FrontWave Imaging, SL is a spin-off of the Barcelona Supercomputing Center (BSC) and Imperial College London (ICL). Our focus is on early breast cancer diagnosis using supercomputing-based medical software, UBIware, which utilizes data obtained through ultrasound tomography (USCT). BIware, our software, operates as a SaaS (Software as a Service)
Our technology enables the capture of high-precision 2D/3D images of breast tissue, achieving high resolution. It is particularly effective in high-density breast tissues where conventional mammography may fall short due to similarities in tissue density between healthy and tumor tissues. Our data acquisition technology is non-invasive, non-ionizing, and cost-effective. Furthermore, it is painless and suitable for patients of all ages and risk levels, making it usable as frequently as needed for enhanced disease detection and monitoring.
The Frontwave Imaging team, led by CEO and co-founder Susana Castel, brings together extensive experience in launching and managing startups within the biotechnology and medical software sectors. It includes three scientific co-founders: Josep de La Puente (CTO), Lluis Guasch (CSO), and Óscar Calderón (CDO). Frontwave Imaging also benefits from the expertise of Rafael García Escarré, our Senior Business Advisor, who has been a part of the management team since the company’s inception. In its initial years, the company successfully assembled a core team of 8 full-time employees and enlisted the expertise of advisors and essential suppliers for product and business development, including roles such as CFO, regulatory experts, cybersecurity specialists, legal counsel, and HR personnel.
The development of our first product, UBIWare, has been strategically planned in phases. The initial version will undergo validation as a breast image reconstruction tool, paving the way for subsequent regulatory clinical validation as a breast cancer diagnosis method. Additional features will be incorporated to enhance disease detection and monitoring, including multiparameter reconstruction and uncertainty quantification.
Regarding the regulatory strategy, as our product is classified as a Medical Software Device, it’s imperative to obtain product certifications before market entry.
Certification requirements differ by market, with CE Marking required in Europe, FDA approval in the US, and CFDA certification in China. These requirements are contingent on the product’s safety classification.
In Europe, UBIware is classified as a Medical Device Software (MDS) class I for the reconstruction tool and class IIb for the diagnostic tool. Certification requirements vary depending on the product’s risk classification. Class I products may undergo self-certification, while the rest require the involvement of a notified body.
In the United States, UBIware falls under the classification of ‘Medical Device Class II’ as per regulation 21CFR 892.270. To obtain marketing authorization, we will submit the 510(k) notification requirement to the FDA.
Our regulatory strategy aligns with our market approach and expansion plans, focusing on key markets with substantial growth potential. We have enlisted the expertise of regulatory consultants who specialize in both European and FDA regulations.
To support our regulatory efforts, Frontwave Imaging is initiating an investment bridge round of €600,000. This round will be followed by a larger round in 2024, totalling €2 million, aimed at completing the development and validation of UBIWARE 2D as a reconstruction tool, along with achieving self-certification as a Class I Medical Device Software (MDS).
Subsequent investment rounds are planned for 2026, coinciding with our company’s more advanced stage of product commercialization and expansion. Frontwave envisions a potential exit scenario for investors around 2027-28, with a valuation potential of up to €120 million, offering a remarkable return on investment estimated at x17 for investors participating in this round.
