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).
“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
Commercial product, proven demand, protected IP, disciplined execution.
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.
cumulative, US + EU — company market model v18
×7 in six years
on GLP-1s · off GLP-1s · surgery-averse
the durable middle path
manual: 60–90 min · 2 operators · ~2,000 specialists
one click · <30 min · 1st-case proficiency
~47,000 US + EU physicians — incl. ~3,000 bariatric surgeons
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.
Fully single-use, disposable device — every procedure drives recurring revenue.
✓ 13–16% TBWL at 6 & 12 months ✓ 51–54% excess weight loss ✓ positive safety profile ✓ improved HbA1c & blood pressure
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
✓ Commercial in Europe today · → Est. U.S. commercialization 2028
Company market model v18 (Jul 2026). Prevalence: CDC NHANES, WHO Europe; procedures: ASMBS. SAM = addressable patients/yr; SOM = serviceable/obtainable procedures/yr.
Strategic appetite for scalable obesity-procedure technology is proven — and priced.
| Target | Acquirer · Year | Value |
|---|---|---|
| Apollo Endosurgery (manual ESG — OverStitch) | Boston Scientific · 2023 | $615M |
| Standard Bariatrics | Teleflex · 2022 | $300M |
| EndoGastric Solutions | Merit 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.
Transaction values per acquirer press releases. No discussions with any named party are implied. Forward-looking statements; actual outcomes may differ materially.
✅ 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
~190 years of combined medical-device experience.
Lloyd Diamond, CEO · lloyd@nitinotesurgical.com
Offer Nonhoff, CFO · offer@nitinotesurgical.com
This page is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities. Forward-looking statements are illustrative; actual outcomes may differ materially. EndoZip® is a registered trademark of Nitinotes Ltd. in the European Union and Israel. EndoZip™ is a trademark of Nitinotes Ltd. in the United States and other jurisdictions.