Cresco Spine Sets a New Global Standard in Scoliosis Treatment

Together with fellow inventor Moyo Kruyt, also an orthopedic surgeon at UMC Utrecht, Castelein specializes in treating children with early-onset scoliosis. In these patients, severe spinal curvature develops during childhood, often leading to significant health complications.

The young patient we treated in 2015 experienced breathing difficulties and cardiac problems,” says Castelein. “At the time, there was no suitable treatment available. After extensive research and discussion, we developed our own solution: a spring-based system that continuously guides spinal growth while allowing the spine to develop naturally.”

Before the first procedure could take place, the surgeons were required to submit an extensive dossier to gain approval for clinical use within UMC Utrecht. Following the successful implantation, additional patients were treated within the academic setting.

What sets the SDS apart from conventional growth-friendly systems is its dynamic approach.

“The implant adapts to different anatomies and continuously supports growth correction,” Castelein explains. “One procedure can provide years of support, reducing the need for repeated surgical interventions. Just as importantly, the dynamic approach helps preserve healthy bone, muscle and cartilage development.”

“Bones, muscles and cartilage remain significantly healthier.”

Following the first successful procedures, Castelein and Kruyt began presenting their findings through scientific publications and international conferences. Interest in the technology quickly grew, both in the Netherlands and abroad, leading them to recognize its potential as a new standard of care.

This prompted them to approach InSpine, a Dutch distributor of spinal implants. In addition to its commercial activities, the company operates InSpine Innovations, a division dedicated to evaluating clinically relevant innovations and bringing them to market through viable business models and strong commercialization strategies.

The SDS immediately attracted attention, although considerable work remained before it could be introduced commercially.

“We had to look at intellectual property protection, market potential and long-term scalability,” explains Dennis Magermans, Director of Innovations at InSpine. “We also observed some wear in the original metal components. While this was not clinically significant, we wanted to fully understand its implications before moving forward.”

To investigate this further, InSpine partnered with BAAT Medical, a leading medical device development company based in Hengelo. BAAT specializes in transforming innovative concepts into fully certified medical products and supports customers with material selection, supplier qualification and product development.

“For this project, we never considered working with anyone else,” says Magermans.

The technical assessments ultimately confirmed the viability of the concept and paved the way for further development. This led to the establishment of Cresco Spine in 2021, a joint venture between InSpine, Castelein and Kruyt, and UMC Utrecht.

According to Business Developer Dymphy van der Wilk, the project perfectly aligns with BAAT Medical’s mission.

“We are involved in many innovative spinal surgery projects, and that is exactly where we want to be,” she says. “The potential benefits for patients are significant, which is why we are committed to supporting initiatives like this.”

Each innovation requires a tailored development and validation strategy.

“Every medical device presents its own challenges,” Van der Wilk explains. “For implants, cleanliness is critical, but the device must also be mechanically robust and intuitive for surgeons to use. We therefore evaluate not only safety and performance, but also usability. Ultimately, our goal is to demonstrate to regulatory authorities that the product is both safe and effective.”

Maintaining high quality standards while preserving efficiency is one of the biggest challenges in medical device development, according to BAAT Medical Project Manager Vittorio Ricca.

“Innovations such as the SDS differ fundamentally from existing technologies,” he says. “At the same time, quality should never become a barrier to bringing a valuable innovation to market. The objective is to develop the most effective solution at a realistic cost without compromising patient safety.”

Close collaboration was therefore essential throughout the process. Ricca and his colleagues worked extensively with Castelein and Kruyt during development.
“We already understood the potential impact on children living with severe scoliosis,” he says. “But hearing directly from the surgeons strengthened our commitment even further and reinforced the urgency of making this solution available as quickly as possible.”

“Quality should never become a barrier to innovation.”

Before commercial launch, one critical challenge remained: ensuring that every implant met the same rigorous standards, without variation.
To achieve this, BAAT Medical partnered with FMI’s medical division in Schiedam. FMI was responsible for scaling production while maintaining the consistency and quality required for medical devices.

According to Stefan Broks, Account Manager at FMI, the collaboration between FMI and BAAT Medical is built on years of mutual trust and technical expertise.
“Everything starts with open communication,” says Broks. “We want to thoroughly understand every instrument and implant so that we can optimize manufacturability through co-engineering. That is how you achieve the right balance between quality, efficiency and consistency.”
Innovation plays a central role at FMI as well.

“We have contributed to many innovative projects over the years, but this one was truly unique,” he says. “The technical challenges were significant, but like BAAT Medical, we immediately recognized the urgency. The potential impact on children’s lives made it a clear priority.”

Earlier this year, the SDS received FDA approval, opening the door to the United States market. According to CEO Dennis Magermans, approvals in Canada, Australia and New Zealand are expected to follow, after which the company plans to expand into the United Kingdom.

The European approval process is already underway, although it may still take several years before completion.

“Once the necessary approvals are in place, our goal is to make the system broadly available worldwide through a strong commercial network,” says Magermans. “Children everywhere should have access to the best possible treatment, regardless of where they live.”

According to Castelein, Cresco Spine has the international network and expertise required to achieve that ambition.

“Although our initial focus is on children with scoliosis, the broader challenge is even larger,” he says. “People are living longer, and age-related spinal conditions are becoming increasingly common. New treatment solutions will be needed for these patient groups as well.”

That vision is already shaping the next phase of development. The current SDS platform is being further enhanced with a rotational correction component, designed to address additional aspects of spinal deformity.

While the technology is still in development, Castelein is convinced of one thing: “The philosophy of scoliosis treatment is ready for change.”

Looking back on the journey from concept to commercialization, Castelein believes one lesson stands above all others: the importance of understanding each other’s expertise.

“A project like this brings together specialists in medicine, engineering, product development, regulatory affairs and business strategy,” he says. “You need to learn how to understand each other’s perspectives and priorities. Every discipline contributes something unique, and together those perspectives create the foundation for success.”

Magermans shares that view.

“The effectiveness of the system is the result of a true team effort,” he says. “Every area of expertise played a vital role. There is no need to reinvent the wheel. By partnering with organizations such as InSpine Innovations, BAAT Medical and FMI, you can build on proven knowledge and experience. That trust is what enables innovation to succeed.”