Bifogade filer
Kurs & Likviditet
Beskrivning
Land | Sverige |
---|---|
Lista | Small Cap Stockholm |
Sektor | Hälsovård |
Industri | Medicinteknik |
2021-02-19 08:30:00
"Today, we have announced the intention of filing a 510(k) application to the US FDA during 2021 for market approval for an Episealer® Patellofemoral System. This is an expansion of the clinical indications for using the Episealer® knee implants", says Pål Ryfors, CEO Episurf Medical.
- Gross order intake amounted to SEK 1.3m (1.2), an increase of 9%. We experienced a 21% increase in orders for Episealer® implants during the quarter with 57 (47) approved orders. Compared to Q3 2020, we experienced a decrease in the gross order intake as renewed COVID-19 restrictions had a significant negative impact on the quarter
- Order backlog amounted to SEK 1.3m (1.1), an increase of 18%
- Total income of SEK 3.1m (1.4), a growth of 118% driven by licensing income
- Group net sales increased by 15% to SEK 1.5m (1.3)
- Loss for the period amounted to SEK -16.2m (-18.7); the improved result depends on income for µiFidelity® software platform during the quarter of SEK 1.5m, and that costs during the quarter decreased, which is mainly due to SEK 0.6m lower costs for the EPIC-Knee study and cost savings in connection with COVID-19
- Earnings per share amounted to SEK -0.08 (-0.21)
- Gross order intake amounted to SEK 5.6m (5.0) an increase of 11%
- 29% increase in orders for Episealer® implants during the financial year with 261 (202) approved orders
- Total income of SEK 7.0m (5.4), a growth of 30%
- Group net sales increased by 2% to SEK 5.0m (4.9) during the financial year
- Loss for the period amounted to SEK -63.9m (-69.8)
- Earnings per share amounted to SEK -0.39 (-1.04)
- Episurf Medical carried out a directed share issue and raised SEK 66m
- Episurf Medical entered into licensing agreement of SEK 1.5m for µiFidelity® software platform
- Episurf Medical entered into a distribution agreement for France and additional markets in Asia
- Episurf Medical entered into an advisory agreement with Prof. Doctor João Espregueria-Mendes regarding establishment of the Episealer® knee technology in India and Portugal
- Data showing high implant survival rate for Episealer® were accepted for publication
- The first Episealer® surgery was performed in the US, Asia and Scotland
- First Episealer® Talus surgery in Scandinavia performed
- Episurf Medical reached milestone of 900 approved implants
- Episurf Medical announced its intention to file a 510(k) application in the US for an Episealer® Patellofemoral System
- First Episealer® Talus surgery in the Asia-Pacific region performed
- New patents approved in Hong Kong and US for Episurf Medical
- Episurf Medical entered into distribution agreement for Australia and New Zealand
- Episealer®: Clinical results with 5-years' follow-up data will be presented at the 3[rd] World Arthroplasty Congress