Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2).
The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two doses of the vaccine candidate beginning in march.
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[Image from Aesculap]
Aesculap recently launched its M.blue hydrocephalus valve.The valve is adjustable gravitational valve that features an integrated fixed pressure differential valve during the most active time of the day, according to the company. The fixed pressure differential valve addresses posture changes.
“We are very pleased to be able to continue to provide healthcare teams with new and innovative solutions,” president Chuck DiNardo said in a news release. “With our strong partnership with Miethke comes an impactful collaborative effort to bring better Hydrocephalus solutions to patients, such as the new M.blue valve.”
It is estimated that over one million people in the U.S. live with hydrocephalus, according to the Hydrocephalus Association. Shunt therapy is the golden standard for treating it, but implantations of shunts have had high failure rates, caused mul…
Zebra Medical Vision announced today that it received its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product.
The Kibbutz Shefayim, Israel-based company’s latest artificial intelligence-based product automatically identifies findings suggestive of compression fractures, which enables clinicians to place patients that are at risk of osteoporosis in treatment pathways that can prevent potentially life-changing fractures.
VCF expands Zebra’s AI1 bundle of FDA-cleared AI products, which now has a fourth U.S. patent in its bone health series, according to a news release. Zebra touts itself as the first AI startup in medical imaging to receive FDA clearance for a population health solution.
“Identifying patients at risk for osteoporosis has a significant impact on patients’ well-being, as 70 percent of vertebral compression fractures are under detected globally,” Zebra CEO Ohad Arazi said in the news release. “Th…
Inari Medical announced today that it launched the roadshow for its initial public offering (IPO) of shares of its common stock.
The venous disease treatment developer is offering more than 7.3 million shares of common stock with an expected additional 30-day option for underwriters to purchase close to 1.1 million more shares.
Irvine, Calif.-based Inari Medical expects the IPO price to fall between $14 and $16 per share with the stock expected to trade on the Nasdaq Global Market under the ticker “NARI,” according to a news release.
Should the shares sold in the IPO average between $14 and $16, Inari Medical could be looking at bringing in proceeds of approximately $110 million, which could range up to approximately $126.5 million if the underwriters exercise the option to purchase the additional shares.
BofA Securities and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. Wells Fargo Securities …
PerkinElmer (NYSE:PKI) is under federal scrutiny for alleged involvement in a scam to bill Medicare for tens of thousands of unnecessary genetic cancer tests, according to a report by Reuters.
The news agency cited three unidentified sources and government documents linking the Waltham, Mass.-based diagnostic and scientific instrument company to the probe. PerkinElmer acknowledged that it has received government subpoenas regarding investigations into third parties and said it is cooperating with authorities, but denied knowledge of wrongdoing.
Get the full story on our sister site, Drug Discovery & Development.
Edwards Lifesciences (NYSE:EW) announced today that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR).
Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and facilitate coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow.
The clasps can be operated independently to facilitate optimized leaflet capture and the implant can then be elongated to a narrow profile to allow for safe maneuvering in dense chordal anatomy, according to a news release.
Edwards touted early clinical evidence of procedural success and clinical improvements, with Pascal demonstrating sustained TR reduction at 30 days. The company is conducting the Clasp II TR pivotal study to investigate Pascal in patients with symptomatic …
Sight Sciences today announced positive results from a clinical trial of its TearCare wearable eyelid technology.
The Olympia study was a prospective, randomized multicenter trial that enrolled 235 dry eye patients across 10 sites in the U.S. The goal was to demonstrate the safety and effectiveness of a single TearCare procedure compared to the LipiFlow Thermal Pulsation System in treating signs and symptoms of dry eye disease.
Study results showed that a single TearCare treatment was able to safely and effectively achieve clinically meaningful improvements in all signs and symptoms of dry eye disease. Improvement in signs included tear break up time, meibomian gland secretion score and corneal and conjunctival staining. Symptom improvement included ocular surface disease index score, symptom assessment in dry eyes score and eye dryness score.
The company reported a significantly greater proportion of TearCare patients that had clinically meaning…
(Image from Integra LifeSciences)
A pair of retrospective studies of an Integra LifeSciences (NSDQ:IART) wound-healing matrix showed positive clinical and economic results, the company announced on Friday.
The studies looked at the results of complex lower extremity reconstruction using Integra’s bilayer wound matrix. The data were published in Plastic and Reconstructive Surgery.
The bilayer wound-healing matrix is formulated to provide an environment where the body can rebuild the layers of the skin to support the healing process, according to Princeton, N.J.-based Integra.
The first clinical publication showed 70% of the wounds successfully salvaged at 180 days, allowing the authors to identify success factors across patient selection and wound types.
The second publication reviewed cost and resource use, comparing Integra’…
BVI announced that it acquired the ophthalmic viscoelastic device (OVD) assets from Croma, as the two will combine for an R&D collaboration in the future.
Financial terms of BVI’s acquisition were not disclosed. The pair of companies outlined their forthcoming collaboration as a partnership for additional products that will come to the market in the foreseeable future, according to a news release.
“We searched across the globe to find the highest quality OVDs to complement and expand our portfolio,” BVI president & CEO Shervin Korangy said in the release. “Croma’s track record, innovation, quality and safety in HA production is unparalleled in the industry. This partnership with the Prinz family (founders of Croma) will position BVI to further innovate in this product category for ophthalmology.”
Waltham, Mass.-based BVI will now launch the NuVisc Pro, a cohesive OVD, in Europe with an eye on additional regions…
N95 respirator [Image from the FDA]
3M (NYSE:MMM) has settled one of several price-gouging lawsuits it filed recently over its N95 respirators, according to a report by Law360.The lawsuit, filed April 30 in federal court in Tallahassee, Fla., had accused Atlanta, Ga.-based 1 Ignite Capital LLC, Institutional Financial Sales LLC, and Auta Lopes of attempting to sell 10 million N95 respirators to the Florida Division of Emergency Management at nearly 460% over list prices, and for falsely claiming that they were working with 3M.
In a filing on Friday, Maplewood, Minn.-based 3M said it had reached a settlement with the company to end the lawsuit, Law360 reported. Terms were not disclosed.
The company filed a total of 10 such lawsuits in April and said it will donate any damages recovered to COVID-19-related nonprofit organizations.
3M did not immediately respond to a request for comment on Fri…
(Image from Unsplash)
The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing.
Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for COVID-19 testing.
The FDA also authorized two COVID-19 diagnostic tests (under two separate EUAs) for use with samples collected using the Everlywell COVID-19 home collection kit. The administration is open to authorizing additional tests should data be submitted that demonstrates the accuracy of the test when used with Everlywell’s kit.
Using the Everlywell kit that contains nasal swabs, a sample is collected from inside the patient’s nose and used with a tube filled with saline to tran…
Medtech stocks ticked down over the course of last week as the COVID-19 pandemic continues to bear economic ramifications.
MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.4 points at the end of last week (May 15). That total represents a -1.9% decline from the 83.98-point total at the same time a week prior (May 8).
The lowest point during the pandemic remains at 62.13 on March 23. Since then, medtech stocks have experienced 32.6% growth in total. However, they are still down -10.7% since the index’s pre-pandemic crash high point of 92.32 on Feb. 19.
Compared to the S&P 500 Index, which experienced a -2.2% increase from May 8 to May 15, the medtech index took a similarly small dip. The Dow Jones Index suffered even more with a -2.6% decline over the same period of time.
More often than not, recent earnings reports are revealing negative results in large part due to COVID-19. E…