- Medical Design Sourcing

AG (NYSE:NVS) has announced a restructuring plan that will result in up to 8,000 layoffs internationally, including 1,400 in Switzerland. The cuts would equate to 7.4% of its workforce.

Novartis currently has approximately 108,000 employees.

The Basel, Switzerland–based company aims to save approximately $1 billion in operating expenses by 2024.

In April, Novartis hinted that such a change was coming with the description of a “new organizational structure” that would “accelerate growth, strengthen pipeline and increase productivity.”

The restructuring could hit the company’s Basel operations the hardest, according to the German language paper Tages-Anzeiger.

The restructuring initiative also will integrate the company’s pharmaceuticals and oncology business divisions into an Innovative Medicines (IM) business.

Furthermore, the company intends to decouple its U.S. operations from international comme…

Nasdaq grants Titan Medical 180-day extension to regain compliance

Titan Medical (Nasdaq:TMDI) announced today that it received an additional 180 days to regain compliance with the Nasdaq market.

According to a news release, the Listing Qualifications Staff of The Nasdaq Stock Market notified the company that it received 180 extra calendar days — running through Dec. 26, 2022 — to evidence compliance with the $1 minimum bid price requirement for continued listing on the market.

Shares of TMDI were down 7.3% at close to 54¢ per share in mid-afternoon trading today.

If at any time before Dec. 26, the bid price for the company’s common shares closes at or above $1 per share for a minimum of 10 consecutive business days (and generally not more than 20 consecutive business days, in Nasdaq’s discretion), it is expected that Nasdaq would provide formal notice that the company has regained compliance with the bid price requirement.

Should Titan not evidence compliance with the minimum bid …

Icosavax shares positive early results for VLP vaccine candidate against RSV

The biopharma Icosavax (Nasdaq:ICVX) has announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a vaccine candidate with a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen.

The Phase 1 portion of the study enrolled 90 healthy young adults between 18 and 45. The Phase 1b portion included 130 healthy adults aged 60 to 75.

IVX-121 had a robust immunologic response to RSV. In addition, Icosovax noted that the vaccine candidate achieved comparable Geometric Mean Titer (GMT) levels at Day 28 in both age groups.

Seattle-based Icosavax noted that the vaccine candidate had a favorable tolerability profile with no vaccine-related serious adverse events.

“Importantly, we believe these Phase 1/1b data provide initial validation of our underlying VLP technology. They also reaffirm our strategy to combine multiple pathogen targets in one vaccine,” said Adam Simpson, CEO of Icosavax, in a news release. “As plann…

Aerin Medical reports positive 4-year results for VivAer treatment

[Image from Aerin Medical]Aerin Medical today announced published results from a four-year clinical trial of its VivAer treatment for nasal airway obstruction (NAO).

Sunnyvale, California-based Aerin designed VivAer, which holds both CE mark and FDA 510(k) approval, to use patented, temperature-controlled radiofrequency energy through a thin, wand-like stylus attached to a console. The stylus is inserted via the nostril to gently remodel the nasal tissue and improve airflow. Aerin Medical was included in MassDevice’s list of hottest startups in 2020.

Results from the trial, published in the International Forum of Allergy & Rhinology, showed the long-term durability of VivAer in those with NAO due to nasal valve collapse (NVC).

The follow-up study demonstrated that patients experienced significant and sustained improvement in symptoms of NAO through four years following a single treatment of NVC with VivAer. The publication adds to a growing body of evid…

Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals. [Photo courtesy of Blackrock]Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

Blackrock wants its BCI platform to be the first one that’s commercially available to people with paralysis. Its implant has been used in patients since 2004 through research studies, with zero FDA-reported serious adverse events since then.

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

Blackrock Neurotech and Pitt work on first at-home BCI system for remote trials

Blackrock Neurotech’s Utah array is used in its brain-computer interface implant to sense brain signals [Photo courtesy of Blackrock]

Blackrock Neurotech and the University of Pittsburgh’s Rehab Neural Engineering Labs (Pitt RNEL) are working together on the first portable brain-computer interface (BCI) to allow patients to participate in research trials from home.

A Blackrock representative said it’s the final step as the company prepares to launch its first commercial product early next year.

Salt Lake City-based Blackrock plans to submit its first commercial BCI device, called MoveAgain, to the FDA this year.

“Through this expansion…

Clarius partners with ImaCor on handheld hemodynamic ultrasound tech

[Image from ImaCor/Clarius]Clarius Mobile Health announced today that it partnered with ImaCor to make available a handheld transesophageal echocardiography (TEE) system.

According to a news release, the partnership will enable the availability of the world’s first handheld TEE system designed to manage and guide care for critically ill patients in the intensive care unit (ICU).

ImaCor designed its Zura handheld hemodynamic ultrasound system, powered by Clarius, to provide an instant, clear window to directly visualize preload and contractility over time. The FDA-cleared platform aims to help clinicians make “the right decisions, at the right time,” the companies said.

“A high-risk patient’s hemodynamic status changes dramatically in a matter of minutes, often while clinicians are waiting for test results they submitted 15 minutes ago,” ImaCor founder Dr. Scott Roth said. “The Zura Handheld provides instant and accu…

Withings appoints Elizabeth Coleon as chief marketing officer

Withings this week announced that it has appointed Elizabeth Coleon as chief marketing officer.

Coleon will lead the Issy-les-Moulineaux, France-based connected health company’s marketing team to grow its consumer devices and health solutions divisions. Withings makes a number of connected health devices such as blood pressure monitors, smartwatches and sleep trackers.

“The last few years have only confirmed the growing need on the part of society to take back control of their health! The challenge of the next few years is to make people aware of the extent to which connected health objects allow the creation of a medical service that benefits each individual and humanity. With her international and service experience, Elizabeth will enable Withings to better communicate the power of a service driven by innovative, contextual and accurate data,” CEO Mathieu Letombe said in a news release.

Prior to joining the company, Coleon was the mar…

Visby Medical raises $135M in expanded Series E

Visby Medical announced today that it added $35 million to an expanded, oversubscribed Series E financing round.

San Jose, California-based Visby plans to use the additional investment, which brings its Series E to $135 million in total, to scale production capacity, expand its product menu to include respiratory health tests and anti-microbial resistance panels and to bring PCR diagnostics to consumers at home.

The company develops PCR diagnostic technology designed to address the significant rise in infectious diseases. Its FDA-cleared sexual health click test has already launched in the U.S. in settings such as urgent care and women’s health clinics to detect gonorrhea, chlamydia and trichomonas via self-collected vaginal swabs and deliver results in less than 30 minutes, eliminating the need for presumptive treatment.

According to a news release, Lightrock led the funding round, joining existing Series E investors including John Doerr, Cedars …

VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

…

How Cybin aims to maximize the potential of two classical psychedelics

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression.

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects.

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin.

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…

Boston Scientific to build new plant outside Atlanta

[Image courtesy of Google]Boston Scientific (NYSE:BSX) will build a new manufacturing and supply chain facility in the Atlanta suburb of Johns Creek, Georgia Gov. Brian Kemp announced today.

Kemp’s office said the $62.5 million investment will bring roughly 340 new jobs to the Peach State over the next seven years.

“As home to some of the leading universities and technical colleges in the country, Georgia produces top talent for growing fields like the life sciences industry,” Kemp said in a news release. “Boston Scientific will find well-educated, well-trained, and hardworking Georgians who are eager to support the company’s life-changing work to fill these new positions. I look forward to seeing the impact of this expansion here in Georgia and far beyond as they keep the Peach State on the cutting edge of medical science.”

Boston Scientific purchased Georgia-based EndoChoice in 2016 and already employs about 300 people in Geo…

NovaXS unveils prototype for smart, needle-free drug delivery device

[Image from NovaXS]NovaXS Biotech announced that it unveiled the new prototype for its needle-free injection therapy smart medical device.

Formed at the University of California, Berkeley, NovaXS designed its patent-pending Telosis technology to administer a narrow stream of medication without a needle in 0.3 seconds and to analyze injection data to allow for smarter health decisions.

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

ResMed names Lucile Blaise as new Sleep & Respiratory Care leader

Lucile Blaise will become president of ResMed’s Sleep & Respiratory Care business on July 1. [Photo courtesy of ResMed]Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today.

She replaces Jim Hollingshead, who became president and CEO of Insulet (Nasdaq:PODD) on June 1. ResMed President and COO Rob Douglas is serving as interim president of the Sleep & Respiratory Care during the transition.

Blaise is ResMed’s VP of Sleep & Respiratory Care for Western Europe. She joined San Diego-based ResMed in 2006 and has more than 25 years of experience in medical device sales, marketing, finance, and business development, the company said in a news release.

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

Philips updates on testing results for recalled ventilators

Royal Philips (NYSE:PHG) today provided an update on the test and research program implemented after its major ventilator recall.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

ResMed names Lucile Blaise as new Sleep & Respiratory Care leader

Lucile Blaise will become president of ResMed’s Sleep & Respiratory Care business on July 1. [Photo courtesy of ResMed]

Lucile Blaise will be the new president of ResMed’s Sleep & Respiratory Care business starting July 1, ResMed (NYSE: RMD) said today.

Blaise serves on the MedTech Europe board and was elected president of French medtech association Snitem this month.

ResMed CEO Mick Farrell …

SpineX enrolls first patient in spinal neuromodulation technology trial

[Image from SpineX]SpineX announced today that it enrolled the first patient in its pivotal trial evaluating the Scone neuromodulation device.

Los Angeles-based SpineX will evaluate the safety and effectiveness of the non-invasive spinal neuromodulation technology for the treatment of neurogenic bladder.

The first patient was enrolled at the Rancho Research Institute of the Rancho Los Amigos National Neurorehabilitation Center in Downey, California, according to a news release.

SpineX designed Scone therapy to treat symptoms such as the lost sensation of bladder fullness, low bladder capacity, frequent urination cycles during both day and night and living with constant fear of uncontrolled urine leakage.

Dr. Evgeniy Kreydin, the company’s co-founder and assistant professor at the University of Southern California, Los Angeles, said in the release that while the inability to walk is the most obvious functional loss for a person in a wheelchair, …

GE Healthcare’s Carescape ventilator battery recall is Class I

(Image from GE Healthcare)

The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind.

GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on batter power only when the battery fails, the ventilation could stop completely, preventing the user from receiving oxygen and breathing support.

Carescape R860 uses main AC power via a wall plug to operate, but has a backup battery intended to keep the ventilator operating for a certain amount of time if a main AC power supply is not available. An example of this occurrence would be a patient transport. Replacement backup batteries are available for use when the original backup battery expires.

The issue can potentially cause a lack of oxygen (hypoxia), especially if it occur…

Cardinal Health starts Zipline drone deliveries of drugs and medical supplies

Zipline’s fixed-wing drones are delivering medical supplies in North Carolina. [Image courtesy of Zipline]

Cardinal Health (NYSE: CAH) today started air delivery of pharmaceutical products and medical supplies via Zipline drone in North Carolina.

San Francisco-based Zipline won FAA Part 135 air carrier certification for the long-range flights earlier this month. The company flew its first commercial deliveries on June 22 with an initial 16-nautical-mile flight.

The flights starting today are out of Zipline’s hub in Kannapolis, North Carolina, on behalf of Cardinal Health as well as Novant Health and Magellan Rx Management.

Zipline said the hub can serve customers within a 7,800-square-mile area in as little as 15 minutes, with 98 percent lower emissions than traditional delivery options.

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

Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.

The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.

In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.

Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.

Foster City, California-based Gilead has also studied oral formulations of the drug.

Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug applicat…

Cardinal Health starts Zipline drone deliveries of drugs and medical supplies

Zipline’s fixed-wing drones are delivering medical supplies in North Carolina. [Image courtesy of Zipline]Cardinal Health (NYSE: CAH) today started air delivery of pharmaceutical products and medical supplies via Zipline drone in North Carolina.

The flights starting today are out of Zipline’s hub in Kannapolis, North Carolina, on behalf of Cardinal Health as well as Novant Health and Magellan Rx Management.

Zipline said the hub can serve customers within a 7,800-square-mile area in as little as 15 minutes, with 98 percent lower emissions than traditional delivery options.

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

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