ZimVie Announces Additional Positive Policy Decisions for Vertebral Body Tethering
ZimVie Inc. (Nasdaq: ZIMV) announces that Highmark and BCBS North Dakota have deemed the Tether™ device as medically necessary for treating pediatric scoliosis. Effective January 30, 2023, and March 6, 2023, respectively, the new policies expand eligibility for vertebral body tethering (VBT) to over 4 million and 280,000 patients. The Tether™ is the only FDA-approved device for VBT, with over 1,300 applications since its humanitarian device exemption in August 2019. Experts indicate these developments highlight advancements in VBT technology, allowing more children to access crucial treatment within their growth window.
- Highmark and BCBS North Dakota have deemed the Tether™ device as medically necessary for pediatric scoliosis treatment, expanding access to VBT for over 4 million and 280,000 patients, respectively.
- The Tether™ device is the only FDA-approved solution for vertebral body tethering, having been used in over 1,300 surgeries since its HDE approval.
- None.
The Tether™ device now deemed “medically necessary” for the treatment of pediatric scoliosis in additional patients covered by Highmark and BCBS North Dakota
WESTMINSTER, Colo., March 15, 2023 (GLOBE NEWSWIRE) -- 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 ZimVie
ZimVie 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 Statements
This 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:
ZimVie
Laura Driscoll • Laura.Driscoll@ZimVie.com
(774) 284-1606
ZimVie Spine
Mark Richards • Mark.Richards@ZimVie.com
(512) 913-9572
Investor Contact Information:
Gilmartin Group LLC
Marissa Bych • Marissa@gilmartinir.com
FAQ
What is the significance of the Tether™ device approval by Highmark and BCBS North Dakota?
When did Highmark and BCBS North Dakota issue their new policies for the Tether™ device?
How many children have received the Tether™ device since its approval?
Is the Tether™ device FDA approved?
What impact does the Tether™ device have on pediatric scoliosis patients?
