Despite fall in net sales, Zimmer Biomet beats consensus in Q2
Orthopedic companies felt pressure from COVID-19 in their most recent quarters. For example, Zimmer Biomet Holdings Inc. reported second-quarter net sales of $1.226 billion, a decrease of 38.3% from the prior-year period. Still, those revenues did come ahead of expectations, as Wells Fargo analyst Larry Biegelsen noted – $432 million ahead of his group's estimate and $305 million ahead of consensus.

Despite fall in net sales, Zimmer Biomet beats consensus in Q2
Orthopedic companies felt pressure from COVID-19 in their most recent quarters. For example, Zimmer Biomet Holdings Inc. reported second-quarter net sales of $1.226 billion, a decrease of 38.3% from the prior-year period. Still, those revenues did come ahead of expectations, as Wells Fargo analyst Larry Biegelsen noted – $432 million ahead of his group's estimate and $305 million ahead of consensus.
Eko teams up with Astrazeneca to advance heart failure diagnosis tools
Eko Devices Inc. said Tuesday that it is collaborating with British pharma giant Astrazeneca plc to speed the development of digital health tools to improve early detection of cardiovascular diseases, including heart failure. The partnership could lead to more personalized care for heart failure patients, improving long-term outcomes.
White House moves on telehealth executive order to counter rural hospital closure
The Trump administration has issued an executive order designed to improve access to telehealth for Medicare beneficiaries in rural America, making permanent numerous changes that had been temporarily added for the COVID-19 pandemic. The news arrives as the Centers for Medicare and Medicaid Services (CMS) posted the draft Medicare physician fee schedule (MPFS) complete with expanded use of telehealth for a number of services.
Today's news in brief
BioWorld MedTech's briefs for Aug. 4.
Siemens Healthineers nabs first FDA nod for semi-quantitative SARS-CoV-2 antibody test
The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.
Adhering to its guns, DBV seeks meeting with FDA on CRL for peanut allergy patch
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
BioWorld MedTech’s Oncology Extra for Aug. 4, 2020
Keeping you up to date on recent developments in oncology, including: Cancer follow-up plummeted in Wuhan after onset of COVID-19 pandemic; T-cell receptor sequencing proves useful for tracking thyroid cancer; Silver nanowires take their place in brain cancer therapy.

Digital health

Investor unruffled over FDA’s approach to AI in discussion paper
Artificial intelligence
A number of entities have sounded off on the FDA’s discussion paper for artificial intelligence (AI), including several medical societies that would like to see autonomously operating algorithms subjected to more stringent review than supervised algorithms. Vibhor Rastogi, general partner at...
Biofourmis deploys Biovitals Sentinel platform in Singapore
Monitoring
HONG KONG – Singapore is Biofourmis Inc.’s latest destination for its Biovitals Sentinel platform to remotely monitor COVID-19 patients, with the country’s Ministry of Health (MOH) becoming the company’s latest customer.
BioWorld MedTech’s Neurology Extra for July 31, 2020
Science
Keeping you up to date on recent developments in neurology, including: Quanterix biomarker technology used to measure neuronal injury in COVID-19 patients; AI could speed up and improve Alzheimer's diagnosis; Mental fatigue of MS linked to inefficient recruitment of neural resources.
Big Health’s new digital therapeutic resolves anxiety in 71% of users
Clinical
More than 70% of individuals using Big Health’s newest digital therapeutic, Daylight, achieved remission of generalized anxiety disorder (GAD) within 10 weeks, and the benefit persisted for at least six months, according to results of a randomized clinical trial published July 29, 2020, in Depressi...

Financings

CAPS Medical snags $3.5 million in series A financing
Cancer
CAPS Medical, of Netanya, Israel, closed a $3.5 million series A round led by Chasing Value Asset Management and the Los Angeles-based Israel Investment Fund Group. The new funds will be used to enable CAPS to undertake its first clinical trial for its minimally invasive, nonthermal plasma device for cancer treatment and further develop its portfolio for the treatment of solid tumors.

Newco news

Starvation safety switch could make cell therapies safer
Cell therapy
By deleting the gene for uridine monophosphate synthetase (UMPS), an enzyme in the pathway for uridine synthesis, researchers have made cells, including embryonic stem cells and T cells, dependent on dietary uridine. The work, which was published in the July 13, 2020, online issue of Nature...

Endpoint Health comes out of stealth mode, lands $12M
Diagnostics
Endpoint Health Inc. has made its official debut, scooping up $12 million in debt and equity financing from a host of investors, including Mayfield, Y Combinator, Ame Cloud Ventures and Wireframe Ventures. The Palo Alto, Calif.-based company is focused on helping people with illnesses such as...
Mastor's growth prospects boosted by Sofinnova seed funding and expertise
Robotic surgery
Mastor SAS secured €3 million (US$3.39 million) in seed investment from Sofinnova Partners' MD Start III Fund and €1.9 million in non-dilutive funding through the i-Nov Innovation Award from BPI France, the French national public investment bank.

Deals and M&A

Siemens Healthineers snaps up Varian for $16.4B
Cancer
In what one analyst labeled as a “summer surprise,” Varian Medical Systems Inc. and Siemens Healthineers AG said they plan to combine in an all-cash transaction valued at $16.4 billion. Varian’s board has backed the agreement, which will see Siemens Healthineers pick up all outstanding shares for $177.50 per share in cash, representing a premium of about 42% to the 30-day volume weighted average closing price of Varian's common stock as of July 31. The transaction is expected to close in the first half of calendar year 2021.
Osprey Medical expands global footprint with GE Healthcare distribution deal
Imaging
PERTH, Australia – Osprey Medical Inc. signed a deal with GE Healthcare that will see the company expand its global footprint for its Dyevert contrast minimization devices across Europe, Russia, the Middle East, Africa, Central Asia and Turkey. GE Healthcare will be the exclusive distributor in those markets, allowing Osprey to grow its commercial presence beyond the U.S. and Australia.
Thermo Fisher subsidizes Genexus systems for oncology labs
Cancer
Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.
Vuno contemplates partnership offers after bagging $2.5M investment from Dong Wha
Collaboration
HONG KONG – Seoul-based Vuno Inc. faces the happy dilemma of being able to choose from multiple partnership offers to add to the string of recent deals inked by the South Korean company. The company’s most recent deal is an agreement with Dong Wha Pharmaceutical Co. Ltd. for a ₩3 billion ($2.5 million) investment. For Dong Wha, the deal is a culmination of a three-year effort to diversify its business via active investments in the latest health care trends.
Strata Oncology, Elevation Oncology partner on CRESTONE enrollment
Clinical
Strata Oncology Inc. has inked an agreement with newcomer Elevation Oncology to ramp up patient identification and enrollment for the latter’s phase II CRESTONE study evaluating the use of seribantumab in patients with recurrent, locally advanced or metastatic solid tumors of any origin that have a neuregulin-1 (NRG1) gene fusion.

Europe

Inheart raises $4.2M for launch of its cloud-based image analysis system for cardiac arrhythmia
Artificial intelligence
PARIS – Inheart SAS completed its first funding round of $4.2 million to improve cardiac arrhythmia treatment using medical imaging, artificial intelligence and digital simulation. This fund round was led by Elvia Partners SAS, a Parisian investment fund managed by Xavier Lazarus specializing in deep tech, and Aquitaine Science Transfer, a company accelerating technology transfer, from the University of Bordeaux.

Asia-Pacific

Medtech Innovator picks 20 startups for Asia Pacific Accelerator program
HONG KONG – Los Angeles-based nonprofit accelerator Medtech Innovator has teamed up with the Asia Pacific Medical Technology Association (APACMed) and picked 20 companies to participate in the organization’s Asia Pacific Accelerator program. With the competition in its eighth year, the accelerator...

With investment platform, China’s Venus Medtech looks to tap new technologies
Cardiovascular
A medical device company has partnered with a couple of investment firms to tap new technologies and help bring them back to China. Venus Medtech (Hangzhou) Inc. formed a health care investment platform, Ascendum Capital Partners, to invest in new medical devices and technologies around the world,...
Chugai, Biofourmis target phase I trials for endometriosis pain measurer
Artificial intelligence
HONG KONG – Chugai Pharmaceutical Co. Ltd. is hoping to start phase I trials for an as-yet-unnamed digital solution for measuring pain levels in endometriosis patients that it is co-developing with Biofourmis Inc.

Clinical

Study finds Scipher RA test can predict nonresponders to TNF inhibitors
Diagnostics
Startup Scipher Medicine, of Waltham, Mass., is developing a blood test to predict which rheumatoid arthritis (RA) patients will not respond to Tumor necrosis factor (TNF) inhibitor therapies. Known as PrismRA, the test is expected to launch later this summer as an LDT; an FDA submission for IVD status is slated to follow in the next two or three years.
With new rapid test, Sorrento expands COVID portfolio
Diagnostics
VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour. The test was developed by Zev Williams and his team at the Columbia University Irving Medical Center, which published results of preliminary studies in MedRxiv.
A bleak financial history behind it, Neovasc boosted by study of its refractory angina device
Cardiovascular
The results of Reducer 1, an international, three-arm observational study of an initial 241 patients with refractory angina were remarkable, Neovasc COO Bill Little told BioWorld.
Exero starts first-in-human trial of wireless, biodegradable GI surgical sensor
Gastrointestinal
Exero Medical Ltd. aims to improve monitoring the gastrointestinal system after surgery with a wireless, biodegradable anastomotic leak sensor implant. It has started a tiny five-patient, first-in-human study as a proof of concept for its technology.
Synairgen stock rockets as inhaled interferon-beta shows signs of efficacy in COVID-19
Combination drug-device
DUBLIN – Synairgen plc has detected what appear to be promising efficacy signals in a phase II trial of its inhaled formulation of interferon-beta 1a, SNG-001, in hospitalized COVID-19 patients.
Celltrion starts phase I trials for COVID-19 antiviral antibody treatment CT-P59
Drugs
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.

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