Rewalk Robotics sees impact of COVID-19 in first-quarter results
Like many companies, Rewalk Robotics Ltd. saw its financials hit by the COVID-19 pandemic. It revealed May 28 that its total revenue for its first quarter fell to $0.8 million, down from $1.6 million during the same period last year. The company, which focuses on solutions that give gait training and mobility for individuals with lower limb disabilities, acknowledged the effects of the pandemic, noting that several Rewalk Personal 6.0 devices were not delivered as a result.

Rewalk Robotics sees impact of COVID-19 in first-quarter results
Like many companies, Rewalk Robotics Ltd. saw its financials hit by the COVID-19 pandemic. It revealed May 28 that its total revenue for its first quarter fell to $0.8 million, down from $1.6 million during the same period last year. The company, which focuses on solutions that give gait training and mobility for individuals with lower limb disabilities, acknowledged the effects of the pandemic, noting that several Rewalk Personal 6.0 devices were not delivered as a result.
Neural Analytics aims robotic transcranial doppler at COVID-19 patients
Doctors are reporting a proliferation of dangerous blood clots in the lungs and other major organs of COVID-19 patients, raising the risk of stroke and other life-threatening complications. While anticoagulant medications can reduce that risk, patients need careful monitoring to ensure their blood is neither too thick nor too thin. To that end, Los Angeles-based startup Neural Analytics Inc. is deploying its robotically assisted transcranial doppler (TCD) system for real-time identification of blood clots and disruptions in blood flow to the brain.
Presumption in favor of petitioner seen as most critical piece of PTO response to SAS v. Iancu
The U.S. Patent and Trademark Office (PTO) has posted a notice of proposed rulemaking in response to a case decided by the Supreme Court in 2018, SAS v. Iancu, and the first item on the PTO agenda is to formally require that an inter partes review (IPR) consist of an exhaustive review of all the claims contested by the petitioner.
Today's news in brief
BioWorld MedTech's briefs for May 28.
Izotropic, Starfish set to commercialize new breast CT system
TORONTO – Vancouver, British Columbia-based Izotropic Corp. has inked a deal with Victoria, British Columbia-based based Starfish Medical Inc. to commercialize a CT scanner Izotropic CEO Robert Thast said will be a major disruptor of the breast imaging industry. Izotropic has spent approximately $20 million over the past 15 years to develop the system and is counting on Starfish to help translate this into a market-ready 3D breast CT imager by the end of 2020.
Centrifugation can be child’s play with fidget spinners
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually. Generating centrifugal force with a fidget spinner takes neither electricity nor trained staff. And that has suggested to several researchers that such spinners, under the right circumstances, could be used for centrifugation under circumstances where reliably operating a centrifuge, for whatever reason, is a challenge.
BioWorld MedTech’s Diagnostics Extra for May 28, 2020
Keeping you up to date on recent developments in diagnostics, including: Double-contrast probe detects tiny tumors on MRI, Identifying risk of ischemic stroke, T cell aging induces broader senescence, ALK is a candidate thinness gene.

Digital health

Regulatory front for May 28, 2020
Regulatory
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Clew Medical, Medtronic.
In Pakistan, digital platform offers a baseline to fight COVID-19
Telehealth
KARACHI, Pakistan – Beyond stepping up manufacturing of the medical devices it needs to fight COVID-19, Pakistan is using technology platforms to reach out to a large diaspora for help. The country is taking steps to leverage limited resources through a more comprehensive system of telehealth...
Kahala Biosciences, Rymedi bring blockchain to COVID-19 antibody testing
Diagnostics
Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona...
Philips debuts wearable vitals sign patch to monitor COVID-19 patients for early intervention
Sensors
Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor...

Financings

Transmedics initiates offering following successful trial showing reduction in liver transplant complications
Clinical
Transmedics Group Inc. reported a proposed public offering of $60 million of its shares of common stock (NASDAQ:TMDX). The Andover, Mass.-based company expects to grant underwriters a 30-day purchase option for additional shares of its common stock up to 15% of the number of shares sold in the offering. J.P. Morgan and Morgan Stanley are jointly managing the proposed offering with Canaccord Genuity acting as lead manager.

Newco news

Israel’s Bat-Call makes a good call with auscultation for COVID-19 approach
Diagnostics
HONG KONG – Whether bats are the source of COVID-19 is a debatable point; however, using sound to navigate like them could prove key for diagnostics and disease monitoring. Bat-Call Ltd. is using its auscultation technology in the battle against the pandemic. It said its patented artificial...

Ventilator mounting system in front line war against COVID-19
Canada
TORONTO – That old military saw “an army marches on its stomach” might just as easily apply to transport of much needed ventilators for patients suffering from the coronavirus. Mounting systems for ground and air ambulances like the Bracket Pro Serie for Ventilators launched March 5 by Quebec...
Astrotech enters COVID-19 fight with screening instrument for lung diseases
Diagnostics
Astrotech Corp., of Austin, Texas, has a broad range, having developed mass spectrometers in agriculture and manufacturing and selling chemical analyzers for use in the airport security and other applications. Now, it is looking to help in the fight against COVID-19.

Deals and M&A

Roche snaps up sequencing startup Stratos Genomics
Cancer
Pharma and diagnostics giant Roche Holding AG, of Basel, Switzerland, has acquired Seattle-based Stratos Genomics Inc., an early-stage sequencing technology company, in a move aimed at advancing development of Roche’s nanopore sequencer. Financial terms of the deal, which was first reported on Friday, were not disclosed.
Mologic collaborating with Biosure to develop COVID-19 antibody self-test
Diagnostics
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.
Roche, Samsung partner to develop digital therapeutic for autism spectrum disorder
Collaboration
Digital therapeutics have had a tough time gaining traction in the last few years. They’ve been hampered by sometimes reluctant payers, providers and regulators who lack familiarity with the approach, which typically employs an app or other technology to treat a patient by supporting behavioral adjustments.
Abiomed up on solid earnings as it buys ECMO startup for heart pump combo, COVID-19 use
Cardiovascular
The restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines.
Cooperative research effort taking aim at genetics affecting COVID-19 infection
Research
LONDON – Leading genome sequencing groups are launching the first meta-analysis in the hunt for genetic factors that explain why some people have worse COVID-19 symptoms than others, after agreeing to share patient sequence data from around the world. The COVID-19 Host Genetics Initiative (CHGI), set up by scientists at the Institute for Molecular Medicine Finland (FIMM), now includes 151 registered studies that are searching for genetic variation associated with severity and outcomes.

Europe

Fineheart successfully completes study of its implantable device for treating severe heart failure
Cardiovascular
PARIS – Fineheart SA, of Bordeaux, France, reported the success of a seven-day preclinical study to evaluate its Implantable Cardiac Output Management System (ICOMS), the first fully Intra-Ventricular Flow Accelerator synchronized to the native heartbeat to restore natural heart pumping capacity.

Asia-Pacific

Peijia raises $302M on HKEX to advance TAVR product, shares up 70% on debut
Cardiovascular
BEIJING – Suzhou, China-based Peijia Medical Co. Ltd. became the second prerevenue med-tech company to go public on the Hong Kong Stock Exchange (HKEX) after Venus Medtech (Hangzhou) Inc., pocketing HK$2.3 billion (US$302 million) with an aim to develop and commercialize its transcatheter valve...

Japan approves first antigen test kit for COVID-19, made by Fujirebio
Diagnostics
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) has given the green light to Tokyo-based Fujirebio Inc.’s antigen test kit. Fumihito Takanashi, a spokesperson from the medical device evaluation division of the MHLW, told BioWorld that the approval came into effect May 14.
Australian researchers develop AI algorithm that uses 3D scans to predict sleep apnea
Clinical
ERTH, Australia – A recent study conducted at the University of Western Australia (UWA) Centre for Sleep Science shows that facial features analyzed from 3D photographs could predict the likelihood of having obstructive sleep apnea.

Clinical

Germline ApoE variants affect melanoma trajectory
Science
Variants in the APOE gene are the strongest genetic risk factor for developing Alzheimer’s disease (AD). Now, researchers at Rockefeller University have demonstrated that APOE variants also affected the risk of progression and metastasis as well as the response to immunotherapy, in melanoma.
Plan with the golden arm deals Navidea phase II imaging win in RA
Immune
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
Israel’s Ben-Gurion University develops one-minute coronavirus test
Diagnostics
HONG KONG – A researcher at Israel’s Ben-Gurion University of the Negev (BGU) has developed a test that identifies those carrying the COVID-19 virus in less than a minute. And it is both affordable and works with greater than 90% accuracy to boot.
FDA greenlights Balt’s STEM trial for subdural hematoma
Neurology/Psychiatric
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct.
Refrigerator cabinets turned into medical devices to fight COVID-19
Latin America
BOGOTA – Mexican home appliances manufacturer Mabe Sa De Cv, from Mexico City, became a new member of the med-tech sector after taking the leap forward and joining the scores of companies around the world shifting their traditional manufacturing lines to develop med-tech products to fight COVID-19.
Quanterix says COVID-19 antibody test with Simoa platform has 1,000x greater sensitivity than current tests
Diagnostics
Quanterix Corp., of Billerica, Mass., reported that researchers have developed a COVID-19 antibody test with 1,000 times the sensitivity of current tests using its Simoa bead-based immunoassay platform.

BioWorld MedTech Perspectives

The demise of the device tax and other fun med-tech stories
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a...
Missed Opportunity: The epidemic of poor sleep
BioWorld MedTech
There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of...
Next up for TAVR; bicuspid valve
BioWorld MedTech
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...
Cabanas and commissioners; med tech in the news
BioWorld MedTech
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two...
FDA’s new man of regulatory mystery
BioWorld MedTech
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American...
Scott Gottlieb and the FDA’s revolving door problem
BioWorld MedTech
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the...
Four “Spooky” ways to fix the 510(k) dilemma
BioWorld MedTech
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot...

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years

BioWorld MedTech

Actionable intelligence on advances in medical devices and technologies for 20+ years

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Today's news in brief

BioWorld

BioWorld MedTech

BioWorld Asia

BioWorld Premium