February 22, 2024

Avana Health’s new solution for abnormal uterine bleeding

In the dynamic field of women’s health, the search for effective treatments for chronic conditions is relentless. Of these conditions, abnormal uterine bleeding (AUB), also known as heavy menstrual bleeding, poses a significant but often under-recognized challenge for millions of women around the world. This article delves 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 widespread problem. With a focus on the mix of personal connection and scientific rigor, we explore how Avana Health is poised to revolutionize AUB management, driven by the founders’ deep personal commitment to tackling 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 worldwide, casting a long shadow on their quality of life and productivity. Under normal circumstances, the uterus secretes a limited amount of blood (less than 5 tablespoons or 80 ml) during each menstrual period. Bleeding that occurs irregularly or excessively regular periods is considered abnormal uterine bleeding (AUB). Unfortunately, menstrual patients are often unaware of the amount of blood they lose each month, and it is also difficult for doctors to assess volume without asking, “How many menstrual products do you use per day during your period?”

This condition has several causes, including endometriosis, fibroids, and polycystic ovary syndrome (PCOS). The International Federation of Gynecology and Obstetrics (FIGO) classifies PLEASE 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 is responsible for one-third of outpatient visits to gynecologists and more than 70% of gynecology consultations among perimenopausal and postmenopausal women. The economic toll is enormous. Based on individual reimbursement claims data from Definitive Health, the U.S. spends more than $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 the often dismissive attitude of health care providers to 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 full of challenges. Current options attempt to diagnose the cause and treat it if possible, often a trial and error process that can take years. Otherwise, management of the chronic condition often involves hormones such as birth control or surgeries such as endometrial ablation or hysterectomy. But what happens when women need immediate help?

Currently, there is no FDA-approved treatment specifically for acute AUB. This leaves healthcare providers dependent on off-label solutions that do not address the immediate need to stop bleeding. The American College of Obstetricians and Gynecologists (ACOG) provides clinical guidance based on studies of off-label use of existing treatments, but innovation in this area has been stagnant for nearly two decades. This lack of progress underlines the dire need for new solutions that can provide immediate relief and address the root causes of AUB. Unfortunately, one in two women in the US undergoes a hysterectomy by age 60, half of which is due to AUB.

Avana Health: pioneering a new approach

Meet Avana Health, co-founded by Dr. John Morehead, a gynecologist with 40 years of experience, and Peter Pacult, a serial entrepreneur, who both witnessed first-hand the effects of severe uterine bleeding and have dedicated themselves to developing a solution. Dr.’s wife Morehead, Angie, endured a 22-year battle with AUB that ultimately led to a hysterectomy. While Peter’s sister-in-law, Rosie, had endometriosis and struggled to conceive. Devastatingly, she experienced life-threatening uterine bleeding when she was 24 weeks pregnant, resulting in a hysterectomy and the loss of her twins. These painful family experiences gave birth to Avana Health to provide hope and opportunity to women with these conditions.

Avana Health’s solution is a groundbreaking approach with medicines and devices. It uses an existing, unpatented drug previously approved by the FDA for other vascular indications and delivered via a proprietary device. The combination of these is intended to stop uterine bleeding. The drug acts on locally disrupted blood vessels to stop bleeding within minutes, regardless of the underlying AUB cause. The device is uniquely designed for intrauterine administration of the drug and for administration only.

This innovative treatment is designed to transform the treatment of acute AUB by providing a fast-acting, minimally invasive option that preserves fertility and can be administered by physicians, nurses, midwives and physician assistants in an outpatient setting. Avana Health’s focus on acute AUB addresses a critical unmet need and offers hope to millions of women who currently have limited options for immediate care.

The impact of Avana Health’s solution

Avana Health’s solution is a catalyst for a paradigm shift in the way AUB is treated. By providing immediate, effective treatment, Avana Health could significantly reduce AUB’s burden of care, 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 fear of irreversible decisions such as hysterectomy.

The importance of Avana Health’s work extends beyond healthcare; it is a step toward increasing access to care for women living in low- or no-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 widespread problem with profound consequences 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, does not meet the needs of women experiencing acute AUB. Driven by personal connections to the problem and a desire to create meaningful change, Avana Health is leading the way in developing an innovative solution that promises to transform the treatment landscape for AUB. As Avana Health continues to advance its clinical trials and expand its reach, the potential impact on women’s health, the healthcare system and society as a whole is enormous. Through their groundbreaking work, Avana Health not only offers a new treatment option; they challenge the status quo and pave the way for a future where women’s health issues are addressed with urgency and care.

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