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.
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) — an OB/GYN with deep expertise in translational medicine, medical device development, and healthcare strategy — NEG+ Innovations combines elite clinical insight with sophisticated engineering and financial rigor.
The multi-device portfolio is designed to mitigate concentration risk through sequenced development tiers — each program maintains an independent FDA pathway, enabling staged de-risking, sequential revenue events, and a unified commercial channel targeting the OB/GYN and urogynecology call point.
To bring innovative solutions to unmet needs in women's pelvic health, leveraging clinical expertise, precision engineering, and data science to produce advanced, differentiated medical devices that improve outcomes for patients worldwide.
We integrate clinical care, translational research, regulatory science, and strategic capital to bring first-in-class devices from concept to commercialization.
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.
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.
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.
Multimodal Uterine Monitoring System — an autonomous, AI-enabled intrapartum platform addressing the $2.45B fetal monitoring market. MUMS integrates continuous multiparameter sensing with AI-assisted classification to support safer labor and delivery, directly aligned with federal maternal health policy mandates and ERAS opioid-reduction objectives.
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, feasibility analysis
Design verification, bench testing, iterative CAD refinement, FDA design controls initiation
Mechanical, electrical, biocompatibility testing; ex vivo and cadaveric studies; Design History File
Human factors validation, Early Feasibility Study, multicenter IDE trial, STTR-funded evidence generation
510(k) / De Novo submission, FDA review, ISO 13485 quality management system compliance
GPO contracts, KOL clinical champions, post-market surveillance, publication strategy execution
Each device addresses a large US addressable market with documented clinical gaps, favorable reimbursement dynamics, and a clear pathway to acquisition by established surgical platform companies.
~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. Strong strategic fit with established medtech platforms serving the gynecologic surgery market.
200,000–300,000 POP surgeries annually; 37.7% surgical recurrence rate driven by staging variability. Three-stream revenue: device kit ($8,500–$12,500), single-use sleeve ($95–$145), SaaS license ($350–$750/month). FDA SaMD framework enables parallel hardware and software pathways.
Landmark-guided pudendal block success rates: 50–70%. Ultrasound-guided: 82–97% (Rofaeel 2008; Karaman 2019). No commercial device integrates guidance and delivery in a single-operator system. Applicable across OB/GYN, urogynecology, midwifery, and pelvic pain medicine — CPT 64430 reimbursement pathway.
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 confidential investor brief — including the full capital deployment schedule, milestone roadmap, and detailed financial model. All inquiries held in strict confidence.
Request Investor BriefOffered under Regulation D, Rule 506(b) to verified accredited investors only.
NEG+ has assembled a multi-disciplinary Advisory Board spanning FDA regulatory strategy, clinical validation, engineering execution, investor access, life sciences partnerships, health economics, and corporate finance — each member occupying a defined, non-redundant value lane built for full commercialization coverage.
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 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 Clinical Associate Professor at Einstein formalizes the institutional relationship and supports IDE site activation with minimal friction.
Wayne State serves as the clinical KOL anchor for POP-Q AutoSense™ and Belotte Colpotomizer™ urogynecology validation, with an advisory board member positioned as STTR academic PI candidate. The institution's NIH funding history and established IRB infrastructure reduce site activation timelines and strengthen the peer-review credibility of STTR Phase I Specific Aims submissions.
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 leading research institutions, clinical investigators, industry partners, and accredited investors who share our commitment to advancing women's health through precision medical technology.