NEG+ Innovations at a Glance

The company is structured as a Delaware C-Corporation with a parallel PLLC medical affiliate (NEG+ Innovations PLLC), providing full IP ownership, clean cap table, QSBS eligibility, and both strategic-acquirer pools simultaneously accessible. The founding team and advisory board encompass FDA regulatory strategy, clinical development, biomedical engineering, and capital markets expertise — covering every function required from pre-clinical through commercialization without reliance on outsourced scientific leadership.

NEG+ is currently raising its initial Seed round via SAFE instrument under Reg D Rule 506(b), with proceeds deployed toward prototype engineering, provisional-to-PCT patent conversion, NIH STTR/SBIR grant development, and regulatory strategy initiation. The founder participates as a co-investor on identical economic terms alongside every outside investor.

Opportunity, Products & Business Model

Opportunity

Women's pelvic health represents one of the most underserved and underinvested segments in surgical medicine. An estimated 1 in 3 women will experience a pelvic floor disorder in her lifetime, yet the diagnostic and surgical tools currently available to clinicians remain largely unchanged from instruments introduced decades ago. Intraoperative precision, objective quantification, and real-time monitoring are either absent or fragmented across disconnected platforms — creating avoidable surgical variability, extended procedural times, and suboptimal patient outcomes.

Existing solutions share a common failure: they were engineered without clinical operator input, leading to tools that prioritize manufacturing convenience over surgical utility. NEG+ addresses this gap by developing devices that emerged from the operating room itself — built on documented deficiencies that Dr. Belotte directly encountered and systematically validated before engineering began.

Product Portfolio

Business Model

Milestones & Progress

Capital Deployment Milestone Map

Each round is tied to defined regulatory and technical inflection points — providing investors clear de-risking benchmarks and sequential value creation events.

Key Structural Achievements

Women's Pelvic Health Device Market

Market Segments

Regulatory & Reimbursement Environment

The FDA has accelerated 510(k) and De Novo pathway timelines for women's health devices under recent policy initiatives addressing sex-based research gaps. CPT reimbursement codes exist for all clinical procedures targeted by NEG+'s portfolio — eliminating reimbursement pathway risk at the device level. NIH STTR/SBIR grant programs specifically fund small business medical device development in reproductive health, providing non-dilutive capital access aligned with NEG+'s pipeline.

Venture Financing in Women's Health MedTech

Women's health technology attracted over $1.8B in venture investment in 2024, with medical devices representing the fastest-growing subsector. Despite the scale of unmet need, femtech and women's health devices remain structurally underfunded relative to comparable male-health equivalents — creating a favorable entry environment for differentiated, physician-originated innovations with clear regulatory paths and large strategic acquirer bases.

Competition

Executive Team & Advisory Board

Investment Terms

Risks

You should be aware that an investment in NEG+ Innovations, Inc. involves considerable risks, including the possible loss of all or a material portion of your investment. The risks set forth below are not the only risks facing investors.

Investment Risks

An investment in NEG+ Innovations is a speculative private placement investment and is not suitable for anyone without a high tolerance for risk and a low need for liquidity. Investors should only invest amounts they are prepared to lose in their entirety. There can be no assurance that investors will receive any return of capital or profit.

Medical Device Development Risks

• Inability to complete pre-clinical feasibility, bench validation, or prototype development within projected timelines or budgets
• Failure to obtain FDA 510(k) clearance, De Novo authorization, or IDE approval for one or more devices in the portfolio
• Delays or failures in NIH STTR Phase I or SBIR Phase I grant applications, reducing non-dilutive capital availability
• Adverse outcomes in first-in-human feasibility studies or IDE-governed clinical investigations
• Changes in FDA regulatory requirements or guidance documents affecting 510(k), De Novo, or PMA pathways
• Inability to achieve ISO 13485 QMS certification or maintain Design History File integrity as required by 21 CFR Part 820

Company Risks

• Need for substantial additional capital beyond the current Seed round to complete development and commercialization — no assurance that Series A or subsequent financing will be available on favorable terms or at all
• Dependence on the founding physician-scientist and key advisory board members — loss of key personnel could materially impair development and regulatory strategy
• Issuance of additional equity securities at prices dilutive to current SAFE investors upon conversion
• Inability to protect intellectual property — patents may not issue, may be challenged, or may not provide sufficient commercial protection
• Potential for strategic acquirers to develop competing technologies internally, reducing acquisition interest or valuation
• Failure to achieve projected revenue milestones in Year-5 platform model — projections are not guarantees of future performance
• Manufacturing scale-up challenges, supply chain disruptions, or inability to identify and qualify contract manufacturers

Industry & Market Risks

• The women's health medical device market is subject to significant competition from large, well-capitalized incumbents with established distribution channels and customer relationships
• Changes in hospital purchasing patterns, GPO contracting, or payer reimbursement policies could adversely affect commercial adoption following clearance
• Adverse clinical data from competing products or broad regulatory actions affecting the medical device industry could impact the company's development and commercialization timeline
• Macroeconomic conditions, interest rate environment, and private market valuation compression could adversely affect the company's ability to raise future capital or achieve exit valuations

Litigation Risks

Medical device companies are subject to product liability, intellectual property infringement, and regulatory enforcement risks. Clinical investigations carry inherent risks of adverse events, protocol deviations, and regulatory scrutiny. As a pre-revenue company, NEG+ does not yet carry commercial product liability insurance, and there is no guarantee that adequate coverage will be available at commercially reasonable terms when required.

Investors must understand that by investing in NEG+ Innovations, Inc. they are voluntarily assuming all of the risks of the investment. This overview is not intended to be, nor should it be construed as, investment, tax, or legal advice. Any offer or solicitation of an investment may be made only by delivery of the Confidential Private Placement Memorandum and SAFE documents to verified accredited investors. Investors should rely solely on those offering documents in making any investment decision.