As ConTIPI Medical Ltd announced its co-commercialization partnership with Indegene, we spoke with Dr Elan Ziv, CEO and Medical Director at ConTIPI, about his entrepreneurial journey, partnership with Indegene, and his road map for future innovations.
1. What inspired you to set up ConTIPI?
I am a Urogynecologist treating women with pelvic floor dysfunction for over 30 years. Back in the day, a new operation was introduced to treat stress urinary continence. After working on this operation, I realized that the same results can be achieved through a nonsurgical comfortable device that is similar in shape and concept to a menstrual tampon. Through my daily work that involved working closely with patients, I saw the necessity of bringing new solutions to existing problems. This got me started on a long R&D process and I set up ConTIPI.
Our mission is to empower and enable women suffering from pelvic floor disorders such as urinary incontinence, pelvic organ prolapses, and fecal incontinence.
2. Let's talk about the current problem you are solving for. What is Pelvic Organ Prolapse? How does it affect women?
Pelvic organ prolapse (POP) occurs when the tissue and muscles of the pelvic floor no longer support the pelvic organs resulting in a drop from their normal position into the vagina and even outside the body. POP is not a life-threatening condition but certainly a quality-of-life condition, which may involve pain, bleeding, discharge, discomfort during intercourse, and the inability to fully drain the bladder or bowel.
3. Is POP a very common problem?
Globally, it is estimated that around 170 million women have POP, with ~3% being treated. In the US, 57 million women over 30 years old are affected annually and only 3.5 million women are diagnosed. About 300,000 operations are conducted every year to treat POP, and around 1.35 million women use pessaries for managing POP.
4. What are the existing therapies to treat POP? And how is ProVate different?
Currently, there are two options – either surgery or nonsurgical vaginal inserts called pessaries that lift the prolapsed organs. These devices are large, intrusive, and replaced every few weeks or months, usually by a medical practitioner. The large dimension expands the vagina, causing discomfort and sometimes even pain to the user, mainly when inserted or removed.
ConTIPI's ProVate device, on the other hand, is small in dimension and can be easily inserted into the vagina in small dimensions, thereby reducing or eliminating any pain or discomfort. The device comes ready for use with an applicator; following insertion, the device separates and the applicator is discarded. The device opens up to provide support to vaginal walls and may remain there for up to 7 days. The procedure is done by the user herself whenever and wherever she wants. A simple pull on the string collapses the device into small dimensions for comfortable removal and disposal.
The innovative solution provides many women who are reluctant to use other options, with a comfortable, clean (disposable), and affordable solution. It improves their health and quality of life. More importantly, it shifts control from the medical arena to women's hands and empowers them to decide whether to use the device; and if so, then to use it whenever and wherever they want.
5. What is your vision for ProVate?
ProVate is cleared by FDA and EU authorities for marketing in the US and Europe. Our objective is to go to market as soon as possible and it is one of the primary reasons for partnering with Indegene.
Today, only about 3.5 million women in the US consult with a doctor for POP every year. The aim is to increase awareness and at least double that number soon. In few years, we would like to see about 60 million ProVate devices used each year, empowering millions of women who have to live with the problem today.
6. What challenges did you face while developing ProVate?
There are 3 major points that you have to consider when you become an innovator in the Urogynecology space, and they all focus on the fact that women will have to walk around with your inventions for years. Thus, effectiveness, safety, and comfort were things that we had to get right.
Designing a device that is intended to work on a large population required a deep understanding of anatomy, physiology, microbiology, and most importantly, the user's needs, all of which required due diligence and thorough research.
7. Why did you choose to partner with Indegene?
We partnered with Indegene due to its well-known expertise in introducing new products into the market. We needed someone who could help us with all aspects of commercialization including clinical, regulatory, safety, medical affairs, medical publications, pricing and reimbursement, and promotion. We needed a partner who is an expert at managing these processes and lets us focus on what we do best: innovate.
Indegene was highly recommended by numerous people. What we loved is that Indegene partners for performance through a flexible commercial model. It shares value equitably compared to partnering with other large companies. Indegene is invested in ConTIPI's success and it brings a unique dimension of trust. Unlike large partners with many products in their portfolio, Indegene is committed to commercializing our single product and advancing our mission.
8. What advice do you have for fellow medical entrepreneurs?
It's simple. Design your product well with deep knowledge in the arena you work in, and find a good friend early to take it to the market.