San Antonio-based medical device start-up Hera Biotech has closed an oversubscribed $1.9 million seed financing round to support its commercialization strategy for its non-surgical diagnostic test for endometriosis, MetriDx.
The funds will be used to complete an in-patient human clinical study, expand Hera’s IP portfolio, and support a regulatory pathway with the U.S. FDA.
Investors in this round include primarily female supporters from individual sources and investment firms Coyote Ventures, Stella Angels, Althea Group Ventures, and the Kendra Scott Women’s Entrepreneurial Leadership Institute.
The company, which was formed to apply advances in biotechnology to address unmet needs in the field of women’s health and reproductive medicine, intends to kick off a series A raise of $15 million in late 2022 to support commercial launch of its product in 2024.
“Our seed round was oversubscribed by nearly 100% from our original goal – which is an enthusiastic validation of our technology and the need for a solution for this pervasive and persistent, yet unsolved problem, in women’s health,” said founder and CEO Somer Baburek.
According to the Mayo Clinic, “Endometriosis is an often-painful gynecological disorder in which tissue similar to the tissue that normally lines the inside of your uterus – the endometrium – grows outside your uterus.”
Endometriosis typically involves other pelvic organs and can spread elsewhere in the body. Despite no longer being inside of the uterus, endometrial tissue functions as it would in the uterus by thickening, breaking down, and bleeding with each menstrual cycle.
However, this tissue has no way to exit the body and becomes trapped, potentially causing cysts, irritation, scar tissue and adhesions. Endometriosis also causes pain, especially during menstrual periods, and the pain can be debilitating to afflicted women.
Common symptoms include painful periods, pain with intercourse, pain with bowel movements or urination, excessive bleeding, infertility, fatigue, diarrhea, constipation, bloating, or nausea. The patient journey from initial symptoms to diagnosis and treatment can last up to 10 years, and the only method for diagnosing endometriosis is by laparoscopic surgery and pathology of the biopsied tissue. This procedure is expensive and nearly half of all biopsies are negative.
Knowing a patient’s status and stage can save thousands of dollars on misdiagnosis and treatments that may be inappropriate for the stage of the disease, and in circumstances of infertility, treatment of the underlying endometriosis prior to fertility intervention can increase the likelihood of future success.
With MetriDx, a sample of the patient’s endometrium is collected during an in-office procedure – similar to a pap smear but in the uterus, eliminating the need for surgery. The test’s configuration uses micro-fluidic analysis of single cells obtained from the patient to definitively diagnose and stage endometriosis.
Hera Biotech said MetriDx will bring diagnostic capability to physicians, lower liability risk within hospitals, eliminate unnecessary surgical procedures, and reduce the considerable time patients suffer before receiving a diagnosis, all the while maintaining tissue collection and a direct pathology diagnosis.
While pursuing FDA clearance, MetriDx will initially be offered to both OB/GYN practices and those in the fertility solutions market as a laboratory developed test. MetriDx can also be utilized as a screening test in OB/GYN practices, in fertility clinics and by reproductive endocrinologist practices.