New Implant Coating Destroys 99.999% Bacteria – The New Standard

On Friday, April 5, the FDA granted De Novo authorization to a new standard in antibacterial technology.

The new technology, being brought to market by New Jersey-based Onkos Surgical, covered by 27 patents and tested in 63 studies, obliterates 99.999% of both gram-negative and gram-positive bacteria that land on an implant surface.

Several authors and researchers have described “the race to the surface” theory which characterizes the contest between the body’s natural healing response and the potential for microbial colonization on the surface of an implant.

With this announcement, that race to the surface, by virtue of Onkos Surgical’s technology, is tilted 99.999% against bacteria commonly found in the OR.

Onkos Surgical announced this ground-breaking news on April 5 and OTW had the opportunity to interview Onkos CEO and Co-founder Patrick Treacy, and Chief Commercial Officer Sean Curry shortly after their announcement.

“We’d been looking at anti-bacterial technologies for a very long time. We wanted to find a technology that would address bacterial contamination but not contribute to bacterial resistance. Also, we wanted to find a technology that did not elute and that could be considered a Class II medical device regulatory pathway,” said Patrick Treacy.

Onkos and Orthobond Partnership

Treacy and his team found this technology at New Jersey-based Orthobond Corporation. “The fundamental technology came from intellectual property spun out of Princeton University and Orthobond had been advancing the platform. Throughout this process, Orthobond has been a great partner to work with,” recalled Treacy. Onkos became Orthobond’s technology partner.

*Schematic showing the chemical structure of the quaternary ammonium compound with positively charged nitrogen ions. / Source: Onkos Surgical*

“Onkos has an exclusive license with Orthobond for musculoskeletal oncology, pelvic reconstruction and modular revision implants,” said Curry. “This field of use is particularly valuable in patients with bone loss due to tumor, trauma, and revision procedures where there is a higher rate of complication due to sickness and prolonged procedural time.”

Onkos developed applications of the technology to their products using translational research and preclinical data to support their own De Novo application. The technology covalently bonds an anti-bacterial compound to an implant’s surface—effectively making the implant itself anti-bacterial.

“Covalent bonding is effectively permanent bonding to the implant. Our anti-bacterial technology essentially becomes an integral part of the implant. This formulation of the coating creates a polymeric chain and on the end of that chain we attach quaternary ammonium. All of this happens at the nanoscale,” said Treacy.

“The coating is about 70 nanometers thick. Human hair is about a hundred thousand nanometers. Extremely thin but devastatingly effective against any bacteria that lands on the implant surface. When bacteria come into contact with this coating, its cell walls disrupted, and the bacteria die

Onkos Surgical

When Patrick Treacy and Tony Koblish founded Onkos in 2015, they made complex orthopedic problems—revision and limb salvage surgeries—the target of their research and product development. “When we started Onkos, we did some research that put a spotlight on addressing three key areas of innovation:

reducing procedural complexity
advancing the value of personalization in complex procedures and
addressing clinical challenges.

That same data pointed to unmet needs in reattaching soft tissue implants, aseptic loosening, and bacterial contamination.

In OTW, we’ve covered Onkos’s remarkable journey so far.

Onkos has demonstrated a cadence of innovation over the past several years using new technologies to address soft tissue reattachment to implants and address aseptic loosening, which are common modes of implant failure.

With the April 2024 announcement, Onkos dramatically took a major step forward in its third major innovation goal—bacterial contamination.

Bacterial Reduction at the Implant Surface

“Bacterial contamination is a complex, multifactorial, and multivariate problem. Surgeons and staff have struggled over the years to reduce bacterial contamination in the operating room—double gloving, draping, gowning, laminar flow, ultraviolet lights, reducing traffic, skin prep, amongst others. And yet, despite all that, the problem of bacterial contamination in the operating room remains,” explained Treacy.

Onkos’s anti-bacteria coating, which have now been authorized for commercial sale by the FDA, are indicated for reduction of bacterial contamination on the implant in the operating room at the time of surgery prior to implantation.

FDA De Novo Authorization and 63 Studies

A De Novo designation means that the device is a first-of-its-kind.

In FDA terms, it’s a device for which there is no predicate. Furthermore, the FDA has also determined that this novel medical device provides “reasonable assurance of safety and effectiveness for the intended use.” (Source: FDA).

This work is groundbreaking. Since the FDA launched its De Novo program in 1997, only 9 orthopedic implants have received De Novo authorization. This technology represents the 10th De Novo authorization. By contrast, approximately 12,000 orthopedic devices received 510(k) decisions during the same period of time.

“We worked closely with the Agency. The technology is regulated as a Class II medical device”, explained Treacy. “The data generated to support this De Novo submission is in many ways on par with what is required for a PMA [pre-market approval], with one exception: we were not required to do human clinical trials. Our team completed 63 distinct studies to support the safety and efficacy profile of the technology. Several of those studies were novel and required scientific breakthroughs to achieve the desired results. We achieved a lot of ‘firsts’ in the process,” said Treacy.

This technology is not a drug; the implant is classified as a device that leverages a proprietary coating to reduce bacterial contamination. “With the global concern of the healthcare community regarding the development of resistant organisms, it was crucial to support antibiotic stewardship in the forefront of the technology development,” explained Treacy.

*Cross sectional histology image of an antibacterial coated Onkos surrogate implant and screw demonstrating bone and soft tissue apposition in an ovine femur. / Source: Onkos Surgical*

“To validate that the technology did not create bacterial resistance, Onkos and Orthobond developed highly sophisticated testing models to validate that the technology not only killed bacteria but did not lead to resistance over time. The studies we conducted demonstrated that gram-negative and gram-positive bacteria exposed to the surface, through multiple generations, did not show any evidence of increased resistance to the surface. Further, these bacteria, over the course of the multiple generations, did not demonstrate any resistance to multiple classes of commonly used antibiotics.”

Onkos will be introducing its new anti-bacterial coated implants later in 2024 starting with the ELEOS™ Limb Salvage System and the company will proliferate it across its entire portfolio of implants.

NEXT STEPS

The Onkos team is, understandably, excited about the FDA’s authorization and the promise the technology holds for patients. “With this technology, we’ve achieved something that nobody else has in the history of orthopedics and multiple surgeons have told us this could be one of the most meaningful advancements in orthopedics over the last 30 years,” said Patrick Treacy.

Onkos is now scaling up manufacturing from laboratory scale to full production. Surgeons should expect to see the ELEOS™ Limb Salvage anti-bacterial coated implant by the end of 2024.

For more information: https://onkossurgical.com/.