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Olympus launches operating room visualization, integration system

The EasySuite ES-IP system in use in the OR. [Image courtesy of Olympus]Olympus announced today that it launched its EasySuite ES-IP system for procedure room visualization and integration in the U.S.

The next generation of EasySuite, ES-IP is a modular, scalable, workflow-based solution. It features the Olympus digital hub and its flexibility to run current software and potential future multi-specialty applications.

“We are excited to bring the power of the Olympus Digital Hub and our digital strategy to the core of our flagship EASYSUITE System,” said Shawn LaRocco, Vice President, Global Head Customer Solutions Business Unit. “The launch of EASYSUITE™ ES-IP system represents Olympus’ commitment to delivering intelligent integrated solutions designed to improve patient care pathways and clinical operations. With an increasing reliance on IT, it’s essential that clinicians and nurses have the right data at the right time, allowing t…

Feasibility study backs Glucotrack implantable CGM

Glucotrack (Nasdaq:GCK) announced today that it completed a feasibility study for its implantable continuous glucose monitor (CGM).

Rutherford, New Jersey-based Glucotrack designed its CGM for patients with type 1 and type 2 insulin-dependent diabetes. The company said late last year that it planned to expand its product pipeline with an R&D program. The program centers around developing a long-term continuous glucose monitor (CGM) for people with type 1 diabetes.

With an aim to commercialize a long-term sensor, Glucotrack hopes its offering will have no requirement for an additional wearable component. The company also hopes for a once-only calibration for the platform. It believes these can serve as key differentiators in the CGM market.

Get the full story at our sister site, Drug Delivery Business News.

The story behind Biogen’s 1,000 job cuts and R&D refocus

Cambridge-based biotech Biogen has unveiled plans to cut 1,000 jobs, or 11% of its workforce, as it prepares for the launch of its newly approved Alzheimer’s disease drug, Leqembi (lecanemab) that it developed with Eisai. This move follows a pattern of significant layoffs, with the company having cut 885 jobs last year after the troubled rollout of its Alzheimer’s drug Aduhelm.

The scope and rationale for the Biogen job cuts

Last year, Biogen eliminated 885 positions following the rocky launch of its initial Alzheimer’s drug Aduhelm in 2021. The latest job cuts are part of Biogen’s new “Fit for Growth” strategic plan aimed at prioritizing resources towards high-value programs with growth potential. The plan intends to deliver $1 billion in gross operating expense savings by 2025. After reinvesting $300 million into product launches and R&D, this would result in $700 million in net savings based on the company’s projections.

“As we looked at the R&…

NeuroOne prices $5.25M public offering

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it priced an underwritten registered public offering.

Eden Prairie, Minnesota-based NeuroOne’s offering includes 5.25 million shares of common stock priced at $1 per share. All shares included in the offering will be sold by the company. NeuroOne also granted the underwriter a 30-day option to purchase up to an additional 787,500 shares. Those common stock shares come at the public offering price less the underwriting discount.

NeuroOne expects the gross proceeds to total approximately $5.25 million. The company scheduled the offering to close on or about July 27, subject to customary conditions.

Proceeds are earmarked for a trio of uses. First, NeuroOne aims to use funds to support the commercial launch of the Evo sEEG electrode line in the U.S. The company began its launch with Zimmer Biomet in May. Zimmer Biomet holds exclusive worldwide distribution…

3M to name CEO for Health Care spinoff soon

3M (NYSE: MMM) + officials say they remain on track to spin off the company’s healthcare business by late 2023 or early 2024.

“We’ve made good progress on our planned spin of our Health Care business, including regulatory filings and system updates in preparation for a soft spin [in November]. We’re also in the final steps of naming a CEO,” 3M CEO Mike Roman told analysts during the manufacturing giant’s Q2 earnings call this morning.

In April, Roman said Jeff Lavers would solely serve as interim group president of Health Care to support the transition to a new management team. (Until then, Lavers was also group president of the consumer business, which is now led by Karina Chavez.)

The Health Care business will stay headquartered in Minnesota during the transition period, but 3M told the Star Tribune of Minneapolis in April that the new company’s eventual management wil…

MedAccred gives first PCBA accreditation in Mexico

NEWS RELEASE: Jabil Mexico achieves MedAccred accreditation for printed circuit board assembly at Chihuahua facility

[Photo courtesy of Jabil]

Jabil’s site in Chihuahua, Mexico, has earned the prestigious MedAccred Accreditation for Printed Circuit Board Assembly (PCBA) after meeting the stringent audit requirements set by MedAccred subscribing members – including Baxter, BD, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, Roche Diagnostics and Stryker. It is the only site in Mexico to currently hold MedAccred PCBA Accreditation.

The MedAccred audit and accreditation program is unique as the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The accreditation assures that critical manufacturing processes meet industry consensus requirements, leading to the production of high-quality end products, ultimately enhancing patient…

BD adds former J&J chief medical officer to its board

Dr. Joanne Waldstreicher. [Image courtesy of BD]BD (NYSE: BDX) + announced that it appointed medtech veteran Dr. Joanne Waldstreicher to its board of directors.

Waldstreicher most recently served as chief medical officer at Johnson & Johnson (NYSE: JNJ) + . She held that position from 2012 until her retirement in 2023. As CMO, she provided strategic and operational leadership with responsibility for safety, epidemiology, regulatory and clinical operations. She also oversaw bioethics and late-stage pipeline programs.

Before taking on that role, she served as CMO for Janssen Pharmaceutical R&D, a J&J division, from 2009 to 2012. Prior to that, Waldstreicher was SVP of global drug development from 2002 to 2009. Over her time at J&J, she held responsibilities for clinical research, biostatistics, regulatory affairs and Asia Pacific R&D and medical affairs.

P…

Baxter names proposed kidney care spinoff ‘Vantive’

Baxter (NYSE: BAX) + announced today that it picked “Vantive” as the name of its proposed kidney care spinoff.

In January, Baxter announced plans to spin its renal care and acute therapies units into an independent, publicly traded company. It said at the time that it expected the company to stand alone in the next 12 to 18 months. Baxter said today that it expects Vantive to launch as an independent, publicly traded company by July 2024 or earlier.

The company picked Chris Toth, EVP and group president, kidney care, to serve as CEO of the new company upon the spinoff’s completion.

“Announcing the Vantive name is a critical milestone in our journey to becoming an independent company focused solely on therapies for kidney disease and other vital organ support,” said Toth “The Vantive name reflects our dedicated employees’ steadfast commitment to patients and our passion for helping them lead ful…

Difficult transmembrane protein targets for therapeutic antibodies

What is the current landscape of antibodies targeting membrane proteins?

As of June 2022, 162 antibodies had been approved for a wide array of diseases in the world, including cancers, immune-related diseases, infectious diseases, and hematological diseases1. Over half target membrane proteins, primarily proteins with large extracellular domains and simple transmembrane domains such as tyrosine kinase receptor proteins. Only two target complex transmembrane proteins like G-protein-coupled receptors (GPCRs)2.

What are the established and emerging membrane protein targets for antibody therapies?

Established antibody targets include transmembrane proteins EGFR, VEGFR2, FGFR2, HER2, and complex membrane proteins CCR4 and CGRPR. Monoclonal and bispecific antibodies targeting complex membrane proteins such as GPRC5D, Claudins (Claudin 6 and Claudin 18), SSTR2, and CXCR4 have shown successful results in CAR-T cell therapy at the preclinical and clinical…

GE HealthCare reports Street-beating Q2, raised guidance

GE HealthCare (Nasdaq: GEHC) + shares were down today, even though second-quarter results topped the consensus forecast.

Shares of GEHC initially rose, but were down slightly to $80.36 apiece by afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up slightly.

BTIG analysts said that with orders facing more challenging comps for the rest of the year at the same time that management raises guidance, investors might view GE HealthCare’s situation as more challenging.

The Chicago-based company posted profits of $418 million. That amounts to 91¢ per share on sales of $4.817 billion for the three months ended June 30, 2023.

GE HealthCare recorded a 13.8% bottom-line slide on sales growth of 7.4%.

Adjusted to exclude one-time items, earnings per share totaled 92¢. That landed 5¢ ahead of projections on Wall…

Fast Five: J&J looks to split-off a business unit, Inspire Medical appoints former Medtronic exec to chief strategy role

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, July 25, 2023.

Fast Five by MassDevice · J&J looks to split-off a business unit, Inspire Medical appoints former Medtronic exec

Philips recently announced Q2 results and an update on the ongoing DOJ talks and layoffs. Industry analysts may discuss Philips’ forward-looking plans to mitigate order intake volatility and maintain a competitive edge in the medical device market. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the quarterly results and what the current status of the ongoing consent decree.

The launch of Biosense Webster’s AFib mapping catheter signifies J&J’s commitment to advancing cardiac ablation technologies for atrial fibrillation patients. Hear how the technology works, how it could benefit clinicians and what doctors and …

Phase 3 trial shows donanemab reduces Alzheimer’s symptoms by 35%

According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.

Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.

Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.

A look at TRAILBLAZER-ALZ 2

The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and fun…