The federal Project Grant award R01HL173767 was provided by the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837). This $910,994 grant supports a multicenter prospective clinical trial to evaluate the efficacy of progestin treatments, specifically the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUD) and oral norethindrone acetate 5 mg daily (NETA), in managing heavy menstrual bleeding (HMB) among adolescents and young...
The National Institute of Child Health and Human Development awarded a $383,192 Project Grant under the Child Health and Human Development Extramural Research program (CFDA 93.865) to Rhode Island Hospital, a division of Lifespan Corporation, to evaluate the use of a smartphone-based, non-invasive method for detecting anemia in young children in Western Kenya. This research seeks to develop and validate a mobile health (mHealth) screening tool that can accurately diagnose anemia, a common and...
This Project Grant award from the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ) under the CFDA 93.226 Research on Healthcare Costs, Quality and Outcomes program is funding the development and testing of a clinical decision support (CDS) tool to improve iron deficiency screening and management for pregnant individuals at high risk of postpartum hemorrhage (PPH). Specifically, the $118,089 award will support a two-phase project at Massachusetts...
This federal Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), provides $585,794 to Tele-Stethoscope Inc., a self-certified small disadvantaged business, to develop a novel mobile phone technology for preeclampsia and hypertension detection. The project aims to demonstrate proof-of-concept that ordinary mobile phones can reproduce physicians' diagnoses of preeclampsia and accurately detect...
This Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), provides $308,526 to Lucie Medical Inc. to develop a novel device for uterine hemostasis (bleeding control) after Cesarean sections. The project aims to finalize the design, validate materials, and test the functional performance of this new system, which is intended to help address the significant challenge of postpartum hemorrhage - a leading...
This Project Grant award from the National Institute of Child Health and Human Development under the Child Health and Human Development Extramural Research program (CFDA 93.865) provides $1,514,498 to Madorra Inc., a for-profit small business, to develop and test an at-home, non-hormonal medical device to treat vulvovaginal atrophy (VVA) in peri- and post-menopausal women, including breast cancer survivors. The Madorra Therapy System uses therapeutic ultrasound to increase vaginal blood flow and...
This $272,835 Project Grant award from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286), aims to develop a new Probe-based Light Sheet Microscopy (PLSM) device and evaluate its clinical utility for in vivo imaging of the anal mucosa during cancer screening. The key objectives are to: 1) Develop the PLSM device, 2) Assess the clinical utility of PLSM for...
This Project Grant award from the National Institute of Child Health and Human Development (NICHD) under CFDA 93.865 Child Health and Human Development Extramural Research program provides $390,000 to Thomas Jefferson University, doing business as Sidney Kimmel Medical College, to evaluate the use of contrast-enhanced ultrasound (CEUS) and subharmonic-aided pressure estimation (SHAPE) techniques for assessing uterine fibroids before and after uterine artery embolization (UAE) procedures. The...
This $199,660 Project Grant award from the National Institute of Child Health and Human Development (CFDA 93.865 - Child Health and Human Development Extramural Research) aims to further the understanding of endometriosis among Black women. The grant supports a prospective cohort study using data from the Black Women's Health Study to: Determine if established risk factors for endometriosis, such as parity, age at menarche, and body size, are associated with endometriosis risk in Black women....
The National Institute of Child Health and Human Development (NICHD) awarded a $343,510 Project Grant under the Child Health and Human Development Extramural Research program (CFDA 93.865) to Theranova LLC, a veteran-owned medical device company based in San Francisco, CA. The grant supports the development and pilot evaluation of the SOLESTIM neuromodulation system, a portable, non-invasive device designed to treat dysmenorrhea (menstrual cramps) through plantar nerve stimulation. The...
A PHOTO-BASED MENSTRUAL BLOOD LOSS METRIC - ABSTRACT IN THE UNITED STATES, APPROXIMATELY 30% OF REPRODUCTIVE AGED WOMEN SUFFER FROM AUB AND THE ASSOCIATED SYMPTOM OF HEAVY UTERINE BLEEDING (MENORRHAGIA), A MENSTRUAL DISORDER THAT DRASTICALLY IMPAIRS QUALITY OF LIFE AND HAS AN ANNUAL ECONOMIC BURDEN OF $37 BILLION. WOMEN AFFLICTED BY AUB EXPERIENCE LIMITATIONS IN SOCIAL, PHYSICAL, AND LEISURE ACTIVITIES, AND INCUR A SUBSTANTIAL PERSONAL FINANCIAL BURDEN DUE TO WORK ABSENCE AND HOME MANAGEMENT COSTS (>$2,000 PER YEAR). DESPITE THE HIGH PREVALENCE OF THIS MEDICAL CONDITION, CLINICIANS RELY ON WOMEN WHO ARE DISTRESSED BY THEIR MENSES TO GIVE A SUBJECTIVE SELF-ASSESSMENT OF THEIR MENSTRUAL BLOOD LOSS (MBL), WHICH HAS PROVEN TO BE UNRELIABLE FOR ACCURATE DIAGNOSIS AND CAN LEAD TO UNNECESSARY SURGERY. GIVEN THAT THESE SYMPTOMS ACCOUNT FOR ONE-THIRD OF ALL OFFICE VISITS TO THE GYNECOLOGIST, CHOOSING AN APPROPRIATE TREATMENT COURSE IS CRITICAL FOR PROVIDING HIGH-QUALITY CARE TO AMERICANS. CURRENT METHODS FOR QUANTIFYING MBL HAVE KEY DRAWBACKS THAT LIMIT THEIR USE. ALKALINE HEMATIN (AH) TESTING IS THE STANDARD REQUIRED BY REGULATORY BODIES FOR OBJECTIVE QUANTIFICATION OF MBL. UNFORTUNATELY, AH TESTING IS IMPRACTICAL FOR ROUTINE CLINICAL PRACTICE AS IT IS EXPENSIVE (~$1000 PER CYCLE) AND HAS POOR ACCEPTABILITY, REQUIRING PATIENTS TO COLLECT ALL USED SANITARY PRODUCTS AND MAIL THEM TO A LAB FACILITY FOR ANALYSIS. WHILE PICTORIAL BLOOD LOSS ASSESSMENT CHARTS (PBLACS) OFFER A LESS COSTLY, SEMI-QUANTITATIVE METHOD FOR MBL QUANTIFICATION, THEY DEMONSTRATE A HIGH RATE OF FALSE POSITIVE RESULTS (~59%), WHICH LEADS TO THE OVER-DIAGNOSIS OF MENORRHAGIA. TO ADDRESS THE NEED FOR A COST-EFFECTIVE, EASY- TO-USE, AND OBJECTIVE METHOD TO QUANTIFY MBL IN PREMENOPAUSAL WOMEN, THERANOVA HAS DEVELOPED A CELL PHONE- BASED DIAGNOSTIC TOOL, THE ELECTRONIC MBL DIARY (EMBLD). PREVIOUSLY, IN A PROOF OF CONCEPT CLINICAL STUDY, WE DEMONSTRATED A STRONG CORRELATION BETWEEN EMBLD AND AH TESTING, THE GOLD-STANDARD METHOD FOR OBJECTIVE QUANTIFICATION OF MBL. THE GOALS OF THIS PHASE II PROPOSAL ARE TO DETERMINE THE EFFECTIVENESS OF OUR DEVICE FOR ACCURATELY DIAGNOSING MENORRHAGIA. FIRST, WE WILL VERIFY THE SENSITIVITY OF THE IMAGE PROCESSING ALGORITHM TO ACCURATELY QUANTIFY MBL IN WOMEN WITH BOTH NORMAL AND HEAVY MENSES (SPECIFIC AIM 1). SECOND, WE WILL CONDUCT A PIVOTAL CLINICAL STUDY TO VALIDATE THE EFFECTIVENESS OF EMBLD FOR DIAGNOSING MENORRHAGIA (SPECIFIC AIM 2). THE DATA OBTAINED WILL SUPPORT FDA 510(K) CLEARANCE AND WILL ALLOW US TO COMMERCIALIZE THE SYSTEM WITHIN FOUR YEARS OF THE FUNDING OF THIS PROPOSAL.