OsteoResorb Corp. intends to be a leading provider of biomaterial solutions by focusing on innovative product development and employing polymer based, implant technologies for surgical applications. Currently, applications exist in Craniomaxillofacial Reconstruction, Small Fragment Osteosynthesis, Sport Medicine, and Spine surgery for the product portfolio being crafted by the company.
OsteoResorb�s bioresorbable implants applications are made from Polylactide (PLA): a copolymer of 70:30 Poly (L-lactide-co-D, L-lactide). Composed of lactic acid, similar to that which occurs naturally in the human body, the copolymer maintains its strength during the healing process, and through hydrolysis slowly breaks down into lactic acid molecules. The molecules are ultimately metabolized into carbon dioxide and water and are released from the body through the lungs. OsteoResorb implants are made with the state of art polymer technology providing an ideal combination of performance, flexibility, and controlled biological resorption.
By drawing a range of selected polymers through the molding process at controlled temperatures, OsteoResorb is uniquely able to orient the material in a way that creates products with increased mechanical performance characteristics. The enhanced properties of our implants prevent premature fracture during implantation and maintain strength throughout the healing process.
OsteoResorb materials can be customized based on the clinical requirements and optimized to provide biological patient solutions. The OsteoResorb polymer process produces material that has controlled resorption; this improves biological resorption and reduces clinical complications.
OsteoResorb Corp. focuses its expertise and technology on developing and providing bioresorbable implants for use in Orthopedic Trauma, Craniomaxillofacial Reconstruction, Small Fragment Osteosynthesis, Sport Medicine, and Spine surgery.
Bioabsorbable Technology is one of the fastest growing segments of the $12 billion worldwide orthopedics field. It has been reported that up to 30% of all metallic implants are removed from the patient at a later date. This means 30% of all patients receiving metallic fixation will have to return to the surgery center or hospital to remove the hardware. In turn, they must also endure trauma from a second surgical procedure. Bioresorbable implants don't need to be removed from the body; the body removes them on its own.
OsteoResorb Corp. is armed with application, a number of intellectual properties and is intending to enter the bioabsorbable market in U.S. and abroad. The Company headquarters is located in Paramus, NJ and is now poised to raise $3.0 million in Manufacturing, Marketing and R&D funding for its first year of operation.
Company Vision
OsteoResorb Corp. will dedicate to delivering the highest quality products to hospitals, surgeons and patients. The team members of OsteoResorb are committed to the ultimate goal of "positively affecting the health of countless human beings."
Company Mission
1. Provide surgeons with safe, effective, less invasive, and more cost-effective treatment options for their patients which includes;
A. Eliminate the need for secondary surgery to remove the implant
B. Elimination of MRI/CT scatter and thermal sensitivities
C. No long-term patient palpability
D. Reduced risks for implant migration or long-term failure requiring re-operation
E. Potential to reduce stress shielding
2. To validate the scientific basis for the acceptance of Bioabsorbable Technology options and thus increase the market shares in Orthopedics trauma.
3. Establish the role of resorbable materials in spine as method of creating a symbiotic relationship between graft incorporation and implant function
Objectives and Milestones
1. Establish Master Files within Dental and Orthopedics divisions of the FDA for OsteoSorb Polylactide based material� Completed
2. Design and develop The OsteoSorb Resorbable Small Fixation System and obtain FDA 510k approval � Completed
3. Design and develop The OsteoSorb Tag and Pin Fixation System and obtain FDA 510k approval � Completed
4. Establish Patent Portfolio to protect Intellectual Property - Completed
5. Establish Spinal portfolio
A. Resorbable cage, Expandable Intervertebral Prosthesis - filed
B. Prosthetic Disk patent, Prosthetic Spinal Disk Implant � filed
C. Resorbable cage, Expandable Intervertebral Implant � filed
6. To raise $3.0 million for first year operations.
7. To finalize device prototypes and complete bench-top strength and endurance testing.
8. To begin marketing Orthopedic Trauma, Craniomaxillofacial, Small Fragment Osteosynthesis, Sport Medicine, and Spine devices in the U.S. and Europe by the second year of operation and generate $3-5 million in sales revenue by the third or fourth year of operations.
9. Obtain 510 K and CE Mark approval for use of OsteoResorb devices in the U.S. and Europe by the end of the first year of operation.
10. To obtain second round capital funding of $4 million by the beginning of the second year of operations.
Keys to Success
1. All the 510K approvals and patent applications filed by Albert Enayati, related to OsteoResorb business are assigned to OsteoResorb Corp.
2. Initial capitalization of $3.0 million obtained.
3. Recruit top-notch technical, regulatory affairs and, marketing staff to execute the goals of the Company.
4. Assemble an outstanding team of Orthopedic Trauma, Craniomaxillofacial, Small Fragment Osteosynthesis (Hand and Foot), Sport Medicine and Spine surgery experts to serve on the Company's clinical advisory board.
5. Perform mechanical testing to satisfy FDA Requirements.
6. Obtain FDA 510 K and CE Mark approval to allow distribution of the device use in both U.S. and Europe to generate an early revenue stream.
7. Report preliminary human trial data on OsteoResorb products at major international medical scientific meetings.
8. Secure second round financing of $4 million.
9. Recruit a dynamic CEO experienced in the orthopedic device market at the time of second round financing.
10. Establish a physician education and training program to encourage greater acceptance and safer and more effective use of OsteoResorb products.
11. Disseminate information to the general public through presentations in scientific conferences regarding the benefits of bioabsorbable medical device.