AMDA : Amedica Corporation Stock Analysis and Research Report
2017-11-10 - by Asif , Contributing Analyst - 300 views
Amedica Corporation is a materials company focused on developing, manufacturing and selling silicon nitride ceramics that are used in medical implants and in a variety of industrial devices. At present, the company commercialize silicon nitride in the spine implant market. The company believe that its silicon nitride manufacturing expertise positions it favorably to introduce new and innovative devices in the medical and non- medical fields. The company also believe that Amedica is the first and only company to commercialize silicon nitride medical implants.
Amedica has received 510(k) regulatory clearance in the United States, a CE mark in Europe, and ANVISA approval in Brazil for a number of its devices that are designed for spinal fusion surgery. To date, more than 28,000 of its silicon nitride devices have been implanted into patients, with an 8-year successful track record. The company intend to file an FDA 510(k) submission for clearance in the United States of a novel composite spinal fusion device that combines porous and solid silicon nitride. The FDA sent it questions about its upcoming submission and Amedica is currently in the process of submitting a response.
The company believe that silicon nitride has a superb combination of properties that make it ideally suited for human implantation. Other biomaterials are based on bone grafts, metal alloys, and polymers; all of which have practical limitations. In contrast, silicon nitride has a legacy of success in the most demanding and extreme industrial environments. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial infection, resistance to corrosion, superior strength and fracture resistance, and ease of diagnostic imaging, among other advantages.
The company market and sell its Valeo brand of silicon nitride implants to surgeons and hospitals in the United States and to selected markets in Europe and South America through more than 50 independent sales distributors who are supported by an in-house sales and marketing management team. These implants are designed for use in cervical (neck) and thoracolumbar (lower back) spine surgery. Amedica is also working with other partners in Japan to obtain regulatory approval for silicon nitride in that country.
In addition to its silicon nitride-based spinal fusion products, the company market a line of non-silicon nitride spinal fixation products which allows it to provide surgeons and hospitals with a broader range of products. These additional products are complementary to its fusion products and are designed for the treatment of deformity and degenerative spinal procedures. Although its non-silicon nitride products have accounted for approximately 49% and 50% of its product revenues for the six months ended June 30, 2017 and 2016, respectively, the company believe the continued promotion and potential for adoption of its silicon nitride products and product candidates, if approved, provides it the greatest opportunity to grow its business in new and existing markets and achieve its goal to become a leading biomaterial company.
In addition to direct sales, Amedica has targeted original equipment manufacturer (“OEM”) and private label partnerships in order to accelerate adoption of silicon nitride, both in the spinal space, and also in future markets such as hip and knee replacements, dental, extremities, trauma, and sports medicine. Existing biomaterials, based on plastics, metals, and bone grafts have well-recognized limitations that the company believe are addressed by silicon nitride, and Amedica is uniquely positioned to convert existing, successful implant designs made by other companies into silicon nitride. The company believe OEM and private label partnerships will allow it to work with a variety of partners, accelerate the adoption of silicon nitride, and realize incremental revenue at improved operating margins, when compared to the cost-intensive direct sales model.
The company believe that silicon nitride addresses many of the biomaterial-related limitations in fields such as hip and knee replacements, dental implants, sports medicine, extremities, and trauma surgery. The company further believe that the inherent material properties of silicon nitride, and the ability to formulate the material in a variety of compositions, combined with precise control of the surface properties of the material, opens up a number of commercial opportunities across orthopedic surgery, neurological surgery, maxillofacial surgery, and other medical disciplines.
The company operate a 30,000 square foot manufacturing facility at its corporate headquarters in Salt Lake City, Utah, and the company believe Amedica is the only vertically integrated silicon nitride medical device manufacturer in the world.