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Physician-Led Medical Device Innovation

Transforming Women's Health
Through Precision Technology

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.

Pre-Clinical Stage
Featured Device · Pudendal Nerve Block Device™
No Opioids. No Guesswork.
Precision Pudendal Analgesia.
Anatomically guided · ERAS-ready · Surgeon-delivered · Outpatient-optimized
Portfolio
Device Programs
~$16.2B
Combined TAM (US) · Four-Device Platform
1.5M+
Annual Addressable Procedures
$51B → $103B
Global FemTech Market · 2023 → 2030 · 12% CAGR
32.9
US Maternal Deaths per 100K Births · Highest Among High-Income Nations
Of Every VC Healthcare Dollar Invested in Women's Health
~$16.2B
Combined US Addressable Market · Four-Device Platform

We Spend More. We Get Less.
And Women Pay the Price.

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.

Intrapartum Monitoring

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.

Gynecologic Surgery

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.

Pelvic Diagnostics

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.

Interventional Analgesia

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.

One Platform. One Exit. One Vision.

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.

MUMS — AI-enabled intrapartum monitoring suite concept
AI-ENABLED INTRAPARTUM MONITOR
Intrapartum Monitoring · Device 1 · Tier 3 — Milestone-Gated

MUMS™

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.

Market (Global) $2.45B · 6.7% CAGR
Indication High-risk labor & delivery monitoring
Regulatory Pathway De Novo / PMA
Policy Alignment White House Blueprint · HRSA Mandate
Development Stage Concept & IP · SBIR Phase I
Learn More →
POP-Q AutoSense — sensor interface and system architecture diagram
Pelvic Diagnostics · Device 3 · Tier 2 — Active Development

POP-Q AutoSense™

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.

TAM (US, 2025) $1.06B → $1.7B by 2030
Annual POP Surgeries 200,000–300,000
Regulatory Pathway 510(k) + De Novo (SaMD)
Revenue Model Capital + Consumable + SaaS
Device Kit ASP $8,500–$12,500
Learn More →
Pudendal Nerve Block Device — 3D-printed prototype components with quarter for scale
Interventional Analgesia · Device 4 · Tier 1 — Immediate Commitment

Pudendal Nerve Block Device™

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.

Market Opportunity $2B+ (US)
Current Success Rate 50–70% (landmark)
Device Success Rate 82–97% (projected)
Regulatory Pathway FDA 510(k)
Specialties Served OB/GYN, MFM, Urogyn, Pain
Learn More →
Belotte Colpotomizer — rotating crown bearing diagram
Surgical Access · Device 2 · Tier 1 — Immediate Commitment

Belotte Colpotomizer™

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.

TAM (US) $10.7B+
Annual Hysterectomies ~450,000
Regulatory Pathway FDA 510(k)
ASP (Disposable) $400–$600
Strategic Acquirers Medtronic, Olympus, Stryker, CooperSurgical
Learn More →
Competitive Landscape · The Moat
The market has left the same quadrant open.
In both procedures.
Competitive landscape quadrant chart showing white-space opportunity for both the Belotte Colpotomizer and Pudendal Nerve Block Device in the low-skill / low-cost quadrant

Physician-Led.
Evidence-Driven. Mission-Focused.

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.

  • Delaware C-Corporation — QSBS & SBIR/STTR eligible
  • All device IP formally assigned to and vested in the C-Corp
  • Founder co-investing personally on identical terms alongside investors
  • Non-dilutive NIH SBIR/STTR funding pursued in parallel with private capital
Physician consulting with a patient — personalized women's health care
Patient-centered care is the foundation of every NEG+ device decision.
Mission

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.

Vision

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.

Values
Patient First, Always Physician-Driven Design Evidence Before Everything Equity in Women's Health Access Rigorous Regulatory Stewardship Transparent Partnership Commercial Purpose in Service of Clinical Mission

Stage-Gated Innovation Methodology

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.

1

Discovery & IP

Clinical needs assessment, provisional patent applications, voice-of-customer research, freedom-to-operate analysis

2

Engineering & Prototyping

Design verification, bench testing, CAD refinement, FDA design controls, ISO 13485 QMS initiation

3

Clinical Validation

Preclinical testing, ex vivo cadaveric studies, human factors, Early Feasibility Study, IDE clinical trial

4

Regulatory & Launch

510(k) / De Novo submission, FDA review, ISO 13485 compliance, GPO contracting, commercial launch

Projected Development Timelines — All Four Programs

Belotte Colpotomizer™ — Surgical Access (FDA clearance target: Q4 2027)
Concept/IP
Prototype (2026)
Preclinical (2026–27)
Clinical Validation (2027)
FDA 510(k)
Launch
POP-Q AutoSense™ — Pelvic Diagnostics (FDA clearance target: Q1 2028)
Concept/IP
Prototype (2026)
STTR-Funded Validation (2026–27)
Multi-Site Clinical (2027–28)
FDA 510(k)+SaMD
Launch
Pudendal Nerve Block Device™ — Interventional Analgesia (FDA clearance target: 2028–2029)
Concept/IP
Prototype Engineering (2026)
EFS & Validation (2027)
IDE Clinical Trial (2027–28)
FDA Review
Launch
MUMS™ — Intrapartum Monitoring · Tier 3 Milestone-Gated (target: 2030–2031)
Concept/IP · SBIR Ph I
Sensor Validation (2027)
Phase I FIH (2028)
Phase II–III Clinical (2028–30)
FDA De Novo / PMA
Launch
Concept & IP
Prototype Engineering
Preclinical / STTR Validation
Clinical Studies
FDA Regulatory
Commercial Launch
NEG+ surgical team in the operating room

"Three unfair advantages no competitor can replicate: the inventor is the surgeon. The regulatory path is mapped. The ecosystem took 15 years to build."

Dr. Jimmy Belotte, MD, PhD, MBA, FACOG  ·  Founder & CEO, NEG+ Innovations

~$16.2B Combined TAM — Four Clinically Validated Markets

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.

Device 1 · Intrapartum Monitoring

MUMS™

$2.45B+
Global Fetal Monitoring Market · 6.7% CAGR

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.

Device 2 · Surgical Access

Belotte Colpotomizer™

$10.7B+
US MIS Gynecologic Surgery Instrumentation Market

~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.

Device 3 · Pelvic Diagnostics

POP-Q AutoSense™

$1.06B → $1.7B
US Market by 2030 (6.6% CAGR)

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.

Device 4 · Interventional Analgesia

Pudendal Nerve Block Device™

$2B+
US Addressable Market (Pelvic Analgesia · Adjacent Indications)

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.

Why NEG+ Innovations Wins

NEG+ does not compete on features. We compete on clinical transformation. Our advantage is structural, durable, and difficult to replicate.

The Inventor Is the Surgeon

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.

The Regulatory Path Is Mapped

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.

15 Years of Ecosystem Building

Academic medical center relationships, clinical society networks, NIH research experience, and industry partnerships built over a career — not assembled after a term sheet.

Advantage
Clinical Impact
Commercial Impact
Lower the Skill Burden
Complex procedures accessible to broader practitioner range
Market expands beyond subspecialty centers into community settings
Increase Access
High-quality care extends to community hospitals and low-resource settings
Aligns with federal health equity priorities and Medicaid contracting incentives
Increase Safety
Reduces adverse events driven by technical variability
Lower readmissions, shorter stays, reduced institutional liability
Decrease Cost
Shorter OR times, fewer complications, reduced opioid utilization
Favorable health economics for hospital systems and payers
Reimbursement-Ready
Existing CPT codes for both lead programs — no new code creation required
Removes payer risk and accelerates adoption timeline
Regulatory

FDA's 2024–2025 women's health device guidance creates a favorable review environment for exactly our programs.

Market

FemTech investment is accelerating. Strategic acquirers — Hologic, Stryker, Medtronic — are actively paying premium multiples in this space.

Reimbursement

Existing CPT codes for both lead programs eliminate payer risk — this is a product quality problem, not a market creation problem.

Competitive Window

No dominant incumbent occupies either lead program category. The first precision device with 510(k) clearance defines the category.

Blended Capital. De-Risked Development.

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.

Non-Dilutive Foundation

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.

  • NICHD & NIBIB — aligned institutes for reproductive health and biomedical sensing
  • NSF STTR parallel track — engineering and AI/ML component development
  • Federal peer-review creates independent third-party technical validation
  • SBIR/STTR eligibility maintained through C-Corp structure and academic partnerships

Private Capital Structure

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.

  • SAFE instrument — Reg D Rule 506(b), accredited investors only
  • Sequential seed and institutional rounds tied to FDA regulatory milestones
  • QSBS eligible — Delaware C-Corp, qualifying small business under IRC §1202
  • Clean cap table — individual founder, investor-ready governance from day one
Investment team reviewing financial charts and projections

Investor Brief Available Upon Request

Accredited investors and institutional partners may request our investor brief — including the full capital deployment schedule, milestone roadmap, and detailed financial model.

Request Investor Brief

Offered under Regulation D, Rule 506(b) to verified accredited investors only.

Expert Advisory Board. Complete Commercialization Coverage.

A multi-disciplinary team spanning regulatory, clinical, engineering, capital, and commercial domains — each advisor in a defined, non-redundant value lane.

FDA Regulatory

Former FDA Principal Deputy Commissioner

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 Validation — Urogynecology

KOL · Urogynecology

Clinical champion for POP-Q AutoSense™ and Belotte Colpotomizer™. Reduces IDE activation friction; serves as STTR PI candidate at an established NIH-funded institution.

Clinical Validation — MIGS

KOL · Albert Einstein College of Medicine / Montefiore

Minimally invasive gynecologic surgery expertise. Co-investigator for Belotte Colpotomizer™ clinical studies; institutional IDE enrollment pipeline.

Engineering & Quality Systems

Repligen / SelasBio

Mechanical engineering execution, FDA design controls (21 CFR Part 820), ISO 13485 QMS implementation, Design History File architecture.

Capital Access — Angel & Early VC

Boston Harbor Angels

Medtech angel and early-stage VC network access. Investor relations strategy, pitch positioning, and seed round pipeline for Series Seed target investors.

Life Sciences Partnerships

Biopharma CVC & Growth-Stage

Corporate venture capital and biopharma strategic partnership lane. Growth-stage BD relationships and strategic acquirer relationship development.

Health Economics & Policy

Brandeis University / Harvard School of Public Health

Healthcare economics, reimbursement strategy, CPT code development pathway, and SBIR/STTR narrative framework for NIH Specific Aims alignment.

Corporate Finance & Legal

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."

RL
Roger Lefevre, MD, MBA
Urogynecologist  ·  Urogynecology & Reconstructive Pelvic Surgery
Beth Israel Deaconess Medical Center  ·  Beth Israel Lahey Health  ·  Harvard Medical School

Built on Institutional Partnerships. Designed for Scale.

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.

Foundational Partnership Tier
Academic Medical Centers — Central to Our Mission
STTR Academic Partner · IDE Clinical Site

Beth Israel Deaconess Medical Center · Harvard Medical School

Boston, Massachusetts · Harvard Medical School Teaching Hospital

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.

Clinical Validation · IDE Co-Investigator Site

Albert Einstein College of Medicine · Montefiore Medical Center

Bronx, New York · National Cancer Institute–Designated Center

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 · HEOR & Policy Strategy

Harvard School of Public Health · Brandeis University

Boston & Waltham, Massachusetts

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.

Government Agencies

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.

  • NIH — NICHD, NIBIB, NCI (primary funding agencies)
  • NSF — STTR engineering & AI/ML track
  • FDA — CDRH (regulatory engagement, Q-Sub program)
  • HRSA — Maternal health policy alignment (MUMS™)
  • HHS Office of Women's Health
  • CMS — Coverage and reimbursement pathway (NTAP)
  • Commonwealth of Massachusetts — MassVentures, EOED
Healthcare Providers & Patient Advocacy

Clinical adoption and patient-centered design require active engagement with the provider community and patient advocacy organizations throughout development — not after clearance.

  • ACOG — American College of Obstetricians & Gynecologists
  • AUGS — American Urogynecologic Society
  • AWHONN — Women's Health, Obstetric & Neonatal Nurses
  • National Partnership for Women & Families
  • Black Mamas Matter Alliance
  • Preeclampsia Foundation
  • Pelvic Health & Rehabilitation patient networks
Payers & Regulators

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.

  • FDA CDRH — 510(k), De Novo, IDE, SaMD pathways
  • CMS — Medicare NTAP and NCD coverage pathways
  • Medicaid — State coverage alignment (MUMS™ intrapartum)
  • BCBS, Aetna, UnitedHealth — commercial payer dialogue
  • Hospital VAC/P&T committees — institutional adoption pathway
  • HEOR and real-world evidence partners
Industry Partners

Strategic industry relationships support device manufacturing, clinical operations infrastructure, regulatory execution, and ultimately position NEG+ for partnership or acquisition by established medtech platform companies.

  • Contract Research Organizations — clinical trial execution
  • Medical device contract manufacturers — prototyping & scale
  • Digital health platforms — SaMD and FHIR integration
  • Robotic surgery platform ecosystem (integration pathway)
  • ISO 13485 / QMS consulting partners
  • Strategic acquirer relationship development (ongoing)
Investing Community

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.

  • Boston Harbor Angels — medtech angel network
  • MassMedic ecosystem — Massachusetts medtech investor network
  • Institutional medtech venture capital funds
  • Healthcare-focused family offices
  • Strategic CVC — pharma and medtech corporate VC
  • Private equity — growth-stage healthcare platforms
Professional Organizations & Consortia

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.

  • ACOG — practice guidelines & clinical dissemination
  • AUGS / IUGA — urogynecology international standard-setting
  • SMFM — Society for Maternal-Fetal Medicine (MUMS™)
  • ISGE — International Society for Gynecologic Endoscopy
  • ASRM — Reproductive medicine ecosystem
  • MassMedic — Massachusetts medical device industry association
  • AdvaMed — national medtech policy & advocacy
Individual Philanthropy & Foundations

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.

  • March of Dimes — maternal and infant health focus
  • Gates Foundation — global maternal health initiative
  • ACOG Foundation — women's health innovation grants
  • Doris Duke Charitable Foundation — clinical research
  • Preeclampsia Foundation — intrapartum innovation alignment
  • Mission-aligned individual donors and family foundations

Robust IP Portfolio Protecting Every Innovation

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.

Patent & IP Counsel Ward Law Office LLC — Boutique patent & trademark law firm · Mechanical, Chemical & Electrical disciplines · International IP prosecution

Belotte Colpotomizer™

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.

POP-Q AutoSense™

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.

Pudendal Nerve Block Device™

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.

MUMS™

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.

Get In Touch

Partner With
NEG+ Innovations

We welcome collaboration with research institutions, clinical investigators, industry partners, and accredited investors committed to advancing women's health.

Headquarters Weston, Massachusetts
Response Time Within 2 business days
Investment Reg D Rule 506(b) · Accredited Investors Only
Confidentiality Assured All inquiries are treated with strict confidentiality. Investor communications are governed by applicable securities laws. NDAs available upon request for clinical partnership discussions.
Women's health physician consulting with patient and family
Advancing care for women and families — across every stage of life.

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