Aspivix is getting ready to go to market in 2022 in Europe and USA. The Renens based Femtech just obtained FDA’s 510(k) Clearance, reflecting its robust regulatory and quality processes as well as its commitment to build a solid medtech company from the ground up. The startup is developing CAREVIX, a medical device allowing gentle handling of cervix for all procedures requiring an access to the uterus in gynaecology.
As Andrea Albornoz, Aspivix Head of Marketing & Global Sales explains to Startupticker.ch, The clearing will also allow the medtech to collect real-world clinical experience in key USA centers, in addition to the results of its first in women clinical trial performed at university hospitals in Switzerland. The startup expects to complete enrollment of its Advance Women trial in Q4-2021 and announce results soon thereafter.
Preparing for the US and European markets
Today Aspivix is fully focused on its target markets for 2022: Europe and the United States. In addition to the just obtained key FDA clearance, the medtech is waiting for CE marking which should be imminent. Speaking of its go to market preparation, Aspivix is currently pursuing distribution agreements with key partners in EU and USA that have access and distribution channels to the clinicians who will benefit the most from its device. The team is also selecting & implementing “Centers of Excellence” in both regions (US & Europe) to support training and education of clinicians. Last but not least, the team of Mathieu Horras is finalizing industrialization & logistics of its product and has fundraising Series A in the pipeline.
(ES)
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