ZimVie Announces Additional Positive Policy Decisions for Vertebral Body Tethering
15 March 2023 - 11:30PM
GlobeNewswire Inc.
ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the
dental and spine markets, today announced that Highmark, one of
America's leading health insurance organizations and an independent
licensee of the Blue Cross Blue Shield Association, which covers
primarily Pennsylvania, New York, Delaware, and West Virginia, and
BCBS North Dakota, the largest payer in the state of North Dakota,
have issued positive medical policy decisions applicable to
vertebral body tethering (VBT). Effective January 30, 2023 for
Highmark and March 6, 2023 for BCBS North Dakota, the policies
outline the criteria for medical necessity and expand potential
treatment eligibility to patients indicated for VBT within the 4+
million members covered under Highmark and the 280,000+ lives
covered by BCBS North Dakota.
“The Highmark and BCBS North Dakota coverage decisions validate
the expectation we noted when we announced the Anthem BCBS positive
coverage decision in July, that additional policy updates would
follow. It is encouraging to see broader endorsement of this
opportunity to positively impact the lives of children with
scoliosis through a motion preserving alternative to spinal
fusion,” said Rebecca Whitney, SVP and President of Global Spine
for ZimVie. “We are honored to work with orthopedic and
neurosurgeons to develop vertebral body tethering solutions that
may allow children with scoliosis to return to their active daily
lives.”
ZimVie’s Tether™ device, a first-of-its-kind non-fusion
scoliosis treatment, is the first and only FDA-approved device for
VBT. Its humanitarian device exemption (HDE) was granted based on
over seven years of clinical data validating the safety and
effectiveness of The Tether in scoliosis correction. Over 1,300
children have received The Tether since HDE approval in August of
2019, with approximately 65 U.S. surgeons performing the procedure
today.
“Highmark’s recent positive policy decision for vertebral body
tethering highlights the advancements that have come through
diligent research in understanding the optimal patient indications
for this promising technology,” said Amer Samdani, M.D.,
board-certified neurosurgeon, chief of surgery for Shriners
Hospitals for Children - Philadelphia, and pioneer in vertebral
body tethering. “As VBT relies on remaining growth potential, I am
thrilled that this timely approval will allow an increased
pediatric patient population to access treatment without missing
the window of opportunity.”
Highmark’s policy decision can be found
here:https://securecms.highmark.com/content/medpolicy/en/highmark/wv/commercial/policies/Surgery/S-279/S-279-001.html
The BCBS North Dakota policy decision can be found
here:https://www.bcbsnd.com/providers/policies-precertification/medical-policy/v/vertebral-body-tethering
For more information on ZimVie Spine solutions for restorative
procedures, please visit https://www.zimvie.com/en/spine.html.
About ZimVieZimVie is a global life sciences
leader in the dental and spine markets that develops, manufactures,
and delivers a comprehensive portfolio of products and solutions
designed to treat a wide range of spine pathologies and support
dental tooth replacement and restoration procedures. The company
was founded in March 2022 as an independent, publicly traded
spin-off of the Dental and Spine business units of Zimmer Biomet to
breathe new life, dedicated energy, and strategic focus to its
portfolio of trusted brands and products. From its headquarters in
Westminster, Colorado, and additional facilities around the globe,
the company serves customers in over 70 countries worldwide with a
robust offering of dental and spine solutions including
differentiated product platforms supported by extensive clinical
evidence.For more information about ZimVie, please visit us at
www.ZimVie.com. Follow @ZimVie on Twitter, Facebook, LinkedIn, or
Instagram.
The Tether is a Humanitarian Device. Authorized by Federal law
for use in the treatment of skeletally immature patients that
require surgical treatment to obtain and maintain correction of
progressive idiopathic scoliosis, with a major Cobb angle of 30 to
65 degrees whose osseous structure is dimensionally adequate to
accommodate screw fixation, as determined by radiographic imaging.
Patients should have failed bracing and/or be intolerant to brace
wear. The effectiveness of this device for this use has not been
demonstrated.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include, but are not limited to, statements concerning
ZimVie’s expectations, plans, prospects, and product and service
offerings, including new product launches and potential clinical
successes. Such statements are based upon the current beliefs,
expectations, and assumptions of management and are subject to
significant risks, uncertainties, and changes in circumstances that
could cause actual outcomes and results to differ materially from
the forward-looking statements. For a list and description of some
of such risks and uncertainties, see ZimVie’s periodic reports
filed with the U.S. Securities and Exchange Commission (SEC). These
factors should not be construed as exhaustive and should be read in
conjunction with the other cautionary statements that are included
in ZimVie’s filings with the SEC. Forward-looking statements speak
only as of the date they are made, and ZimVie disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise. Readers of this press release are cautioned not to
rely on these forward-looking statements, since there can be no
assurance that these forward-looking statements will prove to be
accurate. This cautionary note is applicable to all forward-looking
statements contained in this press release.
Media Contact
Information:ZimVieLaura Driscoll •
Laura.Driscoll@ZimVie.com(774) 284-1606
ZimVie SpineMark Richards •
Mark.Richards@ZimVie.com(512) 913-9572
Investor Contact Information:
Gilmartin Group LLCMarissa Bych •
Marissa@gilmartinir.com
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