Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial. BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker. New […]
Orchestra BioMed
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]
Orchestra BioMed to go public, partner with Medtronic on cardiac neuromodulation therapy
Orchestra BioMed today announced a slew of agreements, including a strategic collaboration with Medtronic (NYSE:MDT) and a SPAC deal to take the company public. The global strategic collaboration will progress the development of Orchestra BioMed’s BackBeat Cardiac Neuromodulation Therapy (CNT) as a potential treatment for hypertension in patients indicated for a cardiac pacemaker. Additionally, Orchestra […]
Smith & Nephew taps ex-Roche chief Diggelman for CEO | Personnel Moves, October 21, 2019
Smith & Nephew (NYSE:SNN) today named former Roche (PINK:RHHBY) chief Roland Diggelmann to replace Namal Nawana next month. Nawana, named to succeed Olivier Bohuon last year, is stepping down effective Nov. 1 “to pursue other opportunities outside of the U.K.,” the London-based healthcare giant said. Nawana is slated to stay on until Dec. 31 to […]
Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. Get the full story […]
Innoblative taps ex-Lumicell chief Londy for CEO | Personnel Moves, Sept. 13, 2019
Innoblative Designs last week named former Lumicell chief executive Kelly Londy as its new CEO. Apart from her two-year stint at the Lumicell helm, Londy was COO at Accuray (NSDQ:ARAY) and worked at GE Healthcare and Philips Healthcare. “Innoblative’s Sira RF ablation device offers unique capabilities that address shortcomings in the current advanced energy surgical market,” […]
Orchestra BioMed wins CE Mark for BackBeat hypertension neurostim, names CMO
Orchestra BioMed said yesterday that it received the CE Mark for its Moderato implantable pulse generator system for BackBeat cardiac neuromodulation therapy (CNT), just nine days after naming a new chief medical officer. BackBeat therapy is a bioelectronic treatment designed to lower blood pressure while modulating the autonomic nervous system. The Moderato implantable device is […]
Dynatronics promotes COO Baker to replace von Jako as CEO | Personnel Moves, August 30, 2019
After deciding this week that its CEO needs to be based in Eagan, Minn., and with chief executive Chris von Jako unwilling to relocate his family, Dynatronics (NSDQ:DYNT) promoted COO Brian Baker to the corner office, effective August 28. “After thoughtful consideration, the board of directors determined that the company’s CEO needs to be based in […]
