Orchestra BioMed

What Orchestra BioMed does

Orchestra BioMed (NASDAQ: OBIO) is a partnership-enabled clinical-stage biomedical innovation company that develops and licenses high-impact therapeutic technologies for large unmet needs in procedure-based medicine, with a 51–100-employee operation headquartered in New Hope, Pennsylvania. The company operates two core technology platforms under wholly owned subsidiaries: (1) AVIM Therapy (also branded BackBeat CNT), an investigational, patented bioelectronic treatment for hypertension that delivers programmable pacing through standard dual-chamber pacemakers (Medtronic Azure/Astra) to lower blood pressure while modulating autonomic nervous system response; and (2) Virtue SAB (Sirolimus AngioInfusion Balloon), an investigational, patented drug/device combination that delivers a proprietary extended-release sirolimus formulation (SirolimusEFR) through an AngioInfusion Balloon during angioplasty without permanent implantation. Both platforms hold FDA Breakthrough Device Designations and are in pivotal trials — BACKBEAT Global Pivotal Trial (AVIM, enrollment completion targeted Q3 2026, primary readout Q2 2027) and Virtue SAB US Pivotal IDE Coronary Trial (740 patients across up to 75 U.S. centers, results expected mid-2027).

The business model is a risk-reward-sharing partnership structure rather than direct commercialization. Orchestra BioMed licenses its technologies to global medical-device leaders for development and commercialization: Medtronic for AVIM Therapy (with Orchestra entitled to $500–$1,600 per AVIM-enabled device sold worldwide and a $20M note that converts to a capped prepaid revenue share upon FDA approval; collaboration recently expanded into leadless pacemakers), and Terumo Corporation for Virtue SAB (including a right of first refusal and a separate $20M Terumo preferred stock investment). The company has also entered a tiered royalty purchase agreement with Ligand Pharmaceuticals ($40 million in capital for a future-revenue royalty interest). Revenue in FY2025 of $33.5 million was driven entirely by deferred recognition of these strategic transaction milestones, not recurring product sales — Q1 2026 revenue dropped to $0.1 million, confirming the pre-commercial state. Go-to-market is thus enterprise partnership-led rather than direct field sales at this stage. The company went public via SPAC merger in 2023 and is led by co-founders David P. Hochman (Chairman/CEO) and Darren R. Sherman (President/COO), with a deeply experienced executive bench drawn from Medtronic, Abbott/St. Jude, Boston Scientific, Cordis/J&J, and Neovasc, and a board that includes two former Medtronic senior leaders.

Name

Orchestra BioMed

Legal name

Orchestra BioMed Holdings, Inc.

Website

https://orchestrabiomed.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

51–100 employees

Short description

Orchestra BioMed (NASDAQ: OBIO) is a clinical-stage biomedical innovation company developing two flagship investigational therapies — AVIM bioelectronic hypertension treatment (with Medtronic) and Virtue SAB sirolimus drug-delivery balloon (with Terumo) — through a risk-reward-sharing partnership model targeting large unmet needs in procedure-based medicine.

Ownership category

akta.pro rank

Headquarters

HQ city

New Hope

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Royalty / Revenue Share from AVIM Therapy-enabled Devices: Long-term revenue-sharing arrangement with Medtronic under which Orchestra BioMed is expected to receive $500 to $1,600 from every AVIM Therapy-enabled device sold by Medtronic worldwide (assuming no changes to existing pacemaker device reimbursement). The Medtronic $20M investment note converts to a capped prepaid revenue share upon FDA approval.
2. Tiered Royalty Financing from Ligand Pharmaceuticals: Royalty Purchase Agreement under which Ligand has paid $40 million in capital ($25M prior + $15M tranche on May 1, 2026) in exchange for a tiered royalty interest in Orchestra BioMed's future revenue and equity. Financing is structured as a capital infusion tied to long-term program success.
3. Strategic Capital from Terumo for Virtue SAB: $30 million strategic agreement with Terumo Corporation (including a $10M upfront payment) granting Terumo a right of first refusal for the Virtue SAB product, plus a $20 million preferred stock investment by Terumo in Orchestra BioMed. Expected future revenue-sharing/royalty arrangement tied to Virtue SAB commercialization.
4. Earnout Proceeds from Vivasure Medical Acquisition: Orchestra BioMed expects up to $21 million in cash proceeds from the acquisition of Vivasure Medical by Haemonetics, including ~$4.7M upfront (received Jan 9, 2026), ~$6.0M expected first milestone payment, and remainder through future revenue-based earnouts tied to defined milestones.
5. Collaboration Revenue (Deferred): Q1 2026 reported revenue of $0.1M and FY2025 revenue of $33.5M (1,539% increase) driven by strategic transactions, milestone payments from partners (Medtronic, Terumo, Ligand), and deferred revenue recognition under existing collaboration agreements. Pre-commercial; investigational products.

Pricing tiers

Go-to-market motion1 record

Core offering

Orchestra BioMed develops two late-stage, investigational, patented flagship biomedical technologies — AVIM Therapy, a bioelectronic hypertension treatment delivered via standard dual-chamber pacemakers with programmable pacing, and the Virtue® Sirolimus AngioInfusion™ Balloon, a drug/device combination that delivers a proprietary extended-release sirolimus formulation during angioplasty without a permanent implant. The company commercializes these candidates through risk-reward sharing strategic partnerships with Medtronic (AVIM Therapy) and Terumo (Virtue SAB), earning royalties/revenue share on partner sales.

Product overview

Orchestra BioMed operates a partnership-enabled business model that develops and licenses late-stage flagship biomedical technologies through risk-reward sharing partnerships with leading medical device companies. The company's product portfolio is built around two flagship investigational therapeutic candidates: AVIM Therapy (also known as BackBeat CNT), a patented bioelectronic treatment for hypertension delivered through standard dual-chamber pacemakers with strategic collaborator Medtronic; and Virtue SAB (Sirolimus AngioInfusion Balloon), an investigational drug/device combination product for artery disease under strategic partnership with Terumo. Both flagship candidates are in pivotal clinical trials, and Orchestra BioMed shares in future revenue generated by its partners' commercialization of these products.

Differentiator

Problem solved

Functional benefit

Brands

• Virtue® SAB (Virtue® Sirolimus AngioInfusion Balloon): 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.
• AVIM Therapy (Atrioventricular Interval Modulation Therapy / BackBeat CNT)
• FreeHold Duo®
• FreeHold Trio®
• BackBeat CNT™

Products and services

• AVIM Therapy (Atrioventricular Interval Modulation Therapy) Investigational, patented bioelectronic treatment for hypertension that uses programmable and adjustable pacing therapy to immediately, substantially and persistently lower blood pressure while modulating the autonomic nervous system. Designed to leverage standard dual-chamber pacemaker hardware (e.g., Medtronic Azure/Astra) using the same implant procedure and lead positions, allowing rapid adaptability for hypertensive patients already indicated for a pacemaker without relying on patient medication compliance.
• Virtue SAB (Virtue Sirolimus AngioInfusion Balloon) Investigational, patented drug/device combination product candidate for the treatment of artery disease. The AngioInfusion Balloon dilates the artery and restores blood flow while delivering a proprietary extended-release sirolimus formulation (SirolimusEFR) through a protected dose unit (DU) without balloon coating, drug loss in transit, coating particulates or permanent implant. Currently in the Virtue SAB US Pivotal IDE Coronary Trial under strategic partnership with Terumo and has received FDA Breakthrough Device Designation.

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• CVRx: CVRx develops Barostim neo, an FDA-approved implantable neuromodulation device for heart failure (with hypertension as a key secondary indication). It is the most direct comparator to Orchestra BioMed's AVIM Therapy bioelectronic approach to hypertension, competing for the same resistant-hypertensive patient population and physician specialty.
• Recor Medical: Recor Medical is developing the Paradise ultrasound renal denervation system for resistant hypertension, competing head-to-head with AVIM Therapy for the same large addressable population. It represents an emerging non-pharmacologic, non-device-implant alternative targeting the same physician call point.
• Inspire Medical Systems: Inspire Medical Systems is a pure-play neuromodulation company (hypoglossal nerve stimulation for obstructive sleep apnea). It is comparable to Orchestra BioMed as a focused, late-stage neuromodulation platform company partnering with physicians and building clinical evidence for an implantable bioelectronic therapy in a large unmet-need population.

Broad incumbents

• Medtronic: Medtronic is Orchestra BioMed's global strategic partner for AVIM Therapy (~$140M+ in combined investment) and the dominant incumbent in cardiac rhythm management, the channel through which AVIM-enabled pacemakers would reach market. It is both a partner and a competitor (leadless pacemakers, internal hypertension programs).
• Boston Scientific: Boston Scientific is a broad incumbent in interventional cardiology (drug-eluting stents, coronary balloons, structural heart) and CRM, with overlapping commercial channels and physician relationships for both AVIM Therapy and Virtue SAB.
• Shockwave Medical: Shockwave Medical developed intravascular lithotripsy for coronary and peripheral artery disease using a partnership-and-licensing-driven model similar to Orchestra BioMed's interventional pipeline, and was ultimately acquired by J&J for ~$13B in 2024. It is the most relevant comparand for Orchestra's partnership-enabled interventional-cardiology business model.

Emerging players

• Concept Medical: Concept Medical develops sirolimus-coated balloons (MagicTouch) for coronary and peripheral indications, directly competing with Virtue SAB's sirolimus-delivery positioning in the same physician call point and patient population (in-stent restenosis, small vessels).
• SurModics: SurModics provides drug-delivery coating technologies and balloon-based delivery platforms for interventional cardiology, with overlapping intellectual property and supply-chain positioning to Virtue SAB's SirolimusEFR and AngioInfusion Balloon platform.
• Axonics Modulation Technologies: Axonics is a neuromodulation-focused company (sacral and now tibial neuromodulation), with a comparable late-stage-pivotal-trial playbook, partnership-style commercialization, and pre-launch revenue ramp profile to Orchestra BioMed's AVIM Therapy.
• Silk Road Medical: Silk Road Medical pioneered a partnership-enabled, focused-portfolio model (TCAR for stroke prevention) with strategic distribution partners and a similar pre-commercial-through-pivotal-trial trajectory. It is relevant as a comparand for Orchestra BioMed's small-team, partnership-led commercialization approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/orchestra-biomed
• Xx.com/OrchestraBioMed

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Subsidiaries4 records

Funding overview

Funding rounds10 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Orchestra BioMed