Asset profile

AVIM Therapy · Orchestra BioMed (OBIO)

Indication: uncontrolled hypertension in pacemaker-indicated patients
Also known as: Atrioventricular Interval Modulation Therapy, AVIM, BACKBEAT

Company

OBIOOrchestra BioMed

Orchestra BioMed Holdings Inc is a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships with medical device companies. The company's flagship product candidates are Atrioventricular Interval Modulation T…

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Timeline

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Oct 1, 2026

12:14 PM

OBIOOrchestra BioMed

Orchestra BioMed exceeds enrollment in BACKBEAT pivotal trial of AVIM Therapy

Topline resultsSEC 8-K Open record

Readiness checklist

Public facts only. We never publish an approval probability.

Updated Oct 1, 2026

Primary endpoint metFavourable

Orchestra BioMed exceeds enrollment in BACKBEAT pivotal trial of AVIM Therapy

Overall survival significant or trendingMixed

12.3 mmHg net vs control

US / Western patient shareConcern

0 of 6 sites in the United States

Advisory committee scheduledFavourable

No advisory committee announced

PDUFA date extendedUnknown

Manufacturing inspection recordUnknown

No public inspection record

Company language signals (label discussions)Unknown

Same-class precedentUnknown

Related companies

Each relationship is backed by the filing that stated it.

OBIOOrchestra BioMedOwner

SEC 8-K Oct 1, 2026

MDTMedtronicPartner

SEC 8-K Oct 1, 2026

Verify every date against the linked primary source. Informational only. Not investment advice. SimianX is not affiliated with the FDA or the SEC.

Registered trials

Registry ID	Phase	Status	Primary completion	Enrollment	Sites
NCT05086523	Phase 1/2	Completed	Aug 11, 2023	28	0 of 6 sites in the United States

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