Leveraging the INNOWWIDE grant, Biosfer Teslab aims to bring a mainly Spanish technology service into Chilean clinics to boost better clinical management, and empower clinicians in difficult and stressful decisions. ‘’It has paved the way for internationalisation proof-of-concept. The explored model will be replicated in other South American countries by deploying a functional prototype in pre-clinical settings. It allows for validation of the optimal user-centric experience leading to improved clinical management’’, says Núria Amigo, CEO and co-founder of Biosfer Teslab. INNOWWIDE had the chance to interview Ms Amigo about the impact of Biosfer Teslab’s participation in the VAP1 grant.
Emerging from a research and university setting, could you explain how Biosfer Teslab’s was founded?
As a biophysicist focused on biomarker discovery, biostatistics, NMR spectroscopy and machine learning techniques application in the context of cardiovascular research, Ms Amigo stood at the cradle of the innovation in NMR spectroscopy application. Following her doctoral studies in the Metabolomics Platform (URV) centred on lipoprotein profiling by using NMR spectroscopy, Biosfer Teslab emerged as a spin-off company of the Rovira i Virgili University (URV) and the Pere Virgili Health Research Institute (IISPV).
Biosfer Teslab operates in the field of in-vitro diagnostics to provide analytical services to study and monitor alterations in metabolism. The lab provides services of analysis of fluids and biological tissues by Nuclear Magnetic Resonance (NMR) and develops medical software, to help and facilitate to the health professionals and the scientific community to study, diagnose and treat metabolic disorders to advance in knowledge and improve the health of people.
What makes the solution unique?
Biosfer appeared intending to reduce the time between the basic scientific results and their future application in patients and of becoming a reference company at the European level in the analysis of biofluids using the Nuclear Magnetic Resonance (NMR) high-performance technology.
As a result of this vocation, the “Liposcale” test was born, which revolutionizes the characterization of the lipoprotein profile (particles that transport lipids through the bloodstream), allowing a direct and rapid determination of the size and number of particles of the main classes of Lipoproteins (VLDL, LDL and HDL), as well as the concentration of particles of nine different subclasses, without having to fractionate the plasma.
Since August 2014, Laboratorios Rubio, a family-owned pharmaceutical company specialized in therapeutic solutions for low’ prevalence diseases, has been part of Biosfer Teslab’s social capital, enabling the industrial development of the Liposcale® test to launch the test at a European level. Besides, Rubió Laboratories are the national and European marketers of the Liposcale® test.
The Chilean health care system attracts considerable praiseworthy attention. Besides this fact, how did the international growth strategy and choice for Chile come about?
Although Chile has been viewed as an exemplar of social and economic progress in Latin America, during the INNOWWIDE project it has suffered an economic collapse and an eruption of widespread civil disorder at the end of 2019. These external factors were not previously contemplated in the Viability Assessment Plan. Biosfer’s choice for the smaller market in Chile compared to the one in Mexico, was decided after a market analysis pointing to higher regulatory burdens and widerspread corruption in the latter market. With roughly half of Chile’s population concentrated in the main capital Santiago, it enabled us to more easily target partners in such a concentrated market.
The analytical validation under the VAP project succeeded in leading Biosfer to the implementation of a new measurement system of lipoproteins in the Chilean market for the improvement of cardiovascular risk assessment. Although delayed by six months due to the Covid-19 pandemic.
How did the INNOWWIDE VAP grant and network support you?
Our participation and the VAP grant within INNOWWIDE helps Biosfer to consolidate in its mission to deliver products and services for healthcare transformation in Europe and beyond. Through the project, we seek to shorten the time-to-market for NMR-metabolomics as a concrete solution to wider medical applications. By bringing metabolomics into the real clinical practice in the Chilean market, it will create new jobs, industries, partnerships and strengths for local health systems and practitioners.
The INNOWWIDE participant network offered us skills and resources helping enclose the complex pathway from lab to market in clinical health. In the four complementary clinical, business, technology and regulatory perspectives, INNOWWIDE provides the strategical and critical skills to bring excellence, efficiency and collaboration on Biosfer’s pathway to market success and scale-out as quickly as possible.
Concretely, INNOWWIDE helped Biosfer to collaborate with our local partner Andinno in Santiago to actualise benefits in:
- Technological: development and implementation of a functional workflow enabling us to operate on clinical use in the Chilean market (during 2021).
- Clinical: collaboration with clinical groups for Chilean market validation (end 2021) and implementation of the Biosfer’s solution in local societies’ clinical consensus.
- Regulatory: generation of all technical file documentation (end 2021) for IVD-R CE for the final project; regulatory approval by a notified organism with new regulation (2022).
- Business: estimation of Chilean initials sales revenues and profit margins (2023).
What are your next steps?
The ADINA NMR project brings a Spanish technology service into Chilean clinics increasing the number of uses and screened patients, reducing the average cardiovascular diseases, boosting better clinical management, empowering clinicians in difficult and stressful decisions.
With a concluded proof-of-concept for the successful scaling of the technology to foreign markets, the explored model will be replicated in other Southern American countries. This step will follow after the initial delivery of a functional prototype in pre-clinical settings to validate the optimal user-centric experience – leading to improved clinical management.
In terms of economic growth, the present project enabled the preparation and realisation of investment readiness status, enabling the next growth step in the next funding cycle.
Read more about the INNOWWIDE VAP Grant and Biosfer Teslab in the case study here.