23 May 2014
Contract manufacturer selected following earlier development of novel CO2 source with Coherent.
Cogmedix, a Massachusetts manufacturer of medical lasers, is to produce the novel carbon dioxide laser system for dental applications that has been developed by Convergent Dental and laser specialist Coherent.
Convergent has just selected Cogmedix, which is a subsidiary of Coghlin Companies, Inc., as its contract manufacturing partner to bring the “Solea” dental laser system to market.
Described as the first CO2 laser system to be cleared by the US Food & Drug Administration (FDA) for hard and soft tissue ablation, it features a 9.3 µm source to precisely match the absorption profile of dentin and tooth enamel.
Regular CO2 lasers operate at 10.6 µm, and so Convergent worked with Coherent to develop a source using the O18 isotope of oxygen in the system, to alter the emission wavelength.
Convergent says that the system is fast, precise and virtually noiseless, but perhaps its most notably – certainly as far as anybody with a long-standing fear of the dentist’s drill is concerned – is that it is said to enable anesthesia-free procedures in the vast majority of cases.
“Solea completely changes the dental experience for both the patient and the doctor,” said Matt Giza, VP and general manager of Cogmedix, in a statement from the contract manufacturer and Convergent. “Cogmedix is proud to help bring this innovative technology to the market.”
“Solea is a game-changer,” added Michael Cataldo, Convergent’s CEO. “We have eliminated the noise, the vibration and the needle from most dental procedures, resulting in an entirely different patient experience, a true paradigm shift.”
“Cogmedix’s medical device manufacturing expertise, their ability to meet FDA regulations and their willingness to totally integrate with our team gave us exactly what we need in a manufacturing partner.”
According to the two firms, Cogmedix is providing Convergent Dental with a turnkey manufacturing solution for Solea, including sourcing and inspection of materials, assembly, comprehensive product testing, and packaging for shipment.
Last month, Coherent CEO John Ambroseo said that he had personally witnessed a Solea demonstration, with patients - including children – vouching for the pain-free experience. Convergent says that 95 per cent of dental procedures with the source can be done without the need for anesthetic.