Website – https://www.formuslabs.com/
Formus Labs is expecting to get the regulatory nod from the FDA to be able to sell its fully-automated 3D planning technology for joint replacement surgeries in the second quarter and has partnered with orthopedic surgery heavyweight for a global distribution program
A New Zealand startup that makes fully automated 3D orthopedic surgery planning software announced Wednesday that it has raised $5 million and struck a partnership with Zimmer Biomet for co-development and global distribution of its technology.
Formus Labs, which bills itself as the world’s first world’s “first automated 3D planner for joint replacement surgeries” received the investment from lead investor GD1 (Global from Day 1), and others including Punakaiki Fund, Icehouse Ventures, Pacific Channel, and Flying Kiwis.The company plans to use the money to speed up product development and its expansion into the U.S.
“Everyone knows someone that has had a joint replacement, but few know just how complex, variable, and costly the process can be,” said Dr. Ju Zhang, founder and CEO of Formus Labs, in a statement. “Our goal is to make orthopedic surgery as simple as it can be by arming surgeons with the latest cutting-edge technology so every joint replacement has a Formus plan that reduces the need for revisions, instills confidence, and facilitates better outcomes for patients, at a lower cost.”
Companies have approached the problem of complexity and variability of a total joint replacement in many different ways. Stryker, the Michigan-based orthopedic company, for instance, has a surgical robot that the company has suggested makes surgeon experience less of a factor in producing good outcomes for patients undergoing total joint replacement and reducing complications.
And there are a whole host of startups that are focusing on the pre-operative surgical planning area as a way to take out the guesswork in a successful surgery — be it in joint replacement or another area. Osso VR and FundamentalVR are two companies that leverage virtual reality to train surgeons to help them be better and more effective surgeons. [Osso VR works with Johnson & Johnson, Stryker and Smith & Nephew, while the latter company announced in 2018 that it was working with Mayo Clinic to develop surgical VR simulation and education products). But Formus Labs’ CEO believes that his company’s solution — is based upon artificial intelligence and biomechanics that produce fully interactive 3D models — are fundamentally superior.
“The Formus Labs [FL] platform uses AI and ML technology on 3D images to produce the most optimized surgical plan for the patient in an hour. Where other technologies still require manual identification of landmarks, the FL platform is able to do that identification as part of the entire planning process,”Zhang said in an email response to questions that a spokesman sent. “3D planning on Formus is automated and rapid, taking just 1 hour of cloud computing time to go from a CT scan to an optimal plan instead of days to weeks of valuable engineering and surgeon time as it does with competing solutions.”
He also argued that the company’s technology is better than the surgical planning technology offered by companies that allow surgeons to practice with 3D-printed joints.
Unlike 3D printing companies who have to custom design and manufacture an implant for each patient (taking weeks), Formus Hip works on widely available standard implants that are ready to go at the hospital. This again adds to our rapid turnaround time, enabling a surgeon to go from a CT to 3D plan to the OR in an hour, something that has not been possible until now. Our platform has automated the whole surgery planning process, from image processing, generating 3D models of the patient’s bones, identifying anatomical landmarks and measurements, optimizing the sizing and fit of implants, and producing OR-ready reports. This is a first in the market.
Formus Labs’ product is officially set to launch later in the month in Australia and New Zealand. And it hasn’t quite hit the market in America though the company expecting FDA clearance in the second quarter of the year. But that hasn’t prevented Zimmer Biomet from cementing a deal with Formus. The software that allows surgeons to plan a hip replacement using Zimmer Biomet hips was actually co-developed by Formus and the Indiana medical device maker. And a global distribution agreeements means that Zimmer Biomet presumably will bundle this software together with the artificial hips it makes when it sells them to providers.
Zhang explained that the overall platform is device agnostic even though the hip surgery planning technology only shows Zimmer-manufactured hips.”
“In our R&D work we have demonstrated the ability of the Formus Platform to plan in other joints as well, e.g. spine, knee, and shoulder,” he said.
Medical device companies have been affected by the pandemic as patients stayed out of the hospital and elective procedures such as joint replacements were delayed. Zimmer Biomet and Formus Labs’ seem be betting that value-added technology like effective preoperative surgical planning software can adrelieve the burden on providers and in turn take costs out of the system through reduced complications and the need for revision surgery.
“Where operational costs and staffing are continued concerns during this time of reduced surgeries, Formus Labs welcomes discussions with hospital systems that want to better understand how our platform can help keep their costs reduced,” Zhang declared. “As revenues are strained, hospitals and implant suppliers need more certainty at a faster turnaround regarding what implants are needed for each surgery to reduce costs. The Formus Platform is an ideal technology to help hospital systems obtain that certainty while at the same time helping surgeons and their teams drive more efficiency in their workflows and provide better outcomes to patients.”