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JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical

JPM 2021: Boston Scientific, Abbott, Dexcom, Insulet, Silk Road Medical

Source : Medtech Insight

Boston Scientific Corporation CEO Mike Mahoney highlighted the commercial success of Boston Scientific’s Watchman left-atrial appendage closure devices during his presentation at the J.P. Morgan Healthcare conference on 12 January.

According to a preliminary report on the company’s fourth-quarter earnings, sales of Watchman devices – including the next-generation Watchman FLX launched in mid-2020 – were down 56% year-over-year during the quarter.

However, most of that apparent revenue decline was caused by the company’s change to a consignment inventory model for marketing Watchman FLX. Accounting for that shift, Watchman sales were up 18% and surpassed 150,000 cumulative implants worldwide, Mahoney said.

“Watchman really had a nice fourth quarter despite the impact of the pandemic,” he said. “The Watchman FLX consignment-conversion program was executed very well in the second half and is now essentially completed.”

Watchman and Watchman FLX are designed to prevent strokes in patients with atrial fibrillation. The company continues to “drive market development and patient outreach in this highly underpenetrated patient population,” Mahoney said.

It is also sponsoring trials to expand the indication for left-atrial appendage closure, including the OPTION trial, which is comparing Watchman FLX to oral anticoagulants in patients undergoing a cardiac ablation procedure, and CHAMPION AF, a 2,000-patient trial comparing Watchman FLX to non-vitamin K antagonist oral anticoagulant drugs in a broad anticoagulant-eligible patient population. ()

Mahoney called Watchman FLX “the cornerstone of our structural heart franchise.”

It will be the most important product for that business for at least the next three years now that the company has decided to discontinue the Lotus Edge transcatheter aortic valve replacement (TAVR) system and focus more resources on developing the Acurate neo2 TAVR system with the Sentinel cerebral embolic protection device.

Mahoney said the launch of Acurate neo2 in Europe, which began in September 2020, has been successful, but the company does not expect the US Food and Drug Administration to approve it until 2024. ()

The pandemic has forced many hospitals to postpone surgeries and interventional procedures, causing a dramatic slowdown in sales across the medical device industry, first in the spring and then again at the end of the year. Mahoney said that sales were up year-over-year in October before leveling off in November and declining in December as the pandemic intensified in Europe and the US. ()

Boston Scientific remains confident that it will return to growth in 2021.

“While 2020 was clearly a tough year, our procedural acuity, site of service and new product launches will aid our recovery,” Mahoney said. “Post-COVID impact, we continue to strive for above-market revenue growth and remain committed to driving operating margin expansion and double-digit earnings per share.”

Boston Scientific expects to record $2.71bn in revenue for the fourth quarter, representing an 8% year-over-year decline on an organic basis. For all of 2020, Boston Scientific’s net sales were $9.91bn, down 11.3% year-over-year on an organic basis.

The company will provide its full fourth-quarter report on 3 February.

Abbott ’s CEO Robert Ford told the audience at the J.P. Morgan Healthcare conference that, despite all the challenges during the pandemic, Abbott has proven to be “incredibly resilient.” He attributed the company’s success to its diversified business model, culture and people and successful adoption of remote care and digital health solutions.

COVID-19 helped augment the launch of the company’s Alinity diagnostic platform, Ford said during the Q&A fireside today. The launch was originally planned for the second quarter in 2020, but was accelerated by the pandemic. The company announced in May the FDA issued emergency use authorization for its molecular test for COVID-19 for use on its Alinity molecular laboratory instrument. He noted that the placement rate for the diagnostic platform was four times higher than planned.

Abbott announced today that it fulfilled the federal government’s order of 150 million BinaxNOW COVID-19 Ag tests. The company said after fulfilling this order, it will make “tens of millions” of the BinaxNOW rapid COVID19 test available per month for direct purchase by schools, workplaces and pharmacies. The test is sold to qualified organizations for $5 per test with the at-home test going for $25 a test. Results are available in 15 minutes. ()

He noted that the company is investing in all rapid assays for COVID-19, but also into different assays.

He pointed to the company’s 11 January announcement that the FDA gave 510(k) clearance for the first rapid handheld traumatic brain injury blood test. The test aims to help clinicians assess whether a person has sustained a concussion with results being available in 15 minutes and is run on Abbott’s handheld i-STAT-Alinity platform.

Ford said the test offers Abbott a great opportunity globally, but especially in the US, pointing to the large number of high schools, colleges and sports leagues that can benefit from having a rapid blood concussion test before sending people to a hospital for a confirmatory CT scan, which is “pretty costly.”

On the device side, there has also been a lot of activity and the company has done very well recently, he said.

In diabetes care, Ford said that after coming of a strong year through the third quarter for its FreeStyle Libre continuous glucose monitoring system, Abbott will continue to explore opportunities to extend the Libre Biosensor platform beyond diabetes. ()

“We’ve got additional iterations and different analytes we’re looking at to build that platform out,” he said.

In cardiology, Ford said the company will have a readout “fairly shortly” on its CardioMEMS trial to support reimbursement by the US Centers for Disease Control and Prevention for remote monitoring of heart failure. “I think this is a significantly large opportunity,” he said. ()

“If you [assume] a 10-15% penetration rate on that patient population, you’re looking at a $1bn to $1.5bn market opportunity for us,” he said.

Looking forward, Ford said that the strength of the COVID business has given the company a lot of opportunities to further invest in their businesses and pipelines but will also look at M&A opportunities provided it is a “good fit strategically” and aligns with the company’s growth strategy.

“I think we came into 2020 strong … and I think we exited even stronger as we go into 2021.”

The company will report fourth quarter results on 27 January.

DexCom, Inc.’s CEO Kevin Sayer kicked off his presentation with a high note on financials. He said the company had a very strong year of growth in 2020 with total revenue up 30% over the prior year with $19.25bn. For 2021, he projected 15-20% growth coming from all segments of the business, the US commercial and Medicare, Medicaid segments and US direct counter distributor channels.

Looking ahead, Sayer said the company has made great progress on the studies evaluating the company’s new G7 continuous glucose monitoring system, which will be 60% smaller than the current G6 CGM, offer better connectivity and interoperability and significantly reduces the cost of the manufacturing process, Sayer told Medtech Insight last month. ()

“We’ve got some good data back,” Sayer said. He noted that the company will provide more data when appropriate, but he remains excited about its launch in multiple geographies in 2021.

Insulet Corporation is preparing to launch its Omnipod 5 automatic insulin delivery system, compatible with DexCom’s G6 CGM, in the first half of 2021. ()

Omnipod 5, previously branded as Omnipod Horizon, is the first tubeless, entirely wearable automated insulin delivery system and delivers several unique customer-friendly features, Insulet CEO Shacey Petrovic said during her presentation at J.P. Morgan.

According to Insulet, Omnipod 5 will be the first automated insulin delivery system that can be fully controlled from a user’s mobile device without a separate controller device.

“This is the number one requested feature by our users,” she said. Initially, it will be compatible with Android devices and the company is working to make it compatible with Apple iOS devices.

Because the algorithm that runs the system is stored on the pod, the user will never have to disconnect from the device. It will also be the first insulin delivery system to allow customization of user’s glucose targets and it also automatically tracks trends in continuous glucose.

“Typically, users have to do a lot of math on their own to account for that and we do that for them,” she explained.

Omnipod 5 also features the HypoProtect software that protects against hypoglycemia, “which is the number one cause of diabetes distress” and a major driver of diabetes-related hospitalizations.

In a pre-pivotal trial, Omnipod 5 users remained in the optimum blood glucose range (time-in-range) 73% of the time, representing a 15-point improvement over baseline. There were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA) or other serious adverse events.

“Fifteen points is remarkable and certainly clinically significant with virtually no hypoglycemia and no cases of severe hypoglycemia or diabetic ketoacidosis,” Petrovic said.

Results from the pivotal trial of Omnipod 5 will be presented at the Endocrine Society’s conference in March.

Omnipod 5 will initially be indicated for patients with type 1 diabetes, but the company is planning a trial to support an indication for type 2 patients.

Silk Road Medical Inc is continuing to drive demand for its Enroute transcarotid artery revascularization (TCAR) system during the pandemic by adapting its physician training programs to the restrictions on large gatherings.

The company’s TCAR Education and Simulation Training (TEST Drive) program “continues to be a part of our important growth story,” CEO Erica Rogers said during her presentation at the conference. “We absolutely can, and we do, move physicians up the adoption curve overtime.”

When the pandemic began, the company “pivoted” its training model to accommodate the new restrictions. While the company used to host large numbers of physicians at its training facility near Chicago, now it is running courses over Zoom supplemented by small group or one-on-one in-person training.

Since the second quarter of 2020, “training has been kind of advancing at a more normal pace since then and the demand for training remains strong,” Rogers said. “This is a testament to our team's persistence, our commitment to innovation in order to bring TCAR to as many patients as possible.”

Silk Road was founded in 2007 and went public in 2019. Since 2015, it has marketed the Enroute system, which includes the Enroute carotid stent and Enroute neuroprotection system. ()

So far, about 1,800 US physicians in the US have been trained to use Enroute and TCAR procedure volume has multiplied six-fold in the past four years. Despite the pandemic, in the third quarter of 2020 the company reported revenue of $20.1m, representing an 18% year-over-year increase.

Although the company is growing rapidly, TCAR has still only penetrated about 6% of the potential US opportunity because the company has had to build the TCAR market from nothing.

“Just a few years ago, there was no such thing as TCAR, there was no acronym TCAR, there was no procedure [called] TCAR, and this company carefully and methodically has built this market,” she said. “We have established an entirely new category. And in so doing, we have ushered in an entirely new era of transcarotid therapies.”

Silk Road is currently focused primarily on the US market, which represents a $2.8bn market opportunity, she said. About $1.1bn of that opportunity comes from patients choosing TCAR over invasive carotid surgery.

Recently published results from the ROADSTER 2 post-approval trial and the TCAR Surveillance Project study validate the clinical effectiveness, safety and cost-effectiveness of TCAR in patients with carotid artery disease.

“We are competing, and we are winning, against invasive surgery,” Rogers said. “With every publication, we see mounting evidence that TCAR will inevitably become the standard of care in our view in treating carotid artery disease.”

Beyond the group of patients currently indicated for carotid surgery, Silk Road expects many patients with carotid disease currently being treated with medical therapy would have better outcomes with TCAR.

“We believe that we can compete, and we can win, against medical therapy alone by continuing to prove that we can reduce the upfront morbidity and mortality associated with [carotid disease] with TCAR.”

The company is currently working “methodically” on gaining market access and reimbursement for TCAR in Japan and China but is still “some years away” from significant international revenue, Rogers said. Rogers said that the overall carotid artery disease market for TCAR represents a $5bn global market opportunity and there are currently no TCAR competitors.

By Marion Webb, Reed Miller