stimOS
Functionalizing Implants With Mimicking Bone Technology

When it comes to orthopedic implants, medical device manufacturers incorporate titanium or polymers like polyether ether ketone (PEEK) or polyaryletherketone (PAEK) in their products.

Bypassing the overarching drawbacks of both types of implants with its Mimicking Bone Technology (MBT) is stimOS. Its stealth surface modification technology functionalizes implant surfaces and offers unique osseointegrative characteristics that support early bone formation and proper anchorage. The technology functionalizes implant materials, biochemically using a covalently bonded surface layer.

stimOS aims to transform implant solutions from an artificial barrier in a patient’s body to a bony surface unsusceptible to allergic reactions, inflammatory responses, infections, bacterial attacks, and postoperative complications.

The Best of Both Worlds

In search of a solution that can strike the perfect balance between metallic and polymer-based implants, many manufacturers and suppliers spray-coat their implants with titanium powder to boost osseointegration. However, melting titanium powder onto a core implant may expose patients to inflammatory reactions, delamination, and abrasion risks. Even in surgical settings, the mechanical force applied by a surgeon hammering in the implant can create surface cracks that scatter titanium-nanoparticles away from the coating, which may cause adverse reactions.

The risks of titanium-coated implants can also expose tissue or the implant’s surface to bacteria under the bone cells and contribute to implant loosening. In these cases, bacteria create a fibrotic layer on the implant surface that may need advanced after-surgery medications, complicating the healing process for patients resistant or sensitive to antibiotics. Dedicated to creating patient-friendly products, stimOS’ solutions mask the implant material to curate a stable, anatomy-anchored surface that is no longer recognized as foreign body. It also delivers clinical data to benefit clinicians wanting to address bone adherence for their dental, hip, knee, bone fractures, and other surgeries that require implant anchorage.

stimOS’ solutions comply with all quality and mechanical mandates, passing every manufacturer’s implant-related (pre-)clinical evaluations. The company also supplies MBT to other legal manufacturers looking to shift from titanium-based treatments to licensed bio-inspired smart implants or to legal manufacturers that want to enhance the osseointegrative characteristics of their titanium implant and mask the implant’s surface with a highly bon-cell-responsive integration layer.

A Proven Technology Enabler for Better Implants

Titanium implants react with bodily fluids to develop a titanium dioxide layer that promotes osseointegration. They have multiple drawbacks, including an increased susceptibility to corrosion, complicated bone growth detection in X-rays and CT scans, and stiffer mechanical stability compared to human bone.

Polymers, alternatively, are biocompatible with a higher elastic modulus for safe nearerto- bone implants.Their radiolucency helps detect bone growth through CT scans and X-rays.

Despite these promising material characteristics, these implants are bio-inert.

Within the orthopedic market where metal and non-metal advocates co-exist, stimOS’ technology acts as the bridge showcasing how metallic implants can have enhanced osseointegrative, osseopromotive, and anti-corrosion characteristics. For example, despite many organizations using additive manufacturing methods like electron beam melting to enhance osseointegration, the final products are expensive and still vulnerable to corrosion. With MBT, which uses natural substances, companies can ensure their products bypass the traditional metallic implant disadvantages.

I Use My Regulatory Affairs Expertise And Certification Knowledge As A Univ.-Lecturer At Swiss Federal Institute Of Technology Zurich (Eth Zurich) And Catarina University Of Applied Science (Dental Applications) To Train And Educate Customers On The Fundamental Regulatory Aspects Of Bringing Their Implants To Market

“Unlike titanium plasma coatings, our MBT solution creates a modified biochemical, covalently bonded surface using gelatine, hydroxyapatite (HA) and calcium phosphate to produce a natural bone-like structure that boosts cell and bone growth,” states Dietmar Schaffarczyk, CEO of stimOS, “enhancing osseointegration and anti-inflammatory characteristics for both – polymer and titanium - materials.”

Generally, performing covalently bonded surface coating requires a laboratory, a clean room, lab experts, chemists, and expensive technologies. Recognizing this, stimOS offers a complete laboratory environment in a highly portable, pre-packaged solution, including an automated machine developed to run necessary chemical processes. The size of a refrigerator, this equipment is as affordable as leveraging conventional settings used for plasma spray coatings, titanium laser-sintered and EBM implants, without their drawbacks.

Equipping implant manufacturers with this modular biochemical system, stimOS is a technology supplier providing a much-needed plug-and-play solution for accessible implant surface treatments.

Alternatively, when conventional suppliers need help handling emerging regulatory requirements of working with implant manufacturers, stimOS helps them successfully navigate their implant certification processes. This immensely benefits businesses under-equipped to cope with the ever-changing regulations across Europe, and beyond.

“I use my regulatory affairs expertise and certification knowledge as a Univ.-Lecturer at Swiss Federal Institute of Technology Zurich (ETH Zurich) and Catarina University of Applied Science (dental applications) to train and educate customers on the fundamental regulatory aspects of bringing their implants to market,” says Schaffarczyk.

Offering comprehensive, in-house regulatory affairs knowledge, stimOS can deliver innovative solutions across three prominent regulatory landscapes—the EU’s Medical Devices Regulation (MDR), the U.S. Food and Drug Administration (FDA), and Brazilian Health Regulatory Agency (Anvisa).

Driven by its ISO-certified and GMP based solutions, robust regulatory and certification pathways, authentic technology, and all-time accessible validation data, stimOS shortens a customer’s time-to-market, replacing the need to self-perform various time-consuming cell tests and procedures (for validating their product and its components) with simplified market access.

A Comparative Animal Study Turned Into a Successful Solution

Recently, stimOS conducted an in vivo comparative animal model testing in collaboration with the University of Zurich and Charité-University Medicine, Berlin, to confirm the effects of its MBT-driven implant materials. This model aimed to eliminate the need for additional medication and minimize the risk of infection and inflammatory reactions while supporting early bone formation and proper implant anchorage. Initially, 36 cylindrical test implants with an external thread were produced by turning round bars of pure titanium, PEEK, and HA-enhanced PEEK to compare with MBT surfaces. stimOS then used a reliable pelvic sheep model in order to have a close comparison to human bone.

Mika Reinauer, Shift Manager at stimOS, loads thesemi-automated coating machine to start the MBT process.

In this case, stimOS installed implants in the sheep’s cranial left and right pelvis with their positions alternating on either side of the lilac bone’s gluteal lines, allowing it to place implants without jeopardizing the animal’s wellbeing. After two weeks of implantation, MBT boosted bone in-growth, demonstrated through fluorescent images showcasing a high bone-implant contact (BIC) percentage. Eight weeks later, the implants were examined to corroborate PEEK-MBT’s ability to fill the screw threads and anchor surrounding healthy bone without damaging it, eliminating the possibilities of any inflammatory reaction, aseptic loosening, and fibrotic layer growth. This study was done according to GLP standards to pass regulatory clearance, empowered by the precise results displaying enhanced osseointegrative characteristics, biocompatibility, and bone deposition.
stimOS also performed many in vitro comparative cell tests to verify PEEK-MBT’s cell adhesion, viability, and proliferation benefits against PEEK, titanium, and HA-enhanced PEEK materials. These tests’ outcome proved that MBT-treated surface effectively “heals” bone tissue, delivering high osteoblast proliferation and intensive formation of mineralized bone modules.

Performing similar clinical trials to understand a product’s usability, stimOS deploys a risk analysis for its in vivo and in vitro animal models, supporting subsequent human model testing. stimOS MBT is certified according the recently published S.P.E.L. requirements (Safety and Performance Evidence Level) and thus provides and guarantees most transparency to stimOS’ customers.

Currently, stimOS is focusing on spreading awareness of its MBT technologies to support implant manufacturers in boosting their product applicability and impact, acting as the gold standard in the domain. stimOS is poised to continue providing its technology to legal manufacturers looking to promote the osseointegrative and osseopromotive characteristics of their implants.