The startup, a spin off of the Barcelona Supercomputing Center (BSC) and Imperial College London, has developed the UBIware software and is preparing its clinical validation in Vall d'Hebron and a financing closure.

Emerging as a spin off from the Barcelona Supercomputing Center (BSC) and Imperial College London, the startup FrontWave Imaging hopes to close a financing round of 600,000 euros with which to clinically validate the UBIware software developed for the Early detection of breast cancer.

So far, the startup has achieved financing of more than 2 million euros between private funds and grants. Among the investors that have supported FrontWave, the participation of Farside, an advanced technology venture builder, stands out, which, through its vehicle 101 Ventures, has acted as co-founder and co-investor of the startup; and the entry FITalent, a corporate venture of the NTT Data group. Among the public funds, the European funding obtained with the QUSTom project of the EIC Pathfinder of 424,000 euros in 2022 stands out; and the Neotec subsidy from the CDTI of the Ministry of Science and Innovation of 250,000 euros awarded this year.

This investment has led to the development of UBIware software, a device that uses supercomputing, ultrasound data and advanced algorithms to provide high-resolution images of the breast. This advance makes it possible to improve diagnosis and reduce mortality rates thanks to the detection of false negatives and false positives of current diagnostic imaging techniques.

Susana Castel, CEO of FrontWave Imaging, explains to La Razón that this technology uses ultrasound computed tomography (USCT), “a safe, affordable and rapid detection modality that, unlike mammography, avoids ionizing radiation and improves the diagnosis in patients with dense breast tissue (a percentage that in some countries reaches 50% of the female population). UBIware processes and analyzes data obtained from machines using ultrasound computed tomography (USCT), allowing quantitative estimates of properties such as speed of sound, density and acoustic attenuation. “The UBIware device transforms this combination of data into high-resolution images with excellent tissue contrast.”

Why breast cancer
It is expected that this technology can be used in other types of cancer (in fact, it is one of the objectives, starting with prostate or brain cancer), although Castel warns that “our only limitation is in the type of data we receive, that is, , in the acquisition technique used. If tomographic ultrasound is used, we can use our image reconstruction technology.”

In fact, it was chosen to start with breast cancer because this organ is made up of soft tissue "which makes the ultrasound technique appropriate", because "there are devices on the market for acquiring the type of data necessary" and because of the fact that “there is an important market need.”

The startup is trying to close a financing round of 600,000 to validate its work. “Medical research requires carrying out very specific validations to guarantee the safety and efficiency of the products developed, prior to putting them on the market. Clinical validations have strict regulation and require a large investment," explains the CEO of FrontWave Imaging, who adds that, depending on the classification of the product to be developed based on its safety, "the requirements are stronger and the certifications are A Notified Body must be carried out that audits not only the product, but the company. These certifications have a very high cost.”

The problem with healthcare-related startups is that “the development and initial validation time is long and expensive, and funds usually look for companies where the risk is lower, so they look for companies with initial validation already done,” summarizes this entrepreneur.

Destination of the round
FrontWave Imaging has opened a financing campaign of 600,000 euros on the Capital Cell platform open to any investor. According to its manager, “this is a very good investment opportunity, with a pre-money valuation of 6 million euros and a seed round of 600,000 euros, expandable up to 1,000,000 euros. The valuation is very reasonable and allows us to estimate a return for investors of x17”.

The minimum investment is 1,000 euros with an expected exit rate of Series B. “Participation offers you the right to carry over, the right to accompany, the right to vote (representative of the SPV), the right to attend the Meeting (representative of the SPV), tax relief and obligation to inform shareholders every 3 months,” explains Susana Castel.

The funding obtained will go towards the clinical validation of the UBIware software that will be carried out at the Vall d'Hebron Hospital in Barcelona. Part of their research is funded by the European Innovation Council and involves the installation of an ultrasound computed tomography (USCT) data acquisition machine from which the results will be compared with classic imaging methodologies, such as mammography.

“The investment obtained will also allow us to begin the regulatory processing of patents in Europe, the United States and China. Since our product is considered a Software Healthcare Product, it is necessary to obtain a product certification before introducing it to the market. Certification varies by market, requiring a CE Mark in Europe, an FDA approval in the US and a CFDA certification in China. The certification requirements vary according to the classification of the product, based on the safety of the product,” the CEO of the startup details to this editorial office.

It is expected that in 2024, once clinical research is completed, UBIware will be certified as Class I medical device software (MDSW), which certifies optimal medical imaging of the breast and allows its commercialization for USCT machines. Also for next year, FrontWave plans its third round of investment to finance a second clinical trial that will allow UBIware to be certified as Class IIb diagnostic medical software. “This certification will allow it to be marketed as SaaS (software as a service) with a payment model per study or by subscription, depending on the client,” he anticipates.