Batm Advanced Regulatory News (BVC)

LEI: 213800FLQUB9J289RU66

11 December 2024

BATM Advanced Communications Limited

("BATM" or "the Group")

Key milestone achieved with commencement of NATlab pre-clinical validation

Latest phase begins at major Italian hospital following successful completion of pre-clinical trials

BATM (LSE: BVC; TASE: BVC), a leading provider of real-time technologies for networking solutions and medical laboratory systems, is pleased to announce that the NATlab molecular biology platform being developed by ADOR Diagnostics ("ADOR"), an associate company of the Group, has commenced pre-clinical validation at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, Italy. This marks a key milestone in the development of NATlab and, the Group believes, will enable initial sales as well as increase industry awareness and interest from prospective partners.

The advanced NATlab molecular biology platform is a point-of-care sample-to-answer solution designed to provide rapid and accurate diagnosis of infectious disease. It uses a patented isothermal amplification method for syndromic multiplex diagnostics to be able to rapidly identify a broad range of pathogens from a single test.

The commencement of the pre-clinical validation phase follows the successful completion of pre-clinical trials, which were conducted at the Tzafom Medical Center in Israel, to confirm the validity of the biological process that ADOR has developed and that it can be performed within the NATlab cartridge and analyser device. NATlab identified all negative samples and had a 97% sensitivity for the positive samples, confirming the efficacy of the system and its ability to out-perform competing solutions available in the market today because of its multiplex diagnostic capability for rapid and accurate diagnosis.

ADOR has now made significant progress with NATlab with the full system entering the pre-clinical validation phase at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome, a leading centre for infectious disease research and treatment. Successful completion of the pre-clinical validation is expected to enable initial sales of the NATlab and the commencement of the regulatory process under the European Union In Vitro Diagnostic Medical Device Regulation to become eligible for sale in the EU market.

In addition, following the success of the pre-clinical trials, ADOR, in collaboration with the Tzafom Medical Center, has received a grant from the Israel Innovation Authority to develop a NATlab panel for the diagnosis of stomach ulcers. The total value is NIS 3.4 million (c. $1 million), which is to be granted over two years based on the achievement of milestones.

Moti Nagar, Chief Executive Officer of BATM, said: "The commencement of the pre-clinical validation phase at a major European hospital is an important milestone in the development of NATlab and represents a key stage towards enabling its market entry. This also follows the successful completion of pre-clinical trials, which delivered excellent results. As the value of the substantial IP that has been built within ADOR continues to increase as well as the industry awareness of the attractiveness of the NATlab solution, we remain excited about its prospects and look forward to reporting on further progress."

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