandise | –0.8 | –0.6 | –2.4 | –1.5 | –2.3 |
| Other expenses | –8.6 | –6.5 | –27.1 | –23.1 | –31.9 |
| Personnel costs | –5.1 | –7.3 | –20.2 | –25.0 | –33.3 |
| Capitalised development expenditure | 2.1 | 1.3 | 7.5 | 5.2 | 7.4 |
| Depreciation | –1.3 | –1.0 | –3.4 | –3.1 | –4.2 |
| Total operating expenses | –13.7 | –14.1 | –45.6 | –47.4 | –64.2 |
| Operating loss | –12.6 | –13.5 | –42.4 | –45.6 | –61.2 |
| Financial items | |||||
| Financial income, other | – | 0.0 | 0.4 | 0.0 | 0.1 |
| Financial expenses, other | –0.3 | 0.0 | –0.5 | 0.0 | 0.0 |
| Results from net financial items | –0.3 | 0.0 | –0.1 | 0.0 | 0.1 |
| Loss before tax | –12.9 | –13.5 | –42.5 | –45.5 | –61.1 |
| Tax on income for the period | 0.0 | –0.1 | 0.0 | –0.1 | 0.0 |
| Loss for the period | –12.9 | –13.6 | –42.5 | –45.6 | –61.1 |
| Net loss attributable to: | |||||
| Parent company shareholders | –12.9 | –13.6 | –42.5 | –45.6 | –61.1 |
| Earnings per share before | |||||
| and after dilution | –0.42 | –0.44 | –1.38 | –1.67 | –2.17 |
| Average number of shares | 31,032,699 | 30,703,416 | 30,829,778 | 27,260,552 | 28,128,343 |
Consolidated statement of comprehensive income
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Loss for the period | –12.9 | –13.6 | –42.5 | –45.6 | –61.1 |
| Other comprehensive income for the period: Other comprehensive income that may be reclassified subsequently |
|||||
| to profit or loss for the period, net of tax | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 |
| Total comprehensive income for the period |
–12.9 | –13.6 | –42.5 | –45.6 | –61.1 |
Consolidated balance sheet
| SEKm | 30 Sep 2018 | 30 Sep 2017 | 31 Dec 2017 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | |||
| Capitalised development costs | 9.3 | 5.8 | 6.8 |
| Patents | 10.9 | 9.1 | 9.3 |
| Total intangible assets | 20.2 | 14.9 | 16.0 |
| Property, plant and equipment | |||
| Equipment | 0.1 | 0.3 | 0.2 |
| Total property, plant and equipment | 0.1 | 0.3 | 0.2 |
| Total non–current assets | 20.4 | 15.1 | 16.3 |
| Current assets | |||
| Inventories | 1.8 | 1.4 | 1.7 |
| Trade receivables | 0.5 | 0.7 | 1.0 |
| Other receivables | 2.0 | 0.9 | 1.2 |
| Deferred expenses and accrued income | 1.4 | 2.1 | 1.8 |
| Cash and bank balances | 29.9 | 87.5 | 71.3 |
| Total current assets | 35.5 | 92.8 | 77.0 |
| TOTAL ASSETS | 55.9 | 107.9 | 93.3 |
| EQUITY AND LIABILITIES | |||
| Equity | 46.1 | 101.0 | 85.6 |
| Liabilities | |||
| Non-current liabilities | |||
| Non-current liabilities | 0.1 | 0.0 | 0.0 |
| Total non-current liabilities | 0.1 | 0.0 | 0.0 |
| Current liabilities | |||
| Trade payables | 1.6 | 2.7 | 2.5 |
| Current interest-bearing liabilities | 4.3 | – | – |
| Other liabilities | 1.3 | 1.2 | 1.4 |
| Accrued liabilities and deferred income | 2.6 | 2.9 | 3.8 |
| Total current liabilities | 9.8 | 6.8 | 7.7 |
| Total liabilities | 9.9 | 6.9 | 7.7 |
| TOTAL EQUITY AND LIABILITIES | 55.9 | 107.9 | 93.3 |
| Equity ratio, % | 82.4 | 93.6 | 91.7 |
| Equity per share, SEK | 1.48 | 3.31 | 2.80 |
Consolidated statement of changes in equity
| Attributable to equity holders of the parent | |||||||
|---|---|---|---|---|---|---|---|
| SEKm | Share capital | Other contributed capital |
Reserves | Accumulated deficit incl. loss for the year |
Total equity | ||
| Opening equity 1 January 2017 | 4.8 | 237.0 | 0.6 | –193.7 | 48.7 | ||
| Total comprehensive income | |||||||
| Loss for the year | –0.0 | –61.1 | –61.1 | ||||
| Total comprehensive income | –0.0 | –61.1 | –61.1 | ||||
| Transactions with shareholders | |||||||
| New share issue, net after issue expenses* | 4.4 | 93.3 | 97.7 | ||||
| Options issued to staff | 0.3 | 0.3 | |||||
| Total transactions with shareholders | 4.4 | 93.3 | 0.3 | 98.0 | |||
| Closing equity 31 December 2017 | 9.2 | 330.4 | 0.6 | –254.6 | 85.6 | ||
| Opening equity 1 January 2018 | 9.2 | 330.4 | 0.6 | –254.6 | 85.6 | ||
| Total comprehensive income | |||||||
| Loss for the period | –0.1 | –42.5 | –42.6 | ||||
| Total comprehensive income | –0.1 | –42.5 | –42.6 | ||||
| Transactions with shareholders | |||||||
| Warrants issued | 0.5 | 0.5 | |||||
| Issue in-kind, for conversion of debt** | 0.2 | 2.2 | 2.4 | ||||
| Options issued to staff | 0.2 | 0.2 | |||||
| Total transactions with shareholders | 0.2 | 2.7 | 0.2 | 3.1 | |||
| Closing equity 30 September 2018 | 9.3 | 333.1 | 0.4 | –296.8 | 46.1 |
* Issue expenses amounted to SEK 11.8m.
** See more information about the financing agreement under financial information on pages 7.
Cash flow statement
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating loss | –12.6 | –13.5 | –42.4 | –45.6 | –61.2 |
| Adjustments for items not included in cash flow |
|||||
| Depreciation | 1.3 | 1.0 | 3.4 | 3.1 | 4.2 |
| Employee stock option expenses | –0.1 | 0.1 | 0.2 | 0.1 | 0.1 |
| Interest received | –0.1 | 0.0 | 0.4 | 0.0 | 0.1 |
| Interest paid | –0.0 | 0.0 | –0.0 | 0.0 | 0.0 |
| Cash flow from operating activities before change in working capital |
–11.5 | –12.4 | –38.4 | –42.4 | –56.8 |
| Change in working capital | |||||
| Decrease/increase in inventory | 0.2 | –0.3 | –0.1 | –0.3 | –0.6 |
| Decrease/increase in trade receivables | 0.4 | –0.1 | 0.5 | –0.1 | –0.4 |
| Decrease/increase in current receivables | 0.4 | 0.3 | 0.4 | 0.3 | 0.3 |
| Decrease/increase in current liabilities | –2.4 | –1.9 | –3.1 | –4.8 | –3.9 |
| Change in working capital | –1.5 | –2.0 | –2.3 | –5.0 | –4.6 |
| Cash flow from operating activities | –13.0 | –14.4 | –40.7 | –47.3 | –61.4 |
| Investing activities | |||||
| Investments of intangible fixed assets | –2.1 | –1.3 | –7.5 | –5.2 | –7.4 |
| Investments of property, plant | |||||
| and equipment | – | – | – | – | – |
| Cash flow from investing activities | –2.1 | –1.3 | –7.5 | –5.3 | –7.5 |
| Financing activities | |||||
| Investment in warrants | – | 0.1 | 0.1 | 0.1 | 0.1 |
| New share issue | – | – | – | 97.7 | 97.7 |
| Emission of convertibles* | – | – | 6.7 | – | – |
| Cash flow from financing activities | – | 0.1 | 6.8 | 97.8 | 97.8 |
| Cash flow for the period | –15.0 | –15.6 | –41.4 | 45.2 | 29.0 |
| Cash and cash equivalents | |||||
| at beginning of period | 44.9 | 103.1 | 71.3 | 42.3 | 42.3 |
| Cash and cash equivalents at end of period |
29.9 | 87.5 | 29.9 | 87.5 | 71.3 |
* Refers to the utilised part of the financing agreement net for transaction costs.
Income statement, Parent Company
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Operating income | |||||
| Net sales | 0.1 | 0.0 | 0.3 | 0.0 | 0.2 |
| Other operating income | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Total income | 0.1 | 0.0 | 0.3 | 0.0 | 0.2 |
| Operating expenses | |||||
| Other external expenses | –4.7 | –3.0 | –14.2 | –14.4 | –19.2 |
| Personnel costs | –2.3 | –3.0 | –9.5 | –9.7 | –13.2 |
| Capitalised development expenditure | 0.6 | 0.6 | 3.6 | 2.4 | 3.7 |
| Amortisation of intangible assets and depreciation of property, plant and |
|||||
| equipment | –0.5 | –0.3 | –1.5 | –1.0 | –1.4 |
| Total operating expenses | –6.8 | –5.8 | –21.6 | –22.8 | –30.0 |
| Operating loss | –6.7 | –5.8 | –21.3 | –22.8 | –29.7 |
| Financial items | |||||
| Financial income, other | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 |
| Financial expenses, other | –0.2 | 0.0 | –0.5 | 0.0 | 0.0 |
| Loss from net financial items | –0.2 | 0.0 | –0.5 | 0.0 | 0.1 |
| Loss before contribution and tax | –6.9 | –5.7 | –21.8 | –22.7 | –29.7 |
| Loss before tax | –6.9 | –5.7 | –21.8 | –22.7 | –29.7 |
| Tax on income for the period | – | – | – | – | – |
| Loss for the period | –6.9 | –5.7 | –21.8 | –22.7 | –29.7 |
Parent Company statement of comprehensive income
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Net profit | –6.9 | –5.7 | –21.8 | –22.7 | –29.7 |
| Other comprehensive income for the period: |
|||||
| Other comprehensive income for the period, net of tax |
– | – | – | – | – |
| Total comprehensive income for the period |
–6.9 | –5.7 | –21.8 | –22.7 | –29.7 |
Balance sheet, Parent Company
| SEKm | 30 Sep 2018 | 30 Sep 2017 | 31 Dec 2017 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | |||
| Capitalised development costs | 9.3 | 6.2 | 7.1 |
| Total intangible fixed assets | 9.3 | 6.2 | 7.1 |
| Tangible fixed assets | |||
| Machinery and equipment | 0.0 | 0.1 | 0.1 |
| Total tangible fixed assets | 0.0 | 0.1 | 0.1 |
| Financial assets | |||
| Shares in group companies | 106.8 | 76.3 | 78.3 |
| Long-term receivables from group companies | 15.6 | 13.0 | 20.0 |
| Total financial assets | 122.4 | 89.3 | 98.2 |
| Total fixed assets | 131.7 | 95.6 | 105.5 |
| Current assets | |||
| Short term receivables | |||
| Other receivables | 1.2 | 0.4 | 0.5 |
| Prepaid expenses and accrued income | 0.8 | 0.9 | 0.8 |
| Total short term receivables | 2.0 | 1.4 | 1.3 |
| Cash and bank balances | 19.9 | 78.9 | 62.5 |
| Total current assets | 21.8 | 80.2 | 63.8 |
| TOTAL ASSETS | 153.6 | 175.8 | 169.3 |
| EQUITY AND LIABILITIES | |||
| Equity | 146.5 | 172.3 | 165.3 |
| Liabilities | |||
| Long-term liabilities | 0.0 | 0.0 | 0.0 |
| Total long–term liabilities | 0.0 | 0.0 | 0.0 |
| Current liabilities | |||
| Trade payables | 0.3 | 1.3 | 0.9 |
| Current interest-bearing liabilities | 4.3 | – | – |
| Other liabilities | 0.5 | 0.6 | 0.6 |
| Accrued liabilities and deferred income Total current liabilities |
1.9 7.0 |
1.6 3.5 |
2.5 4.0 |
| Total liabilities | 7.0 | 3.5 | 4.0 |
| TOTAL EQUITY AND LIABILITIES | 153.6 | 175.8 | 169.3 |
Statement of changes in equity, Parent Company
| SEKm | Share capital |
Develop ment fund |
Other contributed capital |
Loss brought forward |
Loss for the period |
Total equity |
|---|---|---|---|---|---|---|
| Opening equity 1 January 2017 | 4.8 | 1.1 | 235.8 | –110.4 | –34.1 | 97.2 |
| Comprehensive loss for the period | ||||||
| Loss for the period | –29.7 | –29.7 | ||||
| Disposition according to AGM | ||||||
| Loss brought forward | –34.1 | 34.1 | 0.0 | |||
| Development fund | 3.5 | –3.5 | 0.0 | |||
| Total comprehensive loss for the period |
4.5 | –148.0 | –29.7 | 67.5 | ||
| Transactions with shareholders | ||||||
| New share issue | ||||||
| net after issue expenses* | 4.4 | 93.3 | 97.7 | |||
| Warrants | 0.1 | 0.1 | ||||
| Total transactions with shareholders | 4.4 | 93.5 | 97.8 | |||
| Closing equity 31 December 2017 | 9.2 | 4.5 | 329.3 | –148.0 | –29.7 | 165.3 |
| Opening equity 1 January 2018 | 9.2 | 4.5 | 329.3 | –148.0 | –29.7 | 165.3 |
| Comprehensive loss for the period | ||||||
| Loss for the period | –21.8 | –21.8 | ||||
| Disposition according to AGM | ||||||
| Loss brought forward | –29.7 | 29.7 | – | |||
| Development fund | 2.9 | –2.9 | – | |||
| Total comprehensive loss for the period | 9,2 | 7.4 | 329.3 | –180.6 | –21.8 | 143.6 |
| Transactions with shareholders | ||||||
| Warrants issued | 0.5 | 0.5 | ||||
| Issue in-kind, for conversion of debt** | 0.2 | 2.2 | 2.4 | |||
| Options issued to staff | 0.1 | 0.1 | ||||
| Total transactions with shareholders | 0.2 | 2.7 | 0.1 | 2.9 | ||
| Closing equity 31 September 2018 | 9.3 | 7.4 | 332.0 | –180.5 | –21.8 | 146.5 |
* Issue expenses amounted to SEK 11.8m.
** See more information about the financing agreement under financial information on pages 7.
Cash flow statement, Parent Company
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 | Jan–Sep 2018 | Jan–Sep 2017 | Jan–Dec 2017 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating loss | –6.7 | –5.8 | –21.3 | –22.8 | –29.7 |
| Adjustments for items not included in cash flow |
|||||
| Depreciation | 0.5 | 0.3 | 1.5 | 1.0 | 1.4 |
| Interest received | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 |
| Interest paid | –0.0 | 0.0 | –0.0 | 0.0 | 0.0 |
| Change in non-current liabilities | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Cash flow from operating activities before change in working capital |
–6.2 | –5.4 | –19.8 | –21.8 | –28.3 |
| Change in working capital | |||||
| Decrease/increase in current receivables | 0.4 | 0.5 | 0.1 | 0.0 | 0.1 |
| Decrease/increase in current liabilities | –0.9 | –0.1 | –2.0 | –7.0 | –6.6 |
| Total changes in working capital | –0.5 | 0.4 | –1.9 | –7.0 | –6.5 |
| Cash flow from operating activities | –6.7 | –5.0 | –21.7 | –28.8 | –34.8 |
| Cash flow from investing activities | |||||
| Investments of intangible assets | –0.6 | –0.6 | –3.6 | –2.4 | –3.7 |
| Changes in financial assets | –7.7 | –8.8 | –24.1 | –27.9 | –36.9 |
| Cash flow from investing activities | –8.4 | –9.4 | –27.7 | –30.3 | –40.6 |
| Cash flow from financing activities | |||||
| Investment in warrants | – | 0.1 | 0.1 | 0.1 | 0.1 |
| New share issue | – | – | – | 97.7 | 97.7 |
| Emission of convertibles* | – | – | 6.7 | – | – |
| Cash flow from financing activities | – | 0.1 | 6.8 | 97.8 | 97.8 |
| Cash flow for the period | –15.1 | –14.3 | –42.6 | 38.8 | 22.4 |
| Cash and cash equivalents | |||||
| at beginning of period | 35.0 | 93.2 | 62.5 | 40.1 | 40.1 |
| Cash and cash equivalents at end of period |
19.9 | 78.9 | 19.9 | 78.9 | 62.5 |
* Refers to the utilised part of the financing agreement net for transaction costs.
Notes
Note 1 Accounting policies
The interim report for the Group has been prepared in accordance with IAS 34 Interim Reports and the Annual Accounts Act. The interim report for the Parent Company has been prepared in accordance with the Annual Accounts Act.
The Group's accounting policies are unchanged from previous year except from that the company has chosen to clarify costs for capitalised development expenditure and commercial goods and has therefore changed comparison figures in the income statement both for the group and the parent company.
Changes in significant accounting policies
IFRS 9, Financial Instruments and IFRS 15 Revenue from contracts with customers were adopted 1 January 2018.
IFRS 9 deals with classification, recognition and measurement of assets and liabilities. IFRS 9 replaces the parts of IAS 39 that are related to recognition and measurement of financial in struments. IFRS 9 states that financial assets are classified in three measurement categories: amortised cost, fair value through other comprehensive income or fair value through profit or loss. The classification depends on the company's business model and instrument's cash, accounting policies and notes flow characteristics. The standard does not have effect on the company.
IFRS15 specifies how and when to recognise revenue. According to IFRS 15, revenue is recognised when control of the promised good or service have been transferred to the customer and the customer can use and benefit from the good or service. The standard introduces increased disclosure requirements for reporting of information about the nature, amount, timing and uncertainty of revenue, and the cash flows arising from the company's contracts with customers. IFRS 15 replaces IAS 18 "Revenue" and IAS 11 "Construction Contracts". The Company has assessed that the standard currently does not affect the company. It can be changed in the future when the company change its current contract structure at a higher revenue.
IFRS16, IFRS 16 Leases replace existing IFRS related to accounting of lease agreements, such as IAS17 Lease agreement and IFRIC 4 Determining whether an agreement contains a lease. The group plans to apply the standard from January 1, 2019.
IFRS 16 primarily affects leaseholders and, the central effect is that all leases that are currently reported as operating leases are to be reported in a manner similar to the current accounting of finance leases. This means that even for operational leases, asset and liability need to be reported, with the associated accounting for depreciation and interest costs, as opposed to today, when no lease and related debt is recognised, and leasing fees are recognised on a straight line basis as leasing costs. The company has made the initial assessment of the potential effects on its financial reports, but has not yet completed the more detailed analysis. The company's initial assessment is that
there will be no significant effect on the Group's leasing agreements.
Capitalized expenditures for development of products
Expenditure for development, where research results or other knowledge are applied to achieve new or improved products or processes, is recognised as an asset in the Statement of Financial Position only if the following conditions are satisfied:
- 1) It is technically possible to complete the intangible asset and use or sell it,
- 2) The Company intends to complete the intangible asset and use or sell it,
- 3) The conditions to use or sell the intangible asset are in place,
- 4) The Company demonstrates how the intangible asset will generate likely future economic benefits,
- 5) There are adequate technological, economic and other resources to complete development and to use or sell the intangible asset, and
- 6) The expenditure relating to the intangible asset during its development can be measured reliably
Directly related expenditure that is capitalised mainly consists of expenditure from subcontractors and expenses for employees.
Other development expenditure that does not satisfy these criteria is expensed when it arises. Development expenditure previously expensed is not recognized as an asset in subsequent periods. The group has assessed all the above criteria to be fulfilled during the period, the costs for development that has been incurred is therefor activated.
Note 2 Transactions with related parties
Shareholder and Board member Leif Ryd has received consulting fees for ongoing work as well as work for the Clinical Advisory Board of SEK 0.4m (0.5).The Board Chairman, Dennis D. Stripe has received SEK –m (0.3) as compensation for the work during the year as working Chairman.
As a technical measure in order to meet the Investor's demand for immediate access to its shares, certain shareholders, during a transitional period, lend shares to the issuing agent engaged for this agreement.
Note 3 Breakdown of net sales by country is as follows
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 |
|---|---|---|
| Germany | 0.0 | 0.0 |
| Sweden | 0.7 | 0.4 |
| Other countries in Europe | 0.3 | 0.1 |
| Other countries outside of Europe |
0.0 | 0.0 |
| Total net sales | 1.0 | 0.5 |
Note 4 Financial assets and financial liabilities
Current interest-bearing liabilities
| SEKm | Jul–Sep 2018 | Jul–Sep 2017 |
|---|---|---|
| Received cash from issue of convertible debentures | 7.0 | – |
| Transaction costs | 0.3 | – |
| Net proceeds | 6.7 | – |
| Amount classified as equity | 0.5 | – |
| Conversion convertible | 2.4 | – |
| Accrued interest | 0.5 | – |
| Reported value as of September 30, 2018 | 4.3 | – |
Other financial assets and liabilities in the balance sheet are reported as acquisition value, which is judged to be a good approximation to the fair value of the items.
Definitions
General: All amounts in the tables are presented in SEK millions unless otherwise stated. All amounts in brackets () represent comparative figures for the same period of the prior year, unless otherwise stated.
Net debt/equity ratio: Net debt at the end of the period divided by equity at the end of the period.
Glossary
Approved orders: Orders which have been approved for surgery, are in production and will be invoiced.
Arthritis: see Osteoarthritis.
Arthroscopy: Inspection of the inside of a joint with the help of an arthroscope. An instrument is introduced through a small cut to investigate the inside of the joint and possibly correct any problems (a type of keyhole surgery).
Artificial intelligence (AI): The theory and development of computer systems able to perform tasks normally requiring human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages.
Cartilage: The smooth, rubbery layer of shiny, white connective tissue that covers the end of bones at the joints. This tissue allows movement with low friction.
Cartilage defect of grade III (ICRS scale): Lesion through the cartilage, exposing the bone.
Cartilage defect of grade IV (ICRS scale): Lesion through the cartilage and in the underlying bone.
CE marking: CE marking is a manufacturer's or importer's declaration that a product meets the EU's fundamental health, environmental and safety requirements. The product in question undergoes a conformity assessment by a Notified Body, which decides whether the product fulfils the applicable product requirements in the EU. A CE mark means that the manufacturer or importer has the formal approvals necessary to market and sell the product in the European Economic Area.
Cobalt: A chemical element commonly occurring in metal alloys used in knee prostheses.
Cobalt chrome: A metal alloy mainly consisting of cobalt and chromium, commonly occurring in metal alloys used in knee prostheses.
CT scan: X-ray computed tomography scan, a medical imaging technique where a series of x-ray images allows the user to get three-dimensional image data of the patient.
Debridement: Removal of damaged tissue.
Degenerative origin: Conditions in which the cells, tissues or organs deteriorate and lose function. In degenerative joint disease, the deterioration is due to wear, tear or breakdown of cartilage.
FDA: US Food and Drug Administration.
Focal cartilage defect: A cartilage defect in a well defined area.
Gross order intake: Gross order intake represents the aggregated value of Episealer orders recevied and approved by responsible surgeon during the relevant period.
Hyaline cartilage: Natural articular cartilage.
Hydroxyapatite: A mineral that is the major component of human bone tissue and the main mineral of dental enamel and dentin.
Indication: In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery.
Invasive treatment alternative: Treatments that require a surgical procedure.
Investigational Device Exemption (IDE): An exemption that allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.
KOL: Key Opinion Leader, prominent and opinion-leading surgeon.
KOOS: Knee injury and Osteoarthritis Outcome Score, a questionnaire used to assess the patient's opinion about their knee and associated problems.
Microfracture: A surgical technique that can be used in treatment of focal cartilage defects (not extensive osteoarthritis) in an attempt to stimulate the growth of new cartilage.
Mosaicplasty: A surgical technique for treatment of cartilage and underlying bone defects where cylindrical bone and cartilage plugs are harvested from less weight-bearing surfaces of the knee joint and inserted into the damaged area.
MRI: Magnetic resonance imaging, a medical imaging technique where images acquired using a strong magnetic field allows the user to get three-dimensional image data of the patient.
Order backlog: Order backlog represents all orders that have been booked but where no revenue has been recognized.
Orthopaedics: The medical specialty that focuses on injuries and diseases of the body's musculoskeletal system. This complex system includes bones, joints, ligaments, tendons, muscles and nerves.
Osteoarthritis: Osteoarthritis is type of joint disease that is characterised by loss of joint function with varying destruction of joint cartilage and the underlying bone.
Osteochondral autograft procedure: See Mosaicplasty.
Osteochondral defect: Cartilage and underlying bone defect.
Premarket Approval (PMA) application: FDA's process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. A successful PMA submission results in US market approval of the device.
Principal investigator (PI): The person who is responsible for the scientific and technical direction of the entire clinical study (for example, for all sites of a multisite study).
Prosthesis: An artificial device that replaces a missing or injured body part, such as artificial arm or leg. The term prosthesis is also used for certain of the implants that are used to repair joints, such as hip and knee prostheses.
Reimbursement: Reimbursement is the collective term for the financial reimbursement systems which are critical for how payments are settled for various medical procedures.
Traumatic damage: Damage caused by an outside force, such as fall injuries.
VAS: Visual Analogue Scale, a psychometric response scale which is used as a pain scale in questionnaires.
Episurf Medical
– a unique solution for every patient
EPISURF MEDICAL WAS FOUNDED IN 2009 on a commitment to offering people with painful joint injuries a more active and healthy life through customised treatment alternatives. We put the patient in the centre of the design of implants and surgical instruments. By combining advanced 3D imaging technology with the latest manufacturing technologies, we are able to adapt not only each implant to the patient's injury and anatomy, but also the surgical instruments used. In this way, we can ensure that each patient receives treatment that is perfectly suited to his or her anatomy and, thus, ensure a faster, more secure, and better individualised treatment for a more active and healthy life.
A proprietary web-based IT platform for individualised design and surgical pre-planning
Episurf Medical's scalable μiFidelity® system has been developed for damage assessment, surgical pre-planning and cost-effective patient customisation of implants and associated surgical instruments. In a first step, the company's main focus is on early stage arthritic changes in the knee joint.
Three different knee implants with a focus on early stages of arthritis
Episurf Medical currently has three types of individualised implants on the market.
- » Episealer® Condyle Solo for the treatment of localised cartilage and underlying bone defects on the femoral condyles of the knee joint.
- » Episealer® Trochlea Solo for the treatment of localised cartilage and underlying bone defects in the area behind the patella (the trochlea area).
- » Episealer® Femoral Twin for the treatment of elongated localised cartilage and underlying bone defects both on the femoral condyles and in the trochlea area of the knee joint.
Episealer® Condyle Solo Episealer® Trochlea Solo
Episealer® Femoral Twin
Individualised surgical instruments
Every product is delivered with our surgical drill guide Epiguide®. We also offer a surgical drill guide, Epiguide® MOS, that is designed for use in mosaicplasty surgery for treatment of cartilage and deep underlying bone defects in the knee joint.
Patents and patent applications
The generation of new intellectual property and the ongoing maintenance of current IP is of paramount importance for Episurf Medical to ensure that Episurf Medical's proprietary, existing technologies and future innovations are well protected. In total Episurf Medical has approximately 140 patents and patent applications worldwide, distributed over more than 20 patent families.
- » Episurf Medical's head office is located in Stockholm and the company has an in-house sales organisation in Europe.
- » The share (EPIS B) has been listed on Nasdaq Stockholm since June 2014.
Financial calendar
| Year–End Report 2018 | 8 February 2019 |
|---|---|
| AGM | 8 April 2018 |
| Interim Report January-March 2019 | 26 April 2018 |
| Interim Report April-June 2019 | 19 July 2018 |
| Interim Report July-September 2019 | 25 October 2018 |
| Year–End Report 2018 | 7 February 2018 |
This is a translation of the original Swedish interim report. In the event of a discrepancy between this translation and the Swedish original, the Swedish interim report takes precedence.
This information is information that Episurf Medical AB (publ) is obliged to make public, pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, on 26 October 2018 at 08.30 (CEST).
The following analysts follow Episurf Medical's development:
Erik Penser Bank Analyst: Johan Lochen
Redeye Analyst: Anders Hedlund
IR contact
Pål Ryfors
CEO Phone: +46 (0) 709 623 669 e-mail: [email protected]
Veronica Wallin
CFO Phone: +46 (0) 700 374 895 E-mail: [email protected]
Episurf Medical AB (publ) Corp. ID no. 556767-0541 Karlavägen 60, 114 49 Stockholm, Sweden www.episurf.com