REFLECT™ is authorized by means of the FDA’s Humanitarian System Exemption pathway
AUDUBON, Pa., Could 15, 2023 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a number one musculoskeletal options firm, as we speak introduced the REFLECT™ Scoliosis Correction System has been granted approval from the US Food and Drug Administration, as the corporate’s first humanitarian machine. REFLECT™ is designed to right progressive scoliosis in younger sufferers whereas preserving movement, sustaining stability, and permitting for future modulated development.
In contrast to inflexible metallic rods for fusion, REFLECT™ makes use of a versatile, sturdy cord to harness the ability of innate affected person development for correction. The versatile cord is tensioned on the convex aspect to regulate the curve, whereas permitting development on the concave aspect. The implants could also be inserted utilizing a minimally invasive strategy by means of a number of small incisions between the ribs.
“Treating scoliosis within the rising spine presents challenges associated to lowered spinal mobility,” says Dr. Juan C. Rodriguez-Olaverri, board-certified orthopedic surgeon and Director of Pediatric Spinal Deformity Surgical procedure and Early Onset Scoliosis at NYU Langone. “REFLECT™ is an thrilling growth for curve correction that preserves freedom of movement in these younger sufferers, and employs their very own remaining development to assist restore the spinal curvature with out the necessity for fusion.”
Kelly Baker, Senior Vice President, Regulatory and Medical Affairs at Globus Medical, commented, “REFLECT™ has been obtainable internationally for a number of years, and Globus Medical may be very excited to make this method obtainable to sufferers in the USA. This progressive resolution highlights our dedication to addressing the medical wants of the rising spine and enhancing the standard of life in these kids. It’s the newest development in scoliosis remedy that gives a non-fusion possibility for sufferers and their mother and father, as they think about the very best remedy plan for his or her way of life and objectives.”
To be taught extra, go to GlobusMedical.com/merchandise/REFLECT.
Indications
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature sufferers who require surgical remedy to acquire and preserve correction of progressive idiopathic scoliosis, who’ve a significant Cobb angle of 30 to 65 levels whose osseous construction is dimensionally ample to accommodate screw fixation, as decided by radiographic imaging. Sufferers ought to have failed bracing and/or are illiberal to brace put on.
About Globus Medical, Inc.
Globus Medical, Inc. is a number one musculoskeletal options firm based mostly in Audubon, PA. The corporate was based in 2003 by an skilled workforce of pros with a shared imaginative and prescient to create merchandise that allow surgeons to advertise therapeutic in sufferers with musculoskeletal problems. Further data might be accessed at http://www.globusmedical.com.
Secure Harbor Statements
All statements included on this press launch aside from statements of historic truth are forward-looking statements and could also be recognized by their use of phrases reminiscent of “imagine,” “could,” “may,” “may,” “will,” “goal,” “estimate,” “proceed,” “anticipate,” “intend,” “count on,” “plan” and different comparable phrases. These forward-looking statements are based mostly on our present assumptions, expectations and estimates of future occasions and tendencies. Ahead-looking statements are solely predictions and are topic to many dangers, uncertainties and different elements which will have an effect on our companies and operations and will trigger precise outcomes to vary materially from these predicted. These dangers and uncertainties embody, however are usually not restricted to, well being epidemics, pandemics and comparable outbreaks, together with the COVID-19 pandemic, elements affecting our quarterly outcomes, our means to handle our development, our means to maintain our profitability, demand for our merchandise, our means to compete efficiently (together with with out limitation our means to persuade surgeons to make use of our merchandise and our means to draw and retain gross sales and different personnel), our means to quickly develop and introduce new merchandise, our means to develop and execute on profitable enterprise methods, our means to adjust to legal guidelines and laws which can be or could grow to be relevant to our companies, our means to safeguard our mental property, our success in defending authorized proceedings introduced towards us, tendencies within the medical machine business, common financial circumstances, and different dangers. For a dialogue of those and different dangers, uncertainties and different elements that might have an effect on our outcomes, you must check with the disclosure contained in our most up-to-date annual report on Kind 10-Ok filed with the Securities and Change Fee, together with the sections labeled “Threat Elements” and “Cautionary Word Regarding Ahead-Wanting Statements,” and in our Kinds 10-Q, Kinds 8-Ok and different filings with the Securities and Change Fee. These paperwork can be found at www.sec.gov. Furthermore, we function in an evolving surroundings. New threat elements and uncertainties emerge every now and then and it isn’t potential for us to foretell all threat elements and uncertainties, nor can we assess the influence of all elements on our enterprise or the extent to which any issue, or mixture of things, could trigger precise outcomes to vary materially from these contained in any forward-looking statements. Given these dangers and uncertainties, readers are cautioned to not place undue reliance on any forward-looking statements. Ahead-looking statements contained on this press launch converse solely as of the date of this press launch. We undertake no obligation to replace any forward-looking statements on account of new data, occasions or circumstances or different elements arising or coming to our consideration after the date hereof.
Contact:
Brian Kearns
Senior Vice President, Enterprise Growth and Investor Relations
Telephone: (610) 930-1800
Electronic mail: traders@globusmedical.com
www.globusmedical.com
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