The broader impact/commercial potential of this I-Corps project is to identify stakeholders and customers and to develop the most appropriate path forward to translate the company's technology to the clinic and bring it to the patients. Currently young girls suffering from premature ovarian insufficiency (POI) as a result of anticancer treatments have limited and inadequate options to undergo puberty and start their transition into adult life. The existing hormone replacement therapy (HRT) applied to induce puberty in girls with POI leads to long-term morbidities, such as decreased bone density, predisposition to obesity and diabetes. The company's technology allows the restoration of ovarian endocrine function in prepubescent girls and has the potential to become a central mainstream treatment for POI, which would result in significant improvement of the short and long-term health and eliminate long-term morbidities associated with premature ovarian failure. The commercial benefit of the proposed treatment would result from significant lower health costs associated with obesity, diabetes and osteoporosis.
This I-Corps project will further the company's understanding of the current state of the field and the value of the proposed technology, and help identify the next steps for preclinical and clinical studies. The company developed an immunoisolating capsule that supports the survival and function of ovarian allograft eliminating the need for immune suppression. The company's central hypothesis is that ovarian tissue secretes the gonadal hormones, estradiol, progesterone, androstenedione, activins and inhibins, in response to systemic hormone stimulation in a pulsatile and dynamic rate required for physiological progression through puberty, growth and associated metabolic changes. Experimental data from in vivo mouse and primate studies have demonstrated promising results of restoration of hormone function integrated in the endocrine system and neuroendocrine axis, with no evidence of immune rejection or local inflammatory adverse response. The next critical steps in the company's project is to perform customer discovery and identify partners for first-in-human trials.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
