To be the world leader in understanding & addressing diagnostic and therapeutic deficiencies in women's health.
We are building a collaborative culture. driven to advancing the standard of care in women's health.
Relentlessly seek to understand the root cause of diseases in women's health, thereby, uncovering new ways of diagnosing and treating them
Hera Biotech, Inc. was formed to apply advances in biotechnology to address unmet needs in the field of women’s health and specifically, in reproductive medicine. Hera began operations in January of 2020 as a Delaware “C” Corporation with headquarters in San Antonio, TX. Hera’s initial goal is to commercialize the MetriDx™, a novel, non-surgical method for the definitive and early diagnosis of endometriosis.
According to the Mayo Clinic, “Endometriosis is an often-painful disorder in which tissue similar to the tissue that normally lines the inside of your uterus – the endometrium – grows outside your uterus.” Endometriosis often involves other pelvic organs and, in some cases, can spread elsewhere in the body. Despite no longer being inside of the uterus, endometrial tissue continues to function in the same way it would in the uterus. This means it thickens, breaks down and bleeds with each menstrual cycle however, this tissue has no way to exit the body and becomes trapped. This trapped tissue can cause cysts, surrounding tissue can become irritated and, eventually, scar tissue and adhesions can cause pelvic tissues and organs to stick to each other. Further, endometriosis can cause pain, often times severe, especially during menstrual periods. Common symptoms associated with endometriosis are painful periods, pain with intercourse, pain with bowel movements or urination, excessive bleeding, infertility, fatigue, diarrhea, constipation, bloating or nausea.
Endometriosis is estimated to effect 10-20% of women, aged 15-44 worldwide; 7-13 million in the U.S. alone. The average time a woman in the U.S. goes before receiving an endometriosis diagnosis is 7-12 years. One of the largest contributing factors to the length of time it takes for a woman to receive a diagnosis from the time she develops symptoms is because the current method for definitive diagnosis of endometriosis is visualization during laparoscopic surgery, confirmed by histological pathology, which fails to confirm diagnosis ~50% of the time.
In the US, the annual economic burden of endometriosis due to direct medical care of endometriosis is estimated at ~$80B; a cost that could be dramatically curtailed with accurate, early and non-surgical diagnosis.5 Hera’s breakthrough approach is based on cutting edge, single cell, micro-fluidic analysis to identify endometriosis-specific biological markers. This approach enables clinicians to definitively diagnose endometriosis regardless of stage with unparalleled accuracy.
The patient’s endometrial cells are collected during an in-office procedure, thereby eliminating the need for surgical biopsy. The initial MetriDx™ configuration utilizes micro-fluidic analysis of single cells obtained from a uterine pipelle brush biopsy. MetriDx™ will bring unprecedented diagnostic capability to physicians, lower liability risk within hospitals, eliminate unnecessary surgical procedures and reduce the considerable time patients typically suffer before receiving a diagnosis, all the while maintaining tissue collection and a direct pathology diagnosis.
The initial pathway for commercialization will be the development of MetriDx™ as a laboratory developed test (LDT, or “home brew”) following the necessary validation studies and obtaining a CPT®PLA (Proprietary Laboratory Analyses) code for reimbursement. This would enable the company to conduct endometriosis testing from a central CLIA lab operated by the company. The initial target market for Hera is the patients seeking reproductive assistance through fertility clinics or reproductive endocrinologists. As endometriosis is the number one cause of female infertility, the MetriDxTM can be utilized as a screening test to ensure that underlying endometriosis can be resolved prior to starting interventions. Knowing the your Endo status prior to beginning an intervention can save couples thousand of dollars on interventions that have little chance of success without resolution of the underlying endometriosis. Further, resolving underlying Endo prior to intervention will also boost the success rates of the physicians and clinics administering interventions. Lastly, this patient population is accustomed to cash pay, as only 1/3 of women in the US have any insurance coverage for reproductive interventions. This will allow Hera to begin selling prior to receiving our reimbursement code. Following execution of this revenue model, the company will focus it’s attention on marketing the MetriDxTM™ to OB/GYNs as a diagnostic tool to utilize in their practice. Hera Biotech has a highly capable and experienced team and is raising a seed-funding round of $2.0M to initiate and complete the proof of concept trial and refine the parameters of the assay.