As earnings season is upon us, we’re receiving a clearer view of what new medtech could be launching this year in the medical device space.
Companies still feel hamstrung by macroeconomic pressures, supply chain issues and more. However, many pointed out that 2023 has plenty to look forward to. Several quarterly reports and earnings calls included positive outlooks for the year ahead, with plenty of companies banking on significant revenue growth and other successes.
For many, that comes down to some new medtech product launches. Here are a few picked out from earnings calls and other announcements that you might want to look out for:
Abbott
On Abbott’s earnings call last month, CEO Robert Ford pointed to product launches as a major part of its outlook for 2023.
Abbott said it expects to log adjusted EPS of between $4.30 and $4.50. Excluding COVID-19-related sales, the company expects high-single-digit revenue growth.
“The number one part of our guidance is obviously making sure that we feel that our top line is taking advantage of all the good parts, all the good product launches, etc. that we have,” Ford explained. “From that perspective, I think a lot of what we’re doing kind of supports that ongoing high single-digit growth rate.”
Ford picked out a number of examples of new medtech he expects to roll out in 2023. That includes the FreeStyle Libre 3, Amplatzer Amulet, Aveir, Navitor, CardioMems and Eterna. Eterna, a spinal cord stimulation system, received FDA approval in December 2022. Navitor, a transcatheter aortic valve implantation (TAVI) system, picked up approval last month.
Additionally, Ford said Abbott has a new mapping system and ablation catheter ready to launch.
The device portfolio is well set up to be able to drive those high-single-digit, low-double-digit growth rates,” Ford said.
Axonics
Axonics won’t report its most recent quarterly results until March, but it knew it had big things on the horizon for 2023.
In reporting preliminary results on Jan. 11, Axonics mentioned it looked forward to a major regulatory nod. A few weeks later, it announced FDA approval for its fourth-generation R20 rechargeable sacral neuromodulation system. The system provides therapy for patients suffering from overactive bladder or fecal incontinence.
Axonics said it expects to commercially launch the R20 neurostimulation system in the U.S. in March. The company may offer more information on the rollout when it reports its financial results.
BD
CEO Tom Polen said on BD’s earnings call that future growth drivers include “key products recently launched” and other new medtech in the pipeline “that we’re excited about.”
Recent launches mentioned by Polen include the PosiFlush SafeScrub refilled flush syringe. He said the company’s Medical segment aims to improve medication delivery across a range of settings in the year ahead.
Another product BD recently had cleared is the new PowerMe midline catheter. That received clearance by the Chinese regulatory agency, so the company looks forward to the launch later this quarter in that geography.
The company also plans to expand sales outside the U.S. for its BD Max respiratory viral panel. That system detects COVID-19, flu A and B and RSV in a single test. Just this week, BD announced an FDA emergency use authorization for the combo test.
Finally, Polen said the company plans to submit its FDA 510(k) application for the BD MiniDraw capillary blood collection system by the second half of 2023. Depending on the timing there, we could see a launch by the end of the year, although 2024 could be more likely given recent FDA turnaround times.
Boston Scientific
Boston Scientific lands among the companies that recently put out relatively positive earnings reports. Despite missing Wall Street projections, the company strengthened its bottom line and excited investors with its guidance for 2023.
One reason for optimism came just days after the company announced its fourth-quarter results. On Feb. 3, Boston Scientific received FDA clearance for its LithoVue Elite single-use ureteroscope system. The company plans a limited U.S. launch for the digital, flexible ureteroscope system in the coming weeks. It didn’t provide launch information beyond that, but a full-market launch is something to look out for this year.
When it comes to other new medtech, the company recently won Japanese approval for its Agent drug-coated balloon for treating in-stent restenosis and coronary small vessel disease. It anticipates a launch in that geography in the first half of 2023.
On the company’s earnings call, CEO Mike Mahoney mentioned that the company’s footprint could grow in China this year thanks to the company’s December acquisition of Acotec. Perhaps launches are on the horizon there. Acotec is a Chinese medical technology company that offers solutions for a range of interventional procedures, including drug-coated balloons (DCBs) for treating vascular diseases.
“We continue to expand our presence in the China market with the recently announced acquisition of a majority stake in Acotec,” Mahoney said.
Edwards Lifesciences
When it reported positive fourth-quarter results, Edwards Lifesciences attributed some of the success to the U.S. launch of its Resilia transcatheter heart valve technologies. Future financial results could receive a boost from that technology in other geographies, too.
The company reported slower growth in Japan in the quarter, but expects that to diminish, thanks in part to a major launch there. On the company’s earnings call, CEO Mike Mussallem said the company looks forward to launching the Sapien 3 Ultra Resilia “later this year.”
On domestic soil, Edwards recently launched the Pascal Precision transcatheter valve repair system. Mussallem said it received positive feedback from clinicians, and its European launch for the system “is ongoing.” Look out for the Pascal Precision system overseas as that goes on.
Intuitive Surgical
The leader in the surgical robotics space generated buzz with its earnings call, but for the wrong reasons. A quick comment from CEO Gary Guthart spooked investors and sent Intuitive Surgical’s stock spiraling. He said the company does not expect to launch its highly anticipated multiport surgical robotics system in 2023.
“As we start this year, we do not currently expect a new multiport system launch in 2023,” Guthart said.
Despite that disappointment, Intuitive still has a relatively intriguing launch set for this year. Guthart said the company routinely updates its platform operating systems and recently launched its next-generation Endoscope Plus visualization platform. Further upgrades are expected in 2023.
“We expect to launch additional [next-generation]-compatible products and operating system software this year,” Guthart said. “Concurrently, we invest in new generations of our multiport platform that bring new and significantly enhanced capabilities.”
Zimmer Biomet
A strong earnings report came from the fourth quarter for Zimmer Biomet, and an even stronger projection for the coming years followed.
CEO Bryan Hanson said the orthopedic device maker expects to launch “another 40-plus products between now and the end of 2025.” He added that the majority of the new medtech falls in markets producing at least 4% growth for the company.
That includes the company’s cementless knee form factor, adding to its Persona family. The 3D-printed Persona OsseoTi keel tibia received FDA clearance in November, and Hanson said the company has received positive feedback. Zimmer Biomet earmarked mid-2023 for a full launch.
“We continue to believe that our cementless knee penetration will grow significantly and that this differentiated, premium product can really accelerate that growth,” he said. “It’s early days with a full launch planned for the middle of the year, but make no mistake, this is a real growth driver for our knee franchise.”
He went on to say that the company has produced more than 50 new product launches from 2018 to 2022. Perhaps almost matching that from 2023 to 2025 is lofty, but Hanson and Zimmer Biomet seem confident.