Becker's Spine Review

42 Spine Device & Innovation tional level after passing its second consecutive FDA inspection in February 2014. The company's innovative products and distinctive design have set the instruments apart from others available in the field. Globus Medical. At only seven months in, 2014 has already been an excit- ing year for Globus Medical. The company acquired musculoskeletal implant manufacturer Excelsius Surgical in January. Excelsius Surgical is developing the next generation of surgical robotic positioning platforms for the spine, brain and therapeutic markets, which have a huge potential for growth over the next few years. Globus expects to obtain FDA clearance for the system in 2015 and begin commercial sales in 2016. The company also launched the MONU- MENT Anterior Spondylolisthesis Reduction System in May. First quarter fi- nancial results show the company reached $114.2 million in worldwide sales with a net income of $21.1 million. The company launched five new products during the first quarter and grew international sales by 43 percent. Invibio Biomaterial Solutions. Invibio announced a new corporate identity at the end of 2013. The company is a global leader in providing PEEK-based biomaterial solutions for medical device manufacturers, and the new brand covers spine, orthopedic and trauma markets. The company was founded in 1999 and evolved from a materials supplier to a biomaterials solutions provider. The company developed six implantable PEEK grades and the PEEK-OPTIMA polymers are used in more than 4 million implanted devices worldwide. The company launched PEEK OPTIMA HA Enhanced Polymer globally last year and hosted the First International PEEK Meeting in April 2013. As of February 2013, there were 500 medical devices manufactured from PEEK-OPTIMA cleared for market in the United States and more than 80 approved for market in China. K2M. In January, K2M celebrated its 10 th anniversary of innovating in the spine field. The company's focus is on minimally invasive devices for com- plex spine surgery. The company has developed 57 spinal technologies and related techniques since its founding in 2004 and looks to continue growth after closing an initial public offering in May. In its first quarter financial report, K2M reported a total revenue increase of 20.4 percent to $42.3 mil- lion. International revenue was up 34.8 percent to $12.5 million. The IPO brought approximately $120 million in net proceeds, providing the company with the capital resources to improve their balance sheet and fund strategic growth initiatives. The company's CEO Eric Major said in a recent interview the company plans to deliver five to eight new products per year in its target markets of complex spine, minimally invasive and degenerative disc disease. Life Spine. Since 2006, Life Spine has received FDA clearance for several spine products, including the IRIS Anterior Cervical Plate last year. In 2013, the company was named winner of the 12 th Annual Chicago Innovation Award for the AILERON Expandable Posterior Fusion System, chosen from more than 500 nominees. The company also announced continued growth outside of the United States with purchases from Puerto Rico, New Zealand, Bra- zil and India. Life Spine continues to invest resources outside of the United States to generate growth opportunities worldwide. In May, the company an- nounced partnership with China Pioneer Pharma, based in Shanghai, which sells to more than 23,000 hospitals in China. During the first quarter of 2014, the company reported 41 percent revenue growth. LDR. After announcing an initial public offering last September, LDR has continued to grow through the beginning of this year. On May 7 the com- pany reported total revenue up 20.2 percent to $31.1 million for the first quarter, with revenue from exclusive technology products growing 26.9 per- cent to $26.5 million. A week later, the company announced a follow-on of- fering of 1.3 million shares of its common stock. The company also received good news for its Mobi-C artificial disc; it became the first cervical disc to receive FDA approval for one- and two-level disc replacement. The AMA also granted two-level cervical disc replacement a Category I CPT code effective Jan. 1, 2015, opening opportunities for the company in the future. NuVasive. On May 13, NuVasive rang the NASDAQ Opening Bell to celebrate 10 years as a publicly-traded company. Best known for their lateral approach technique, eXtreme Lateral Interbody Fusion, NuVasive has experienced several successes over the past several years and is now focused on the next milestone: bringing in $1 billion in revenue in conjunction with increasing profitability. The company reported a total revenue increase of 11.3 percent over the same period last year, reaching $177.5 million. Over the past year, NuVasive has moved to expand its workforce in the United States as well as strengthen its leadership overseas. In 2013 NuVasive launched the ALIF ACR, XLIF Decade Plate and MAS PLIF devices. Paradigm Spine. In 2012, Paradigm Spine promoted Guntmar Eisen to President and COO as well as announced Steven Amelio would be the com- pany's new CEO to promote long-term growth and success; Hallett Mathews, MD, MBA, also joined the company that year as executive vice president and chief medical officer. Since then, the company achieved FDA premarket ap- proval for the coflex Interlaminar Technology and several studies have been released on the safety and efficacy of the device. The company received good news in 2013 when Cahaba GBA determined coflex could be covered in Ala- bama, Georgia and Tennessee. The company is now gearing up for additional growth. In February 2014, Paradigm Spine entered into a credit agreement with PDL BioPharma to provide Paradigm with up to $75 million of secured debt financing. Armentum Partners acted as financial advisors to Paradigm Spine, which initially received $50 million at the close of the transaction. The company's coflex is now sold in more than 50 countries and Paradigm plans to use the proceeds from the financing transaction to refinance its existing credit facility and expand domestic commercial operations. SI-BONE. SI-BONE received good news in March when the AMA an- nounced it would assign a Category I CPT code to minimally invasive sac- roiliac joint fusion, beginning Jan. 1, 2015. SI-BONE focuses on the MIS SI joint solution iFuse, which is used in many procedures every year. Around 700 surgeons in the United States have adopted MIS SI joint fusion, per- forming more than 10,000 of the procedures nationwide over the past five years. Around 90 percent of all SI joint fusions are done using the minimally invasive technique and since 2012 there have been 16 peer-reviewed clinical articles on the procedure's effectiveness. The company closed a $33 million growth capital financing at the end of April with Orbimed and Novo A/S investing along with the company's other current investors, Skyline Ventures and Montreux Equity Partners. The proceeds will be used to expand the com- pany's U.S. sales organization and bolster research and development, medical affairs, regulatory, compliance and reimbursement. The company received addition good news in May, when Medicare Novitas removed MIS SI joint fusion from non-coverage. SpineCraft. Over the past year, SpineCraft has launched several new systems, including the OsteoPore DBM products and VELOX ACP System, and re- ceived clearance for the APEX Spine System in Australia and New Zealand. The company signed a distribution agreement with Zimmer for the APEX Spine System in July 2013 for healthcare organizations in the United States, Canada, Australia and New Zealand. Since then, the company has opened a new expansion to its facility dedicated to workshop and training labs as well as warehouse space. At the beginning of this year, the company extended their APEX product line to include a full range of uniplanar screws. The com- pany has big plans for the future as well: it will release its next generation deformity correction technology, the ASTRA Spine System, during the fourth quarter of the 2014 fiscal year. n Becker's ASC 21st Annual Meeting - The Business and Operations of ASCs October 23-25, 2014 • Chicago Keynotes: Terry Bradshaw, Co-Host and Analyst, FOX NFL Sunday and NFL Legend; Bill Taylor, Founding Editor, Fast Company and Best-Selling Author; Lolo Jones, 2-Time Olympic Hurdler and World Champion, 2014 Olympic Bobsledder For more information, call (800) 417-2035 30 Great Surgeons, 36 Leading Administrators and 80 Surgery Center Speakers in Total

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