The Innovation

The state of the art methods used to remove skin layers are cryo-therapy (freeze and cut away skin) and dermabrasion (mechanical or by laser). Main drawbacks are:
  • Tendency of leaving scars
  • Heat development and high pain levels
  • High potential for bleeding
  • Multiple treatments necessary

Application areas

Tattoo removal
  • Aprox 5.500 new tattoos/day in Germany and later, aprox. 10% of people regret their tattoos
  • Potentially 800.000 people (or 1% of population) in Germany and many more in anglosaxon countries (higher prevalence of tattoos ) are subject for tattoo removal
  • 14%-29% of Americans have at least one tattoo. 17%-23% of those with tattoos say they ever regret getting one4
  • According to several sources, the Tattoo Removal global market and is expected to generate multi-billion $ within the next 6 years5
Scar removal
  • There is no proven effective method for scar treatment or removal in the market today. Scars are often linked to distress and pain
  • 100 M patients develop scars each year after surgery, 40-70% thereof are hypertrophic (over excessive raised scar)1
  • Acne leaves significant scars in 2 -7% of all cases2
Seborrheic keratosis

(or senile warts)

  • Non-cancerous skin tumor
  • In large studies, 100% of the patients over 50 had at least one seborrheic keratosis
  • The most common skin lesion (83 M Americans affected, more than 33% with more than 15 lesions)3
Actinic keratosis
  • Actinic keratosis is generally observed on 10% for persons with light white skin and above 50 years of age
  • Risk increases with age. 11,5 % prevalence for people aged 60- to70-years in Germany

coolPen advantages

coolPen is offering with several advantages
  • Precise treatment and easy to use
  • Personalization to each indication / requirement
  • Anesthetic impact of crystals leads to low risk of infection
  • No direct skin contact and cools down the skin surface during treatment (compared to surgery or laser)
  • Nearly blood free treatment
  • Low investment and training cost in practice / clinic

Photodynamic method

Single use material and instruments; potential higher costs for complicated surgery

The removal of different color pigments requires the use of several different lasers (different wave length and absorption depth. The purchasing price is potentially a multiple of the provided number at approx. EUR 300 – 500.000

Status

Functional prototype is built.

For the initial design and product development planning aesthetiCare cooperated with Seleon GmbH (engineering partner), Prof. Dr. med. Ruzicka and PD Dr. med. Hartmann, Ludwig Maximilian University Munich (scientific and medical partner). Both will perform all necessary activities towards registration

Seleon’s product development process will have 4 phases:

  • Phase 1 Specification (months 1-2): Screening of product requirements incl. risk management and FMEAs – Failure Mode and Effect Analysis
  • Phase 2 Definition of Requirements (months 3-5): Assessment of R&D concept, implementation options and necessary documentation
  • Phase 3 Development of functions (months 5-7): Feasibility, dimensioning and development (size and performance) of functional demonstrators for each of of the individual functions
  • Phase 4 Detailed design and Prototyping (months 8-10): Reduce functional groups to their necessary specification with respect to function, shape and size
    • Set up prototype (0-series)
    • Satisfy security and certification requirements as well as support clinical tests
    • Test electromagnetic and biological compatibility

Pre-clinical studies will start after phase 3. Approx. 6 month later we can start the clinical tests can with the final prototype. Serial production and commercialization will start after CE certification
We anticipate market launch approx. 30 month after initiation of development

Galery

coolPen – Tests