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Kyverna Therapeutics wins $85 million in Series B financing

The cell therapy company Kyverna Therapeutics (Emeryville, California) has closed an oversubscribed $85 million Series B funding round led by Northpond Ventures.

The company plans to use the funding to launch a Phase 2 trial for its lead asset, KYV-101, in the first half of 2022.

KYV-101 is an autologous anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with potential applications in B cell-driven autoimmune diseases, including lupus nephritis, systemic sclerosis and inflammatory myopathies.

Kyverna secured rights to KYV-101 from the National Institutes of Health (NIH) for autologous and allogeneic CAR T-cell therapies.

Kyverna will also use the most recent funding to further the development of KYV-201, an investigational candidate that integrates its CD19 CAR T construct with Intellia’s (NSDQ:NTLA) ex vivoCRISPR/Cas9-based allogeneic platform.

The company also intends to use its recent funding to bolster its development activiti…

Distalmotion closes $90M Series E financing to support its Dexter surgical robot

[Image from Distalmotion]Surgical robot maker Distalmotion announced today that it closed a Series E financing round worth proceeds of $90 million.

Revival Healthcare Capital led the round, with participation from 415 Capital and existing investors.

According to a news release, Lausanne, Switzerland-based Distalmotion intends to use the funding to support the global commercialization of its Dexter surgical robot. Dexter received CE mark approval in Europe in December 2020.

Distalmotion designed Dexter for laparoscopic surgery in the fields of genera, gynecological and urological surgery. The company said the latest investment arrives as the platform takes its first steps into the operating room and the imminent commercial rollout looms.

The company says that the Dexter system combines the affordability of laparoscopy with the benefits of robotic surgery to increase simplicity and versatility in the space. Leading European hospitals are currently spea…

Leyden Labs closes $140M in Series B funding

After announcing a licensing deal for CR9114, a monoclonal antibody for influenza A and B from Janssen (NYSE:JNJ), Leyden Labs has won $140 million in Series B funding.

Amsterdam-based Leyden Labs plans on developing an intranasal spray based on CR9114.

Leading the round were Casdin Capital and GV (formerly Google Ventures).

Leyden plans on using the most recent funding round to advance its pipeline dedicated to targeting a range of respiratory viruses.

In March, Leyden Labs won €40 (approximately $45) million in Series A financing in a round led by GV.

The company notes that its total fundraising is approximately $200 million.

The most recent funding round “underscores our investors’ belief that Leyden Labs’ platform can generate cornerstone products to combat respiratory diseases,” said Koenraad Wiedhaup, a founder and CEO of Leyden Labs, in a press release. “The ongoing COVID-19 pandemic teaches us we need to expand our arsenal of…

Israeli advisory committee backs fourth dose of COVID-19 vaccine

Photo by cottonbro from Pexels

Israel could be one of the first countries to begin administering a fourth dose of COVID-19 vaccine to individuals over 18 after an advisory committee decision.

Before the decision becomes binding, the director of Israel’s Ministry of Health, Nitzan Horowitz, must sign off on the recommendation.

If implemented, Israeli adults would be eligible for a fourth dose five months after receipt of the third dose or recuperating from a COVID-19 infection.

In making its decision, the panel cited data from Sheba Medical Center that shows a fourth dose of the Pfizer-BioNTech COVID-19 vaccine yields a three- to five-fold increase in protection against severe disease. A fourth dose, however, is unlikely to offer robust protection against infection.

While Israel has already begun providing a fourth dose to immunocompromised people, healthcare workers, and those over 60, H…

Pfizer and BioNTech test omicron-specific COVID-19 vaccine in adults

With COVID-19 cases continuing to hover near record levels, Pfizer (NYSE:PFE) and partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-based vaccine candidate in adults aged 18 to 55.

The study will enroll 1,420 participants divided into three cohorts.

The first cohort will have already received two doses of the initial Pfizer-BioNTech COVID-19 vaccine. Members of that cohort will then receive one or two doses of the updated vaccine.

The second cohort, after already receiving three doses of the current Pfizer-BioNTech vaccine, will get one dose of the omicron-based vaccine.

The third cohort will include vaccine-naïve subjects, which will get three doses of the omicron-specific vaccine.

The omicron variant remains more resistant to vaccines than other SARS-CoV-2 variants of concern.

Pfizer and BioNTech hope the updated vaccine will ultimately offer more effective and longer-lasting protection against the o…

FDA approves Medtronic’s spinal cord stimulation for chronic pain from diabetic neuropathy

Medtronic (NYSE:MDT) announced today the FDA approved its Intellis and Vanta neurostimulator for treating chronic pain.

The approval covers the Intellis rechargeable neurostimulator and the Vanta recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy.

Get the full story at our sister site, MassDevice.

‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time

University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope. [Photo courtesy of the University of Arizona]After years of development, University of Arizona researchers have captured their first images inside fallopian tubes with a new device that could be used to search for early signs of ovarian cancer before it spreads.

University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 mm.

“It’s itty bitty,” she said in a news release. “You just couldn’t have fabricated something like this, even six, seven years ago.”

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

‘Itty bitty’ falloposcope imaging device used inside fallopian tubes for the first time

University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope. [Photo courtesy of the University of Arizona]

After years of development, University of Arizona researchers have captured their first images inside fallopian tubes with a new device that could be used to search for early signs of ovarian cancer before it spreads.

University of Arizona BIO5 Institute Director Jennifer Barton developed the high-resolution falloposcope, which has a diameter of only 0.8 mm.

“It’s itty bitty,” she said in a news release. “You just couldn’t have fabricated something like this, even six, seven years ago.”

Dr. John Heusinkveld has used the falloposcope since September to look inside the fallopian tubes of four volunteers who were having their tubes removed for non-cancer reasons.

“This is the first endoscope that can fi…

Hantel appoints VP of business development

Hantel recently announced that it appointed Ron Balogh as VP of business development.

The Hayward, California-based medtech design and contract manufacturing company appointed Balogh on Jan. 3. He will be responsible for serving the company’s current clients and growing the company by improving communications and its presence within the industry.

Get the full story on our sister site, Medical Tubing + Extrusion.

J&J medical device sales increase 4.1% in Q4

Johnson & Johnson (NYSE: JNJ) this week posted fourth-quarter results that beat the earning consensus on Wall Street but missed revenue estimates.

The New Brunswick, N.J.-based company reported profits of $4.7 billion, or $1.77 per share, on sales of $24.8 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 172.5% on sales growth of 10.4% compared with Q4 2020.

Adjusted to exclude one-time items, earnings per share were $2.13, 1¢ ahead of The Street, where analysts were looking for sales of $25.2 billion.

Medical device sales increased by 4.1% to $6.9 billion in Q4. Pharmaceutical sales rose 16.5% to $14.3 billion and consumer health product sales were up 1.1% to $3.7 billion over the same quarter of 2021, the company reported.

“Our 2021 performance reflects continued strength across all segments of our business. Guided by Our Credo, I am honored to assume the role of CEO, leading our global teams in continuing our work…

Glytec enters insulin management partnership with Nebraska Medicine

Glytec announced today that it entered into a strategic partnership with Nebraska Medicine to advance patient safety and innovation in insulin management.

Under the agreement, Nebraska Medicine will implement Glytec’s eGlycemic Management System (eGMS) across all 800 beds at its two hospitals, the Nebraska Medical Center and Bellevue Medical Center. The agreement will also see a collaboration on research and development initiatives to improve the safety and efficacy of insulin management in all hospital departments.

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

GE misses Q4 projections as supply chain issues cause healthcare revenues to dip

GE (NYSE:GE) shares took a dip today on fourth-quarter results that came up shy of the consensus forecast amid supply chain problems.

The Boston-based company posted losses of $3.9 billion, or $3.55 per share, on sales of $20.3 billion for the three months ended Dec. 31, 2021, for a massive bottom-line slide from profits of $2.4 billion this time last year on a sales decline of 3.5%.

Adjusted to exclude one-time items, earnings per share were 82¢, 5¢ behind Wall Street, where analysts were looking for sales of $21.5 billion.

GE’s healthcare segment also experienced a slight revenue decline, registering sales of more than $4.6 billion for a dip of 4.1%. The company attributed the sales drop to ongoing industry-wide supply shortages and inflation, but said its healthcare arm is well-positioned for continued profitable growth as GE prepares to stand up the business as an independent company in 2023.

“2021 was an important year for the GE team, …