Periodic Reporting for period 1 - AmbiJet (AmbiJet: the world’s first and only highly effective plasma-based solution for Europe’s 16 Million periimplantitis patients urgently needing help to avoid losing their dental implant)
Période du rapport: 2022-10-01 au 2023-09-30
A healthy smile is a valuable asset for work, our everyday life and overall health. It plays an enormous role in self-esteem and social integration. In Germany, adults are missing 2 teeth on average, elderly are missing more than 9 teeth. Every eighth senior has no natural tooth at all! Worse: those oral health statistics are among the best in an international comparison.
This explains why so many implants are inserted in the EU (>7 million in 2022), with a strong YoY-growth. It is estimated that a total of 88 mio. dental implants have already been inserted in the EU by the end of 2022. On one hand, implantology is a powerful tool to fight edentulism. On the other hand, implants poses a challenge: Studies show that 60% get infected by bacteria within a few years, which lead to oral health issues, up to the implant loss. Moreover, oral health is related to systemic diseases and can trigger or aggravate illnesses such as cardiovascular diseases, strokes, diabetes or premature births.
We developed AmbiJet to improve the oral health and quality of life of patients with dental implants. AmbiJet disintegrates biofilm and inactivates bacteria to stop periimplantitis. It is a game-changing medical device for a highly effective, safe and healthier implant care. With AmbiJet, Freiburger Medizintechnik (FrMED) is pushing the boundaries of plasma medicine. Dentists are given an new option to disinfect the surface of the implant, prevent reinfection and promote cell adhesion to support the healing process. AmbiJet is the solution that dentists and patients are waiting for. It is a unique one-button technology for a rapid, painless, and effective solution to save dental implants and smiles, without adverse side-effects.
The overall objective of this project is the transfer of the technology to the market. Turning the prototype into a CE product includes regulatory certification, mass-manufacturing and a successful marketization.
This explains why so many implants are inserted in the EU (>7 million in 2022), with a strong YoY-growth. It is estimated that a total of 88 mio. dental implants have already been inserted in the EU by the end of 2022. On one hand, implantology is a powerful tool to fight edentulism. On the other hand, implants poses a challenge: Studies show that 60% get infected by bacteria within a few years, which lead to oral health issues, up to the implant loss. Moreover, oral health is related to systemic diseases and can trigger or aggravate illnesses such as cardiovascular diseases, strokes, diabetes or premature births.
We developed AmbiJet to improve the oral health and quality of life of patients with dental implants. AmbiJet disintegrates biofilm and inactivates bacteria to stop periimplantitis. It is a game-changing medical device for a highly effective, safe and healthier implant care. With AmbiJet, Freiburger Medizintechnik (FrMED) is pushing the boundaries of plasma medicine. Dentists are given an new option to disinfect the surface of the implant, prevent reinfection and promote cell adhesion to support the healing process. AmbiJet is the solution that dentists and patients are waiting for. It is a unique one-button technology for a rapid, painless, and effective solution to save dental implants and smiles, without adverse side-effects.
The overall objective of this project is the transfer of the technology to the market. Turning the prototype into a CE product includes regulatory certification, mass-manufacturing and a successful marketization.
We successfully built prototypes of the base station and applicators that can be mass-manufactured and fit the market needs. We successfully performed and passed all necessary tests required by the European regulatory framework, incl. the Medical Device Regulation. Those tests include the electrical and general safety, usability and ease-of-use as well as the clinical requirements.
The implant is the screw placed in the jawbone and on which the crown is fixed. Bacteria are part of the oral flora. They can adhere, gather and grow at the intersection between implant, crown and bone, underneath the gum. Patients cannot clean this area with a toothbrush. Bacteria grow and cause an inflammation, the bone degrades and reduces in size around the implant, the gingiva laying on top of the bone caves in. At some point the bone has degraded so much that the screw becomes visible. At a later stage of the disease, the implant loses its integrity in the jaw and must be removed.
This is called periimplantitis and is considered a major and growing problem in dentistry. Recent industry-independent studies showed a dramatic progression of this disease over time. After 5 years, a third of all implants are affected; after 9 years, 60% of all implants present a bone loss of about 30%. In Europe, we estimated that >22 million dental implants required a treatment in 2022. This number will soar to 28 million by 2024. Dentists are facing periimplantitis every day. The commonly applied therapies are based on a combination of mechanical, physical, chemical and pharmaceutical measures that were designed for other diseases and are not adapted here.
In contrast, AmbiJet goes far beyond state of the art. It is a device that generates and uses a plasma jet to clean and save dental implants. Plasma is an electrically activated gas, and can be designed to kill and disintegrate microorganisms, like bacteria, viruses and fungi. The treatment does not lead to the development of multi-resistance as antimicrobial agents do. In dentistry as in all fields of medicine, a race takes place between bacteria and body cells; AmbiJet tailors the surface properties of the implant to reduce bacterial reinfection and improve cell adhesion. Per design, the plasma jet is guided towards the implant; thus, AmbiJet proved a much higher efficacy than any competing treatment option, without harming the surrounding tissues. Moreover, the crown, which is fixed on the dental implant inserted in the bone, does not need be removed for the treatment. With AmbiJet, dentists get an easy-to-use device for a holistic therapy concept to reliably treat periimplantitis.
This is called periimplantitis and is considered a major and growing problem in dentistry. Recent industry-independent studies showed a dramatic progression of this disease over time. After 5 years, a third of all implants are affected; after 9 years, 60% of all implants present a bone loss of about 30%. In Europe, we estimated that >22 million dental implants required a treatment in 2022. This number will soar to 28 million by 2024. Dentists are facing periimplantitis every day. The commonly applied therapies are based on a combination of mechanical, physical, chemical and pharmaceutical measures that were designed for other diseases and are not adapted here.
In contrast, AmbiJet goes far beyond state of the art. It is a device that generates and uses a plasma jet to clean and save dental implants. Plasma is an electrically activated gas, and can be designed to kill and disintegrate microorganisms, like bacteria, viruses and fungi. The treatment does not lead to the development of multi-resistance as antimicrobial agents do. In dentistry as in all fields of medicine, a race takes place between bacteria and body cells; AmbiJet tailors the surface properties of the implant to reduce bacterial reinfection and improve cell adhesion. Per design, the plasma jet is guided towards the implant; thus, AmbiJet proved a much higher efficacy than any competing treatment option, without harming the surrounding tissues. Moreover, the crown, which is fixed on the dental implant inserted in the bone, does not need be removed for the treatment. With AmbiJet, dentists get an easy-to-use device for a holistic therapy concept to reliably treat periimplantitis.