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MedTech 100 roundup: Markets skid after strong stretch

Following a strong performance over the last couple of weeks, the medtech market experienced one of its most significant drop-offs in recent months amid investor worries over a rise in COVID-19 cases in some states.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.12 points at the end of last week (June 12). That total represents a -6% decrease from the 87.37-point total at the same time a week prior (June 5), highlighting a significant drop from one of the strongest stretches the medtech market had seen since the COVID-19 pandemic hit.

Meanwhile, the S&P 500 Index experienced a -4.8% decrease from June 5 to June 12, and the Dow Jones Index fared even worse with a -5.6% increase over the same period of time. The drop-off is stark compared to this time a week ago, when both indexes saw sizeable growth — rising 3.14% and 6.81%, respectively.

The earlier market surge came on the back of t…

Abbott declares 386th consecutive quarterly dividend

Abbott (NYSE:ABT) announced today that it has declared a quarterly common dividend of 36¢ per share.

The Abbott Park, Ill.-based company said in a news release that the declaration marks the 386th consecutive quarterly dividend paid by the company since 1924. The dividend is payable on Aug. 17, 2020, to shareholders of record at the close of business on July 15, 2020.

Abbott said it has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, tracking companies that have increased dividends every year for at least 25 consecutive years.

Shares of ABT were up 0.8% at $88.44 per share in mid-afternoon trading today.

Surmodics wins CE Mark for drug-coated balloon

Surmodics (NSDQ:SRDX) announced today that it received CE Mark approval in Europe for its SurVeil drug-coated balloon (DCB).

SurVeil is a next-generation DCB designed for treating peripheral artery disease (PAD) with a proprietary drug-excipient formulation for a durable balloon coating. Pre-clinical data shows a more evenly distributed and durable drug effect and lower incidence of downstream drug particles compared to control DCBs, according to a news release.

In February 2018, Abbott (NYSE:ABT) paid $25 million up front for the global commercialization rights to the SurVeil device. The deal put another $67 million in milestones on the table, the first of which was triggered when Surmodics closed enrollment for its Transcend pivotal trial in August 2019.

Obtaining CE Mark approval clinches another milestone payment in the agreement, as Surmodics is now set to receive $10.8 million. The company said it will recognize approximately $6.5 million as revenu…

MedTech 100 roundup: Stocks stand pat in June’s first week

While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease from the 87.17-point total at the same time a week prior (May 29), which represented the industry’s highest point since before the COVID-19 pandemic took hold of the markets.

Meanwhile, the S&P 500 Index experienced a 3.14% increase from May 29 to June 5 and the Dow Jones Index fared even better with a 6.81% increase over the same period of time. The market surge came on the back of the White House announcement that 2.5 million jobs were added in May and unemployment rose to 13.3% when a surge to nearly 20% was expected, according to Yahoo Finance.

The lowest point for medtech during the COVID-19 pand…

Abbott shares take hit after Goldman Sachs lowers rating

Abbott (NYSE:ABT) shares took a hit this week after Goldman Sachs reduced its rating on the stock to sell, from neutral.

The dip also comes on the back of an urgent field safety notice warning on issues with the TactiCath quartz contact force ablation catheter.

According to The Street, Goldman Sachs advised investors on June 1 to sell Abbott stock, claiming it “lost its early lead in coronavirus tests to competitors.” The report also mentioned that while the company has delivered on heightened expectations for testing, there had been concern over testing accuracy.

The safety notice, dated on May 28 and issued in Germany, warns of complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial fibrillation (AF) recurrence or need for the procedure to be repeated.

On May 29, a day after the notice was issued, Abbott shares were trading at $9…

Abbott issues urgent field safety notice over ablation catheter

Abbott (NYSE:ABT) has issued an urgent field safety notice to notify users of complaints about the TactiCath quartz contact force ablation catheter.

The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial fibrillation (AF) recurrence or need for the procedure to be repeated.

Other risks include those associated with the insertion of a replacement catheter or catheter exchanges, the potential for cardiac perforation and associated harms and clinically significant or minor delays in the procedure.

Abbott said in the notice that, over a 26-month period, more than 3,600 of 84,104 (4.3%) catheters distributed had loss of contact force information reported.

In total, there were 2,985 cases in which a single catheter was exchanged due to the issue and 381 cases in which three, four or five catheters w…

Bigfoot Biomedical raises $55m in Series C

Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series C financing round.

Abbott (NYSE:ABT) led the funding round with participation from new investor Smile Group and existing investors Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management.

Get the full story at our sister site, MassDevice.

Bigfoot Biomedical raises $55m in Series C

Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series C financing round.

Abbott (NYSE:ABT) led the funding round with participation from new investor Smile Group and existing investors Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management.

Milpitas, Calif.-based Bigfoot said in a news release that the proceeds will support product development and the regulatory pathway for its Bigfoot Unity system as a part of the Bigfoot Unity Diabetes Management Program.

The program is a real-time, dose-decision support system for people with insulin-requiring diabetes that rely on multiple daily injection therapy, which is the most common therapy for people with Type 1 and Type 2 diabetes. The Unity system features smart pen caps for basal and meal-time insulin dosing recommendations through integration with Abbott’s FreeStyle Libre system.

Plans for Bigfoot U…

FDA adds reference panel to study COVID-19 diagnostics

The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19.

Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency.

Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA), and the FDA said its new reference panel provides developers access to this material.

The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Jeffrey Shuren, director of the FDA’s Center for Devi…

15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

Get the full story on our sister site, Medical Design & Outsourcing.

Abbott: ID NOW COVID-19 results more accurate with earlier testing

Abbott’s ID Now test machine (Image from Abbott)

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms.

The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization (EUA) on March 27 and said it is now investigating whether false-negative results could be due to the types of swabs used or the type of viral transport media.

Abbott began advising customers in mid-April that ID NOW is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples.

Today, the company announced an interim analysis of an ongoing clinical study at five urgent care clinics in New Jerse…

Abbott to supply millions of its COVID-19 antibody tests to U.K. government

Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today.

The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has granted interim authorization for the IgG serology test, which last month received an FDA emergency use authorization in the U.S. and CE Mark in the EU.

The IgG test runs on Abbott’s Architect i1000SR and i2000SR and Alinity i laboratory instruments. Widely used in laboratories around the world, the Architect system is able to run 100–200 tests per hour.

“Abbott is proud to support the NHS’ COVID-19 antibody testing strategy announced today, with agreement to supply antibody tests to NHS laboratories across the U.K.,” said Mike Clayton, Abbott’s managing director of Northern …