FOR PARTNERS AND INVESTORS
An early-stage opportunity in a market that has been waiting for this.
Zera Medical is developing ZeraFlow, a clinic-based bowel preparation system that addresses a universally recognized, quantitatively large, and structurally unsolved problem in colorectal cancer screening. Zera Medical is building toward a planned U.S. launch following FDA clearance, and we welcome conversations with clinical, strategic, and industry partners..
THE OPPORTUNITY
Why ZeraFlow. Why now.
MARKET
$2.3B+
Pre-procedure U.S. colonoscopy ecosystem
15 million annual U.S. colonoscopies. No active clinic-based prep competitor in the United States. A category waiting to be defined.
PRODUCT
125
PATIENT CLINICAL DATA COHORT¹
89.4% prep adequacy rate. Peer-reviewed publication¹. FDA Class II 510(k) pathway in development.
BUSINESS MODEL
67–80%
Estimated gross margin on consumables
High-margin, recurring per-procedure disposable revenue. Capital-efficient. Scales with procedure volume rather than fixed infrastructure.
STAGE
Pre Seed
Privately funded early-stage company. Next milestones: FDA clearance and a structured U.S. clinical pilot, with results intended for peer-reviewed publication.
CLINICAL VALIDATION
125
Consecutive Patients studied
89.4%
Prep adequacy rate (BBPS)²
98.4%
Patient
completion rate³
Zero
Serious Device related adverse events⁴
MILESTONE ROADMAP
2013
Peer-reviewed publication
Ziv Y, Scapa E. Techniques in Coloproctology. Foundational clinical study published.
COMPLETE
2022–2025
Continued Clinical Evaluation
ZeraFlow evaluated across international patient cohorts with zero serious adverse events reported.
COMPLETE
2025
Zera Medical LLC founded
U.S. entity established to commercialize ZeraFlow for the North American market.
COMPLETE
2026
ZeraMed.com launches
Company website live. SAFE round in progress. Pilot site recruitment underway.
COMPLETE
2026
FDA 510(k) submission
Class II 510(k) regulatory track. Milestone updates to follow submission.
IN PROGRESS
POST CLEARANCE
U.S. clinical pilot launch
Flagship pilot with 1–3 leading GI practices or ASCs. Target: approximately 1,000 procedures.
UPCOMING
2027
U.S. outcomes publication and regional expansion
U.S. pilot data prepared for peer-reviewed publication. Expansion to 5+ centers.
UPCOMING
GET IN TOUCH
Interested in learning more?
¹ ²³⁴ Ziv Y, Scapa E. Techniques in Coloproctology. 2013;17:39–44. DOI: 10.1007/s10151-012-0876-8.