ConTIPI Medical, an innovator in the field of providing non-surgical and disposable solutions for women with various pelvic floor dysfunctions, has selected EVERSANA, a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse (POP).
Approximately 57 million American women over the age of 20 years suffer from POP1. Current treatment methods include largely either invasive surgery with up to a 30% failure rate or the use of non-invasive pessaries which, in most cases, require a physician’s care to insert and remove, and are associated with various adverse events.
ProVate is a ready-to-use, disposable device that is prescribed to patients to be used at home. It is inserted vaginally in small dimensions within a disposable applicator, very similar to the concept of the menstrual tampon applicator, empowering women to take control of their medical condition. The device is available in six sizes and may be used for up to seven days. It also may be removed at any time prior, by a pull on a string, for disposal.
EVERSANA will provide a full array of commercialization services to support the launch of ProVate including pricing, reimbursement and market access, pharmacovigilance, medical communications, sales, regulatory, marketing and commercial operations support, all supported by the company’s leading data and analytics offerings.
“To bring new treatment options to patients requires clinical innovation combined with a proven track record of commercialization success,” said Jim Lang, CEO, EVERSANA. “ConTIPI is pioneering new ways to help women in need, and we’re honored to bring our depth of services to support a successful commercial launch.”
ConTIPI Medical’s mission is to help women suffering from various pelvic floor dysfunctions, currently dealing with POP. ProVate has a 510(k) clearance from the FDA for marketing in the U.S. and bears the CE mark for marketing in Europe.
“We’ve found that it is critical that a commercialization partner understands our mission and vision and has proven success in navigating the complexity of product commercialization and patient adoption,” said Dr. Elan Ziv, MD, OBGYN, Urogynecologist, CEO & Medical Director with ConTIPI Medical. “EVERSANA checks all the boxes, and we look forward to a long and prosperous partnership to bring this new therapy to women in need.”
ProVate is expected to be available for prescribing by clinicians in September 2024. To learn more about ProVate, visit https://contipi.com/provate-device/.