News
Company News: Curetis Expects Near-Term U.S. FDA Decision on 510(k) Clearance of Unyvero LRT for BAL Specimens
— All formal FDA requests for additional information answered
— Interactive review ongoing as review nears completion
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that the Company has filed its formal response to the FDA’s AI (Additional Information request letter regarding the Company’s filing for 510(k) clearance of the Unyvero LRT – Lower Respiratory Tract Application Cartridge for bronchoalveolar lavage (BAL) samples.
Company News: Curetis Publishes Third Quarter and 9-Month Business and Financial Update
– Signed IVD partnership for Ares Genetics
– Progressed implementation of the Curetis – OpGen business combination with S4 filing
– More than tripled total contract order volume received year-over-year to EUR 3.4 million in 9M-2019
– Revenue growth of approximately 16%
– Near-term FDA decision on clearance of Unyvero LRT for BAL specimen expected
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today published its third quarter and 9-months business and financial update.
Company News: Curetis Provides Business Update for the First Nine Months of 2019
– Signed IVD partnership for Ares Genetics
– Progressed implementation of the Curetis – OpGen business combination with S4 filing
– More than tripled total contract order volume received year-over-year to EUR 3.4 million in 9M-2019
– Revenue growth of approximately 16%
– Near-term FDA decision on clearance of Unyvero LRT for BAL specimen expected
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today provided a business update for the first nine months ended September 30, 2019, including key financial results.
Company News: Evonik and BellaSeno partner to enable the launch of an innovative 3D printed breast implant technology
— 3D printed breast scaffolds to be made of RESOMER®
— Degradation of RESOMER® to match the growth of the patient’s own tissue for natural breasts
— Technology designed to improve quality of life for patients after breast reconstruction and augmentation
— Human clinical trials to commence later this year
Evonik, a global leader in biomaterials for implantable medical devices, and BellaSeno GmbH, a developer of 3D printed absorbable scaffolds, today announced the signing of a long-term agreement for the use of a RESOMER® bioresorbable polymer for an innovative breast implant technology.