Carlsmed Announces aprevo® Launch and NTAP Reimbursement

CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., announced today the U.S. launch of the aprevo® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement.

“We are grateful for our surgeon partners that worked with the company early on to develop a truly personalized solution for patients and to collect the clinical data for improved outcomes,” said Mike Cordonnier, CEO of Carlsmed. “We would like to recognize Dr. Christopher Ames at University of California San Francisco, Dr. Vijay Yanamadala at Hartford Healthcare, and Dr. Justin Smith at the University of Virginia Medical Center. These talented surgeons and their dedicated staff collaborated with Carlsmed and patients to complete the first in world aprevo® anterior, lateral, and transforaminal procedures respectively earlier this year as part of a Limited Clinical Release.”

Justin Smith, MD, PhD, Chief of Spine Surgery at the University of Virginia Medical Center, commented, “Data from the multi-institutional Spinal Deformity Study Group has demonstrated that surgery significantly reduces disability and pain and improves the health status for adults of all ages, with the elderly having a disproportionately greater improvement.¹ While elderly adults can be expected to have more complications with surgical treatment than younger patients, having tools such as aprevo® to achieve the optimal personalized correction for each patient may help to reduce these.”

Starting today, spine fusion procedures utilizing Carlsmed’s aprevo® devices are eligible for additional reimbursement from CMS and private payors through the NTAP program. A copy of the final rule correction notice from CMS for the aprevo® NTAP can be found in CMS-1752-CN here: https://www.cms.gov/fy-2022-ipps-final-rule-home-page.

About Carlsmed

Carlsmed’s mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The company’s aprevo® devices are designed to improve the standard of care for the surgical treatment of patients with adult spinal malalignment. Carlsmed uses patient data and proprietary digital technologies to create optimal surgical plans and personalized aprevo® spine fusion devices to align with the surgeon’s goals for each patient. The Carlsmed® aprevo® devices are FDA cleared and have been granted FDA Breakthrough Designation, an industry first for any implanted device, and are commercially available in the U.S.

For more information, visit carlsmed.com or contact us at [e-mail].

References –

1. Smith, et al. Risk-Benefit Assessment of Surgery for Adult Scoliosis - An Analysis Based on Patient Age. Spine 2011;36:10, pp 817–824.
2. CMS-1752-CN: https://www.cms.gov/fy-2022-ipps-final-rule-home-page