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Globus Medical Announces First Case with Next Generation 3D Printed Spine Implant

HEDRON IA is the only commercially available 3D printed integrated Anterior Lumbar Interbody Fusion (ALIF) spacer with anchor technology

AUDUBON, Pa., Feb. 04, 2020 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (GMED), a leading musculoskeletal solutions company announced Dr. Joshua S. Rovner became the first spine surgeon to implant HEDRON IA, a 3D printed integrated ALIF spacer that leverages anchors or screws for vertebral body fixation. The minimally invasive outpatient procedure was recently performed at Englewood Health, one of New Jersey’s leading hospitals and healthcare networks.

“Offering my patients the benefits of smaller incisions and less exposure to potential complications is why I specialize in minimally invasive surgery,” said Dr. Joshua S. Rovner. “For the ALIF procedure, I require an implant that’s easy to insert yet provides a sturdy construct. HEDRON delivered with the additional benefit of endplate-to-endplate porosity to promote fusion.”

HEDRON spacers feature a biomimetic porous scaffold designed to promote bone formation onto and through the implant. Unlike first generation 3D printed implants, HEDRON strikes the optimal balance of strength and porosity through a sturdy frame and a pore size distribution similar to trabecular bone.

“The launch of HEDRON demonstrates our commitment to improving patient outcomes by commercializing innovative musculoskeletal solutions that advance our market leading position,” said Mark Adams, VP of Product Development. “HEDRON IA is the second in a full line of 3D printed interbody fusion spacers with an internal architecture that demonstrates significantly more bone ingrowth in an animal model at 6 weeks post-op compared to PEEK and titanium implants1.”

Visit globusmedical.com/hedronia to learn more.

Indication
HEDRON IA™ Integrated Lumbar Spacers are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). HEDRON IAÔ Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). Hyperlordotic implants (≥25° lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).

About Globus Medical, Inc.
Based in Audubon, Pennsylvania, Globus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

1. Lumbar Ovine Sheep Model Study Data on file

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Brian Kearns
Senior Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email: investors@globusmedical.com 
www.globusmedical.com