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Antimicrobial Coatings Closer to Commercialization

     


Coatings
Special Section 
Sponsored by

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Orthopedic Stakeholders Talk
Coating Standards

Device Companies Emphasize Coatings in FDA 510(k) Announcements

Numerate, Mayo Clinic Look to Drug and Device Combination to Coat Implants for Better
Bone Integration

Orthopedic Coatings Play Pivotal Role in
Implant Success

       

University researchers and members of industry have long considered coatings an avenue for infection prevention in orthopedic procedures. These coatings, some of which utilize silver, have largely not been commercialized because regulators seek greater evidence of their safety, creating a long, expensive road for device companies. Announcements in the last half of 2018 and early 2019, as well as conversations we’ve had with members of industry, indicate that companies continue to push toward getting these coatings on the market and that productive conversations are taking place with regulators.

aap Implantate, a public trauma company based in Germany, reached significant milestones for its silver coating technology in 2018. The company received approval from the Federal Institute for Drugs and Medical Devices to conduct a human clinical trial, which is expected to launch in 1H19. An initial grant of €0.7MM (~US $0.8MM) from the German federal government will address expenses for study concept and qualification.

aap says its silver coating technology has several unique propositions, including high stability, good biocompatibility and cost-effectiveness that is scalable to higher production volumes. The company is applying the coating to the LOQTEQ® plating system though emphasizes it will be a platform technology. In that vein, aap is initiating joint product development and approval projects with companies and seeks U.S. FDA approval, as well as a CE Mark.

Antimicrobial coated products are on the market in Europe and being sold in trauma by large strategics like Stryker and small startups like Silver Bullet Therapeutics. Our conversations with two manufacturers indicate that FDA has provided them a path to regulatory guidance—one that is less stringent than in years past.

Most recently Bio-Gate, a provider of antimicrobial products and multifunctional surfaces, publicly announced that during an FDA pre-submission process they identified that a 510(k) route without human data is available for certain orthopedic products. Bio-Gate's HyProtect coating is an ultra-thin plasma coating of pure silver and polysiloxane.

We believe that this is an exciting area in coatings that will gain more attention in years to come. As companies that are early to commercialize these coatings prove their success, we expect antimicrobial coatings will see greater commercialization.

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