Blog | 2/26/2024

AAOS 2024: Evolutionary to Revolutionary Changes in MSK

Key Highlights

• AI rapidly advancing capabilities in MSK – from the design of personalized implants to predictive recovery curves – expect more and quickly.
• Robotics and other digital modalities – AR, navigation, etc. continue to make in-roads but advances in technology, specifically AI, will likely help improve outcomes as the verdict on value proposition for robotics is still mixed.
• More products in “early intervention” – both biologic and implant-based approaches to delay the need for total joint replacement.
• Continued product launches in F&A particularly in MTP.
•  Less invasive approaches – from trauma fixation to carpal tunnel release.
• The future of large association meetings in question?

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There is so much great coverage of AAOS – before I even boarded my red-eye home Thursday night, analysts and journalists were commenting on what they saw at AAOS. A lot of this coverage, unsurprisingly, focuses on the major, publicly listed players in orthopedics. These companies are the commercial engines of the industry, drive the most volume, and ultimately are the main acquirers of the industry. Undoubtedly – positive trends like strong procedure volume tailwinds and sustained pricing, benefit these players.

To their credit – the industry leaders: Stryker, Zimmer, DePuy, Smith and Nephew, Arthrex have all had exciting years in their own right. Major implant system launches are fairly rare for these players and at AAOS Smith and Nephew launched its new AETOS shoulder, while Stryker launched a new hinged revision knee. Stryker extended their myMako planning app to Apple’s recently launched Apple Vision Pro – allowing surgeons to interact with their surgical plan in the newly created AR world. Not to be outdone, just days after AAOS – Zimmer announced that they were first to market with a robotic shoulder application on their ROSA robot – in addition to a full suite of pre-op planning products for shoulder. You can read about some more of these great stories here (MassDevice, by Chris Newmarker), here (OrthoWorld, by Carolyn LaWell), and here (MedTech Insight | Citeline, by Reed Miller and Marion Webb).

But it is rare for large multi-billion dollar companies to be agile in innovation – so the innovation most often lies around the perimeter of the exhibit floor, at the small booths, and THAT is where I focus my time.
 

The AI Revolution

The AI Revolution in Healthcare has certainly arrived in MSK. If a year or two ago we were wondering how AI would murkily be applied, or where it would be applied in ortho, today – there are few digital products in ortho that aren’t utilizing AI. This isn’t surprising given that most of us are probably utilizing LLMs and ML in our day to day lives (ChatGPT, BingChat, LinkedIn “Rewrite with AI”…”, and AI altering the pictures in your smartphone).

So much innovation that we have seen over the years, that we continue to see is often described as incremental, evolutionary, but the role that AI will play over the next few years does have the opportunity to make revolutionary changes to our care paradigm.

AI has the potential to predict outcomes and prescribe treatments and approaches to improve outcomes. You have likely heard me evangelize about the benefits of personalization in MSK care – AI is a tool that can truly bring personalization forth. Not simply in recreating the perfect fit of a personalized implant to match native anatomy (though that in itself is an amazing feat – way to go restor3d), or correct kinematic alignment, but also in helping us ultimately understand the etiology of a patient’s OA or infection – in choosing the right treatment for them to rapidly cure them. We already see tools like Zimmer’s WalkAI and Canary and Zimmer’s joint PersonaIQ predicting which patients are likely to have a worse trajectory in terms of ROM and even maybe loosening, so that surgeons can intervene on them early and aggressively. The reality is, we are just at the beginning of understanding the value of these tools and how best for clinicians, patients, and others to interact with them. It will require patience but also persistence.
 

Robotics and Other Digital Navigation Modalities

I want to address the elephant in the room right off the bat. Robotics is undoubtedly here to stay. While penetration of robotics is still likely around 20% in the total joint market (but as high as 60% of Stryker’s total knees based on their own reports), and the jury is still out on its value add, utilization and placements are growing. So is the number of options available – handheld (THINK, S&N CORI, Corin Apollo), freestanding (MAKO and ROSA), more compact, table-mounted (J&J Velys) and so many more. I admittedly have been in the skeptic camp for a while. For every study that implies it improves some aspect of care, there is another, that refutes this point. At this AAOS, an analysis of the AJRR showed that robotic cementless TKA does not decrease the 2-year revision rate vs conventional techniques. Is it a flawed study? Probably. But it continues to raise the question…

My take is that we have some way to go on optimizing robotic surgery to a point where we can undoubtedly show its benefit. There are human factors in the mix as well. The outcomes of a robotic surgery can only be as good as its pre-op plan. As I wrote about in my AAOS summary from 2022, surgeons have had to change their skillset from “cutter” to “planner”. Here to an area that technology will undoubtedly help us. We continue to debate whether a mechanically or kinematically aligned knee leads to a “more naturally” feeling knee.

I have always believed that AR and mixed reality allows surgeons the autonomy, but simultaneously the information and data they need to better perform surgeries. Some companies, including Medacta and Enovis, have staked their strategies on this – for now, evading the siren song of the “robot”. Similarly, we continue to see a lot of players in the handheld navigation space (for instance OrthAlign, NaviSwiss) and will be interesting to watch how these products rival larger capital in the space and cost constrained ASCs where we know most joints are now performed.

My guess is that there are tweaks and changes being made behind the scenes for all these technologies. As physicians use them, companies learn more about how to optimize them, but the fact that some of my themes from two years ago are still the same, validates my feelings that true innovation felt limited this year.
 

Early Intervention – Polymers and Metal?

One thing is clear in the world of Ortho – we are trying to figure out how to address conditions earlier and less invasively. Neither is this a NEW trend per se, but I am seeing products that, in the (for now) absence of true regenerative solutions, are emerging to bridge the gap to joint replacement. With people more active than ever (hello pickleball?) and the average life expectancy at an (almost) all time high, this makes a lot of sense. Those receiving total joints at age 60, or even earlier, are highly likely to outlive their joints. Finding solutions that can delay joint replacement addresses this unmet need.

You may already by familiar with the Moximed MISHA – last year the company gained FDA clearance for the knee “shock absorber” which has shown superiority in trials to high tibial osteotomy. Other products looking to bridge this gap are synthetic alternatives to cartilage repair for focal defects – something between a resurfacing and a synthetic or collagen cartilage plug. BioPoly has had products approved on the European market for many years (over a decade in fact). A metal base is implanted into the space with the cartilage defect and uses the proven poly technology for its articulating surface. Hyalex and Sparta Biomedical are looking to offer similar solutions and both purport to be “chondrophilic”, or “cartilage friendly”. The Hyalex system leverages hydrogel technology to create the lubricity for motion. Sparta has been a bit more “hush hush” with the makeup of its “chemically engineered” Ormi implant.

Given the high regulatory bar that the FDA has put forth for anything knee cartilage related, all these products will require an IDE for knee condyle studies, and each is in various stages of receiving this initial approval.
 

Overcrowding of Toes

Given the challenge of launching in knee – many products have targeted the MTP (metatarsophalangeal) joints. Particularly the first MTP joint. While I am thrilled that patients will now have a solution for OA of the first MTP, I wonder (in fact, I suspect) if we may have too many entrants in this space. At their Canaccord presentation, Hyalex estimated that the MTP space is a $40MM US market. This reminds me of TAR (total ankle replacement) – while we have a few strong market leaders, the entire TAM for the market is 20K procedures and today is ~10k procedures and yet has so many entrants (see an article I wrote on that topic in 2022 here). It is as yet unclear who will emerge the leader here.

Displaying jointly with AddUp – a leader in additive manufacturing technology, Anatomic Implants was advertising their FDA submission for the first 3D printed MTP joint replacement. BioPoly had clearance of its greater toe and lesser toe hemi-arthroplasty system for several years. Hyalex hopes to have their 510K by year end. Episurf, a company focused on custom metal resurfacing implants, filed its 510K application in Oct of 2023. Unlike Hyalex – it expects the MTP product to increase its company’s TAM by $400MM. So is it $40MM or $400MM – a good question for us to explore in the future 😉

The foot and ankle segment has undoubtedly been on fire and companies focused on innovation in the space have been rewarded with success as surgeons who, for years, felt neglected finally feel like someone is paying attention. Paragon28 has been one of the winners here. A smaller player we noticed on the floor with a dedicated extremities portfolio was BioPro. By no means new to the industry having been founded by a surgeon innovator in 1987, their MTP hemi-arthroplasty product (MPJ) has been on the market for many years and boasts >20 years survivorship data and a 95% average implant survivorship. Their broader portfolio includes various screws, guides, wires, and staples (include the cool looking clover compression staple for hand fractures). They also offered a novel Tendon Anchor System for sutureless soft-tissue reattachment to bone, aimed at reducing pullout. Improved soft-tissue to bone attachment is another trends in the industry.
 

What is New in Sports Med – More Biologics, Fewer Wires

Like BioPoly – Spain based ABANZA is also looking to reduce pull-out and improve soft-tissue to bone reattachment with their “Washercap” ACL fixation system, and RC fixation system, coming soon. Their technology is aimed at enhancing fixation in non-optimal bone quality. Meanwhile, Tetrous’ EnFix, designed to address enthesis failure, is looking to disrupt the rapidly growing rotator cuff augmentation market. Their biologic based TACs made of highly organized demineralized bone fibers, are intended to fix tendon to bone in RC repair, especially in larger tears. They hope that by absorbing blood and growth factors and bringing it directly to the biologic tissues at the site of the union, they will improve repair rates and obviate the need for the overlays and underlays (like S&N’s Regeneten, Conmed’s BioBrace, Zimmer’s Embody Tapestry, Atreon’s Rotium, and others). While cost and reimbursement are yet to be fully elucidated, the two technologies could also be complementary. Given the various use cases surgeons have developed and to date, the lack of standardization of protocols, we believe the penetration opportunity for augmentation is still sizeable – though will be easier accessed with either direct reimbursement or lower pricing.

Several products continue to pursue the holy grail of treating OA with biologics. We are still a ways a way from accomplishing this outright, but a few promising treatments are in the clinic to help delay surgery and offer effective alternatives to steroids and hyaluronic acid (both of which still represent over a billion dollar market).

Australia-based OrthoCell uses ACI (cell therapy) technology (similar to Vericel’s MACI) to develop an injectable product targeting upper extremity pathologies – Rotatory Cuff is pending a phase 2b in the US and in AUS they are in phase 3 for Lateral epicondyle, commonly known as tennis elbow.

Lipogems continues to pursue their IDE study to ultimately receive a PMA for their patented Microfragmented Fat (MFat) – Adipose tissue processing system to be able to market for the treatment of OA. Currently, the device and system are FDA cleared for use in orthopedics, but given lack of RCT data, are primarily a cash-pay procedure. The 12-month study will examine the safety and efficacy compared to corticosteroids, traditionally the first line interventional treatment. Lipogems is a device that will enable the administration of an autologous cell-based treatment.

Looking to disrupt the off-the-shelf injectable treatments is Bioventus-management-spin-out Doron Therapeutics, which presented at the Canaccord Genuity MSK meeting. Led by CEO (and former Bioventus Chief Science Officer) Alessandra Pavesio, the company hopes to develop and commercialize MOTYS, an allogeneic placental based injectable that is intended to delay progression of OA. Preliminary studies suggest a 9-12 month duration. The “magic” lies in the placental secretome which Pavesio mentioned has three separate factors – anti-inflammatory, anti-catabolic (prevents destruction of cartilage), pro-anabolic (helps build cartilage). The company is seeking to raise a series A to fund a Phase III study.

Meanwhile in the world of arthroscopy, many are likely familiar with startup darling, Lazurite, which has pioneered a wireless arthroscope to enhance surgeon maneuverability in the OR without sacrificing image quality. At the same time, the interest in office-based arthroscopy, or just improved efficiency, has invited innovation in disposable arthroscopes (Trice Medical, Pristine Surgical). Even with disposables being relatively new to market, feedback on utility is somewhat mixed. This year, however, we saw a new fusion product – Integrated Endoscopy’s NUVIS scope – a single use AND wireless 4K arthroscope. I will be eager to hear surgeon’s reactions. Are the wireless adopters eager for a sterile, single-use product in their ASCs? Or is this product better suited ex-US?  
 

Fingers, Clavicles, and Knee Pain – Oh My!

You can imagine that its hard to put a trend to every innovation that I fall in love with. Some come out of no-where to surprise me. How innovative can treatments for carpal tunnel syndrome be? But for us “office athletes” (as an orthopedist endearingly once called me, he wasn’t wrong), carpal tunnel can be a serious concern. Sonex, a company looking to update treatment options through ultrasound guidance says that there are 13 million diagnosed patients, and it’s the number one entrapment neuropathy.

Many patients who are otherwise eligible to be treated surgically, opt out today as open surgery is the gold standard – leaving a nasty long scar, endoscopic approached are hard. Sonex uses an inflated balloon to protect the nerve and artery and isolate the treatment site. The company received 510k clearance in 2019 and is waiting for a CPT code to help accelerate its commercialization.

Another new company that caught my eye was Anser Implants, with a new, minimally invasive, intramedullary pin for clavicle fixation. The product is a more refined solution than plating for midshaft fractures and prevents non-unions and other issues with more conservative treatment. I am really eager to hear from trauma surgeons about this product – its elegance impressed me.

Finally, we all know the post-op pain space is always a hot debate topic and Pacira’s Exparel continues strong prominence as it gains additional indications, especially for nerve block. But we have a gap after patients are discharged, for some patients it is a week, 10 days, for some 2 weeks or more. Several companies are using mixed modalities to approach this (see also Gate Science). Allay Therapeutics presented their preliminary, but exciting data, at Canaccord as well. Their patented, dissolvable, biopolymer, placed intra-operatively by the total joint surgeon, will deliver targeted pain relief (in this case bupivacaine) over the course of weeks. Their goal is to reduce, or maybe even eliminate the need for post-op opioids. Could they possibly replace the need for many intra-op pain products too? Their ensuing data may show that…
 

So What’s the Deal with AAOS?

If you have spoken with anyone in the industry, you have probably heard a grumble about this year’s meeting. Estimates were that surgeon attendance was between 20 and 33% of normal levels. So, is this the death of large society meetings? (Wait…deja vu, I have asked this before).

We all understand that certain timing and geographic decisions did not optimize for attendance – but beyond that, some argue that the proliferation of smaller society meetings have obviated the value FOR SURGEONS of attending the big ones. So, what is industry to do? Does it make sense to continue to invest? Complex question with no simple answer…

For one, there is tremendous value in the mixing of the minds, AND the specialties. Only a handful of very special meetings (you all know my love for OSET) foster this comradery. But if AAOS is not able to maintain the attention of its members, not only will the whole industry suffer – patients will too! We learn and push the envelope from collaboration – not just competition. Take spino-pelvic health, ortho-oncology, disasterplasties, the “bridging to OA” metal products…all of these are areas where cross-pollination between specialties will breed innovation.

On that note…hope to see you next year!

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Masha Dumanis is a Vice President at Health Advances with over 12 years of experience in healthcare consulting supporting clients developing commercial strategies with expertise in market assessment, competitive landscape, due diligence, and product and corporate strategy. Masha is the co-leader of the Health Advances MSK Practice and a member of the Digital Health and Health IT, and MedTech Practice leadership teams. Masha also serves as Senior Advisor to the Journal of Orthopaedic Experience and Innovation and is a member of the Education Planning Committee for Ortho Summit 2024.