1. Development of Raw material by compression molding – Producing implant parts is produced today by machining of molded blocks and much material is wasted during this procedure. The aim is to produce rods where machining is easier and with less waste or produce near-net-shape products using compression molding in molds with minimal or no waist of material. This stage involves calculating, engineering and production of new molds and determining the compression parameters (pressure, temperature, time and amount of resin) for optimal properties and homogeneity.
2. FDA/Helsinki/Master file
The Master File for FDA was finalized and was submitted to the FDA. Potential companies who wish to apply MP-1™ in their products will use this MAF.
Pre-submission towards 510K, the output of this stage is: approval of the regulatory strategy- 510k, initial approval of number of clinical studies including a follow-up period.
Helsinki- Approval of Clinical study in Israel – in process. The clinical study is registered in clinical trials.gov, NIH no. NTC02503891
3. CLINICAL STUDIES- choosing centers for these studies in Israel, Europe and US, enrolment of suitable cases and starting the studies (according to exclusion/inclusion criteria). 20 cases are enough as FEASIBILITY studies towards Pre-submission and will increase tremendously the value of the company towards agreements with orthopedic companies.
4. New applications research:
New applications such as knee implant heart valves, stents, facial reconstruction, spinal implants, trauma and dental implants will require new prototypes.
This involves engineering design and machining. It is important to seek new applications for the task of expansion of the development of MP-1™ and entering into new fields in medical applications. All the mentioned above areas suffer from lack of suitable engineering materials, which can survive in the harsh environment of the body fluids and under high mechanical stress and wearing conditions.
5. Conferences, marketing and travel
An aggressive marketing effort is planned, to introduce the material to the appropriate and potential users. This can be done in the various conferences and exhibitions that are taking place at various times during the year in central locations. Some promotion and advertisement may be required to market the product.