Caliber Therapeutics
Orchestra BioMed is a biomedical innovation company dedicated to developing high-impact, evidence-based therapeutic solutions for large unmet medical needs, particularly in cardiovascular disease and hypertension. It collaborates with established market leaders to accelerate product development, clinical trials, and global commercialization, aiming to generate long-term revenue streams through royalties, revenue sharing, licensing, and strategic partnerships. The company's pipeline includes innovative therapies such as Virtue® Sirolimus-Eluting Balloon (SEB) for artery disease and BackBeat® Cardiac Neuromodulation Therapy (CNT) for hypertension, both of which have demonstrated promising clinical results and received regulatory designations like FDA Breakthrough Device status.
Industries
Nr. of Employees
small (1-50)
Caliber Therapeutics
Patents
Balloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-12144945-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-10806909-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-10207084-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-9649479-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-9649478-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-8715230-B2
View Details
Balloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-12144945-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-10806909-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-10207084-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-9649479-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-9649478-B2
View DetailsBalloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body
US-8715230-B2
View DetailsProducts
Implantable cardiac neuromodulation delivered via pacemaker systems (investigational)
Programmable cardiac stimulation therapy intended for delivery through dual‑chamber pacing hardware to modulate preload/afterload and autonomic tone for blood pressure control while maintaining standard pacing functions; supported by ambulatory blood pressure monitoring in clinical studies.
Non‑coated porous angioplasty balloon system with sustained‑release sirolimus formulation (investigational)
A porous/microporous balloon angioplasty system designed to deliver a bioabsorbable, nanoparticle‑encapsulated sirolimus formulation directly to the arterial wall during angioplasty to provide extended focal drug release without a surface coating or permanent implant.
Intracorporeal adjustable hands‑free surgical retractor system
Minimally invasive, adjustable intracorporeal retractors intended to improve visualization, reduce external retractor clutter, and enable hands‑free retraction during laparoscopic procedures.
Implantable cardiac neuromodulation delivered via pacemaker systems (investigational)
Programmable cardiac stimulation therapy intended for delivery through dual‑chamber pacing hardware to modulate preload/afterload and autonomic tone for blood pressure control while maintaining standard pacing functions; supported by ambulatory blood pressure monitoring in clinical studies.
Non‑coated porous angioplasty balloon system with sustained‑release sirolimus formulation (investigational)
A porous/microporous balloon angioplasty system designed to deliver a bioabsorbable, nanoparticle‑encapsulated sirolimus formulation directly to the arterial wall during angioplasty to provide extended focal drug release without a surface coating or permanent implant.
Intracorporeal adjustable hands‑free surgical retractor system
Minimally invasive, adjustable intracorporeal retractors intended to improve visualization, reduce external retractor clutter, and enable hands‑free retraction during laparoscopic procedures.
Services
Structures and executes strategic collaborations with established medical device companies to co‑develop product candidates, support pivotal studies, negotiate licensing and supply agreements, and enable partner‑managed regulatory approval and global commercialization.
Provides clinical trial design, operational management, core‑lab coordination, data analysis, safety monitoring and scientific communication support for multi‑center interventional device and combination‑product trials.
Advises on regulatory pathways, prepares for regulatory interactions, supports IDE/registrational planning, and assists in pursuing expedited regulatory designations and CE marking across jurisdictions.
Develops sustained‑release local arterial drug formulations and negotiates manufacturing and supply arrangements for incorporation into device platforms.
Provides advisory support and committee representation for development of international device and drug‑delivery standards.
Structures and executes strategic collaborations with established medical device companies to co‑develop product candidates, support pivotal studies, negotiate licensing and supply agreements, and enable partner‑managed regulatory approval and global commercialization.
Provides clinical trial design, operational management, core‑lab coordination, data analysis, safety monitoring and scientific communication support for multi‑center interventional device and combination‑product trials.
Advises on regulatory pathways, prepares for regulatory interactions, supports IDE/registrational planning, and assists in pursuing expedited regulatory designations and CE marking across jurisdictions.
Develops sustained‑release local arterial drug formulations and negotiates manufacturing and supply arrangements for incorporation into device platforms.
Provides advisory support and committee representation for development of international device and drug‑delivery standards.
Expertise Areas
- Clinical trial management for interventional device and device–drug combination studies
- Bioelectronic neuromodulation integrated with cardiac pacing systems
- Local arterial drug delivery and drug–device combination development
- Preclinical-to-clinical translation using large‑animal models and tissue retention studies
Key Technologies
- Cardiac pacing‑based neuromodulation techniques
- Integration with dual‑chamber implantable pulse generators
- Porous/microporous angio‑infusion balloon delivery
- Bioabsorbable nanoparticle‑encapsulated sustained‑release arterial formulations
News & Updates
The FDA granted Breakthrough Device Designation to Virtue SEB for the treatment of coronary in-stent restenosis (ISR), recognizing its potential to address a significant unmet clinical need with a novel, non-coated sirolimus-eluting angioplasty balloon system.
Publication of clinical data demonstrating significant and durable blood pressure reduction in patients treated with BackBeat CNT™, supporting its potential as a breakthrough therapy for hypertension.
FDA Breakthrough Device Designation for Virtue SEB
Virtue SEB received FDA Breakthrough Device Designation for the treatment of coronary in-stent restenosis, highlighting its innovative approach and potential to improve patient outcomes.
CE Mark Approval for BackBeat CNT™ for Hypertension
The company received CE Mark approval for its BackBeat CNT™ therapy, enabling its use in Europe for the treatment of hypertension.
Presentation of 2-Year Clinical Data for BackBeat CNT at TCT 2018
Clinical data showed significant, immediate, and sustained blood pressure reduction, demonstrating the therapy's potential to be a breakthrough in device-based hypertension management.
Results of SABRE Trial Demonstrate Efficacy of Virtue SEB in Treating Coronary ISR
The SABRE trial showed excellent safety and efficacy of Virtue SEB in a challenging patient population with long, diffuse lesions, with promising 3-year clinical outcomes.
The FDA granted Breakthrough Device Designation to Virtue SEB for the treatment of coronary in-stent restenosis (ISR), recognizing its potential to address a significant unmet clinical need with a novel, non-coated sirolimus-eluting angioplasty balloon system.
Publication of clinical data demonstrating significant and durable blood pressure reduction in patients treated with BackBeat CNT™, supporting its potential as a breakthrough therapy for hypertension.
FDA Breakthrough Device Designation for Virtue SEB
Virtue SEB received FDA Breakthrough Device Designation for the treatment of coronary in-stent restenosis, highlighting its innovative approach and potential to improve patient outcomes.
CE Mark Approval for BackBeat CNT™ for Hypertension
The company received CE Mark approval for its BackBeat CNT™ therapy, enabling its use in Europe for the treatment of hypertension.
Presentation of 2-Year Clinical Data for BackBeat CNT at TCT 2018
Clinical data showed significant, immediate, and sustained blood pressure reduction, demonstrating the therapy's potential to be a breakthrough in device-based hypertension management.
Results of SABRE Trial Demonstrate Efficacy of Virtue SEB in Treating Coronary ISR
The SABRE trial showed excellent safety and efficacy of Virtue SEB in a challenging patient population with long, diffuse lesions, with promising 3-year clinical outcomes.