Connected Catheter (C2P) Study for Bladder Management

Spinal Singularity had developed C2P system to address several drawbacks of current
standard-of-care urinary catheters. The C2P is fully internal, urethral indwelling urinary
prosthesis designed for improved bladder management in males with urinary retention disorders
requiring catheterization, including NLUTD. The C2P is a sterile, single-extended use device
that resides fully internally to the male lower urinary tract for an intended service life of
up to 29 days per catheter

Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of neurogenic lower urinary tract dysfunction
(NLUTD)

2. Must be clinically suitable and capable of safely managing bladder using an
intermittent voiding or indwelling strategy

- Must have stable urinary management history: no significant changes in bladder
management regimen within past 12 months

OR:

- Must have urodynamic profile suitable for C2P, as assessed via urodynamics study
within past 12 months (including bladder capacity > 200mL without uninhibited
bladder contractions)

3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the
C2P device, as specified in the investigational device instructions for use (IFU).

Exclusion Criteria:

1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may
receive the device after Urinary Tract Infection (UTI) has been treated)

2. Significant risk profile or recent history of urethral stricture (e.g. stricture
within past 90 days)

3. Significant risk profile or recent history of clinically significant autonomic
dysreflexia (AD) (e.g. History of hospitalization due to AD within past 12 months)

4. Significant intermittent urinary incontinence (between catheterizations)

5. Uninhibited bladder contractions and/or vesico-ureteral reflux that is not reliably
controlled with medication or alternate therapy (e.g. Botox injections)

6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower
urinary tract or bladder (assessed during in-depth medical screening, including
cystoscopy and urine analysis)

7. Urinary tract inflammation or neoplasm

8. Urinary fistula

9. Bladder diverticulum (outpouching) > 5cm in size

10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6
months)

11. Impaired kidney function or renal failure

12. Active gross hematuria

13. Active urethritis

14. Bladder stones

15. Dependence on an electro-magnetic medical implant (e.g. cardiac pacemaker or implanted
drug pump) or external device

16. Any unsuitable comorbidities as determined by the investigator or complications
related to use of certain medications

17. Any physical or cognitive impairments that diminish the subject's ability to follow
directions or otherwise safely use the C2P System