Critical Success Factors
The company believes that this is an outstanding opportunity for the following reasons:
- The market potential for minimally invasive sterilization devices is very large, with more than 800,000 procedures performed in the United States and over 15 million performed annually world-wide.
- In the US and UK, 40% of couples over age 40 elect sterilization. This market is currently underserved. The medical community is recognizing the opportunity for minimally invasive, non-incisional, transcervical methods of sterilization performed in the comfort of the doctor’s office or surgicenter under local anesthesia.
- ZR-Operculum’s proprietary technology provides the possibility of offering the medical community a device that offers a very cost effective solution. The device may be difficult for other technologies to mimic. It may provide the potential for reversibility due to the benign effect the device has on basic anatomic structure compared to other tissue destructive alternative methods or devices.
- The ZRO device is implanted using current standard hysteroscopic instrumentation systems that gynecologists are familiar using. As a result, the Company anticipates a rapid and minimal learning curve for the medical professional. This is essential for a mass worldwide market.
- The company intends to leverage regulatory work conducted by other entrants and believes it can fast track development leading to product introduction.
- There is rapidly growing market with increasing number of candidates for permanent female sterilization surgery.
- We have a highly experienced executive management team with significant experience in related medical device and manufacturing industries.
- World class medical expertise in product design, enhancements, and implementation have been utilized from the beginning.
- Proof of concept has been established by clinical and biomechanical studies as well as current use of similar devices.
- Operculum has obtained superior intellectual property rights.
- A business model has been designed to reduce procedural costs while generating profit.
- Specialized first-hand medical and management knowledge, experience, and international contacts facilitate understanding and address customer niche market needs.
- Key long term strategic relationships with physicians, sales and distribution channels, medical associations, etc. facilitate obtaining vital resources, market data, and new customers.
- An effective Medical Advisory Board will direct overall product strategy for the Company.
- Time to market products require a short Phase 1- Feasibility Clinical Human Trial and a Phase II – Safety and Efficacy Human Clinical Trials based on conversations for requirements for regulatory clearance by the FDA.