The annual American Heart Association's Scientific Sessions saw some significant findings, with the results of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial standing out in particular. Of note, investigators found no evidence that invasive procedures – such as stent implants or bypass surgery – in individuals with severe but stable heart disease had lower rates of major, disease-related events vs. those treated with medications and lifestyle changes alone, also known as optimal medical therapy (OMT).
Axonics Modulation Technologies Inc., of Irvine, Calif., reported revenue of $1.3 million for the third quarter of 2019, up from $0.2 million in the same period last year, but below Wall Street's forecast of $1.4 million. CEO Raymond Cohen attributed the miss to a seasonal slowdown in implants of Axonics' rechargeable sacral neuromodulation (r-SNM) system in international markets, as well as some U.S. physicians who were waiting for the device to win urinary approval. That milestone came Thursday when the U.S. FDA approved Axonics' r-SNM for the treatment of overactive bladder (OAB) and urinary retention. The indication for urinary retention represents the largest segment of the market for SNM devices and comes just two months after FDA approved the r-SNM to help patients with fecal incontinence. (See BioWorld MedTech, Sept. 10, 2019.)
Senseonics Inc., of Germantown, Md., reported gloomy results for its 2019 third quarter, with revenue of $4.3 million, down 17% from the same period last year. The tally also fell far short of the consensus on Wall Street, which estimated third-quarter revenue of $6.07 million.
SAN JOSE, Costa Rica – Cross reality (XR) technology is gaining traction in the med-tech sector thanks to advancements in the virtual reality (VR), augmented reality (AR) and mixed reality (MR) fields that comprise it, triggered by a surge of investments that have driven cash flow to med-tech startups. The new technology is already impacting the health care sector.
SAN JOSE, Costa Rica – The tiny Latin American country that has become the region's second largest med-tech exporter behind Mexico is betting on disruptive technologies and trends to stay at the technological forefront. Costa Rica's med-tech exports have become one of the nation's most important sources of income and employment, and the country is focused on expanding the sector.
Warsaw, Ind.-based Zimmer Biomet Holdings Inc. is moving ahead of schedule in terms of its turnaround as it reported revenue of $1.892 billion for the third quarter. That figure represents an increase of 3% over the same period last year, impressing analysts.
San Diego-based Tandem Diabetes Care Inc. reported financial results for the third quarter of 2019, with worldwide pump shipments soaring 112% to 17,839 pumps from 8,434 pumps in the same period a year ago. Revenue rose 105% to $94.7 million, up from $46.3 million in the third quarter of 2018.
Madison, Wis.-based Exact Sciences Corp., which provided an update on promising research in a collaboration with the Mayo Clinic, saw a jump in revenue during its third quarter, with 12,000 providers ordering their initial Cologuard test during the period. The company posted impressive numbers, with revenue increasing 85% to $219 million on Cologuard volume growth. The revenue came in $3 million above consensus, and the operational update was as expected, noted Sean Lavin, BTIG analyst. Even though management was upbeat, "with investor sentiment fairly weak, an in-line result was simply not good enough, and we guessed that a $5 [million]-$10 [million] beat was probably needed to nudge shares," Lavin added.
It was a standout quarter for San Diego-based Resmed Inc., which saw revenues jump to $681.1 million, with the U.S., Canada and Latin America serving as bright spots. "We have started fiscal year 2020 right where we left off with 2019," Michael Farrell, Resmed's CEO, said during a call on the results. "Our team achieved another quarter of the balanced growth across the portfolio, driven by continued strong performance in the mask category."
Edwards Lifesciences Corp. has been unstoppable so far this year, driven by the rapidly expanding adoption of transcatheter heart valve therapy. It beat expectations in its third-quarter earnings report, drawing praise and even higher expectations from Wall Street analysts. The Irvine, Calif.-based company recently received an expanded FDA indication for its Sapien 3 and Sapien 3 Ultra TAVR systems to treat surgical low-risk patients with severe aortic stenosis. (See BioWorld MedTech, Aug. 19, 2019.)
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