Fuse Medical, Inc. is a distributor of medical devices. It provides a broad portfolio of orthopedic implants, including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications; human allografts, substitute bone materials, and tendons; and regenerative tissues and fluids to augment orthopedic surgeries and wound care. The company was founded in 1968 and is headquartered in Richardson, TX.
If the statutes and regulations in our industry change, our business could be adversely affected.
U.S. federal and state governmental regulation could restrict our ability to sell the products.
Our operating earnings are dependent on certain significant suppliers.
The FDA regulates the manufacturers and suppliers of the products that we sell, market, manufacture, and distribute, and regulatory compliance is costly and could contribute to delays in the availability of our products.
Future regulatory action remains uncertain.
Our revenues will depend on our customers’ continued receipt of adequate reimbursement from private insurers and government sponsored healthcare programs.
The FDA and similar state authorities require us to list and register certain products, because we are a distributor, marketer, specification developer and repackager/relabeler and Manufacturer for FDA-regulated products.
Intellectual property litigation and infringement claims could cause us to incur significant expenses or prevent us from selling certain of our products.
We operate our business in regions subject to natural disasters and other catastrophic events, and any disruption to our business resulting from natural disasters would adversely affect our revenue and results of operations.
We depend on the knowledge and skills of our executives and other key employees, and if we are unable to retain and motivate them or recruit additional qualified personnel, our business may suffer.
Pressure to contain costs and reduce prices could negatively impact on our future operations.
We have significant concentration in and dependence on a small number of customers.
To grow revenues and profitability from certain products, we must expand our relationships with hospital systems, third-party distributors and independent sales representatives, whom we do not control.
Our growth and profitability will depend in large part upon the effectiveness of our marketing strategies and investments.
Interruption of manufacturing operations could adversely affect our business.
Uncertainty in future changes to tax legislation, regulatory reform, or policies could have a material adverse effect on our business.
We do business with companies that are owned or controlled by our Chief Executive Officer and Chairman of the Board and President, which could create actual or potential conflicts of interest.
Some members of our executive team may dedicate inadequate time and attention to our Company.
Future business combinations or acquisitions may be difficult to integrate, which could cause us to shift our attention away from our primary business and its operations.
General economic conditions may adversely affect demand for our products and services.
Because the market for our Common Stock is limited, persons who purchase our Common Stock may not be able to resell their shares at or above the purchase price they paid.
Our current executive team can exert significant influence over our Company and make decisions that are not in the best interests of all stockholders.
If our Common Stock becomes subject to a “chill” or a “freeze” imposed by the Depository Trust Company (“DTC”) our stockholders’ ability to sell shares may be limited.
We are currently the master distributor of a next generation total-knee joint replacement product line (the “Sterizo Total-Knee Replacement System”) manufactured in the U.S. by Modal. We continue to expand our customer base of the Sterizo Total-Knee Replacement System by increasing new hospital and surgeon acceptance. During the second quarter of 2019, 8 hospitals and 7 surgeons were approved and utilizing our Sterizo Total-Knee Replacement System reflecting an increase in revenues of approximately $340,000, or an increase of 320% over the first quarter ending March 31, 2019.