Strategic acquirers — Hologic, Intuitive Surgical, Stryker, Medtronic — are actively paying premium multiples for women's health device platforms. NEG+ Innovations is building squarely in their acquisition lane with a physician-designed, IP-protected, reimbursement-ready precision technology platform. Women's health is not a niche. It is one of the largest, least-penetrated markets in all of medicine.
Six structural advantages that differentiate NEG+ from typical pre-revenue medtech investments at the same stage — each grounded in clinical credibility, regulatory preparedness, and capital efficiency.
Every device emerged from a gap Dr. Belotte encountered firsthand — in the operating room, the labor suite, and the clinic. Each need was validated through voice-of-customer research before a single patent was filed. No translation required between clinical insight and engineering solution. No product-market fit risk.
A cross-life-stage platform spanning labor & delivery, minimally invasive gynecologic surgery, urogynecology, and pelvic pain. Two structurally distinct strategic-acquirer pools — maternal-fetal monitoring majors and gynecologic surgery leaders — with single-device divestiture optionality preserved at every product level.
NIH SBIR and STTR grants are pursued in parallel with private capital — delivering independent federal peer-review validation of core technology at zero dilution to investors. Every non-dilutive dollar awarded extends runway, protects equity, and strengthens the diligence record heading into Series A.
Dr. Belotte co-invests personally on identical economic terms alongside every outside investor — no separate founder pricing, no preferred economics. Capital conviction is demonstrated in cash, not only sweat equity. Investor and founder interests are fully aligned from the first dollar raised.
FDA 510(k) strategy is defined, predicate analysis is complete, and specialized regulatory counsel is engaged. Pre-Submission Q-Sub meetings are scheduled. The founder's clinical development experience at GlaxoSmithKline Oncology brings industry-grade regulatory discipline directly to our program execution.
NEG+ is a Delaware C-Corp structured for Qualified Small Business Stock eligibility under IRC §1202. Investors entering at this stage may qualify for up to 100% federal exclusion on qualifying gains — a material tax advantage that is unavailable at later funding rounds.
NEG+ is raising its initial Seed round via SAFE instrument under Reg D Rule 506(b), open exclusively to verified accredited investors. Full term sheet and financial model available upon execution of NDA.
Accredited investors may request our full Investor Companion (Edition 2 — MUMS Integrated) including updated market sizing (~$16.2B combined TAM), acquirer map, capital deployment schedule, and SAFE term sheet.
Request Investor Brief →Offered under Regulation D, Rule 506(b) to verified accredited investors only. This is not an offer to sell securities.
Each round of capital is tied to defined regulatory and technical inflection points — providing investors clear de-risking benchmarks and sequential value creation events.
| Milestone | Device / Program | Target Timeline | Round |
|---|---|---|---|
| Pre-clinical feasibility — bench prototype validation | Belotte Colpotomizer™ · PNB Device™ | 2026 | Seed |
| NIH STTR Phase I Specific Aims submission | POP-Q AutoSense™ | 2026 | NIH |
| MUMS™ ISA + SaMD concept design · SBIR Phase I preparation | MUMS™ | 2026 | Seed |
| Patent filings — provisional to PCT conversion | Full Portfolio | 2026 | Seed |
| ISO 13485 QMS implementation · Design History File initiation | Belotte Colpotomizer™ | 2026–2027 | Seed |
| IDE submission — first-in-human feasibility study | Belotte Colpotomizer™ · PNB Device™ | 2026–2027 | Seed |
| FDA 510(k) submission — Belotte Colpotomizer™ | Belotte Colpotomizer™ | 2027–2028 | Series A |
| NIH STTR Phase I award + clinical validation study initiation | POP-Q AutoSense™ | 2027 | NIH |
| FDA 510(k) clearance — Belotte Colpotomizer™ (commercial launch) | Belotte Colpotomizer™ | 2028 | Series A |
| MUMS™ pivotal clinical trial initiation (De Novo / PMA pathway) | MUMS™ | 2028–2030 | Series A+ |
| Platform exit / strategic acquisition or IPO target | Full Portfolio · 11-Acquirer Pool | 2028–2031 | Series A+ |
Seed capital deployed across four priority areas — optimized for maximum milestone velocity and de-risking per dollar.
Bench prototype validation for Colpotomizer™ and PNB Device™ · ISO 13485 QMS · Design History File
Provisional-to-PCT conversion · Freedom-to-operate analysis · All four programs
STTR Phase I Specific Aims (POP-Q AutoSense™) · SBIR Phase I (PNB Device™) · Academic PI engagement
Pre-IDE meetings · IRB preparation · KOL engagement · Working capital reserve
Accredited investors and institutional partners are encouraged to reach out directly. All inquiries are held in strict confidence.
Complete the form below to request access to our secure investor data room. Available to verified accredited investors only under Reg D Rule 506(b).
This page is for informational purposes only and does not constitute an offer to sell or solicitation to buy securities. Offered under Regulation D, Rule 506(b) to verified accredited investors only.