| MEDTECH r&D | anaLYsIs
and experience. It would compete against injectable drugs,
silicone gel,
corticosteroids, and dressings. It was also being developed for the keloidal scar market, where a study by AP-HM (Marseille Hospitals) has showed that therapeutic drugs fail in 50% of keloid patients.
Need for trials Mr Cornil puts the turn of events down to experience, knowing that entrepreneurs frequently have to roll with the punches. Whatever led to the withdrawal of
Ekkyo’s funding, it was not the result of a lack of participation in trials. His Ekkylite device had been used for cosmetic purposes by surgeons in Europe since October 2008, had undergone proof-of-concept in animals, and demonstrated safety and efficiency in humans within a 2-year period. He muses that being a pioneer and first
to market can be a disadvantage, as there are no precedents to rely on. 'That is why we did clinical trials.' One trial, demonstrating the efficacy of
the LASH technology, was published in Aesthetic Plastic Surgery. A second, on uses for keloidal scarring, and a third on the application of LASH in dermatological surgery, were due to begin before the end of 2011. A fourth, studying the use of the technique in preventing acute hypertrophic scars, was also planned. Some of the trials were being run in the
Netherlands and Italy, to raise international awareness, with China and the US expected to come later. A US trial was planned for 2012. Lack of reimbursement was and will
always be a hurdle to technology uptake, although in the cosmetic surgery sector, this is traditionally less of an issue. The product’s concept was also not always easy to understand,
and had been received with some curiosity and even scepticism. The idea of treating once at the time of wound closure, and seeing benefits only 6 months later, was totally new. Nevertheless, Mr Cornil typifies the
innovative potential in the French device sector. The key with new cosmetic surgery technology, reimbursed or not, is to have belief in your product and, crucially, invest in clinical data, he tells Prime. 'Today a new product cannot make its
mark without clinical data.' The tricky part is how much to accumulate. 'It can be a balancing act — how much data you have and when to move on with commercialisation efforts. The big question is, can you afford to wait?' To aspiring entrepreneurs, he says:
'Be prepared to spend twice as much on marketing as you budget for.' Another lesson is to prepare for
setbacks when seeking to develop and commercialise cosmetic surgery devices. Like Mr Cornil, you might get almost all the way only to be dashed late in the day. Ent repreneurs have a good record of bouncing back, however, which is good news.
prime-journal.com | September 2011
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