NEWPORT BEACH, Calif.–January 16, 2024—Hall of Fame Health, a healthcare concierge and care coordinator formed in partnership with the Pro Football Hall of Fame in 2020, proudly announces the formation of a new Spine Advisory Board. This strategic advisory team of distinguished surgeons aims to develop a nationwide network of Spine Elite Care Centers, uniting top-tier medical and orthopedic spine specialists across the United States. The Carrell Clinic in Dallas has been chosen as the inaugural facility in this network, which will eventually comprise eight specialized centers dedicated to spine care.

<h5>November 6, 2024</h5>
<h6>Carlsmed Launches Cutting-Edge Digital Production Line, Revolutionizing Spine Surgery</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, a commercial-stage medical technology company and pioneer of the personalized spine surgery market, today announced the successful launch of its state-of-the-art digital production line.

<h5>October 8, 2024</h5>
<h6>Carlsmed Adds Industry Veteran, Kevin O’Boyle, to Board of Directors</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, the leader in personalized spine surgery, announced that Kevin O’Boyle has joined its Board of Directors and will serve as the Chair of the Audit Committee.

<h5>August 5, 2024</h5>
<h6>Carlsmed Announces Favorable Medicare Reimbursement Decision for Spinal Fusions with Custom-Made Anatomically Designed Devices</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, the leader in personalized spine surgery, announced today that in the Hospital Inpatient Prospective Payment System Final Rule for fiscal year 2025, the Centers for Medicare &amp; Medicaid Services (CMS) assigned spinal fusion cases with aprevo<sup>®</sup> custom-made anatomically designed interbody fusion devices to the highest level of the new spinal fusion Medicare Severity-Diagnosis Related Groups (MS-DRGs) it created. The new assignments and payment rates are favorable and will go into effect on October 1, 2024.

<h5>March 18, 2024</h5>
<h6>Carlsmed Raises $52.5M in Series C Financing to Advance Personalized Spine Surgery</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed, an AI-enabled personalized surgery Medtech company, announced today a $52.5M Series C funding round co-led by B Capital and U.S. Venture Partners. These proceeds will be used to accelerate the commercialization of the aprevo<sup>®</sup> personalized spine surgery platform for lumbar fusion procedures and the development of aprevo<sup>®</sup> for cervical fusions, which will launch in 2025.

<h5>January 8, 2024</h5>
<h6>Compelling Clinical Data Released for Carlsmed’s aprevo<sup>®</sup> Technology</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed announced today that new clinical data on its aprevo<sup>®</sup> technology has been published in the Global Spine Journal. This landmark study of a patient-matched cohort concluded that the use of aprevo<sup>®</sup> personalized interbody devices enables a significant improvement in achieving alignment.

<h5>September 20, 2023</h5>
<h6>FDA Grants Second Breakthrough Device Designation for Carlsmed<sup>®</sup> Technology</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)– Carlsmed announced today that the FDA granted Breakthrough Device designation for its aprevo<sup>®</sup> technology for treatment of patients with cervical spine disease. This is Carlsmed’s second Breakthrough Device designation, complementing the company’s family of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches.

<h5>October 11, 2022</h5>
<h6>COMPaSS™ Personalized Spine Surgery Study Begins Enrollment</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed<sup>®</sup> announced today that the first patients have been enrolled in the COMPaSS™ study. COMPaSS, Clinical Outcome Measures in Personalized aprevo<sup>®</sup> Spine Surgery, is a multi-center post market prospective observational registry. The study will collect data on patients with degenerative spinal conditions and are treated surgically with Carlsmed<sup>®</sup> aprevo<sup>®</sup> devices and will track outcomes for a period of two years.

<h5>April 19, 2022</h5>
<h6>Carlsmed<sup>®</sup> Raises $30M in Series B Funding to Scale Personalized Spine Surgery</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed<sup>®</sup> announced today that it closed an oversubscribed $30M Series B funding round, led by B Capital Group, a global, multi-stage investment firm. Existing investors, U.S. Venture Partners, The Vertical Group, Cove Fund and Wavemaker Three-Sixty Health, also participated in the round. The company plans to use the Series B funds to ramp commercialization of aprevo<sup>®</sup>, Carlsmed’s FDA cleared personalized surgical devices.

<h5>October 19, 2021</h5>
<h6>CMS Grants Transitional Pass-Through (TPT) Payment for Carlsmed<sup>®</sup>’s aprevo<sup>®</sup> Personalized Interbody Devices</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed<sup>®</sup> announced today that the Center for Medicare &amp; Medicaid Services (CMS) has granted aprevo<sup>®</sup> a Transitional Pass-Through (TPT) payment as part of the quarterly update of the 2021 Medicare Hospital Outpatient Prospective Payment System. The aprevo<sup>®</sup> Personalized Interbody Devices were the only devices to receive TPT status in this update. The pass-through payment provides outpatient facilities with an incremental Medicare payment for procedures in which aprevo<sup>®</sup> is used.

<h5>October 1, 2021</h5>
<h6>Carlsmed<sup>®</sup> Announces aprevo<sup>®</sup> Launch and NTAP Reimbursement</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed<sup>®</sup> , Inc., announced today the U.S. launch of the aprevo<sup>®</sup> patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement.

<h5>July 28, 2021</h5>
<h6>Carlsmed<sup>®</sup> and the International Spine Study Group Foundation Announce Long-term Partnership</h6>
CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed<sup>®</sup> , Inc., a commercial stage medical device technology company, is announcing today that it has partnered with the International Spine Study Group Foundation (ISSGF), the premier study group on adult spinal deformity, to collect data on surgical treatment with personalized interbody devices. Long term outcomes data will be collected to assess the role of aprevo<sup>®</sup> devices in improving patient outcomes and reducing postoperative complications.

<h5>February 23, 2021</h5>
<h6>World’s First aprevo<sup>®</sup> Personalized Spine Surgery Performed Using the Only Available Spine Technology with FDA Breakthrough Designation</h6>
SAN DIEGO–(BUSINESS WIRE)–Carlsmed<sup>®</sup> , Inc. is announcing today that the first aprevo patient specific spinal surgery has been successfully performed. Christopher Ames, M.D., director of spinal tumor and spinal deformity surgery at UC San Francisco Medical Center, assisted by Patrick Maloney, M.D., performed this landmark surgical procedure.

<h5>December 08, 2020</h5>
<h6>Carlsmed<sup>®</sup> aprevo<sup>®</sup> Granted Unprecedented Decision by FDA</h6>
SAN DIEGO–(BUSINESS WIRE)–Carlsmed<sup>®</sup> , Inc., today announced it has been granted 510(k) clearance and Breakthrough Device Designation by the FDA for its aprevo patient specific interbody devices for the correction of adult spinal deformity. The Carlsmed<sup>®</sup> aprevo<sup>®</sup> device is the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from the FDA.