Clinical Infrastructure

The Clinical Operations
Behind NEG+ Innovations

New England Gynecology Plus PLLC is the dedicated clinical operating entity and managing partner that powers the device validation, evidence generation, and patient care infrastructure supporting NEG+ Innovations, Inc.'s medical device pipeline.

Two-Entity Architecture

One Mission. Two Distinct Entities.

NEG+ operates through a deliberate two-entity structure designed to maintain clean corporate governance, protect intellectual property, and preserve SBIR/STTR eligibility — all while keeping clinical operations and device development under unified physician leadership.

Delaware C-Corp

NEG+ Innovations, Inc.

Medical Device Company · IP Holding Entity
Purpose
Device research & development, intellectual property ownership, regulatory strategy, and investor capital vehicle.
IP & Assets
All device IP, patent applications, and proprietary designs are formally assigned to and vested in the C-Corp under executed assignment agreements.
Funding Eligibility
NIH SBIR/STTR grant eligibility, Reg D investor capital (SAFE, Series Seed), QSBS-eligible under IRC §1202.
Governance
Independent board of directors. NEG+ PLLC holds no equity, no governance rights, and no board representation in the C-Corp.
Massachusetts PLLC

New England Gynecology Plus PLLC

Clinical Practice Entity · Managing Partner
Role
Clinical services vendor and managing partner to NEG+ Innovations, Inc. under a formal formal contractual arrangement. Provides the clinical infrastructure, patient care platform, and investigator-site infrastructure supporting device validation.
Clinical Operations
Evidence-based, non-obstetrical gynecologic care including telehealth services. Six operational pillars spanning clinical care, R&D support, education, community engagement, and medical innovation.
Relationship to C-Corp
Services vendor under written contractual agreement. Operates as the designated clinical investigator site for NEG+ device feasibility studies and early clinical validation work.
Founded
September 2023 · Weston, Massachusetts
Contractual Structure

Managing Partner Agreement

The two entities interact exclusively through a formal formal contractual arrangement. This structure maintains clean corporate governance for investors while providing the C-Corp with a dedicated clinical operations for device validation.

Managing Partner
NEG+ PLLC
Clinical practice · Patient care · Investigator site · Education & community engagement
⇄
Arm's-Length
Services Agreement
C-Corp · IP Holder
NEG+ Innovations, Inc.
Device R&D · IP ownership · SBIR grants · Investor capital · Regulatory strategy
IP Firewall
All device intellectual property is assigned to and owned exclusively by the C-Corp. The PLLC has no IP rights.
Clean Cap Table
The PLLC holds no equity interest, governance rights, or board representation in NEG+ Innovations, Inc.
SBIR Integrity
Structural separation ensures full NIH SBIR/STTR eligibility is preserved in the C-Corp as the small business applicant.
NEG+ PLLC Operations

Six Pillars of Clinical Excellence

New England Gynecology Plus PLLC operates across six integrated domains that collectively form the clinical foundation supporting the NEG+ Innovations device pipeline.

Clinical Patient Care

Evidence-based, patient-centered gynecologic care serving women in Weston and the greater Boston area, including telehealth. Comprehensive non-obstetrical GYN services delivered with subspecialty precision.

Core Operations

Research & Development Support

Designated clinical investigator site for NEG+ Innovations feasibility and early validation studies. Provides real-world clinical context, patient population access, and IRB-ready infrastructure.

Device Validation

Education & Training

Physician education initiatives in women's pelvic health, surgical technique, and evidence-based practice. Collaboration with academic medical centers to advance clinical training standards.

Academic Mission

Community Engagement

Active health equity programming and cancer prevention outreach. Partnership with Rotary International District 7910, community health fairs, and underserved population screening initiatives.

Health Equity

Medical Device Innovation

Clinical needs identification, physician-inventor insight, and real-world procedural feedback that informs NEG+ Innovations' multi-device portfolio. The clinical practice is where device concepts originate.

Innovation Pipeline

Strategic Partnerships

Academic medical center collaborations, society relationships (ACOG, SGO, AAGL, AUGS), and clinical KOL engagement that support the evidence generation roadmap for all four NEG+ devices.

Network
Clinical Validation Infrastructure

The PLLC as Investigator Site

4
Active device programs with clinical validation requirements across the NEG+ portfolio
1.5M+
Annual US procedures targeted by the NEG+ device portfolio — the patient population the PLLC operates within
ERAS
Clinical platform aligned to Enhanced Recovery After Surgery protocols — the unifying commercial narrative across all four NEG+ devices
Phase 0→II
Closed-loop evidence system: feasibility → bench validation → early clinical use → pivotal study enrollment
Validation Infrastructure

From Clinical Observation
to Commercial Evidence

The PLLC functions as Phase 0 of the NEG+ Innovations evidence roadmap — providing the clinical environment in which device concepts are stress-tested against real procedural workflows before entering formal bench and clinical validation.

  • Physician-inventor site: All four NEG+ device concepts originated from direct clinical observation within the PLLC's surgical and diagnostic practice.
  • IRB-ready infrastructure: The PLLC provides the institutional framework for IRB application, patient consent workflows, and early clinical data collection under the NEG+ Integrated Evidence Roadmap.
  • ERAS alignment: Every NEG+ device reduces an opioid, standardizes a technique, or prevents a surgical complication — a narrative anchored in the PLLC's patient care philosophy.
  • KOL network access: PLLC's academic society affiliations (SGO, AUGS, AAGL, ACOG) provide the KOL relationships that drive Phase II multi-site clinical enrollment.
  • Evidence publication: The PLLC's existing publication record (13 peer-reviewed papers, 20 abstracts) establishes the clinical credibility that anchors NIH SBIR grant applications.
Unified Clinical Narrative

NEG+ Innovations is the ERAS Company
for Women's Health

Enhanced Recovery After Surgery protocols are transforming women's pelvic surgery — reducing opioid dependence, shortening hospital stays, and improving outcomes. Every device in the NEG+ portfolio directly supports an ERAS objective. The PLLC's clinical practice is the proof point that makes this narrative credible to hospital VAC committees, payers, and strategic acquirers.

↓ Opioid
Pudendal Nerve Block Device — preferred ERAS analgesic per 2024 Society guidelines
↓ OR Time
Belotte Colpotomizer — 8–12 min savings per hysterectomy case
↓ Reoperation
POP-Q AutoSense — objective staging reduces misdiagnosis-driven repeat surgery
↓ Adverse Events
MUMS — autonomous intrapartum monitoring targeting adverse perinatal outcomes

Engage with the NEG+ Platform

Research institutions, clinical investigators, and industry partners interested in the NEG+ Innovations device programs are invited to connect with our team.

Contact NEG+ Innovations View the Device Portfolio