MEDVIA member Specifix has developed an AI-powered, 3D software solution – by surgeons, for surgeons – to transform pre-operative planning for wrist fractures, improving surgical outcomes and reducing the need for corrective procedures.

A teenage boy is playing a soccer game, with his family cheering him on, when a sudden tackle throws him to the ground. He lands awkwardly, catching himself on one hand, and when he sits up his parents are horrified to see that his wrist is jutting out at an unnatural angle. Rushing him to the nearest emergency department, they receive the news that his wrist is broken and will require immediate surgery, including a plate and screws to help realign the bone fragments so they heal correctly.

The doctor assures the parents that the hospital is using the latest technology to plan their son’s surgery, doing everything possible to ensure that there will be no issues or need for corrective surgery down the line. That evening, everyone returns home, exhausted but OK. A few weeks later, the boy’s cast is removed; his wrist has healed perfectly, and he’s back on the soccer field, no worse for wear.

This is the reality made possible by Specifix’s revolutionary AI-powered solution – a patient-specific, 3D pre-operative planning tool for orthopedic surgeons.

By surgeons, for surgeons

Specifix began with an idea by Prof Matthias Vanhees, an internationally renowned hand and wrist surgeon working at AZ Monica and Antwerp University Hospital (UZA). His wife, Alejandra Ortega – a doctor of Biomechanical Sciences – is now CEO of Specifix. “AZ Monica was the first hospital in Belgium to have a 3D printing facility in house, and Matthias had specialized in using 3D technologies,” she says. “But he saw a gap: Although 3D printing was being used for certain procedures, it wasn’t for wrist fractures.”

The most common fractures involve the wrists  because people routinely  put out their hands out to catch their fall. Broken wrists are most common in young or adolescent boys and older women suffering from osteoporosis. In all cases, it’s imperative that the fracture is fixed correctly the first time around, but sadly this is often not the case.

“One in four patients suffer post-operative complications,” Ortega notes. “Wrist fractures can be very complex, demanding a high level of expertise from the surgeons. But they’re also time-dependent, meaning that operations are usually undertaken in the local hospital by surgeons who are often not specialized in wrist surgeries.”

“When a fracture doesn’t heal properly, it has huge socio-economic implications, not only for the healthcare system but for the patients.” – Alejandra Ortega

Vanhees, frustrated with the number of patients seeing him for corrective procedures, realized that better pre-operative planning was key to preventing improper healing. This is especially important for boys with wrist fractures, who may otherwise spend the rest of their life impacted by an unfortunate accident.

“When a fracture doesn’t heal properly, it has huge socio-economic implications, not only for the healthcare system but for the patients,” explains Ortega. “Anyone who has had a sprained or broken wrist knows how important hands are to our quality of life. Without two functional hands, we struggle with even the simplest of tasks; small restrictions on wrist rotation can make the difference between normal function and battling with squeezing shampoo into your hand in the shower.”

Specifix’s surgical solution

Vanhees reached out to the University of Antwerp to propose his idea: use AI to convert a patient’s CT scan into a digital 3D model. This way, surgeons can visualize how to position the bone fragments during surgery. The software also proposes the best implant for each patient from the list of  available surgical plates.

Finally, it also provides the blueprint for a surgical drill guide, which can be 3D printed and used during the operation to ensure the best placement of the plate and screws. Unlike the few competitors on the market, the software is fast, fully automated and doesn’t require a specially trained operator. This means even non-specialist surgeons can quickly and easily integrate the tool in their pre-operative planning.

“Matthias simply said to the university: ‘Look, I know this solution could really help me in my clinical practice. No other company is doing it – let’s develop it together.’ He started working with the Imec-Vision Lab, and, together with the university, they developed the core technology, proof of concept and feasibility studies.”

“This is my first time as a CEO, but the support from the ecosystem has been exceptional.” – Alejandra Ortega

When Specifix was officially founded as a University of Antwerp spin-out in early 2023, Ortega joined the company as CEO. “Matthias is a surgeon, and his passion is working in the clinic,” she shares. “Although he helped develop this technology, he never wanted to leave his practice to run the company. My background is in medical imaging, and I had been supporting this idea since the start. So it was a natural transition for me to take on the mantle of CEO of the start-up.”

Vanhees and Ortega were joined by a third co-founder, the company’s CTO Soha Mahdi. An expert in AI medical applications, Ortega met her during her post-doc. “This is my first time as a CEO, but the support from the ecosystem has been exceptional,” says Ortega. “Specifix is part of the imec.istart accelerator program, where we’ve received a lot of help from workshops and mentors. Through MEDVIA, I also recently followed NoBoCap’s C-level program on how to navigate the European medtech regulatory landscape. And just last month, I took part in the HealthTech Investor Summit, where I was able to connect with investors and other entrepreneurs from around the world. It’s been a steep learning curve, but there’s been great support every step of the way.”

Good things on the horizon

Specifix presented its first prototype to a roomful of hand surgeons at the European hand congress FESSH last year. “They were very positive and enthusiastic about our solution,” says Ortega. “I had multiple surgeons coming up to me after the presentation saying: ‘This is what we need to bridge the gap between the clinical practice and 3D technologies, because I’m fed up with doing this manually. I’m a surgeon, not a computer technician; I want to spend more time with my patients, not with a screen.’”

“We need funding to set up the pilot sites and mature the company and technology further.” – Alejandra Ortega

Following the congress, Specifix received leads from more than 10 hospitals interested in setting up a pilot site for the technology, including in Belgium, the UK, Italy, Sweden and The Netherlands. The company is now raising funds for the next steps. “It’s a bit of a chicken-and-egg situation,” Ortega shares. “We’re too early stage for most VCs, but we need funding to set up the pilot sites and mature the company and technology further.”

Fortunately, Specifix recently secured funding from BeAngels after meeting with one of their investors at the HealthTech Investor Summit last year. Ortega: “The financial support and advice from BeAngels are going to be a game-changer for us. We have big things on the horizon and really feel that these next 12 months are going to give us the push we need to prove our value to VCs and to the market.”

By Amy LeBlanc. Images ©frederikbeyens