3D LifePrints Re-launches as “Insight Surgery” in Houston and Achieves FDA 510k Clearances for Orthopedic and CMF Solutions
HOUSTON, TEXAS, UNITED STATES
At the official launch of their US business in Houston yesterday, 3D LifePrints announced a new company name, Insight Surgery. The re-brand comes alongside receiving their 2nd FDA 510(k) clearance for non-joint replacing osteotomies in the appendicular skeleton. Insight Surgery also announced the opening of their cleanroom manufacturing facility at the Texas Medical Center.
Insight Surgery’s re-brand reflects the evolution of the organisation from a UK-based medical 3D printing company to a cross-Atlantic provider of Personalized Surgery.
Henry Pinchbeck, Co-Founder and Chief Executive Officer said “Firstly, I’d like to thank Houston for such a warm welcome. We have chosen the launch of our US business as the ideal time to rename the company to “Insight Surgery” so that it aligns with our focus on Digital Planning and Personalized Surgery. Having supplied Personalized Devices to over 1000 surgeries in the UK we now turn our attention to the US market, specifically Texas.”
Insight Surgery’s official USA launch took place at the British Consulate General’s residence in Houston. It was attended by many members of the city’s medical and academic community including representatives from Houston Methodist, Texas Children’s Hospital, MD Anderson and Texas Medical Center Innovations.
Peter Ellingworth, Chairman of Insight Surgery said “I’m delighted to be back again amongst so many friends and colleagues in Houston. Texas quickly became our first choice as a landing spot and given its proximity to so many world class hospitals, the Texas Medical Center is an ideal location for our first US facility.”
Insight Surgery’s FDA Cleared Digital Platform, “EmbedMed™” is an end-to-end solution for surgeons that digitizes the surgical planning process and enables the rapid design and manufacture of patient-specific medical devices. Embedmed’s functions includes the processing of patient scan data and as a pre-operative software tool for simulating and evaluating surgical planning options. The output files from the system can be provided digitally or as physical Models and Surgical Guides for use in surgery.
Following up their initial clearance for CMF solutions, Insight Surgery’s most recent FDA clearance is for non-acute, non-joint replacing osteotomies, including the resection of bone tumors, for the appendicular skeleton. It is believed to be the widest clearance of its type yet obtained by covering both upper and lower extremities.
Paul Fotheringham, Insight Surgery CTO said “Our 2 recent FDA clearances enable us to bring our full range of CMF and Orthopaedic devices to the US market. Our aim is to put these highly impactful devices in surgeons’ hands within 5 days of receipt of scan data.”
Insight Surgery is a UK and USA based provider of Personalized Surgery. Their FDA cleared platform EmbedMed0™ digitizes the surgical planning process and allows the rapid design and manufacture of patient-specific medical devices. Insight Surgery provide their services from facilities at the Point of Care greatly reducing the time to delivery.
Chief Executive Officer