Convergent Dental’s Solea CO2 dental laser system receives FDA clearance

Convergent Dental, Inc.Aug 1 2013

Convergent Dental, Inc., a privately held dental device and technology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared Solea™ for ablation of hard tissue for caries removal and cavity preparation. Solea is the first CO₂ laser technology system that has received FDA clearance for hard tissue indications. The FDA clearance news follows the company's recent FDA clearance for soft tissue indications in February 2013. Solea is expected to set a new standard for speed and precision for cutting hard and soft tissue in the oral cavity. Today, Convergent Dental also announced the closing of Series A & B funding rounds totaling over $13.5 million.

“Receiving FDA clearance for hard tissue indications allows dentists to put the drill away for the vast majority of hard tissue procedures for the first time, and even more importantly eliminates the notorious drill-dread anxiety for patients”

Solea is the first 9.3µm CO₂ Computer Aided Preparation (CAP) dental laser system on the market that uses pulsed energy, and other highly-advanced, patented technologies to safely and effectively cut hard tissue and perform incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity.

"Receiving FDA clearance for hard tissue indications allows dentists to put the drill away for the vast majority of hard tissue procedures for the first time, and even more importantly eliminates the notorious drill-dread anxiety for patients," said Michael Cataldo, Chief Executive Officer, Convergent Dental. "Our goal from the outset was to partner with the dental community to develop a computerized laser system for hard tissue preparation that they could master in a day and felt as easy and familiar as a drill but without the dread, and we're very excited to have achieved that. We are also very pleased to have closed our funding rounds which will anchor our continued product research and development focus and market growth strategy."

Solea Key Differentiators:

• Solea is virtually silent, vibration-free and can completely replace the need for drills or needles in a vast majority of procedures.
• Solea's wavelength, 9.3µm, is different from the naturally occurring CO₂ laser wavelength, 10.6 µm, because the oxygen molecules in the laser system are of the oxygen-18 isotope.
• Solea's 9.3 µm CO₂ cuts soft tissue more precisely and cleanly than other CO₂ soft tissue lasers on the market.
• Solea is very fast and unlike erbium, does not require a drill to cut smooth margins, between teeth or decayed enamel.
• Solea's computer-controlled mirrors are capable of moving 10,000 times per second, distributing a pre-defined beam in selectable patterns that optimize speed and precision.
• Solea's variable speed, computer controlled foot pedal will allow for a very easy transition from traditional drill equipment. The user can control the speed of ablation by varying pressure on the foot pedal. This enables high precision cutting and sets Solea apart as the most advanced laser technology available in dentistry.
• Solea does not have any of the limitations of existing erbium lasers that require the dentist to use the drill to complete most procedures.
• Solea will enable drill-free procedures that will remove the anxiety traditionally associated with dentistry for patients.

"I've been involved in dental lasers for over 25 years and in my experience Convergent Dental's innovations in this area have been truly visionary and innovative," said Gerard Kugel DMD, MS, PhD Associate Dean for Research and Private practice dentist at the Boston Center for Oral Health Boston, MA. "Research indicates that Solea's wavelength will deliver six times faster cutting speed and more precision than any erbium laser. Based upon my experience with the system, I fully expect that Solea will modernize the practice of dentistry in the removal of decay and helping to prevent it in the first place."