Orthobond has received new FDA approval for its Ostagard antimicrobial technology. This technology could be used in a wide range of medical devices in the future, not just medical devices.
For the first time, the Monmouth Junction, N.J.-based device developer has received FDA approval for a new application for a non-leachable coating designed to actively kill bacteria that can contaminate the surfaces of medical devices. He said that.
Orthobond was founded by Jeffrey Schwartz, professor emeritus of chemistry at Princeton University, and the late Dr. Gregory Lutz, chief physical therapist emeritus at the Hospital for Special Surgery. Lutz, who died of cancer on March 5, knew FDA approval was on the way.
Orthobond CEO David Nichols said in a statement shared with Mass Devices that the FDA approval is “a testament to Gregory's legacy.” “We are proud to take it into its next chapter.”
In an exclusive interview with MassDevice, Nichols, a former Zimmer Biomet executive, said the first application will be an Ostergard-treated Seaspine Mariner pedicle screw, which could be used in patients early next year.
Orthobond's proprietary technology is a quaternary ammonium compound coating that is highly effective at neutralizing a variety of bacteria that cause most device-related infections and can be applied to almost any device, he said. Ta.
The Ostergard method permanently modifies the surface of the device and mechanically disrupts the cell walls of bacteria, viruses, and fungi. If these infection-causing microorganisms are present in the operating room, they can adhere to the implant after it is removed from the sterile package or when it is placed in the patient's body.
Unlike antibiotic elution devices, Ostergard does not use antibiotics, so there is no risk of developing drug-resistant superbugs. And while antimicrobial materials such as silver, palladium and copper can kill bacteria, these toxic metals are not biocompatible with human tissue, Nichols said.
“They've been a barrier for decades,” he says. “[Ostaguard] This is a completely new category for the FDA. It never comes off the device – it's considered a device – and actively kills bacteria. ”
The FDA gave this new category the common name “quaternary ammonium compound-coated spinal fixation devices,” and added, “single or multiple spinal fixation devices intended to facilitate immobilization in skeletally mature patients. defined as “a rigid metal implant device or system consisting of components”. The device contains a quaternary ammonium compound coating covalently bonded to the device. When applied, the coating is intended to reduce microbial contamination of the device surface prior to implantation. This device does not contain any antimicrobial agents that act in or on the body, and this type of device does not contain combination products. ”
According to the approval letter shared by Ostergard, the FDA has classified the product as a Class II device and established special controls, which Orthobond declined to disclose.
Nichols said Orthobond tested Ostagard against more than a dozen types of microorganisms that cause device-related infections on a variety of surfaces. These studies (submitted to FDA and considered in FDA review) showed that the technology was safe for mammalian cells, but not for Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and methicillin-resistant Staphylococcus aureus (MRSA). ), was shown to be lethal to microorganisms such as E. coli. . Cloaca and C. acnes.
Orthobond said it found no evidence of local or systemic toxicity in sheep, guinea pig and dog trials, but the coating technology has not been evaluated in human clinical trials.
According to Orthobond, the technology's intellectual property extends to 2037 through three patent fences covering covalent surface chemistry, antimicrobial layers, and analytical processes, including 27 patents and 12 pending applications. It is said that it will be protected.
Orthobond plans to obtain 510(k) clearance for additional orthopedic spinal implant indications before expanding into other areas such as joint reconstruction, oncology, sports medicine, plastic surgery, and cardiovascular.
“We're working on neuromodulators, we're working on trauma devices, we're going to be working on cochlear implants,” Nichols said. “If you have a cochlear implant and you get an infection, you almost lose your hearing. That's what they want to solve.”
“We want to be as broad as possible,” he continued. “…this should be on every device that is used. There's no reason why it shouldn't be. If you're going to package it as sterile, why not put an antimicrobial on it?”
Beyond medical technology, Orthobond leaders believe the technology has potential commercial and industrial applications in areas such as automotive, consumer products, and textiles.
Read more about how Orthobond's Ostaguard antimicrobial technology works and other potential applications on our sister site. Medical design and outsourcing.
