As a neurosurgeon at Danbury Hospital, with a specialty training in strokes, Dr. Joshua Marcus spends much of his time in the operating room performing surgeries that involve the cranium.
“For treatment of a stroke, hemorrhaging, or vascular disorders of the brain, a decompression surgery is sometimes necessary where patients need to have part of the skull taken off to relieve pressure,” Marcus said.
Those types of surgeries also require surgically-created cranial pieces to be reconstructed, which has created a market opportunity for Canton-based Kelyniam Global, a maker of custom cranial implants that uses 3D printing as part of the manufacturing process.
The global cranial implant market, valued at nearly $1 billion in 2018, is forecast to grow 6.4% annually through 2026, driven by the increasing prevalence of neurological diseases, traumatic brain injuries, and an aging population, according to Grandview Market Research.
Although a small competitor in the implant market compared to giants like Johnson & Johnson and Stryker, Kelyniam has carved out a niche through its proprietary design, the durability of its product and its industry-leading ability to deliver custom implants within 24 hours.
Those competitive advantages have allowed Kelyniam to grow over the past three years under CEO Ross Bjella, who has led the company since 2017.
In 2020, despite a steep decline in surgical procedures nationwide during the pandemic, Kelyniam saw its total revenue increase by 15% to $2.5 million. It also returned to profitability, a year-three goal of Bjella’s five-year plan to turn around a company that had been struggling to turn a profit since its founding in 2007.
The turnaround has been fueled by an exclusive focus on its core product, custom-made implants of medical-grade plastic, which contain a trademarked fixation feature, similar to screw holes, that enable surgeons to more easily reconstruct a skull and with a more cosmetically-appealing end result for patients.
Chris Breault, Kelyniam’s chief operating officer, says the company’s 3D-printed pieces, which are each created in consultation with the doctors performing the surgery, are crafted to exact specifications, based on a computer-aided design from a patient’s CT scan.
The company, which is publicly-traded as an over-the-counter stock, uses the 3D model to ensure the best outcome for every surgery. The benefit to both patient and surgeon is a custom product that fits like a puzzle piece into the part of the skull that needs to be reconstructed.
“Our piece just fits right in, so doctors don’t have to mill out [skull] bone,” Breault said.
That not only saves time, but minimizes risk to patients versus conventional reconstruction methods that frequently rely on metal plates — mostly titanium — or bone cement, which can increase the risk of complications and infections, Breault explained.
Kelyniam uses PEEK (polyether ether ketone), a thermoplastic polymer to create its finished products. Breault says it’s ideal material because it has strength, ductility and stiffness — all good qualities to replicate a skull — but also is biocompatible with living tissue, meaning it does not produce a toxic or immunological response when exposed to the body.
But it comes with a costly price tag, says Bjella. A single slab of PEEK can run between $30,000 to $40,000, placing a premium on Keylniam’s manufacturing efficiency.
“We’ve designed different fixtures to enable our five-axis cutting tools to more efficiently create our implants,” he said.
Bjella credits much of his company’s success to the highly-skilled employees who operate the Canton-based manufacturing facility.
“We’ve been able to find employees in the Greater Hartford area who have unique knowledge around modeling and 3D printing,” Bjella said, noting the company has managed to increase its number of employees by 30% over the past three years.
To ensure it could keep its talent and the company on track with his five-year growth plan, Bjella secured federal Paycheck Protection Program funding last year. The additional funds helped the company weather the loss of business in certain parts of the country, as COVID spikes fluctuated geographically throughout the year.
“Early on, the Northeast was [almost] entirely shut down and that was a large [portion] of our business,” Bjella explained. “By the fourth quarter, western states started shutting down.”
With vaccinations increasing, Bjella said he is bullish on his company for 2021. Now in his fourth year of leadership, he is looking to expand Kelyniam’s product offerings with the longer-term goal of doubling the company’s market share in the $150 million to $200 million U.S. cranial implant market from roughly 2% to 4%.
He says one of the big challenges a small company like his faces is that many larger competitors whose suite of products include medical implant devices, often lock healthcare systems into bundled contracts. That creates even more incentive for Bjella to innovate.
In addition to 3D-printed technology, Bjella — who has a background in software — sees numerous software-based opportunities such as augmented reality or virtual reality, specifically for neurosurgeons.
He’s also open to the possibility of adding to the companies’ product line by acquiring a smaller medical device company that is struggling with regulatory or manufacturing requirements the industry demands.
But as surgeons, patients and insurers look to save time, reduce risk, and provide better long-term outcomes for cranial surgical patients, companies like Kelyniam are positioned to grow.