SALT LAKE CITY, UT, Jan. 25, 2018 (GLOBE NEWSWIRE) -- Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today provided a business update related to its business strategy and certain recent developments.
BUSINESS UPDATE AND RELATED DEVELOPMENTS
Commercialization Report
In 2017, Amedica successfully launched its updated Taurus™ Pedicle Screw System, a pedicle screw system designed for degenerative spine surgery. With over 250 procedures performed, this product has generated almost $1.3 million in new revenue since its introduction to the market. The company released additional instrument sets in the fourth quarter of 2017 to meet surgeon demand.
Other commercialization highlights include:
- 40% increase in surgeon users during 2017, predominantly from surgeons performing lumbar fusion surgeries utilizing Valeo II silicon nitride implants and Taurus pedicle screws.
- 14 new sales agents added in 2017, primarily to establish representation in underrepresented areas of the United States.
- The hire of a new Area Vice President for the Western Region, resulted in all members of the sales team having significant experience in spine surgery related sales.
- The product pipeline was prioritized and defined for 2018 and beyond, with the goal of launching several new products in 2018.
- Year-over-year revenue growth in Brazil from 2016 to 2017.
- Expanded sales channel in the UK in 2017.
- Identification of potential distribution partners in Australia.
- Progress toward regulatory clearance in Japan.
The company has received feedback from the FDA on its 510k submission for the “C+CSC with Lumen” spinal implant and is submitting a response.
Clinical
With over 33,000 silicon nitride spinal interbody implants implanted since 2008, Amedica is comprehensively reviewing its large-scale clinical outcomes – a requirement under the new European Medical Device Regulation. The resulting data will be published later in 2018.
The company has completed the data collection associated with its Level 1 SNAP lumbar spine clinical trial. Initial review supports the efficacy of silicon nitride as a spine fusion material, consistent with a large volume of data already published by Amedica. Results of the SNAP trial are expected to be published during 2018.
The company is planning several international clinical investigations during 2018 to strengthen clinical evidence of the advantages of silicon nitride, i.e., ease of imaging, improved spinal fusion, and antibacterial properties. These studies are expected to build upon the existing foundation of extensive material science data supporting the use of silicon nitride in spine fusion surgery.
Research and Development
During 2017 the company had 20 peer-reviewed publications, 10 published conference proceedings, and participated in 27 presentations at conferences and scientific meetings. These R&D efforts have validated the underlying science of silicon nitride, and contributed to increased company visibility that has attracted inquiries and collaborations in areas outside of spine surgery. Scientific and clinical data are critical toward attracting new surgeons to silicon nitride implants, both in the United States and overseas markets.
Financial Update
The company continues to focus on stabilizing its finances, having substantially reduced its monthly cash burn during 2014-2017. On January 3, 2018, Amedica paid off its loan with Hercules Capital via a debt exchange transaction with other accredited investors - a significant step in reducing costs.
Strategic Direction
"Our strategic priorities are three-fold. The first priority is revenue growth, while controlling expenses, with the goal of financial self-sufficiency. Second, we will continue to investigate the full potential of silicon nitride ceramic and build collaborations with external partners. Third, while we consider ourselves to be a leader in the scientific knowledge of silicon nitride, the company is focused on building a strong portfolio of clinical evidence. Taken together, revenue growth, external collaborations, and clinical validation of our products are necessary to support product acceptance, and long-term sales growth," said B. Sonny Bal, MD, MBA, JD, PhD; Chairman and CEO of Amedica.
About Amedica Corporation
Amedica is focused on the development and application of spinal interbody implants made with medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s products are manufactured in its FDA registered and ISO 13485 certified manufacturing facility, and it has a partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, as well as OEM and private label partnerships.
For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements, which include statements regarding the company’s goal to release several new products in 2018, anticipated future revenues, FDA clearance of our products, addition of new surgeon users, and, results of clinical studies are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K/A, filed with the Securities and Exchange Commission (SEC) on December 27, 2017, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.