Tracking our progress from concept to clinic — corporate formation, advisory appointments, academic partnerships, and development milestones.
Pudendal nerve block is one of the quiet workhorses of obstetric and gynecologic care. Published literature puts average failure rates around 20%, with some series reporting failure on at least one side in up to half of cases. In this clinical perspective, Dr. Jimmy Belotte examines why a routine procedure built on landmark-based technique still fails at such rates — and what NEG+ is building to address it.
Read the full article →NEG+ Innovations has executed a mutual Confidential Disclosure Agreement with leadership at Beth Israel Deaconess Medical Center (BIDMC) and Harvard Medical School — opening the door to long-term co-development of the NEG+ device portfolio and joint NIH, DoD, and MLSC grant applications supporting clinical validation and early adoption. Michelle Hacker and Dr. Roger Lefevre have been designated as Institutional PIs on the BIDMC side. This milestone formalizes one of NEG+'s most critical academic partnerships and positions BIDMC/HMS as the anchor institution for IDE-phase clinical studies and STTR co-applications.
NEG+ Innovations has been officially selected into the Perot Jain TechLab program at the University of Michigan's Center for Entrepreneurship — a competitive accelerator that pairs early-stage ventures with top UM engineering and business development student teams for a year-long collaboration. The program provides NEG+ with a structured pipeline for technical talent, outside engineering momentum, and entrepreneurial resources as the company advances toward its Seed capital raise. Selection into TechLab reflects independent external validation of the NEG+ platform and its commercial readiness.
NEG+ Innovations is proud to announce the appointment of Anya Harry, MD, PhD to its Scientific Advisory Board and as Acting Chief Medical Officer. Dr. Harry brings deep expertise in FDA regulatory strategy, medical device R&D, and drug-device combination products, currently serving as VP & Chief Medical Officer at West Pharmaceutical Services — a global leader in drug delivery systems and medical device packaging. A Yale School of Medicine–trained physician with prior experience as an FDA reviewer and at GlaxoSmithKline and Voisin Consulting Life Sciences, Dr. Harry will lead NEG+ Innovations' clinical strategy, regulatory pathway development, and medical affairs across the POP-Q AutoSense™ and MIGS device programs.
NEG+ Innovations has retained Morse Law and Ward Law to anchor its corporate legal infrastructure. Morse Law has been engaged as lead counsel for corporate governance and SAFE (Simple Agreement for Future Equity) execution — overseeing investor documentation, cap table structuring, and financing round mechanics as the company prepares its Seed capital raise. NEG+ is represented at Morse Law by Elizabeth A. Resteghini and Monica B. Sax. Ward Law continues in its advisory capacity supporting the company's broader legal strategy. Together, the two firms provide NEG+ with institutional-grade legal coverage across transactional, regulatory, and strategic matters.
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 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. 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 Former 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 is positioned as the primary STTR academic partner. 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.
Contact Us Explore R&D