Medical device company Soliton Inc (Nasdaq:SOLY) said on Tuesday that it has completed the human trials of its proprietary Rapid Acoustic Pulse (RAP) technology to accelerate tattoo fading in support of US FDA 510(k) submission.
In connection with the US FDA 510(k) submission, the company has launched three rounds of human trials to study the use of the RAP device to accelerate tattoo fading.
According to the company, its first planned commercial product is designed to use rapid pulses of designed acoustic shockwaves in conjunction with existing lasers to accelerate the removal of unwanted tattoos (RAP device).
The human trials provided evidence that the combination treatment of the RAP device and a laser outperformed a laser alone, showing an average of 80% fading after only two visits vs 44% fading for the laser alone. After three Soliton Multi-Pass treatments, 100% of the treated tattoos had a 'Complete' (76-100% faded) response. In comparison, only 17% of the tattoos treated with the Laser Only had a 'Complete' response, the company's CEO Dr Chris Capelli stated.
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system