Dive Brief:
- Inquis Medical said Monday it has raised $40 million to complete a pivotal trial of its Aventus thrombectomy system and prepare to launch the product in 2025.
- Aventus, which first received 510(k) clearance in November 2023, enables non-surgical removal of clots from blood vessels. Like Inari Medical’s Flowtriever, the device uses aspiration to remove clots.
- Inquis’ attempts to differentiate its product center on sensing technology that tells the operator if the tip of the device is in contact with blood, a clot or vessel walls.
Dive Insight:
Inquis cited Innova Vascular’s Malibu aspiration catheter as its 510(k) predicate but said it added features to increase the convenience of use and eliminated coating or surface materials. Meanwhile, Innova cited Inari’s Flowtriever, which recently beat catheter-directed thrombolysis in a trial, as the predicate device for Malibu.
The Food and Drug Administration cleared Flowtriever in 2018.
While Inquis has ceded a headstart to its rivals, the company has identified technologies such as its tissue-sensing tip, blood return system and integrated navigation catheter that it believes differentiate Aventus from the competition. The company said in the funding announcement current products are often limited by significant blood loss and procedural inefficiencies.
Inquis’ pivotal trial is enrolling 120 people with acute pulmonary embolism to undergo aspiration thrombectomy with Aventus. The co-primary endpoints look at major adverse events related to the device, including death, major bleeding and cardiac injury, as well as the change in the right ventricle/left ventricle ratio.
Investment firm Marshall Wace is supporting Inquis’ efforts to complete the trial, leading a $40 million Series B financing round with assistance from existing backers including ShangBay Capital, Yu Star, EnPointe Ventures and Pierre Lamond.
The funding will support the pivotal trial, preparations for the commercial launch of Aventus in 2025 and the continued advancement of Inquis’ tissue-sensing platform.
