NEG+ Innovations, Inc. is building a differentiated, physician-designed medical device portfolio targeting critical unmet needs in women's pelvic surgery, diagnostics, interventional analgesia, and intrapartum monitoring — positioned as the ERAS innovation engine for women's health.
The United States spends more on healthcare per capita than any other nation on earth — yet we rank last or near-last among peer nations on avoidable mortality, maternal survival, and chronic disease management. This is not a funding problem. It is an innovation and prioritization problem.
Technology Unchanged Since the 1970s
Fetal monitoring relies on concepts that have not meaningfully evolved in over 50 years — while preventable perinatal deaths continue to occur annually.
No Standardized Colpotomy Platform Exists
600,000 hysterectomies annually, yet colpotomy — a critical surgical step — is still performed with tools designed for other purposes, producing surgeon-dependent outcomes.
Manual Staging With No Digital Standard
Pelvic organ prolapse staging remains a manual, examiner-dependent process — driving a 37.7% surgical recurrence rate from staging variability alone.
A Blind Procedure With Predictable Failures
Pudendal nerve blocks are performed by landmark and feel — no depth control, no anatomic confirmation. Published success rates range from 50–80%. No purpose-built precision device exists.
"These are not future problems awaiting future solutions. They are today's problems — and they require today's capital."
These are device problems. Device problems have device solutions.
Each program addresses a distinct, clinically documented unmet need in women's pelvic surgery, diagnostics, interventional analgesia, and intrapartum monitoring — with independent regulatory pathways and a unified ERAS clinical narrative delivered through a single OB/GYN and urogynecology commercial channel.
Every labor carries risk. MUMS™ transforms the delivery room — a sub-centimeter intravaginal AI platform that continuously monitors fetal heart rate, uterine contractions, cervical dynamics, and maternal vitals, giving care teams real-time intelligence at the most critical moment in human life. Targeting the $2.45B fetal monitoring market and directly aligned with the White House Maternal Health Blueprint.
A sensorized conformable anatomical sleeve system with indexed ring electronics, providing real-time simultaneous measurement of all nine POP-Q reference points. Delivers a digital twin 3D visualization and HL7 FHIR-compliant EMR export — eliminating the 30% inter-observer variability that currently drives repeat surgeries and misclassification.
A novel finger-mounted modular system integrating a reusable sensing module with PMUT ultrasound ring array and near-infrared optical ring for real-time nerve localization and vascular avoidance — raising pudendal nerve block success rates from 50–70% (landmark-guided) to the 82–97% range achieved by image-guided techniques, in a single-operator workflow.
A reusable handle + single-use disposable crown system for laparoscopic and robotic-assisted hysterectomy. Integrates automated 360° electrosurgical colpotomy, pneumatic vaginal stenting, and microprocessor-regulated energy delivery — targeting a 60-second colpotomy time versus the 8–14 minute current standard of care.
NEG+ Innovations, Inc. is a physician-founded Delaware C-Corporation headquartered in Weston, Massachusetts, built around a singular mission: to develop transformative medical devices that address persistent, clinically documented gaps in women's pelvic health and surgical instrumentation.
Founded by Dr. Jimmy Belotte (MD, PhD, MBA, FACOG) — OB/GYN, physician-scientist, and Medical Director at GlaxoSmithKline Oncology — NEG+ combines elite clinical insight with engineering rigor and financial discipline.
Each device addresses an independent FDA pathway, enabling staged de-risking, sequential revenue events, and a unified commercial channel targeting OB/GYN and urogynecology.
To close the expression gap in women's health by designing, developing, and commercializing novel medical devices that improve clinical outcomes, enhance procedural safety, and give every woman — regardless of geography or socioeconomic status — access to the standard of care she deserves. We exist for the patient first.
To become the defining physician-led women's health medical device company of the next decade — one where every innovation in our portfolio is grounded in evidence, protected by strong IP, built in partnership with academic medicine, and scaled through a commercial infrastructure designed for lasting patient impact.
Our development process follows a rigorous, evidence-driven stage gate framework — translating clinical insight into FDA-cleared products through defined milestones, non-dilutive NIH funding, and institutional collaboration.
Clinical needs assessment, provisional patent applications, voice-of-customer research, freedom-to-operate analysis
Design verification, bench testing, CAD refinement, FDA design controls, ISO 13485 QMS initiation
Preclinical testing, ex vivo cadaveric studies, human factors, Early Feasibility Study, IDE clinical trial
510(k) / De Novo submission, FDA review, ISO 13485 compliance, GPO contracting, commercial launch
Four devices. A combined US addressable market of ~$16.2B. Each program addresses a documented clinical gap with favorable reimbursement dynamics and a clear pathway to acquisition by one of eleven identified strategic acquirers across two distinct pools.
4M+ US births annually. MUMS™ targets the intrapartum monitoring gap where staffing shortages make continuous bedside engagement impossible. Autonomous intravaginal SaMD platform with no direct competitor at equivalent modality. Aligned with federal maternal mortality reduction mandates (White House Blueprint, HRSA). Strategic acquirer pool: Philips, GE HealthCare, Masimo, Edan, Nihon Kohden.
~450,000 hysterectomies annually (55–60% laparoscopic/robotic). Quantifiable OR time savings per procedure create a hospital VAC economic argument without requiring a new CPT code — reimbursement absorbed within existing hysterectomy procedure fees. Strategic acquirer pool: Medtronic, Olympus, Stryker, CooperSurgical.
200,000–300,000 POP surgeries annually; 37.7% surgical recurrence rate driven by staging variability alone. Three-stream revenue: device kit, single-use sleeve, and SaaS license. FDA SaMD framework enables parallel hardware and software pathways toward 510(k) and De Novo clearance.
Landmark-guided pudendal block success rates: 50–70%. No commercial device integrates guidance and delivery in a single-operator system. CPT 64430 anchors reimbursement from day one — the platform's near-term commercial proof point. Adjacent markets: chronic pelvic pain, vulvodynia, in-office hysteroscopy analgesia.
NEG+ does not compete on features. We compete on clinical transformation. Our advantage is structural, durable, and difficult to replicate.
Every device was designed by the physician who felt the limitation — in the operating room, the labor suite, and the clinic. No translation required between need and solution.
FDA 510(k) strategy is defined, predicate analysis is complete, and specialized regulatory counsel is engaged. Pre-Submission meetings are scheduled. We know the path — and we are on it today.
Academic medical center relationships, clinical society networks, NIH research experience, and industry partnerships built over a career — not assembled after a term sheet.
FDA's 2024–2025 women's health device guidance creates a favorable review environment for exactly our programs.
FemTech investment is accelerating. Strategic acquirers — Hologic, Stryker, Medtronic — are actively paying premium multiples in this space.
Existing CPT codes for both lead programs eliminate payer risk — this is a product quality problem, not a market creation problem.
No dominant incumbent occupies either lead program category. The first precision device with 510(k) clearance defines the category.
NEG+ employs a staged blended capital strategy combining non-dilutive NIH STTR funding with private investor capital — preserving founder equity while building federal peer-review validation.
NEG+ pursues NIH SBIR and STTR grants as the primary early-stage funding mechanism — providing peer-reviewed federal validation of core technology before institutional capital is required. This approach preserves equity while simultaneously strengthening investor diligence materials through independent scientific review.
Private investment is structured to be milestone-linked, founder-aligned, and equity-efficient — with each round tied to defined regulatory and technical inflection points. The founder participates personally on identical terms alongside every investor, reflecting direct skin-in-the-game conviction.
Accredited investors and institutional partners may request our investor brief — including the full capital deployment schedule, milestone roadmap, and detailed financial model.
Request Investor BriefOffered under Regulation D, Rule 506(b) to verified accredited investors only.
A multi-disciplinary team spanning regulatory, clinical, engineering, capital, and commercial domains — each advisor in a defined, non-redundant value lane.
Exceptional regulatory access and strategic pathway expertise — a resource most medtech startups at any stage do not have. Key lane: 510(k) / De Novo / IDE strategy.
Clinical champion for POP-Q AutoSense™ and Belotte Colpotomizer™. Reduces IDE activation friction; serves as STTR PI candidate at an established NIH-funded institution.
Minimally invasive gynecologic surgery expertise. Co-investigator for Belotte Colpotomizer™ clinical studies; institutional IDE enrollment pipeline.
Mechanical engineering execution, FDA design controls (21 CFR Part 820), ISO 13485 QMS implementation, Design History File architecture.
Medtech angel and early-stage VC network access. Investor relations strategy, pitch positioning, and seed round pipeline for Series Seed target investors.
Corporate venture capital and biopharma strategic partnership lane. Growth-stage BD relationships and strategic acquirer relationship development.
Healthcare economics, reimbursement strategy, CPT code development pathway, and SBIR/STTR narrative framework for NIH Specific Aims alignment.
Investor governance, SAFE documentation, cap table management, IP agreement architecture, and Series Seed transaction readiness for institutional VCs.
"In more than two decades of urogynecologic practice, I have witnessed firsthand how subjective POP-Q examination leads to inconsistent staging — and, ultimately, inconsistent patient care. The POP-Q Sensorized Device™ represents a meaningful step toward the objective, reproducible pelvic floor assessment our field has long needed. I am committed to supporting its rigorous clinical validation at BIDMC and to advancing a platform that can meaningfully improve outcomes for women with pelvic organ prolapse."
NEG+ Innovations operates within a strategically assembled ecosystem of academic, governmental, clinical, regulatory, and capital partners — each engaged to accelerate development, validate evidence, open commercial channels, and support a sustainable path from bench to market. Academic medical center partnerships are foundational to every layer of this strategy.
BIDMC/HMS anchors NEG+'s NIH STTR academic partnership strategy — providing co-investigator infrastructure, IRB pathway access, and OR-based enrollment capacity central to the clinical validation programs for Tier 1 devices. The institutional relationship supports STTR subaward structure, academic PI credentialing, and a research-grade evidence generation platform that satisfies FDA IDE and NIH peer-review standards simultaneously.
Albert Einstein / Montefiore provides minimally invasive gynecologic surgery clinical validation expertise, co-investigator access for Belotte Colpotomizer™ clinical studies, and direct connection to high-volume surgical enrollment pipelines. Dr. Belotte's academic appointment as Former Clinical Associate Professor at Einstein formalizes the institutional relationship and supports IDE site activation with minimal friction.
Health economics and policy expertise embedded directly in the Advisory Board — driving reimbursement pathway development, CPT code strategy, and SBIR/STTR Specific Aims narrative for NIH funding applications. The partnership informs HEOR models required for hospital value analysis committee (VAC) adoption and CMS coverage determination arguments across the device portfolio.
Federal and state agencies provide non-dilutive funding, regulatory guidance, and policy alignment across the portfolio — from NIH grant mechanisms to HRSA maternal health mandates.
Clinical adoption and patient-centered design require active engagement with the provider community and patient advocacy organizations throughout development — not after clearance.
Early engagement with regulatory bodies and commercial payers is embedded in development strategy — ensuring that clearance timelines and reimbursement pathways are validated before capital is committed to pivotal trials.
Strategic industry relationships support device manufacturing, clinical operations infrastructure, regulatory execution, and ultimately position NEG+ for partnership or acquisition by established medtech platform companies.
NEG+ is building relationships across the medtech capital ecosystem — from angel networks and seed-stage funds to institutional medtech VCs and healthcare-focused private equity — with a clear milestone-linked capital roadmap.
Membership and active engagement in leading professional societies accelerates clinical adoption, creates publication and KOL access, and positions NEG+ devices within the evidence-based practice guidelines that drive hospital formulary decisions.
Mission-aligned philanthropic capital and foundation grants complement the SBIR/STTR strategy — funding early discovery, community-based research, and health equity work that federal mechanisms do not fully cover.
NEG+ maintains a comprehensive intellectual property strategy across all multiple device programs. All IP is formally assigned to and vested in the C-Corp under executed assignment agreements.
Provisional patent application on file covering the integrated electrosurgical colpotomy system — a novel combination of automated rotation, energy delivery, and tissue management in a reusable handle / single-use disposable architecture for laparoscopic hysterectomy.
Provisional patent application on file covering the sensorized multi-point anatomical measurement platform, EMR-integrated digital staging architecture, and associated software classification system for automated pelvic organ prolapse quantification.
Provisional patent applications on file covering the single-operator integrated nerve localization and anesthetic delivery system — a novel combination of multimodal sensing and controlled delivery in a finger-mounted form factor.
Provisional patent application on file covering the multimodal intrapartum sensing and AI-enabled classification platform for autonomous labor and delivery monitoring. IP strategy aligned with De Novo / PMA regulatory pathway and pre-competitive clinical evidence standards.
We welcome collaboration with research institutions, clinical investigators, industry partners, and accredited investors committed to advancing women's health.
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