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Our experienced management team has over 200 years of collective industry experience with extensive focus in medical devices. The pioneering and collaborative efforts of the management team have created an organization that strives for integrity in all actions, innovation in development activities, excellence in operations, and the highest quality products. The team is complemented by world-class medical advisors. Our products have been organically conceived, researched and developed by the Company and all manufacturing activities are conducted to ensure compliance with the U.S. Food and Drug Administration (FDA) per the requirements of 21 CFR 820, as well as ISO 13485. Femasys has achieved significant milestones to date, including numerous issued patents and filings, recruitment of a team of experts, clearance of multiple regulatory filings by the U.S. Food and Drug Administration (FDA), European Union, Canada, and Japan with other select countries in process. Making a difference in the lives of women one product at a time is a great privilege and serves to drive the Company`s mission.
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ValenTx was founded with the goal of treating some of the most pervasive health problems of our time: obesity and obesity-related metabolic disorders such as type-2 diabetes and hypertension. Our approach is to create a non-surgical, endoluminal bypass device that builds on the success of established medical interventions, resulting in a highly effective and least-invasive therapy. Current treatments for these diseases include surgery, pharmacology, and medically supervised lifestyle management. The risks, costs, and in some cases poor efficacy of these treatments have hampered their broad adoption by patients, physicians, and payers alike. A truly unmet clinical need exists for a therapy that can deliver the efficacy obtained through surgery, but without the risks and costs associated with surgical intervention. The ValenTx endoluminal bypass therapy mimics the attributes of a Roux-en-Y gastric bypass and is implanted through a non-surgical, endoscopic procedure. This procedure does not require gastric stapling or permanent changes to the patient`s anatomy. The device is removable, replaceable and designed so that the physician could change the therapeutic profile, thereby optimizing the treatment towards the individual patient`s needs. ValenTx has developed a strong intellectual property portfolio, which lies at the foundation of this therapy. The company has successfully conducted a series of clinical studies demonstrating the viability, safety, and efficacy of the therapy.