Here are 15 fast-growing spine-focused device companies in the market today.
Many of these companies have introduced several new products over the past few years and are poised to expand their platforms going forward. A few of the companies recently filed initial public offerings to spread their reach. Others have announced plans to expand internationally and grow into emerging markets.
These companies are also growing through acquisitions, research and product development. They are setting aside resources for marketing and sales growth with a new strategic outlook for their business going forward. The companies are listed in alphabetical order.
AccelSPINE. In 2012, AccelSPINE achieved six FDA clearances and has been building on their success ever since. In 2014 the company received FDA clearance for the Picasso II next generation minimally invasive system and named Bala Giri, MD, chief medical officer. The company also recently selected TrizCom as its public relations agency to continue their commercial growth. Beyond serving the spine community, the company is involved in community growth efforts. AccelSPINE participated in the Disney Dreamers Academy, a national community outreach program to address goal setting, planning and networking. AccelSPINE representatives shared their career experiences and a hands-on workshop for teens interested in neurosurgery. Several members of the team also went on a medical mission trip to Ethiopia in January to perform procedures and educate local physicians about providing spinal care.
Alphatec Spine. Alphatec Holdings, parent company for Alphatec Spine, announced executive leadership changes in April to complement the company's further growth in the future. Leslie H. Cross stepped down from his position as CEO, but continues to serve as chairman of the board of directors; James M. Corbett took his place and now serves as president and CEO. During his tenure, Mr. Cross built a strong leadership team, improved company revenue, increased the depth and breadth of Alphatec's global product portfolio and implemented lean excellence and enterprise initiatives. But don't expect this transition to slow the company down. Mr. Crobett has experience driving growth in several products and geographies. The company reported first quarter sales from less-invasive products increasing 10 percent. During the quarter, the company received FDA clearance for the Arsenal device and launched the CoreX minimally invasive biologics product. Alphatec Spine also received approval for and launched the DiscoCerv cervical disc prosthesis in China.
Amedica. Amedica is growing its presence in the orthopedic and spine marketplaces after beginning an initial public offering in February. The company announced an IPO of 3.5 million shares of common stock at a price of $5.75 per share with JMP Securities acting as the sole book-running manager for the offering. During the first quarter, the commercial biomaterial company known for its silicon nitride products reported a 41 percent increase in the silicon nitride ceramic products to $2.5 million. Revenue increased 7 percent over the fourth quarter of 2013, primarily due to second generation Valeo spinal interbody device adoption. The company will soon become more focused in its growth; in June, Amedica stopped distributing its amniotic derived allograft products to focus on its proprietary biomaterials, which yield much higher gross margins. Earlier this month, Amedica received $26 million in funding for the future.
Aurora Spine. Aurora Spine has received clearances for its products on a global scale. The FDA approved its new ZIP MIS system and additional sizes for the ZIP ULTRA Minimally Invasive Interspinous Fusion System. In September 2013, the company announced an initial public offering of 5.15 million shares at $0.70 per share for approximately $3.61 million in proceeds. At the time, the IPO was expected to accelerate the company's position as a global spine innovator in minimally invasive fusion, dynamic stabilization and regenerative technologies. In 2013, the company reported revenue of $206,994 at the nine-month's end. The company has also had recent leadership changes, including the Executive Vice President of U.S. Sales Mike Keegan and Regional Vice President of Sales for the Eastern United States Doug Johnson.
Baxano Surgical. TranS1 was conceived in 2000 and the company's AxiaLIF received FDA clearance in the fourth quarter of 2004, with first cases performed in the United States in 2005. That same year Jeff Bleich, MD, founded Baxano to develop less invasive techniques for lumbar decompression. TranS1 completed an initial public offering in 2007 and announced the 2,000th case performed with AxiaLIF the same year. Baxano separately achieved FDA clearance for the iO-Flex system in 2007 and both companies continued to grow over the next few years. In 2012, the AMA announced a Category I code for presacaral fusion, including AxiaLIF, and CMS assigned significant RVUs to the procedure later that year. Then, in 2013, the two companies merged to form the publicly-traded spine company Baxano Surgical. In the first quarter of 2014, the company reported $4.4 million revenue and FDA clearance for the Avance MIS Pedicle Screw System. The company also achieved $10 million financing and despite revenue coming in slightly below expectations, President and CEO Ken Reali expects a new marketing strategy to drive sequential revenue growth and reduce operating expenses in the future.
Eminent Spine. Steve Courtney, MD, and David Freehill co-founded Eminent Spine in 2008 to provide new spine technology to the field. In May, the company was issued patents for the DiamondBack Pedicle Screw Fixation System and the Fang Bone Plate and Plating System. The company also recently released white papers detailing the effectiveness of their King Cobra anterior cervical plate and Copperhead PEEK Cervical Cage. The company continues to position itself for growth on the national 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 exciting 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 MONUMENT Anterior Spondylolisthesis Reduction System in May. First quarter financial 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 10th anniversary of innovating in the spine field. The company's focus is on minimally invasive devices for complex 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 million. 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 12th 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, Brazil and India. Life Spine continues to invest resources outside of the United States to generate growth opportunities worldwide. In May, the company announced 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 company reported total revenue up 20.2 percent to $31.1 million for the first quarter, with revenue from exclusive technology products growing 26.9 percent to $26.5 million. A week later, the company announced a follow-on offering 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 and in July 2014 the company announced plans for an international operations center in Ireland.
Paradigm Spine. In 2012, Paradigm Spine promoted Guntmar Eisen to President and COO as well as announced Steven Amelio would be the company'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 approval 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 Alabama, 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 announced it would assign a Category I CPT code to minimally invasive sacroiliac 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, performing 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 company'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 received 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 company 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.
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