TACT 5-year follow-up

interim clinical data

FDA Pivotal Study: TULSA-PRO Ablation Clinical Trial (TACT)
Clinical Phase I TACT Real World CAPTAIN
Pre-Clinical
Treat-and-Resect Clinical Trial Pivotal Trial Outcomes RCT
2005-2012 2010-2013 2013-2014 2016-2018 2018-ongoing 2022-ongoing

Study population: DKFZ

• 115 men, 45-80 years old, 13 sites, 5 countries Radboud UMC
Uniklinik Köln
• Low (33%) or intermediate (67%) risk, Sunnybrook ResoFus Alomar
biopsy-proven localized prostate cancer Western U Johns Hopkins
UCLA
UT Southwestern
Whole gland ablation with urethral cooling Indiana University
Vanderbilt
U Chicago
Primary endpoints (1 year): Beaumont
• PSA reduction Yale
Klotz et al, Journal of Urology 2021
• Adverse Events Cover Article of March Issue
RSNA 2021: Selected as one of 3
Secondary endpoints (to 5 years): Best Clinical Trials
• Prostate volume reduction at 1 year
• Prostate biopsy at 1 year in all patients
• Multi-parametric MRI at 1 year
• QOL (EPIC, IIEF, IPSS), adverse events, FFS to 5 years
 TACT ablation efficacy to 5 years

PSA Histological outcomes

• Baseline: 63% Grade Group 2,
most bilateral disease or ≥ 5 positive cores.
PSA (ng/mL), median (IQR):
• 1 year: No significant disease in 80% of men
Baseline: 6.3 (4.6 – 8.0) (65% negative, 14% Low volume GG1).
Nadir: 0.26 (0.10 – 0.53) Extensive sampling with 10 cores in median
PSA (ng/mL)

1 year: 0.53 (0.28 – 1.25) 3 cc residual prostate volume.

5 years: 0.63 (0.18 – 1.9)
Prostate MRI
• Median prostate volume decreased by 92%
to 3 cc in 12 months.
• MRI has 94% Negative Predictive Value for
absence of GG2 disease on 1-year biopsy.

Progression-free survival
• 21% had additional intervention for prostate
cancer by 5 years without unexpected
complications

Months 3
Progression-free survival & context to radical prostatectomy

TULSA (single procedure) Radical Prostatectomy

• 21% had additional intervention for prostate cancer • Progression to additional intervention for prostate cancer
by 5 years without unexpected complications after radical prostatectomy in intermediate-risk men
N=10 RP, N=10 RT, N=3 RT+ADT, N=1 RP+RT PIVOT, CapSURE, propensity-matched RP vs. ablation

100% 100%
PIVOT RCT, Wilt et al NEJM 2017

80% 80%
CapSURE, Morgan et al PCAN 2014
PSW, van Son et al PCAN 2021
% Patients

% Patients
60% 60% PSW, Shah et al PCAN 2021

40% 40%

20% 20%

0% 0%
0 1 2 3 4 5 0 1 2 3 4 5
Time (years) Time (years)

4
 TACT safety and functional preservation is durable to 5 years
100 97%
% Pts Continent (EPIC)

92% Adverse events to 5 years:

80
• No grade 4 events, no rectal fistula,
60 no intraoperative complications.
socially continent
40
• 8% serious (SAE) or severe (G3)
pad-free continent events, all resolved by 1 year.
20

0 HR-QOL to 5 years:
Baseline
0 12 mo 24 mo 36 mo 48 mo 60 mo
(n=111) (n=111) (n=91) (n=85) (n=80) (n=66) • Urinary continence
97% socially continent (≤ 1 pad/day)
100 92% pad-free
% Pts Potent (IIEF Q2≥2)

87% • Erectile function

80
76% 0% severe ED (medication not helpful)
60 87% previously potent patients
reported erection firmness sufficient for
40 penetration after TULSA
EF recovered at any visit after TULSA
20 EF recovered at visit

0
Baseline
0 12 mo 24 mo 36 mo 48 mo 60 mo 5
(n=92) (n=92) (n=92) (n=92) (n=92) (n=92)
Urinary continence & context to radical prostatectomy

Pad-Free Continence (no pads) Social Continence (≤ 1 pad/day)

100% 100%

80% 80%

60% 60%
% Patients

% Patients
TACT, TULSA-PRO
40% 40%
PIVOT, Radical Prostatectomy

PIVOT, Observation (Control)

20% 20%

0% 0%
0 1 2 3 4 5 0 1 2 3 4 5
Time (years) Time (years)

6
TULSA-PRO: Precise, Flexible, Durable

Demonstrated Median prostate

0% severe
histological benefit volume decreased by
Whole Gland

erectile disfunction
in 80% men 92% in 12 months
Ablation

1% patients reported 87% maintained or

21% underwent an
more than one pad per recovered erectile
additional intervention
day at 12 months, firmness for penetration
by 5 years
stable to 5 years within 5 years of follow-up

Screening Immediate Post 1-month Post 3-months Post 12-months Post

Prostate Volume

T2w MRI CE-MRI CE-MRI CE-MRI CE-MRI

Reduction

PSA 5.5 ng/ml PSA 6.0 ng/ml PSA 0.3 ng/ml PSA < 0.1 ng/ml PSA < 0.1 ng/ml
58 cc 0.5 cc

7
TULSA-PRO: Precise, Flexible, Durable
Whole Gland Ablation Partial Gland Ablation
Focal – subtotal Hybrids with low grade Very large prostates –
Whole Gland Radiation failure gland cancer and BPH BPH relief

TULSA Precision
• Real-time MRI allows for changes to treatment plan in real time
• Real-time temperature measurement and visualization allows for tissue kill with pixel-by-pixel accuracy,
killing cancer cells and avoiding vital tissue
TULSA Flexibility
• Treatment planning allows for treatment of whole gland or partial gland, customization for what is best for the patient
• Directional ultrasound linear wave, allows for treatment of large or small prostates, anywhere in the gland
TULSA durability
• 5-year clinical data shows progression rates similar to that of prostatectomy but better side effects
• One year outcomes data can predict longer term outcomes 8