In the dynamic field of women’s health, the quest for effective treatments for chronic conditions is ceaseless. Among these conditions, abnormal uterine bleeding (AUB), also known as heavy menstrual bleeding, poses a significant yet often under-discussed challenge for millions of women worldwide. This article dives into the intricacies of AUB, its impact on women’s health and the economy, current standards of care and treatments, and introduces Avana Health’s innovative solution to this pervasive issue. With a focus on the blend of personal connection and scientific rigor, we explore how Avana Health is poised to revolutionize the management of AUB, driven by the founders’ deep personal commitment to addressing this problem.
Abnormal Uterine Bleeding (AUB): A Closer Look
Abnormal uterine bleeding (AUB), characterized by irregular menstrual cycles and excessive blood flow, affects an estimated 1 billion women globally, casting a long shadow over their quality of life and productivity. Under normal circumstances, the uterus sheds a limited amount of blood during each menstrual period (less than 5 tablespoons or 80 mL). Bleeding that occurs erratically or excessive regular menstrual bleeding is considered to be abnormal uterine bleeding (AUB). Unfortunately, menstruators are often unaware of the quantity of blood they are losing each month and it is similarly difficult for physicians to assess the volume beyond asking, “How many menstrual products do you use per day during your period.”
This condition arises from various causes including endometriosis, fibroids, and polycystic ovarian syndrome (PCOS). The International Federation of Gynecology and Obstetrics (FIGO) classifies AUB using the acronym PALM-COEIN [pahm-koin] by describing two groups of AUB etiologies: “PALM” describes the structural causes, and “COEIN” – the non-structural causes. One or more of these causes can lead to AUB.
In the United States alone, AUB accounts for one-third of outpatient visits to gynecologists and more than 70% of gynecologic consults among perimenopausal and postmenopausal women. The economic toll is staggering. Based on individual reimbursement claims data from Definitive Health, the U.S. spends over $33 billion annually on AUB-related healthcare, not to mention the indirect costs associated with lost productivity and absenteeism from work and school.
Despite its prevalence and impact, AUB remains a condition shrouded in silence and stigma, with two-thirds of affected women not seeking the help they need. This reluctance is compounded by healthcare providers’ often dismissive attitudes towards women’s reports of heavy menstrual bleeding, leaving many women to suffer in silence and without adequate care.
The Current Landscape of AUB Treatment
The treatment landscape for AUB is fraught with challenges. Current options try to diagnose the cause and treat it if possible, often a trial and error process that can take years. Otherwise, managing the chronic condition often involves hormones like birth control or surgery like endometrial ablation or hysterectomy. However, what happens when women need immediate relief?
Currently, there is no FDA-approved treatment specifically for acute AUB. This leaves healthcare providers to rely on off-label solutions that fail to address the immediate need to stop bleeding. The American College of Obstetricians and Gynecologists (ACOG) offers clinical guidance based on studies of off-label use of existing treatments, but innovation in this space has been stagnant for nearly two decades. This lack of advancement underscores a dire need for novel solutions that can provide immediate relief and address the root causes of AUB. Sadly, one in two women in the U.S. undergo a hysterectomy by age 60 and of which, half are due to AUB.
Avana Health: Pioneering a New Approach
Enter Avana Health, co-founded by Dr. John Morehead, an OB-GYN of 40 years experience, and Peter Pacult, a serial entrepreneur, who both witnessed severe uterine bleeding’s impact first hand and have dedicated themselves to developing a solution. Dr. Morehead’s wife, Angie, endured a 22-year battle with AUB that ultimately led to a hysterectomy. While Peter’s sister-in-law, Rosie, had endometriosis and difficulty becoming pregnant. Devastatingly, she experienced life-threatening uterine bleeding at 24 weeks pregnant that resulted in a hysterectomy and loss of her twins. These painful family experiences gave rise to Avana Health in order to provide hope and opportunity for women with these conditions.
Avana Health’s solution is a groundbreaking drug-plus-device approach. It uses an existing off-patent drug previously FDA-approved for other vascular indications and delivered through a proprietary device. The combination of which is intended to stop uterine bleeding. The drug acts on locally disrupted blood vessels to stop the bleeding in minutes regardless of the underlying AUB cause. The device is uniquely designed for intrauterine delivery of the drug and for administration only.
This innovative treatment is designed to transform the management of acute AUB by providing a fast-acting, minimally invasive option that preserves fertility and can be administered by physicians, nurse practitioners, midwives, and physician assistants in an outpatient setting. Avana Health’s focus on acute AUB addresses a critical unmet need, offering hope to millions of women who currently have limited options for immediate relief.
The Impact of Avana Health’s Solution
Avana Health’s solution is a catalyst for a paradigm shift in how AUB is treated. By offering an immediate, effective treatment, Avana Health could significantly reduce the healthcare burden of AUB, freeing up resources and improving the quality of life for affected women. Furthermore, by demonstrating the ability to preserve fertility, Avana Health’s solution will empower women to make choices about their reproductive health without the fear of irreversible decisions like hysterectomy.
The importance of Avana Health’s work extends beyond the realm of healthcare; it is a step towards increasing access to care for women that live in low and high resource settings. In a society where women’s health issues are often marginalized, Avana Health’s commitment to addressing AUB is a beacon of progress.
Conclusion
Abnormal uterine bleeding is a pervasive issue with profound implications for women’s health and the economy. The current standard of care, characterized by a lack of FDA-approved treatments and reliance on off-label solutions, falls short of meeting the needs of women experiencing acute AUB. Avana Health, driven by personal connections to the problem and a desire to effect meaningful change, is at the forefront of developing an innovative solution that promises to transform the treatment landscape for AUB. As Avana Health continues to advance its clinical studies and expand its reach, the potential impact on women’s health, the healthcare system, and society at large is immense. Through their pioneering work, Avana Health is not just offering a new treatment option; they’re challenging the status quo and paving the way for a future where women’s health issues are addressed with urgency and care.
