Adagio Medical : Presentation (ff9318)

Published: 2026-04-27 08:12:32 ET ADGM

Published on 04/27/2026 at 08:12 am EDT

FULCRUM-VT Investor Event

Dr. Atul Verma • Dr. William Stevenson • Dr. Matthew Hakimi April 27, 2026

EFFECTIVENESS AND SAFETY OF ULTRA-LOW TEMPERATURE ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS WITH STRUCTURAL HEART DISEASE: OUTCOMES OF THE PIVOTAL FULCRUM-VT TRIAL

Atul Verma, MD, McGill University Health Centre

on behalf of FULCRUM-VT investigators THANK YOU TO ALL CO-INVESTIGATORS!

April 26, 2026

Research Grants - Bayer, Biotronik, Biosense Webster,

Medtronic, Abbott, Cardiofocus

Advisory Board - Cardiofocus, Adagio Medical, Lilly, Biosense

Webster, Kardium, Medtronic, Medlumics, Abbott, Volta Medical

Clinical trials - Biosense Webster, Adagio Medical,

Cardiofocus, Medtronic, Abbott

RF lesions - insufficient depth for effective endocardial-only ablations in the ventricle

Safe application of PFA to achieve deeper lesions in the ventricle is an open question

Lack of universal approach (and approved devices) for ablations in both the ICM and NICM patients

RF=Radiofrequency; PFA=Pulsed Field Ablation; ICM=Ischemic Cardiomyopathy; NICM=Non Ischemic Cardiomyopathy

PURPOSE-BUILT FOR ENDOCARDIAL VENTRICULAR ABLATIONS

ABLATION PROTOCOL

(freeze - thaw - freeze cycle)

15 mm

Console + 9 Fr bi-deflectable catheter

15 mm long ablation element, -120 C

8 electrodes for EGM, EAM, pacing

No irrigation

Freeze Duration (sec)

Lesion Depth Range (mm)1

< 4

4-6

120

7-9

180

≥ 10

1 Adagio Medical, Inc. MKT-086 Rev B. Data on file

Fr=French; EGM=Electrocardiogram; EAM=Electroanatomical Mapping

Ablative power to produce large footprint, depth-controlled endocardial lesions ≥10 mm,

unaffected by the presence of the scar

PRE-CLINICAL LESIONS

Dewland T, et al. Ultra-low temperature cryoablation versus ultra-low temperature cryoablation combined with pulsed field ablation in a swine ventricular infarct model. JACC EP 2026

Protocol-defined Major Adverse Events

(MAEs) 0-7 days

Primary Endpoints

Freedom from sustained VT or appropriate

ICD intervention without AAD escalation

Acute non-inducibility of VTs targeted for

ablation

Study Design

Single arm

209 patients

19 sites

Endocardial access only

(ablation or mapping)

Patient Population

20% ≤ LVEF ≤ 50%

ICM

NICM, incl. ARVC

≤ 1 prior VT ablation

in last 2 years

THE FIRST IDE TRIAL OF A PURPOSE-BUILT VT ABLATION CATHETER

EARLY FEASIBILITY PHASE

PIVOTAL ENROLLMENT PHASE

20 PATIENTS

4 CENTERS

ICD= implantable cardioverter defibrillator; AAD=anti-arrhythmic drug

+189 PATIENTS

+15 CENTERS

All patients

ITT Cohort*

Number of Patients

209

157

Age

68 ± 11 y.o.

69 ± 10 y.o.

Male Sex

92.8%

94.3%)

BMI

30 ± 6

Cardiomyopathy

ICM

64.1%

65.6%

NICM

30.1%

28.0%

both ICM and NICM

5.7%

6.4%

LVEF

35% ± 10%

≤ 30%

38.3%

36.3%

31-40%

33.0%

35.0%

41-50%

23.9%

24.8%

>50%

4.8%

3.8%

Congestive Heart Failure

75.6%

78.3%

History of AADs

90.4%

91.7%

Amiodarone

69.4%

71.3%

*Intention to Treat (ITT) Cohort excluded Early Feasibility Study

(EFS) and Roll-in patients

ICM n=103

NICM* n=54

Lesions / patient

12 +/- 6

11 +/- 7

Total freeze time/lesion, min

4 +/- 1

250

209

*includes patients with combined NICM-ICM cardiomyopathy

ICM

200

Minutes

150

100

109

54 55

NO ABLATION-INDUCED VF OR MEANINGFUL EFFECT ON THE PERFORMANCE OF ICD NICMCANS, PACING OR

DEFIBRILLATION LEADS

Procedure Time

Catheter Dwell Time

Ablation Time Freeze Time Mapping Time Fluoroscopy

Time

Primary Safety Endpoint: 2.4% (5/209)

2 (1.0%) device-related events

8% (17/209) rate of non-device, procedure-related events

OTHER PROCEDURE-RELATED SERIOUS ADVERSE EVENTS*

MAJOR ADVERSE EVENTS

EVENT DESCRIPTION

# PATIENTS

Death

1 (0.5%)

Cardiac

perforation/tamponade

2 (1.0%)

Cerebral infarct or

systemic embolism

1 (0.5%)

Major bleeding requiring

transfusion

1 (0.5%)

EVENT DESCRIPTION

# EVENTS

Access site complications

Fluid overload (HF)

PEA arrest

Cardiogenic shock

Infection/sepsis

Pericardial effusion

Cardiac perforation

Respiratory Failure

Hemoptysis

Total

17 (16 pts.)

* None of these events was adjudicated as definitely or probably device-related

Primary Acute Effectiveness:

98.0%

PATIENT-LEVEL ACUTE SUCCESS

No VT induction after pre-ablation PES

157 patients

(296/302) 5

24 patients

Post-ablation PES not performed

133 patients

11 patients

122 patients

302 Target VTs

115

Re-Inducible

Post-ablation PES

296

Non-Inducible

- Clinical Success

98.4%

- Full Success

94.3%

Cumulative Freedom From Primary Event, %

KAPLAN-MEIER FREEDOM FROM ANY VT RECURRENCE OR AAD ESCALATION

By Etiology

p-value

ICM

58.0%

0.938

NICM*

59.3%

Days From Index Ablation

*includes patients with combined NICM-ICM cardiomyopathy

59.0%

PRIMARY EVENTS, BY TYPE

Number of Events

n=58

ICD Therapy (ATP or Shock)

ATP Only

ICD Shock

Monitoring Zone VT > 30 sec

AAD Escalation

ATP=anti-tachycardia pacing

✓

PRIMARY EFFECTIVENESS PERFORMANCE

GOAL MET

IDENTICAL EFFECTIVENESS for both ICM and NICM patients

Cumulative Freedom From ICD Therapy, %

K-M FREEDOM FROM ANY ICD THERAPY: 61.8% K-M FREEDOM FROM ICD SHOCK: 84.3%

Cumulative Freedom From ICD Shock, %

NICM*: 84.5%

NICM*: 63.2%

ICM: 60.7%

p=0.893

ICM: 84.0%

p=0.970

Days From Index Ablation Days From Index Ablation

VT BURDEN PRE- AND POST-ABLATION*

-25

-50

-75

75 50 25 0 25 50 75

PRE-ABLATION POST-ABLATION

MEDIAN (IQR) MEDIAN (IQR)

3 (1,7) 0 (0,1)

p<0.001

PATIENTS WITH ICD SHOCK* POST-ABLATION

ICM : 81%

NICM

: 82%

* 85 patients with > 150 days of ICD data in both pre- and post-ablation

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

AMIODARONE USE*

72%

36%

28%

Baseline Post-procedure 6 months New Rx

AT 6 MO

* 137 patients in study through 6 months follow-up

Literature Reported1,2

FULCRUM-VT

7-8%

1.9% (3/154)

2-3%

1.3% (2/154)

All-cause

14-19%

8.4% (13/154)

1Cheung et al. Circ Arrhythm Electrophysiol. 2018;11:e006754

2Tan MC et al. Journal of Interventional Cardiac Electrophysiology (2024) 67:513-521 HF=heart failure

NOW ENROLLING

FREEZE TIME PER LESION REDUCTION*

2nd vs 1st GENERATION OF ULTA CATHETER

1st Gen

2nd Gen

Sheath compatibility

9 Fr

8.5 Fr

Shaft stiffness profile

Uniform

Variable

Bi-directional deflection

F/F

D/F

Ablation element length

15 mm

12 mm

Number of electrodes

# of freezes per lesion

Total Freeze Time / Lesion, min

FULCRUM-VT AVERAGE

75%

1st Gen Catheter 2nd Gen Catheter

* K. Dyrda et al. Initial Pre-Clinical Evaluation of the Augmented Ultra-Low Temperature Cryoablation Catheter for Ventricular Ablations. J Cardiovasc Electrophysiol 202C

THE FIRST IDE FOR PURPOSE-BUILT VENTRICULAR CATHETER

Endocardial ablation only, one-third non-ischemic CM

2.4% primary safety event rate

59% freedom from ANY VT recurrence or AAD escalation

84% freedom from ICD shock

Equivalent outcomes in ischemic and non-ischemic CM

Median burden 3 → 0 pre- to post-ablation

72% free from or on reduced dose of amiodarone

Objective standards to compare VT outcome trials

Q & A

- CFIDETIAL - 2

Disclaimer

Adagio Medical Holdings Inc. published this content on April 27, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 27, 2026 at 12:11 UTC.