Implantica publishes Interim Report Q4, January-December 2020
“The extraordinary 3-year results of our pivotal RefluxStop™ clinical trial was the highlight of the fourth quarter, with patient data supporting that RefluxStop™ has the attributes to cause a paradigm shift in acid reflux treatment.”
- Peter Forsell, CEO and Founder of Implantica
Significant events during the fourth quarter, 2020
- Implantica’s RefluxStop™ trial showed exceptional three-year follow-up results. None of the patients in the study were in need of regular daily use of PPIs (proton-pump inhibitors), which were taken by all before surgery.
- Implantica completed a pre-submission to the U.S. Food and Drug Administration (FDA) for RefluxStop™.
- In executing its commercialisation strategy, Implantica recruited additional sales representatives in Germany.
- Surgical webinars were launched to facilitate surgeon outreach and training during Covid-19.
- A registry study has been prepared and is ready to be launched including a web-based data collection system. The registry will support the sales efforts in Germany, Switzerland and the UK in order to collect standard of care data for RefluxStop™.
Significant events after the end of the reporting period
- Implantica will start selling in the UK with reimbursement and is now reinforcing the sales organization in the UK.
- In Germany, Implantica has received our own Operation and Procedure Classification System (OPS) code and a reimbursement Diagnosis Related Group (DRG) for RefluxStop™. This is a milestone in Germany.
- Implantica had two meetings with the FDA. After the initial pre-submission meeting for RefluxStop™, the FDA requested a second follow-up meeting with their surgical expertise. The next step will most likely be a pre-submission supplement leading to a third meeting.
- Applications for regulatory approval of RefluxStop™ are ongoing in 30 countries around the world in parallel.
September – December 2020
- Net sales amounted to TEUR 26 (7)
- Operating loss (EBIT) increased to TEUR 3,350 (1,080)
- Loss after tax amounted to TEUR 3,150 (1,203)
- Basic and diluted loss per Class A share amounted to EUR 0.05 (0.03)
- Liquid funds as at the end of the period amounted to MEUR 97.5
- No interest-bearing debt at end of the period
January – December 2020
- Net sales amounted to TEUR 152 (28)
- Operating loss (EBIT) increased to TEUR 10,641 (4,570) driven by listing costs
- Loss after tax amounted to TEUR 10,277 (4,805)
- Basic and diluted loss per Class A share amounted to EUR 0.20 (0.11)
- Cash outflow from operating activities amounted to TEUR 10,364 (3,573) with listing costs being the key driver
Implantica will hold a telephone conference on February 25 at 15:00 CET
The presentation will be in English via an audiocast with teleconference.
Conference call dial-in:
- Sweden: +46 85-055 83 53
- United Kingdom: +44 3333 009266
- United States: +1-833-526-8382
Webcast:
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 25, 2021 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.