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Implantica publishes Interim Report Q1, January-March 2021

12.05.2021
 | Regulatory

“We would like to utilize the momentum in the digital industry and maintain the goal to be in the forefront of the eHealth transformation.”
- Peter Forsell, CEO and Founder of Implantica

Significant events in the first quarter of 2021

  • Implantica is able to sell RefluxStop™ in the UK with reimbursement and is now expanding the sales organization in the UK.
  • In Germany, Implantica has received its own Operation and Procedure Classification System (OPS) code and a reimbursement Diagnosis Related Group (DRG) for RefluxStop™. This is a milestone in Germany.
  • Applications for regulatory approval of RefluxStop™ are ongoing in 30 countries around the world.
  • Implantica has 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 be a pre-submission supplement.
  • Implantica has been accelerating the integration of the eHealth platform technology in its pipeline products and is utilizing the momentum in the digital industry to maintain the goal to be in the forefront of the eHealth transformation.
  • Thanks to excellent clinical results, several international leading anti-reflux surgeons have decided to start to use RefluxStop™.
 

Significant events after the end of the period

 

  • RefluxStop™ to be implemented at one of the largest hospitals in Europe, University Hospital AKH Vienna. Professor Schoppmann, one of Europe’s leading anti-reflux surgeons, will start to operate with RefluxStop™ and conduct a study with 25-30 reflux patients.
  • In Sweden, which is Implantica’s second home market, RefluxStop™ can be implanted with reimbursement by public healthcare. Discussions have been initiated with key centers in Sweden.
  • Implantica has started to commercialize RefluxStop™ on a reimbursed basis in Italy and Spain based on local and regional hospital agreements.
  • Implantica successfully raised approximately SEK 600 million in a directed new share issue to speed up the commercialization of RefluxStop™ and to accelerate bringing our eHealth platform technology to the market.
  • Implantica is reinforcing its management with additional important core competencies to build an even stronger team supporting the Company’s future growth.

   

First quarter financial summary

  • Net sales amounted to TEUR 82 (23).
  • Operating loss (EBIT) increased to TEUR 2,279 (1,397) .
  • Loss after tax amounted to TEUR 1,966 (1,252).
  • Basic and diluted loss per Class A share amounted to EUR 0.03 (0.03).
  • Liquid funds as at the end of the period amounted to MEUR 93.3.
  • No interest-bearing debt at end of the period.
     
 

Implantica will hold a telephone conference on May 12 at 15:00 CEST

The presentation will be in English via an audiocast with teleconference:

Conference call dial-in:

  • Sweden: +46 85-055 83 57
  • United Kingdom: +44 3333 009269
  • 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 May 12, 2021 at 8:00 CEST.

 

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.