Open Reduction Internal Bone Fixation

Broken Bones Fixation:

Open Reduction Internal Fixation Device (ORIFD)

Millions of people around the world suffer from fractured bones where fixation requires metal hardware such as plates, screws, pins, and wires and a complex multi-phase surgical procedure. The two-phase procedure requires the surgeon to use “cerclage wires” to hold the fractured bones in place and a bone plate is needed for stability. During the first phase, the bone plate is shaped, and holes are drilled according to the screw type. Such procedure requires about five-six hours assuming no complications. The second phase is the removal of the hardware. The medical costs, the time required for recovery and the impact on business productivity can be enormous.

The invention addresses most of the complications associated with the current procedure, reduces the time at the operation room, potentially speed the healing process and more. Briefly, the invention is based on using medically approved biodegradable materials for all components essential for fractured bone treatment. The procedure is a one-phase process since all materials (plates and screws) are dissolvable and absorbable by the body i.e. there is no need for removing any hardware.

The idea of using biodegradable materials such polyglycolic acid for fracture fixation plates and screws was patented in 1973, and such devices are known for years. While continuing, experimentation has resulted in better products with higher strength, higher modulus of absorbable materials; surgeons have been avoiding such devices due to the complexity of the procedure. For clarity, to achieve the desired results, the same biopolymeric material must be used for both the screw and plate. When the same material was used, the screw thread was not strong enough to hold the plate. The required stress causes striping of the thread. In another word, the biopolymeric material is not the issue but the screw design is the real problem.

The Open Reduction Internal Fixation Device (ORIFD)new invention suggests replacing the surgical screws with a unique device that will solve the problems discussed above opening doors to known dissolvable materials, for the new designs without adding complexity to the current procedure. The new technique will include drilling the holes into the bone, placing, and adjusting plates, inserting the new fasteners, and tightening them until the plate is secured in place. It is worth mentioning that almost all tools needed for using the new device are currently used in this surgical procedure.

The global trauma fixation devices market, mainly driven by the prevalence of osteoporosis and the increasing incidence of accidental fractures, was valued at $5.4 billion in 2013 and is expected to reach $8.6 million by 2018, at a CAGR of 6.7%. We envision the invention will provide a platform for an array of new devices for the bone fixation surgeries that can be completed in the one-phase procedure, not two.

Intellectual property status

Patent already applied for

Patent application number :

Where : USA

Current development status

Laboratory prototypes

Add use of Proceeds

Expenses. Avicenna will be externally financed via private equity or similar funding mechanisms. The funding will be utilized to fuel the product development through the design, pre-clinical/animal, and related performance studies and subsequently through FDA Premarket (510(k)) submission and market clearance. Administrative and operational costs will be maintained at a minimum given the process by which the company will develop the product. The company will provide a project direction and management function while striving to achieve key objectives and milestones. This will be accomplished by utilizing contracted services versus actual hired full-time personnel. Additionally, the company will not be beholden to develop and maintain operational systems critical for the development work as well as the respective traditional brick & mortar assets such as buildings, offices, laboratories, testing and manufacturing equipment. The hiring, development, and maintaining personnel are also not required since critical services will be performed by contractors. Essentially, once a functional objective and milestone have been attained, there is no longer any need to continue paying for that asset or related resource or workforce. The funds are expected to be utilized in the following manner. 1. Market Research – Improved Market Research to more precisely identify prioritized product configurations and market targets 2. Key Opinion Leaders (KOL) and Innovative Orthopedic Surgeons - Identify and recruit KOL and Orthopedic surgeons who are more apt to utilize innovative technologies to improve the related science. They will also be used to facilitate identification of optimum product configurations 3. Design & Development – Drive the design and development of prototypes which will be used in development studies such as bench studies and pre-clinical studies. Additionally, the prototypes will also be used for demonstration to professionals. This also will include the performance studies necessary for submission which includes bench and pre-clinical studies. 4. Administration – this shall include rental of any small office space in which to conduct the company business, outside consultants or contractors not covered in the above and compensation to the small company staff which will lead all of the above activities. As previously indicated, there will be minimal to no assets needed or acquired in which funding will be utilized for. Funds will be almost entirely directed for the use of activities or tasks needed to complete the objective of Avicenna which is to create a product line targeted at the $4.5 billion bone fixation sector of the U.S. orthopedic medical devices market. Costs related to the product development through Exit Strategy are expected to be as follows: 1. Functional Operations (TOTAL) - $3,750,000 2. Administration - $700,000 3. Technical Operations - $750,000 4. Contract Services (labs, FDA, prototyping, etc.) - $2,300,000