Optimo Medical announced that Optimeyes is ready to enter the US market after the FDA decided not to enforce any regulatory requirements, known as enforcement discretion.
This important step forward opened the doors for Optimo Medical to receive the additional boost of a Swissnex bootcamp program, which supports Swiss businesses in getting access to the US market.
“The software from Optimo Medical combines the Swiss values of precision and high-tech in the medical field,” Franziska Steiner Head of Entrepreneurship at swissnex San Francisco, said in a company news release. “We are delighted to support Optimo Medical with our program to scale-up their resources to be successful within the US market.”
“The US market is strategically important to us. No other country has more surgeons using femtosecond laser arcuate keratotomy surgery in the battle against astigmatism,” Dr. Harald P. Studer, co-founder and CEO of Optimo Medical, said in the news release. “With our software Optimeyes, we give the surgeons a breakthrough technology to plan surgical interventions in a patient-specific manner, usually carried out during laser-based cataract surgery. Our sophisticated algorithms are capable of calculating the best possible treatment parameters for the individual eye, which the surgeon then simply plugs-in into the laser software. Compared to traditionally used nomograms, the risk of over-correction and the variability in outcomes are reduced. Following the ongoing global mega-trend of personalized medicine, the procedure is tailored to the individual patient’s anatomy .”
Optimeyes closes the gap in the lower diopter range of astigmatism treatment (from 0.50 – 2.00 Diopter) needs, with limited overlap to the toric IOL portfolio and is also indicated for astigmatism re-treatments.
During the last months, patient messaging has been simplified and the commercialization tools have been adapted accordingly. “We have listened carefully to the needs of surgeons and patients. The developed toolset has been designed to educate and inform the patient accurately, which is crucial for patients, surgeons, and us. Finally, our product supports ophthalmologists to provide higher patient satisfaction and increases the acceptance of the femtosecond laser surgeries” says Alexander van der Mey, CCO of Optimo Medical.
The company has begun to look for suitable distribution partners in the US and will work closely with US cataract surgeons to implement a tailored education program.
 Truffer et al., Optimization of surgical parameters based on patient-specific models: Application to arcuate keratotomy, J Cataract Refractive Surgery. 2019