A rather unusual pet project has evolved into a full-time undertaking for Kaarlo Paakinaho.
Paakinaho developed an interest in bone graft substitutes while working on his doctoral dissertation at the Tampere University of Technology in 2007–2008. He realised that the bioceramic materials that had been used and proven safe in medical procedures for decades had suboptimal properties.
“Their usability, given that they were hard and brittle, wasn’t something that in my view made the surgeon’s work easier; in fact, it was one of the main factors limiting their use even though they were great in terms of biological activity,” he tells. “They’ve since been refined into a toothpaste-like form, but surgeons aren’t fans of that either.”
“I had a lab at my disposal and, as a hobby, I set out to see if I could create a material that makes bone substitutes flexible and resilient – mouldable – instead of brittle.”
With a background in the processing of biodegradable components, he began to experiment with various combinations of materials that had already been approved for clinical use in order to facilitate the approval procedure. The answer, he discovered, was supercritical carbon dioxide, which is not only produced naturally by metabolism and therefore completely safe, but also functions as a softener and solvent.
“It can be used to make a composite material porous or frothy,” he highlights. “And you don’t have to prove that all the solvents have been removed when none are used in the first place.”
He continued to work on the project on his own time together with a colleague for two-and-a-half years, gradually pushing it forward through several funding rounds. It was the fifth round that finally caught the attention of Tekes, the predecessor of Business Finland.
After three years of further product development, it was time to explore the commercial potential of the solution. Tekes chipped in again, bringing its contribution to the project to around one-and-a-half million euros and enabling the team to proceed to pre-clinical testing.
“Based on the results, we sent patent applications and decided to found a company to commercialise this,” tells Paakinaho.
And so Biomendex was born, in October 2018.
Millions of operations a year
The Tampere-based six-person startup is currently preparing its clean rooms and acquiring equipment, with a view to securing the requisite health, safety and environmental certificates for the clinical use of its proprietary bone graft substitute, Adaptos.
“Clinical testing on humans is set to start this spring. It’ll be used first to fill the sockets after tooth extractions,” tells Paakinaho.
Bone grafts and substitutes are used annually in up to four million procedures, including spinal, oral and dental, orthopaedic and osteoarthritis surgeries. The global market for bone grafts and substitutes is expected to grow to over five billion US dollars by 2027, according to Market Research Future.
Roughly two-thirds of the operations presently involve the use of autologous grafts – bone transported from another part of the patient – and thus consist of two separate procedures and create additional costs for the hospital.
“Statistically every other patient experiences mild and roughly one in five more serious complications, such as prolonged pain, bleeding and neural damage, at the harvest site of the graft,” says Paakinaho.
“There also aren’t too many sites in the human body suitable for harvesting bone,” he adds.
A standard in the making
Biomendex, he underscores, is not aiming so much to compete against the existing synthetic bone substitutes, but rather to offer a more user- and patient-friendly alternative to bone grafts with the same technical properties.
“The idea is that it’s as similar as possible to a real bone graft,” he sums up. “It gives the surgeon the opportunity to focus on the procedure rather than the material.”
“Adaptability has been our main selling point: the material is customisable, flexible rather than brittle and doesn’t break in surgery. That’s the first material technology we’re introducing to clinical use, but we’re also able to modify it – if a surgeon wants something more rigid or durable, we can provide it.”
As Biomendex clears the regulatory hurdles to enter its main market, it intends to generate cash flow in the less heavily regulated field of veterinary medicine. Paakinaho reveals that its partnering veterinary surgeons have successfully operated on some two dozen small animals and that the product should be ready for commercial launch in the second half of the year.
“Our aim is to price the products so that the price tag doesn’t limit their use. The goal is to create a new global standard, ultimately.”
Good News from Finland is published by Finnfacts, which is part of Business Finland.