The Israeli startup Nobio Ltd., a developer of particles that can kill germs on contact, said it has received US Food and Drug Administration approval to market its antibacterial material for dental fillings.
The approval gives Nobio access to the $1.4 billion dental materials market, CEO Yoram Ashery said in a phone interview, forecasting that the first products will reach the market at the end of the year or the start of the next year an bring in revenues for the four-year old company.
Nobio will make its anti-bacterial dental filling products available to practicing dentists through its own brand as well as licensing them to other manufacturers for use in their own products, the firm said.
The startup is currently negotiating with distributors and manufacturers and intends to announce its first commercial partnerships later this year, the firm said in a statement Monday, announcing the approval.
Products that have been developed with the Nobio materials will bear a mark that indicates the reliability of its antibacterial properties, said Ashery, likening it to “Intel inside” as a mark of quality for computer chips or “Dolby” for sound systems.
The FDA nod also increases the chances for the firm to get further approvals for additional products its technology could be used for, said Ashery.
“The fact that we got our first approval is going to make the subsequent ones a lot easier,” he said. “The FDA now knows our technology.”
The startup employs some 20 people and has raised $9 million to date from investors including Israel’s aMoon Fund and Dr. Ole Jensen, a surgeon and dentist and a co-founder of ClearChoice, the largest US network of dental implant clinics, acquired by Sun Capital.
About bacteria, teeth and much more
Known as white fillings, dental composite restoratives treat tooth decay by filling cavities with materials matching a patient’s natural tooth shade and strength. More than 200 million tooth restorations are performed each year in the US alone, many to replace existing fillings that deteriorate due to bacteria that penetrates the tooth-restoration interface, which is a common site of recurrent decay. Tooth decay affects over 90% of the adult population and more than 40% of children in developed countries.
Nobio has used the anti-microbial particles it has developed to create two products, Infinix Flowable Composite and Bulk Fill Flow Composite, both of which have received the FDA marketing nod. They provide advanced, anti-bacterial material made from insoluble polymers and are designed to remain in the teeth for decades.
“Preventing the recurrence of tooth decay around dental fillings is a major challenge in everyday dentistry,” John Featherstone, MSc, PhD Professor Emeritus and Dean Emeritus at University of California, San Francisco (UCSF) School of Dentistry, wrote in a text message. “Long-acting antibacterial filling materials could have a big impact on this problem.”
Based in Petah Tikva, the firm was founded in 2015 by Prof. Ervin Weiss, an oral rehabilitation specialist and the dean of the School of Dental Medicine at the Tel Aviv University, and Julia Rothman. The technology is a spin-off from Weiss’s academic research at the School of Dental Medicine at Hadassah Medical Center in Jerusalem.
Once germs settle on a surface they grow rapidly and colonize the area by creating a glue-like matrix called biofilm, which makes the bacteria 1,000 times more resistant to antibiotics, disinfectants and the immune system. Biofilm can be found on medical devices placed in bodies — contact lenses, dental fillings, implants and catheters.
Enter Nobio, whose anti-microbial particles bind with a wide range of materials and can be incorporated into the aforementioned medical devices. As bacteria approach the surface, the particles exert strongly attractive electrostatic forces. On contact, the membranes of the bacteria are disrupted, causing them to die.
Antimicrobial resistance, or AMR, is seen as one of the greatest threats that mankind is facing, now and in the coming decades. According to a May 2016 review on antimicrobial resistance, Tackling Drug-Resistant Infections Globally: Final Report and Recommendations, chaired by Jim O’Neill, by 2050 AMR deaths will reach 10 million a year, more than all cancer deaths put together, forecast to be 8.2 million a year.
“We are a material sciences company that is developing this technology that can prevent contamination,” Ashery said in the interview. The firm started with oral cavity products, but is in talks with “dozens” of different companies in the medical devices field or in consumer products to incorporate their materials into their products and keep them bacteria free.
One such application is for breast implants, Ashery said, in a bid to avoid the creation of subclinical infection — when a bacterial film can grow and can go undetected for years until it triggers a genetic mutation that could become cancer. Earlier this month pharma giant Allergan Plc issued a worldwide recall of some breast implants, as they were linked to a rare form of cancer.
“We are working with some of these major” breast implant companies, he said.
“There is a big concern” that not enough is being done about antimicrobial resistance, Ashery added. Drugs will never be able to catch up to all of the constantly changing bacteria, he said. One way to tackle this is via prevention, which is where Nobio comes in, and another way is through developing rapid diagnostics.
“Not enough is being done to prevent the potential pandemic of microbial resistance,” said Dr. Yair Schindel, co-founder and managing partner of aMoon, the main investor in the startup. “Nobio’s technology is rare in the breadth of its potential to affect healthcare in so many areas.”