GREAT PROGRESS IN U.S. APPROVAL
STOCKHOLM, Feb. 18, 2022 /PRNewswire/ --
Significant events in the fourth quarter of 2021
- The U.S. approval has taken a giant leap forward since the FDA has agreed to receive a PMA marketing application for RefluxStop based solely on existing European clinical data. If approved, this would allow for U.S. market entry without a premarket U.S. clinical trial. As agreed with FDA, Implantica will provide the FDA with additional current longer-term safety and efficacy data from its ongoing European clinical investigation.
- The fourth wave of COVID-19 has affected RefluxStop surgeries with hospitals terminating elective surgeries during Q4 2021, however, implantations have started to resume during Q1 2022.
- Before the latest close down, surgeons from several hospitals in UK and Germany received training on the RefluxStop procedure.
- Implantica appointed new highly experienced Chief Market Access & Strategy Officer having spent over 15 years in market access, reimbursement, health economics and payer relations.
Significant events after the end of the period
- Implantica appoints former Medtronic executive as Chief Operating Officer, who brings nearly 20 years of diverse experience, most recently having led several Operating Units as Vice President Europe with additional responsibility for EMEA, LATAM and Canada.
- Implantica progresses on eHealth development and conducts 3-day eHealth workshop with 20 experts from all over Europe to advance the usability of our unique eHealth platform technology. When launched, the unique ability to change treatment on distance is designed to bring Implantica to the forefront of the eHealth revolution.
Fourth quarter financial summary
- Net sales increased 312% to TEUR 107 (26).
- Adjusted gross margin amounted to 91% (92%).
- Operating loss (EBIT) decreased to TEUR 3,990 (3,350).
- Loss after tax amounted to TEUR 6,365 (3,150).
- Basic and diluted loss per Class A share amounted to EUR 0.09 (0.05).
- Cash and short-term investments as at the end of the period amounted to MEUR 132.7.
Full year financial summary
- Net sales increased 155% to TEUR 387 (152).
- Adjusted gross margin amounted to 93% (97%).
- Operating loss (EBIT) increased to TEUR 13,141 (10,641).
- Loss after tax amounted to TEUR 15,472 (10,277).
- Basic and diluted loss per Class A share amounted to EUR 0.23 (0.20).
Implantica will hold a telephone conference on February 18 at 15:00 CET.
The presentation will be in English via an audiocast with teleconference:
Conference call dial-in:
- Sweden: +46 8 505 583 75
- United Kingdom: +44 3 333 009 270
- United States: +1-646-722-4957
Webcast:
https://tv.streamfabriken.com/implantica-q4-2021
Speakers:
- CEO Peter Forsell
- CFO Andreas Öhrnberg
- VP Operations & IR Nicole Pehrsson
For further information, please contact:
Nicole Pehrsson, Investor Relations
Telephone (CH): +41 (0)79 335 09 49
nicole.pehrsson@implantica.com
Implantica is listed on Nasdaq First North Premier Growth Market in Stockholm.
The company's Certified Adviser is FNCA Sweden AB, +46 (0)8 528 00 399, info@fnca.se
The information was sent for publication, through the agency of the contact person set out above, on February 18, 2022 at 08:00 a.m. CET.
About Implantica
Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica's lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and has developed a broad, patent protected, product pipeline based partly on two platform technologies: an eHealth platform designed to monitor a broad range of health parameters, control treatment from inside the body and communicate to the caregiver on distance and a wireless energising platform designed to power remote controlled implants wirelessly through intact skin. Implantica is listed on Nasdaq First North Premier Growth Market (ticker: IMP A SDB). Visit www.implantica.com for further information.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/implantica/r/implantica-publishes-year-end-report--january---december-2021,c3509652
The following files are available for download:
https://mb.cision.com/Main/19732/3509652/1537217.pdf | Implantica publishes Year-end Report, January '" December 2021 |
https://mb.cision.com/Public/19732/3509652/ae189e105f06a2eb.pdf | Year-end 2021 Report ENG |
