Orchestra BioMed
Orchestra BioMed is a biomedical innovation company that develops late-stage therapeutic device and drug–device combination candidates and advances them through strategic partnerships and licensing with established medical device companies. The company’s pipeline targets procedure-based cardiovascular indications (including implantable cardiac neuromodulation and focal intravascular drug delivery) and also includes minimally invasive surgical device development. Development activities reported by the company include preclinical testing, randomized clinical trials, regulatory interactions, standards engagement, and partnership-enabled commercialization and supply arrangements.
Industries
Nr. of Employees
medium (51-250)
Products
Implantable cardiac neuromodulation therapy (AV-interval modulation)
Programmable cardiac neuromodulation therapy implemented via implantable pulse generator platforms to modulate atrioventricular timing and autonomic responses, intended for patients requiring dual-chamber pacemakers as a mechanism to lower systolic blood pressure.
Non-coated angioplasty angio-infusion balloon system for focal sustained-release sirolimus delivery
An angioplasty balloon system that uses a protected, non-coated porous balloon mechanism to deliver a bioabsorbable sustained-release sirolimus formulation to the vessel wall during angioplasty, designed to provide focal therapeutic delivery without a surface coating or permanent implant.
Intracorporeal hands-free adjustable surgical retractor system
A fully adjustable, hands-free intracorporeal surgical retractor designed to optimize visualization, minimize incision size and procedural collisions, and enable surgeon-controlled positioning throughout minimally invasive procedures.
Implantable cardiac neuromodulation therapy (AV-interval modulation)
Programmable cardiac neuromodulation therapy implemented via implantable pulse generator platforms to modulate atrioventricular timing and autonomic responses, intended for patients requiring dual-chamber pacemakers as a mechanism to lower systolic blood pressure.
Non-coated angioplasty angio-infusion balloon system for focal sustained-release sirolimus delivery
An angioplasty balloon system that uses a protected, non-coated porous balloon mechanism to deliver a bioabsorbable sustained-release sirolimus formulation to the vessel wall during angioplasty, designed to provide focal therapeutic delivery without a surface coating or permanent implant.
Intracorporeal hands-free adjustable surgical retractor system
A fully adjustable, hands-free intracorporeal surgical retractor designed to optimize visualization, minimize incision size and procedural collisions, and enable surgeon-controlled positioning throughout minimally invasive procedures.
Services
Structures and executes development, clinical, regulatory and commercialization collaborations with established medical device companies to advance device and drug–device candidates, including partner-managed manufacturing and commercialization transitions.
Operational leadership for multicenter randomized and registry trials, core-lab endpoint adjudication, statistical analysis, regulatory submission support and preparation of peer-reviewed publications.
Structures and executes development, clinical, regulatory and commercialization collaborations with established medical device companies to advance device and drug–device candidates, including partner-managed manufacturing and commercialization transitions.
Operational leadership for multicenter randomized and registry trials, core-lab endpoint adjudication, statistical analysis, regulatory submission support and preparation of peer-reviewed publications.
Expertise Areas
- Clinical trial management and endpoint adjudication
- Bioelectronic neuromodulation therapy development for hypertension
- Drug–device combination product development and formulation
- Interventional vascular device development and engineering
Key Technologies
- Programmable cardiac pacing algorithms for atrioventricular interval modulation
- Implantable pulse generator integration with dual-chamber pacing leads
- Porous/microporous angioplasty balloon-mediated focal drug infusion
- Nanoparticle-encapsulated bioabsorbable sustained-release drug formulations
News & Updates
Presentation of long-term clinical results showing significant reductions in ambulatory and office systolic blood pressure in patients who crossed over to active cardiac neuromodulation therapy.
Announcement of a global strategic collaboration to develop the angioplasty drug–device product and financing to support development and planned pivotal trials.
Publication reporting randomized trial data showing a statistically significant reduction in 24-hour ambulatory systolic blood pressure with an implantable neuromodulation therapy.
Regulatory Breakthrough Device designation granted for the non-coated angioplasty balloon system for below-the-knee peripheral artery disease and for coronary in-stent restenosis to prioritize review and agency interactions.
CE mark reported for the implantable pulse generator platform that delivers cardiac neuromodulation therapy while providing standard pacemaker functions.
Presentation of multi-year safety and efficacy data for implantable neuromodulation therapy and the non-coated sirolimus-eluting balloon at conferences including EuroPCR, TCT and AHA.
Presentation of long-term clinical results showing significant reductions in ambulatory and office systolic blood pressure in patients who crossed over to active cardiac neuromodulation therapy.
Announcement of a global strategic collaboration to develop the angioplasty drug–device product and financing to support development and planned pivotal trials.
Publication reporting randomized trial data showing a statistically significant reduction in 24-hour ambulatory systolic blood pressure with an implantable neuromodulation therapy.
Regulatory Breakthrough Device designation granted for the non-coated angioplasty balloon system for below-the-knee peripheral artery disease and for coronary in-stent restenosis to prioritize review and agency interactions.
CE mark reported for the implantable pulse generator platform that delivers cardiac neuromodulation therapy while providing standard pacemaker functions.
Presentation of multi-year safety and efficacy data for implantable neuromodulation therapy and the non-coated sirolimus-eluting balloon at conferences including EuroPCR, TCT and AHA.