Orchestra BioMed
Medical device developer using a partnership-enabled model to originate device-based innovations, sponsor pivotal clinical development, and transfer manufacturing, regulatory submissions, and global commercialization to strategic partners. Current late-stage programs include a firmware-delivered pacemaker therapy intended to reduce blood pressure and a non-coated, microporous balloon system for liquid sirolimus arterial delivery. The company emphasizes pivotal randomized trial sponsorship, regulatory engagement, and structured financing to advance programs toward regulatory submission and commercialization.
Industries
Nr. of Employees
medium (51-250)
Orchestra BioMed
New Hope, Pennsylvania, United States, North America
Products
Pacemaker firmware therapy to modulate atrioventricular timing
Firmware-delivered therapeutic algorithm designed to adjust atrioventricular timing in dual-chamber pacemakers to achieve ambulatory blood pressure reduction and favorable cardiac hemodynamics without additional implanted hardware.
Microporous non-coated sirolimus angioinfusion balloon system
A balloon-based arterial drug-delivery system that loads a protected liquid dose and releases extended-release sirolimus through micropores during inflation to achieve focal arterial tissue concentrations while avoiding permanent implants or surface drug coatings.
Atrioventricular Interval Modulation Therapy
AVIM Therapy is an investigational patented bioelectronic treatment for hypertension that is designed to drive an immediate, substantial and sustained reduction in blood pressure while simultaneously modulating autonomic nervous system responses to maintain the reduction.
Virtue® Sirolimus AngioInfusion™ Balloon (SAB)
Virtue SAB is an investigational patented drug/device combination product candidate for the treatment of artery disease designed to deliver a proprietary extended release formulation of sirolimus, Sirolimus EFR, during balloon angioplasty without the need for balloon coating or a permanent implant.
Virtue Sirolimus-Eluting Balloon
Bioresorbable particle delivery technology designed to achieve targeted arterial tissue concentrations of sirolimus with a micro-porous angioplasty system.
Pacemaker firmware therapy to modulate atrioventricular timing
Firmware-delivered therapeutic algorithm designed to adjust atrioventricular timing in dual-chamber pacemakers to achieve ambulatory blood pressure reduction and favorable cardiac hemodynamics without additional implanted hardware.
Microporous non-coated sirolimus angioinfusion balloon system
A balloon-based arterial drug-delivery system that loads a protected liquid dose and releases extended-release sirolimus through micropores during inflation to achieve focal arterial tissue concentrations while avoiding permanent implants or surface drug coatings.
Atrioventricular Interval Modulation Therapy
AVIM Therapy is an investigational patented bioelectronic treatment for hypertension that is designed to drive an immediate, substantial and sustained reduction in blood pressure while simultaneously modulating autonomic nervous system responses to maintain the reduction.
Virtue® Sirolimus AngioInfusion™ Balloon (SAB)
Virtue SAB is an investigational patented drug/device combination product candidate for the treatment of artery disease designed to deliver a proprietary extended release formulation of sirolimus, Sirolimus EFR, during balloon angioplasty without the need for balloon coating or a permanent implant.
Virtue Sirolimus-Eluting Balloon
Bioresorbable particle delivery technology designed to achieve targeted arterial tissue concentrations of sirolimus with a micro-porous angioplasty system.
Services
Advisory and execution of strategic collaboration agreements and licensing arrangements to advance device candidates through late-stage development and into partner-led manufacturing and commercialization.
End-to-end trial sponsorship services including protocol design, site network activation, enrollment management, clinical operations and support for regulatory submissions.
Advisory services to prepare for and engage with regulatory authorities using expedited device pathways and IDE processes, including alignment on study design and reimbursement strategy.
Advisory and execution of strategic collaboration agreements and licensing arrangements to advance device candidates through late-stage development and into partner-led manufacturing and commercialization.
End-to-end trial sponsorship services including protocol design, site network activation, enrollment management, clinical operations and support for regulatory submissions.
Advisory services to prepare for and engage with regulatory authorities using expedited device pathways and IDE processes, including alignment on study design and reimbursement strategy.
Expertise Areas
- Clinical trial management for medical devices
- Regulatory strategy and expedited device pathways
- Implantable device firmware therapeutics
- Arterial drug-delivery system development
Key Technologies
- Firmware algorithms for implantable pacemakers
- Microporous balloon drug infusion systems
- Extended-release arterial drug formulations (sirolimus-based)
- Pivotal randomized, double-blind device trial methodology
News & Updates
Updated timeline for a global pivotal trial with an FDA-approved protocol amendment that reduced sample size while preserving statistical power and aligned with a strategic partner's regulatory plans.
Announcement of $35 million in strategic capital commitments from strategic investors to support completion of pivotal-stage cardiovascular programs.
FDA approval of an amended Investigational Device Exemption enabling initiation of a randomized U.S. pivotal trial comparing a microporous sirolimus angioinfusion balloon to an approved comparator for coronary in-stent restenosis.
Regulatory authority granted Breakthrough Device Designation for a firmware-delivered pacemaker therapy across defined patient populations to support accelerated engagement with the agency.
Summary of investor call describing multi-component financings, partner alignment, and capital runway extension to support pivotal programs and strategic optionality provided by rights agreements.
Investor call summary discussing trial initiation, enrollment dynamics, partner collaboration, and program milestones for two late-stage device programs.
Updated timeline for a global pivotal trial with an FDA-approved protocol amendment that reduced sample size while preserving statistical power and aligned with a strategic partner's regulatory plans.
Announcement of $35 million in strategic capital commitments from strategic investors to support completion of pivotal-stage cardiovascular programs.
FDA approval of an amended Investigational Device Exemption enabling initiation of a randomized U.S. pivotal trial comparing a microporous sirolimus angioinfusion balloon to an approved comparator for coronary in-stent restenosis.
Regulatory authority granted Breakthrough Device Designation for a firmware-delivered pacemaker therapy across defined patient populations to support accelerated engagement with the agency.
Summary of investor call describing multi-component financings, partner alignment, and capital runway extension to support pivotal programs and strategic optionality provided by rights agreements.
Investor call summary discussing trial initiation, enrollment dynamics, partner collaboration, and program milestones for two late-stage device programs.