Tracking our progress from concept to clinic — corporate formation, advisory appointments, academic partnerships, and development milestones.
NEG+ Innovations launched its official digital presence, providing academic partners, prospective investors, clinical collaborators, and government agencies with a comprehensive overview of the company's mission, multi-device portfolio, advisory board, and institutional partnership strategy. The platform reflects NEG+'s commitment to transparent, science-first communication with all stakeholders.
Roger Lefevre, MD, MBA — Urogynecologist, Urogynecology & Reconstructive Pelvic Surgery, at Beth Israel Deaconess Medical Center (BIDMC) / Beth Israel Lahey Health, Harvard Medical School — entered a Scientific Advisory Board agreement with NEG+ Innovations in connection with the POP-Q Sensorized Device™. Dr. Lefevre's 20+ year peer-reviewed publication record in POP-Q examination methodology, prolapse staging accuracy, and surgical outcomes positions him as the primary STTR academic PI candidate for BIDMC-based clinical feasibility studies.
NEG+ Innovations completed assembly of an eight-member Scientific Advisory Board spanning FDA regulatory strategy (former FDA Principal Deputy Commissioner), clinical validation in urogynecology and MIGS (KOLs at Wayne State and Albert Einstein / Montefiore), engineering and quality systems (Repligen/SelasBio), capital access (Boston Harbor Angels), life sciences partnerships, health economics (Brandeis/Harvard School of Public Health), and corporate finance and legal strategy (Katten Muchin Rosenman LLP). Each advisor occupies a defined, non-redundant value lane built for full commercialization coverage.
NEG+ Innovations formalized its academic partnership with Albert Einstein College of Medicine and Montefiore Medical Center, a National Cancer Institute–designated center in Bronx, New York. Dr. Belotte's appointment as Clinical Associate Professor at Einstein provides an institutional foundation for co-investigator enrollment in Belotte Colpotomizer™ clinical studies and direct access to high-volume surgical enrollment pipelines for IDE-phase feasibility studies.
NEG+ Innovations, Inc. was formally incorporated as a Delaware C-Corporation — the standard structure for venture-backed life sciences and medical device companies. The incorporation establishes the legal foundation for SBIR/STTR grant eligibility, SAFE and preferred equity financing, advisory board equity grant programs, and the full range of institutional investor and strategic acquirer transaction structures. Headquarters established in Weston, Massachusetts.
NEG+ Innovations initiated active engineering concept development across its full device portfolio: the Belotte Colpotomizer™, POP-Q AutoSense™, Pudendal Nerve Block Device™, and MUMS™. Each program addresses a distinct, documented unmet clinical need in women's pelvic health — from precision surgical delineation and objective prolapse staging to guided nerve localization and non-invasive fetal-maternal monitoring. Regulatory strategy development initiated in parallel with device concept work.
NEG+ Innovations is actively developing NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding applications targeting Phase I feasibility funding for the POP-Q AutoSense™ and Belotte Colpotomizer™ programs. STTR applications require an academic co-applicant institution — BIDMC/Harvard Medical School and Wayne State University School of Medicine are positioned as primary STTR academic partners. Advisory Board health economics expertise informs the Specific Aims narrative and significance framing for peer review.
NEG+ Innovations is targeting the launch of a formal Seed capital round to complement non-dilutive NIH grant funding. The round will support engineering prototype development, pre-clinical validation studies, regulatory strategy execution, and STTR application co-development. Investor Brief available to verified accredited investors upon request.
Subject to NIH grant award, prototype validation, and IRB approval, NEG+ Innovations is targeting submission of an Investigational Device Exemption (IDE) application for the POP-Q AutoSense™ Early Feasibility Study at BIDMC/Harvard Medical School. Study design, patient population, and endpoints are being developed in coordination with Advisory Board clinical and regulatory members.
We welcome collaboration with leading research institutions, clinical investigators, industry partners, and accredited investors who share our commitment to advancing women's health.
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