Series C · $25M · August 2026

Re-Shaping the Future of Obesity

When GLP-1s are not enough — and bariatric surgery is too much.

EndoZip™ automates endoscopic sleeve gastroplasty (ESG) — the durable middle path — expanding physician reach 23-fold. CE-marked. Revenue-generating in Europe. US Pivotal underway to support traditional 510(k).

23×PHYSICIAN REACH — automation opens ESG to ~47,000 doctors
$24BANNUAL ESG-ADDRESSABLE MARKET — growing with every GLP-1 dropout
<30 minSINGLE-OPERATOR, OUTPATIENT PROCEDURE — vs. 60–90 min manual
1st casePROFICIENCY — automated, standardized suturing vs. 30+ cases
Explore the opportunity ↓
EndoZip automated ESG platform
THE PATIENT

“After 12 months on GLP-1s, I have plateaued and now I can’t afford them anymore. I am not ready to have bariatric surgery — I don’t want incisions or the long recovery. But I want to live a healthier lifestyle, without diabetes and high blood pressure.”

47-year-old patient, obese since a teenager — Magellan primary research, 2026

THE OPPORTUNITY

Six converging signals.

Commercial product, proven demand, protected IP, disciplined execution.

Commercial in Europe

CE-marked Nov 2025; revenue-generating since Q1 2026 in reimbursed, high-volume centers.

U.S. pivotal underway

Head-to-head vs. Boston Scientific's OverStitch; 20% enrolled; 510(k) submission early 2028.

Patent moat

21 patents across 4 families protecting automated ESG; coverage into the 2040s.

$24B annual market

ESG-addressable demand per year across three patient streams (company market model v18).

Strategics are buying

Boston Scientific paid $615M for the manual incumbent. Two more exits: $300M, $105M.

Recurring economics

Single-use disposables; every procedure drives revenue; >60% product GM at scale.
THE GLP-1 REALITY

GLP-1s didn’t solve obesity. They are building our market.

The most common investor objection — answered head-on with the data.

>50%
of patients stop GLP-1s within 12 months — cost, side effects, injection fatigue.


2/3
regain most of the lost weight after stopping. The disease persists; the drug does not.


~15%
of obese adults will be in sustained treatment by 2030 — drugs alone cannot close the gap.

Patients off GLP-1s, seeking a durable answer

cumulative, US + EU — company market model v18


6M
2024
20M
2026
33M
2028
44M
2030

×7 in six years

THE STORY IN ONE CHAIN

From middle path to mass market.

The last link is the unlock: automation finally puts ESG in the hands of the physicians who already hold the patients — whether they took GLP-1s, came off them, or considered surgery.

THE PRODUCT

EndoZip™ — automated suturing, standardized outcomes.

1 · Insert

Introduced orally — no incisions. An articulating head positions easily in any anatomy.

2 · Click

Vacuum captures tissue; one button executes a full automated suture line — tightened and clipped in ~45 seconds.

3 · Repeat

Up to 5 suture lines complete the sleeve. Consistent, reproducible sutures — every time, every physician.

Fully single-use, disposable device — every procedure drives recurring revenue.

▶ Watch the 60-second procedure video

CLINICAL VALIDATION

Clinically and technically de-risked.

THREE COMPLETED EU TRIALS — 94 patients, 397 procedures

2019
FIH study
2024
EU pivotal (GIE)
2025
Comorbidity study (GIE)

✓ 13–16% TBWL at 6 & 12 months   ✓ 51–54% excess weight loss   ✓ positive safety profile   ✓ improved HbA1c & blood pressure

U.S. PIVOTAL TRIAL — UNDERWAY · 20% ENROLLED

Design: randomized, multi-center, non-inferiority  ·  Comparator: head-to-head vs. Boston Scientific’s OverStitch  ·  Pathway: supports FDA 510(k), Apollo ESG predicate  ·  Readout: target Q1 2028 · 184 patients, 10 U.S. sites

“Easily teachable — it doesn’t require much endoscopic skill.”Dr. Reem Sharaiha · Weill Cornell
“Inspect, position, apply suction, press the button. That’s it.”Dr. Manoel Galvao Neto · Orlando Health
“The same reliable suture, over and over, with no additional effort.”Dr. Ivo Boškoski · Gemelli, Rome
MARKET OPPORTUNITY

A $24B market opens every year.

TAM
$0.9T
Obese population, US + EU (BMI 30–40)
SAM
$24B
ESG-addressable per year — three demand streams
SOM
$1.1B
Serviceable by 2030 (~5% of annual SAM)

✓ Commercial in Europe today  ·  → Est. U.S. commercialization 2028

BUSINESS MODEL & MILESTONES

Disposable-driven recurring revenue.

Single-use device

Every procedure consumes 3–5 disposable devices — revenue tied directly to volume.

Center economics

1 trained center → 6–10 procedures/mo: EU $290–480K · US $468–780K per year.

Expanding margin

38% (2027) → >60% product GM at scale via volume + Gen-2 outsourcing.
CE MarkNov 2025 ✓
EU launchQ1 2026 ✓
U.S. IDE20% enrolled · now
FDA 510(k)early 2028
U.S. launchmid 2028
EXIT LANDSCAPE

Acquirers are already buying this market.

Strategic appetite for scalable obesity-procedure technology is proven — and priced.

TargetAcquirer · YearValue
Apollo Endosurgery (manual ESG — OverStitch)Boston Scientific · 2023$615M
Standard BariatricsTeleflex · 2022$300M
EndoGastric SolutionsMerit Medical · 2024$105M

The anchor: Boston Scientific paid $615M for the manual version of this market — before the Category-I CPT code, limited to ~2,000 specialists. An automated platform with U.S. clearance, a 23× expansion of physician reach and recurring disposable economics addresses everything the manual asset lacked. Medtronic and J&J face declining bariatric-surgery volumes and need an answer in less-invasive obesity care. Strategic optionality opens from 2027, after U.S. pivotal readout.

THE ASK
THE ASK
$25M
Series C
$6.2M secured · $3M committed

Use of proceeds

✅ EU commercial scale — toward >$5M revenue run-rate by 2027

✅ U.S. IDE completion — supporting FDA 510(k) submission early 2028

✅ Manufacturing scale-up — industrialization & outsourced production

✅ Commercial working capital — inventory & market development

TEAM

Operators who have built, scaled and exited MedTech.

~190 years of combined medical-device experience.

Lloyd Diamond · CEO

Ex-CEO Pixium Vision & BoneSupport (IPO).

John Barr · Chairman

Chaired Apollo Endosurgery through its $615M exit.

Offer Nonhoff · CFO

30+ years finance & operations; IPO; raised >$180M.

Raz Bar-On · CTO

25 years design & technical leadership.

Diego Paone · Commercial

Ex-Apollo national sales manager.

Scientific Advisory Board

9 global KOLs incl. Sharaiha (Weill Cornell), Boškoski (Gemelli), López-Nava (Madrid), Abu Dayyeh.
CONTACT

The only automated ESG platform.
Built to fill obesity’s treatment gap.

Lloyd Diamond, CEO · lloyd@nitinotesurgical.com
Offer Nonhoff, CFO · offer@nitinotesurgical.com

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