$15 million payment fulfills previously scheduled tranche under royalty-based financing agreement, bringing total capital received from Ligand to $40 million to date in exchange for tiered royalty ...
Bio-Med Devices Inc. has been shaping the future of respiratory care for over 50 years, but its story is more than a timeline – it’s a legacy built on family, risk and deep-rooted purpose. The company ...
Therapy Food and Drug Administration (“FDA”) Breakthrough Device Designations span the broader population of patients with uncontrolled hypertension despite medication at increased cardiovascular risk ...
Orchestra BioMed (Nasdaq:OBIO) announced today that it received a second FDA breakthrough device designation for its AVIM ...
Orchestra BioMed has announced that the FDA has granted Breakthrough Device Designation for its atrioventricular interval modulation (AVIM) therapy, aimed at treating over 7.7 million U.S. patients ...
Orchestra BioMed’s hypertension treatment is the latest medical device to earn the FDA’s breakthrough designation. The device is an atrio-ventricular interval modulation therapy, meaning it uses a ...
Orchestra BioMed holds two best-in-class medical device therapies targeting large markets, with strong partnerships and equity investments from Medtronic and Terumo. Both AVIM Therapy and Virtue SAB ...
Orchestra BioMed Holdings, Inc. announced significant regulatory advancements and financial results for the first quarter of 2025, including the recipient of FDA Breakthrough Device Designation for ...
Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) ...
As quantum computers advance, they are expected to be able to break tried-and-true security schemes that currently keep most sensitive data secure from attackers. Scientists and policymakers are ...
Ligand to $40 million to date in exchange for tiered royalty interest in Orchestra BioMed’s future revenue as well as equity Funding supports continued execution of Orchestra BioMed’s pivotal trials ...
Breakthrough Device Designation (“BDD”) applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk BDD also encompasses ...