To perform seamless joint replacement surgery, surgeons must create a customized preoperative plan for each patient. However, surgeons who have to perform multiple surgeries in a day are often too busy to devote enough time to this step.
Formas Labis a New Zealand-based medical technology start-up with a mission to significantly shorten the preoperative planning process.company on wednesday received With 510(k) clearance from the FDA, Formus Hip is a fully automated 3D software for hip replacement pre-surgery planning.
company announced It plans to expand to the US next year. Wednesday’s FDA clearance marks an important milestone, as it allows Formus to market its products to surgeons and health care providers nationwide.
Founded in 2017, Formus seeks to solve the problem of patient frustration and unsustainable costs in joint replacement surgery, CEO Ju Zhang said in a recent interview.
“Our approach to solving this problem is an automated method that is scalable to all patients, and how to optimize joint replacement surgery for each individual patient, based on their morphology and function.” to predict,” he said.
To expedite the joint replacement planning process, Formus Hip combines AI and computational biomechanics to calculate a patient’s implant fit and create an interactive 3D surgical plan.
The software first extracts patient-specific 3D anatomy from CT scans and then simulates the fitting of an implant catalog to that patient’s anatomy. Based on fit and surgeon preference, Formus Hip recommends the best implant for the patient. The surgeon can then review the patient’s anatomy and implant recommendations and make changes if necessary, Zhang explained.
Surgeons also receive a report containing important information needed to perform the surgery. Each report includes the patient’s recommended implant type and size, its location and orientation, intraoperative measurements to help deliver the implant, the patient’s expected postoperative measurements, and images to guide implant placement. increase.
“Unlike other planners and planning services that take days or weeks to develop a plan, Formus Hip automatically transitions from scan to plan in less than an hour, freeing surgeons and their teams to focus on the patient. This automation also means that highly accurate 3D preoperative planning can be extended to all surgeons and all patients,” said Zhang.
Medical software companies are already planning thousands of surgeries in New Zealand, he noted. The startup last year Zimmer BiometCommercialize .Formus Hip, a manufacturer of hip and knee implants, first in Australia and New Zealand, and later in the global market.
Zhang said the company is excited to bring Formus Hip to the US, and hopes to begin piloting it on healthcare sites in the coming months.
But this startup isn’t the only one focused on preoperative surgical planning, whether it’s in joint replacement surgery or elsewhere.For example, virtual reality companies such as Osso VR and Fundamental VR Train surgeons to hone their skills. Formus also competes with other his 3D planning software such as: Medicad, peak med and zedhip.
But Zhang cites AI as a point of differentiation from these companies.
“What sets us apart is our ability to execute a plan without anyone – surgeons, personnel, engineers on the other side of the world. on the order of days and thousands of dollars,” declared Zhang.
Formus also believes that “less is more” when it comes to medical software, and the company prides itself on its simple and intuitive user experience, he added. Zhang calls the startup’s user interface: [its] competitor. “
Photo: Formus Labs