ODT’s Most-Read Stories This Week—July 2

ODT website visitors were intrigued this week by a call to action from Enhatch Co-Founder and CEO Peter Verrillo, who made a case for hip and knee implant personalization. “Many cases today still involve manual templating using X-rays, despite having the technology to use 3D anatomic modeling and additive manufacturing to make personalized solutions. We’re overdue for a change,” Verrillo wrote in an online exclusive. Artificial intelligence-based 3D anatomic modeling can provide patients with a customized implant fit, as the modeling digests millions of anatomical data points and medical images to generate a 3D version of the joint anatomy to find the best-fit implant. “The benefits of AI in orthopedics also go beyond efficiency in surgical planning. What we need is an open, digital ecosystem to deliver a universe of innovation that enhances the future of surgery not only for orthopedics but the entire medical device industry,” he concluded.

Playing second-fiddle to Verrillo’s call to action was the opening of Boston Centerless’ second manufacturing plant in Fort Wayne, Ind. The facility increases manufacturing and distribution capacity by more than 16,000 additional square feet and features state-of-the-art equipment. 

Other traffic drivers this week included Tecomet’s new CEO, 3Spine’s clinical trial approval, and a promising new bone defect patching material.  

Former Tecomet CEO Bill Dow returned to his old job, becoming the company’s president and chief executive officer; he replaces Victor Swint, who stepped down from his roles effective June 21. Dow was Tecomet’s CEO from 2008 through 2015 and has served more than 25 years as a leader and CEO for companies across various product sectors, ranging from high-end medtech to commodity disposables. 

Researchers at Tokyo Medical and Dental University have discovered a new type of bone repairing material: a bio-responsive ceramic that interacts with an enzyme found in blood to be absorbed into the body at a precise and predictable rate.
At the heart of this discovery is a biological reaction: an enzyme called alkaline phosphatase (ALP), which is present in human serum and reacts with various phosphate esters to generate bone mineral known as hydroxyapatite.
 
3Spine, meanwhile, received FDA Investigational Device Exemption (IDE) approval for its U.S. pivotal clinical trial. The company previously completed contracting and site initiation at 16 U.S. centers for a prospective real-world evidence (RWE) fusion study, which has been enrolling since May. As sites complete enrollment of their RWE cohort, each center becomes eligible to participate in the IDE. 3Spine plans to complete enrollment of roughly 150 RWE patients to propensity match with approximately 150 IDE patients in an adaptive statistical design.

1. A Call to Action in Orthopedics: We Need to Personalize Every Single Hip and Knee Surgery

2. Boston Centerless Opens Second Manufacturing Plant in Indiana

3. Tecomet Appoints Bill Dow as President and CEO

4. Researchers Discover Novel Patching Material for Bone Defects

5. 3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial