Additive Orthopaedics (AO) recently achieved significant milestones, namely the US Food and Drug Administration (FDA) approval of the first and only patient-specific implant for talus replacement in the U.S. Now, the startup will be carrying this achievement onto Paragon 28, Inc., which has just announced the acquisition of AO’s product lines.
The Additive 3D-printed Patient Specific Talus Spacer, approved as a humanitarian use device earlier this year, is meant to replace the talus bone, which connects the leg and foot. With no other such implants available, patient’s suffering from talus-related issues, such as avascular necrosis, were made to either live with the pain associated with those problems or undergo less effective surgical interventions, particularly ankle fusion therapies.
As a first-of-its-kind implant, not just in terms of additive manufacturing but for talus replacement altogether, the device demonstrated AO’s innovation in the foot and ankle space. It was also only the latest in FDA approvals for the firm, which also included 3D printed locking lattice plates for aligning and stabilizing small bones in the foot and ankle, as well as AO’s first product, a 3D printed titanium digital fusion implant.
We’ve reached out to Paragon 28 to determine if the company is purchasing these assets, as well. What is known is that, in addition to the talus implant, Paragon 28 has acquired AO’s proprietary pre-operative surgical planning application, a cloud-based communication platform that allows surgeons and engineers to create patient-specific surgical plans and implants.
“The addition of the Additive Orthopaedics product portfolio and surgical planning capabilities provides Paragon 28 customers exclusive access to the only FDA-approved patient specific total talus replacement implant,” said Albert DaCosta, Co-Founder and Chief Executive Officer of Paragon 28. “The Additive acquisition also significantly accelerates the Company’s strategy to leverage smart tools, artificial intelligence and advanced technology to improve patient outcomes.”
AO was one of the first companies invested in by Asimov Ventures, who was also AO’s largest investor. The sale of AO’s assets to Paragon 28 represents the venture capital firm’s first exit. Tyler Benster, General Partner at Asimov Ventures, had this to say about the deal:
“We are proud of Greg and the entire AO team. In just five years AO managed to position itself as synonymous with 3D printed foot and ankle implants and today’s acquisition cements the effort. This deal also validates Asimov Ventures’ investment model and we look forward to a bright future in 3DP/AM venture capital.”
Paragon 28 is Colorado-based firm dedicated specifically to developing foot and ankle products. The purchase of AO assets complements the company’s existing portfolio, which includes the APEX 3D Total Ankle Replacement System, a 3D printed ankle implant also approved by the FDA. While the purchase of AO’s talus replacement device is obviously noteworthy as the only type of talus implant on the U.S. market approved by the FDA, its preoperative planning platform could be essential to introducing patient-specific, 3D printed implants to the broader orthopedic community.
As it stands, 3D printed implants are currently being adopted in a somewhat piecemeal fashion due to the regulations required for medical devices. For this reason, large device manufacturers like Stryker have begun rolling them out using the one-size-fits-all method already prominent in implant manufacturing. These products do not take full advantage of 3D printing in that they are not tailored to patients based on their medical imaging data, but only provide the benefits of AM related to osteogenesis.
However, to design patient-specific implants is no-easy task. While Materialise offers numerous software tools to aid in the process, surgeons will often have to rely on third parties, like Materialise, for the actual design and production of these devices. In turn, every service bureau that works in this field will likely work hand-in-hand with doctors to create the product. For instance, 3D Systems’ growing healthcare division excels in this department. These implants are then manufactured on a case-by-case basis until there can be some way to introduce some greater standardization to the production of custom implants.
If AO’s surgeon-engineer communication platform offers a specific set of advantages for presurgical planning, Paragon 28 could see that tool deployed more widely in the orthopedic sector before more widespread implementation in the medical field. From there, it may just be a hop, skip and a jump to mass customized implants approved by the FDA and other regulatory bodies.
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