Tsunami Medical – Next Gen 3D Printed Titanium

Based out of the Biomedical Valley in Italy, Tsunami Medical are a Spinal Implant manufacturer on the rise. Formed in 1997 by CEO Stefano Caselli, Tsunami are at the forefront of innovation in 3D printed spinal implants. Having hired Peter Witke as Chief Commercial Officer last year, Tsunami Medical, announced the CE Mark approval, in May this year, for the 2nd generation spinal implants. The 2nd generation will improve on their earlier release with a focus on stand alone fixation as well as offering some expandable options. Tsunami also earlier this week announced a strategic alliance with Ulrich Medical which will help them grow their presence in Germany.

I sat down with Peter to understand what Tsunami are planning for the rest of 2021 and the years ahead.

Peter, now you have CE Mark for the 2nd generation, what are your plans for commercial growth? Are you planning to apply for FDA approval and enter the US market?

Our latest release means we now offer a range of eight 3D printed interbody fusion solutions and a world-first 3D printed screw and rod system, which makes it a full portfolio of spinal fusion systems. Building on the success of our 1st generation 3D printed cages, we now offer four additional cages with a built-in fixation mechanism (certified as ‘standalone’ cages) and another four cages with an expansion mechanism (allowing individual controlled expansion in multiple directions).

Stromboli-J DLIF 3D Printed Titanium Cage with Built-In Fixation Together with alternative fusion systems – already available as part of the 1st generation products including Interlaminar fusion solution, facet fusion solution and an interspinous fusion solution – the screw and rod system is the icing on the cake.

It makes our range the largest 3D printed portfolio for spinal fusion… in the world! 

Tsunami Medical’s growth strategy will be focusing on offering a full portfolio; catering to surgeons’ preferences, international market trends and requirements as required in tender submissions on a global scale. This involves meeting all regulatory requirements – including, but not limited to, being prepared for MDR and specific local regulatory requirements. We employ a fully dedicated group of professionals for this – they’re also currently preparing our submission for FDA approval. This will allow surgeons and patients in the USA to benefit from Tsunami Medical’s unique surgical solutions.

What makes Tsunami medical stand out from 3D printed titanium cages currently available on the market?

An industry colleague once asked me why we’re focusing on cages when “you can buy them in any supermarket nowadays?” He suggested all suppliers offer 3D printed cages now which is true to some extent.

However Tsunami Medical’s 3D printed solutions really are both innovative and unique. Looking at the history of cages in general, the first generation were solid Titanium cages that were nothing like natural bone – they were hard as stone, causing most of them to subside into the vertebral bodies.

Serious issues in radiological imaging then prompted the industry to move to another material – PEEK. This is radiolucent and has an elasticity similar to natural bone. However, over the years, we’ve learned nothing beats PEEK – whereas the main purpose of an interbody cage is to remain or restore stability of the vertebral segment by building a bony bridge. The industry’s solution? Alternative manufacturing options including 3D printing which seems to be the holy grail nowadays.

3D printing allows implant designs which can’t be achieved with traditional manufacturing –bone grows on the fine structures of the implant and even radiological imaging characteristics are satisfactory. However most suppliers chose to manufacture a 3D printed version of their original PEEK design. When it comes to implant stiffness, this is like going back in time!

Tsunami Medical’s solutions outshine others by offering an implant design with better elasticity than PEEK – similar to natural bone.

Together with excellent stability characteristics – due to the unique net structure, geometrical design, pore size and surface roughness – Tsunami Medical’s Bone Ingrowth technology cages are both innovative and unique. Our 2nd generation cages have a built-in fixation mechanism that uses pins instead of screws; other than with screws, no additional material is required for which means its elasticity isn’t compromised.

How do you see the future of 3D printed spinal implants?

I see a bright future for 3D printed spinal implants, but only for those that offer modern Bone Ingrowth technology. Implants that show an elasticity similar, or at least as close as possible, to natural bone and with regards to pore size, surface roughness and geometrical design allow bone growth cells to do their job. This, along with satisfying radiological imaging characteristics, suggests a great future for 3D printed implants.

What can people do to learn more about Tsunami when they’re interested in using or distributing your products?

The easiest way would be to contact me: we’re more than happy to answer any questions and consider all distribution opportunities. Alternatively, you can head to our website or visit Tsunami Medical’s sales professionals during international exhibitions. We will be at EuroSpine in Vienna from 6th – 8th October. When COVID travel restrictions are lifted, although not exhibiting, I will also be at NASS, in Boston USA from 29th September – 2nd October.