Connected Catheter- Evaluation Study

Spinal Singularity had developed Connected Catheter System to address several drawbacks of
current standard-of-care urinary catheters. The Connected Catheter is fully internal,
urethral indwelling urinary prosthesis designed for improved bladder management in males with
urinary retention disorders requiring catheterization. Each subject will use the Connected
Catheter for up to 35-40 days. This includes five routine follow-up appointments. The
follow-up appointments are spaced 7 days apart and at each appointment the catheter will be
replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the
final appointment after the subject discontinues use of study device and reverts to his
original catheter.

Inclusion Criteria:

1. Males age ≥ 18 with clinical diagnosis of significant urinary retention

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 Connected Catheter (including bladder
capacity > 200mL without uninhibited bladder contractions)

3. Subject's lower urinary tract anatomy must fall within the ranges serviceable by the
Connected Catheter, as specified in the Investigational Device Instructions for use
(IFU)

Exclusion Criteria:

1. Active symptomatic urinary tract infection (UTI), as defined in this protocol
(subjects may receive the device after 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 (uncontrolled)
autonomic dysreflexia (AD)

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)

1. Urinary tract inflammation or neoplasm

2. Urinary fistula

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

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

5. Impaired kidney function or renal failure

6. Active gross hematuria

7. Active urethritis

8. Bladder stones

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

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

9. Any physical or cognitive impairments that diminish the subject's ability to follow
directions or otherwise safely use the Connected Catheter System -