From Research to Registration and Market Launch
We developed Phivea® platform, a comprehensive decision support software for healthcare professionals. Phivea® was created by bringing together genomics, artificial intelligence, and blockchain. In particular, to analyze different gene sequences, we developed the machine learning algorithm Torchlex. Torchlex reduces computational complexity and significantly increases the speed of analysis, while maintaining the same quality and accuracy compared to conventional methods. This method allows to significantly reduce the cost of analysis per gene sample.
In May, we achieved CE marking for our Phivea® v1.0.0 platform. Phivea® v1.0.0 is now registered successfully at the Danish Medicines Agency and marketed as an In Vitro Diagnostic (IVD) medical device product under the Directive 98/79/EC for In Vitro Diagnostic medical devices.
We would like to thank our strategic partner Netcetera for their valuable support during the development of the Phivea® platform.
Quality management system
Back in February, we were certified with ISO 13485 within the scope “Design and Development and Service Provision of In Vitro Diagnostic Medical device software”. To become ISO 13485:2016 compliant, we worked intensively for 4,5 months with Star, our strategic partner in meeting regulatory requirements, to finalise and fully document our Quality Management System.
International Collaborations
In September, we expanded our research cooperation with Polish biotech company genXone, towards the development and launch of a novel test based on the Phivea® platform and nanopore technology for the screening of carriers of rare genetic diseases. Read more about our collaboration with genXone.
In December, we entered into an agreement with the National Centre for Scientific Research “Demokritos” for joint research and development in the field of Artificial Intelligence (AI) and Machine Learning. Read more about our collaboration with Demokritos.
New Board of Directors
In November, we announced our first Board of Directors and welcomed Lars Staal Wegner, Chairman, and Hanna Pyokari, Member, to the Board, effective November 1st, 2022. The Board will guide the company forward, especially through shaping public private partnerships, a key factor in unlocking the potential of the gMendel technology for mass screening of genetic disorders.
Funding
In 2022, we raised funding from public and private institutions such as the Innovation Fund Denmark, the Danish Agency for Higher Education and Science, as well as the Danish angel investors iFutura and Quaternity. Read more.
In the meanwhile, we are happy to announce that we have received an EU grant to expand our technology in prenatal screening from EUROSTARS. We will announce more about it in January.
Overall, in 2022, we raised approximately 800k Euro from grants and another 800k Euro from angel investors.
Awards
In October, gMendel was shortlisted as a Finalist for the European Lifestars Awards, in the medtech category, representing the Nordic region. Earlier in the year, gMendel had been selected by the Nordic Asian Venture Alliance to join the Nordic healthtech delegation to Japan. The delegation consisted of 16 Nordic companies with amazing cutting-edge healthtech solutions from lifescience to pharmaceuticals, medicaldevices to #biotech, and a strong aim at the Japanese market, as well as other ecosystem members and incubators.
Notable customers
We have signed cooperation agreements with diagnostic laboratories, hospitals, industry and public bodies across Europe (DK, PL, GR, UK) and beyond (US, BR, EG).
EXTERNAL COMMUNICATION ACTIVITIES & OUTREACH
Participation in Conferences & other Events
During the year, our team has actively participated in numerous conferences, delegations and meetings across the world, from the U.S. to Japan, with the aim to inform patients, scientists, healthcare professionals and regulators about the gMendel® technology and its benefits for timely diagnosis. You may find all our publications, posters, abstracts and videos in a dedicate page on the gMendel website: https://www.g-mendel.com/PUBLICATIONS/.
Digital Communication
Website
We have revamped our website to reflect all our major achievements during the past year and have introduced new pages about:
Social Media
LinkedIn: More than 120 announcements on LinkedIn and 1,850+ followers!
OUR STRATEGIC COMMITMENTS FOR 2023
Commitment #1: Basic Carrier Test – extend Phivea® Platform & gMendel®Test
Commitment #2: Start commercialization in DK, PL, GR, ES. Pilot projects within private/public hospitals and private diagnostic centers. Through these projects, we will be able to collect more data and receive invaluable customer input for our future products.
Commitment #3: Close our seed funding round and raise additional grants.
Commitment #4: Continue building interconnected partnerships with public health systems, industry, KOLs and communities. We expect to enhance our current collaborations and partnerships and initiate new ones in selected countries. We also expect to participate in more conferences and congresses and be active members of more advocacy groups.
Commitment #5: Blockchain technology for highest security and reliability. We employ blockchain technology through our Phivea® platform for data safety. The gMendel®Test delivers a report, which is generated by the Phivea® platform. The report is “signed” and turned into a hash code. The hash code provides patients with the proof and confidence that the report will not and cannot change. In the future, we can decide to leverage blockchain and securely store Phivea® reports and patients may decide to share information upon their own will.