Scope Fluidics launches Early Access Program for BacterOMIC system


Scope Fluidics S.A. (WSE: SCP) – a Venture Studio biotechnology company included in the sWIG80 index, which led the largest deal in the history of the Polish life science market in 2022 – announced that it has begun testing the BacterOMIC system in a hospital laboratory under the Early Access Program, according to schedule.

  • The start of testing at the first external facility is the result of activities carried out over the past months, during which the BacterOMIC team, established relationships with numerous domestic and foreign centers, which are potential end users of the system.
  • The in-house laboratory and production space for conducting the Early Access Program have been launched and validated. Work continues on completing the validation of the production line.
  • The BacterOMIC system has been presented at major international industry events in recent months.
  • In recent weeks, the Company has completed activities under further operational goals for the BacterOMIC system, starting preparations for commercial production of the system and extending patent protection in the United States of America.
  • BacterOMIC is the flagship medtech system being developed by Scope Fluidics. The groundbreaking technology is dedicated to challenge antibiotic resistance in bacteria – one of the fastest growing medical threats globally.

Piotr Garstecki, co-founder, significant shareholder and CEO of Scope Fluidics said:

– The launch of the Early Access Program is the effect of several months of hard work by the entire team. We have organized our in-house laboratory and production facilities, while carrying out parallel research and development activities, oriented, among others, to optimize the cost and logistics of product manufacturing and storage. We now have the capacity to address the needs of the Early Access Program.

Gajane Żurawska, Global Business Development Director of Scope Fluidics said:

– In the past months, we have participated in several international scientific and business events, presenting the BacterOMIC system to a wide range of audiences, including distributors, companies in the field of diagnostics, suppliers of technology, services and production capacity, scientists, or investors. We significantly strengthened the recognition of our technology and established relationships that will bring support in the next stages of its development.

In 2023, the BacterOMIC system was presented at ECCMID 2023 (April, Denmark), AACC2023 (July, United States), and Medica 2023 (November, Germany), among others. In January 2024, the Company will participate in one of the largest investor conferences in the world, organized in the United States by JP Morgan.

In the past months, the BacterOMIC team, together with international public affairs consultant Rud Pedersen Group, held many meetings and undertook numerous activities to promote the BacterOMIC system both in Poland and abroad.

Bernd Eberhardt, CEO of Bacteromic said:

– The launch of the Early Access Program is an important, but only one of the key areas we address. We are focusing on activities that are essential to the value of the BacterOMIC system. We have recently begun working with an international supplier to prepare for commercial production of the system, as well as to extend intellectual property protection of our technology in the US market, which is crucial from our point of view.

Scope Fluidics is working to achieve the BacterOMIC operational goals presented in May 2023. At that time, the company announced: 1) Commencement of testing of the BacterOMIC system under the Early Access Program; 2) Commencement of commercial production of the BacterOMIC system; 3) Expansion of the product and patent portfolio.

In November 2023, the company announced that it has begun preparations for commercial production of the BacterOMIC system, signing a cooperation agreement with German company BIT Analytical Instruments, based on which BIT is to produce 10 BacterOMIC devices. The devices will be available for the start of commercial production and for the expansion of the Early Access Program. Under the terms of the agreement, most of the analyzers are to be delivered in Q1 2024.

In mid-December, Scope Fluidics announced that its subsidiary Bacteromic sp. z o.o. had been granted a patent for a method and system for ultrafast determination of drug resistance of microorganisms by the United States Patent and Trademark Office. The European patent protection for the solution, obtained in 2020, was thus extended.

The BacterOMIC system is a response to the growing global medical threat of antibiotic-resistant bacteria. The World Health Organization estimates that by 2050, the annual number of deaths from infections caused by drug-resistant microorganisms will rise from 700,000 to 10 million per year, making them one of the leading causes of death worldwide.

BacterOMIC’s technology is expected to make patient treatment faster and more effective by pinpointing the best targeted therapies for a given patient. In up to 16 hours, it will accurately assess the susceptibility of bacteria to all clinically important antibiotics and provide the physician with comprehensive information on the pathogen in question. The test’s market-leading informativeness is a key among several competitive advantages of the system.

BacterOMIC has been CE-IVD certified for marketing in the European Union since 2021. Development of the system began in 2016, and a special purpose vehicle, Bacteromic sp. z o.o., was established in 2017. In 2019, the BacterOMIC project became a semi-finalist in the prestigious American Association for Clinical Chemistry Disruptive Technology Award Competition.