Xaira’s $1 billion launch one of the biggest recent biotech funding rounds

The same week that BenevolentAI announced it was cutting 30% of its staff, AI-focused biotech Xaira Therapeutics debuted with a $1 billion funding round with little precedent in healthcare over the past year — or beyond that. A survey of the biggest fundraising rounds over the past year revealed that the absolute largest investments were attracted by sectors such as semiconductors (China-based Changxin New Bridge — $1.99B and GTA Semiconductor — $1.86B), data centers (Vantage Data Centers — $6.4B in equity investment), AI (Inflection AI — $1.3B) and automotive (Leapmotor — $1.6B). But in healthcare, Xaira’s $1 billion in fundraising is one of the largest in recent memory — with the $3B emergence of Altos Labs in early 2022 being one exception.



Support from high places

Arch Venture Partners and Foresite Capital co-led Xaira Therapeutics’s $1 billion funding round. The San Francisco-based company, with former Genentech chief scientific officer and…

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CroíValve’s Duo takes a unique approach for treating tricuspid regurgitation

The Duo tricuspid valve device [Image courtesy of CroíValve]

CroíValve is making inroads in the tricuspid regurgitation (TR) treatment market currently occupied by Abbott and Edwards.

In February 2024, Edwards’ Evoque tricuspid valve became the first TR treatment to win FDA approval, followed by Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system in April.

Edwards designed its device to replace the native heart valve, while Abbott designed its TEER system to repair it.

CroíValve’s investigational Duo tricuspid coaptation valve system is different, with an approach that CEO Lucy O’Keeffe calls “the best of both worlds.”

O’Keeffe, who comes from an engineering background, was working on early TAVR programs at Medtronic when she met CroíValve co-founder Dr. Martin Quinn, the cardiologist who placed the first transcatheter aortic valve replacement (TAVR) implant in Ireland.<…

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Philips gets judge’s OK to settle Respironics recall economic losses

Philips (NYSE: PHG) + will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices.

U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday.

“The amount of value created and number of persons benefitted favors approval of this award,” Conti said in her order.

“Under the terms of the settlement agreement, there are set payments ranging from $55.63 to $1,552.25 per recalled device … for device payment awards, and $100 per recalled device for device return awards to users. Thus, the non-reversionary $506.3 million refund represents a floor, not a ceiling, and that amount will increase as additional returns of recalled devices are made, and additional claims for device payment awards are filed and app…

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Roivios wins FDA breakthrough nod for renal assist device

The JuxtaFlow renal assist device system features a catheter (left) and pump (right). [Image from the Roivios Website]Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD).

The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced damage under acute conditions.

JuxtaFlow combines a catheter and pump system. A trained urologist inserts the catheters in a manner similar to ureteral stent placement. Then, the catheter connects to the pump to deliver the negative pressure. Roivios designed the negative pressure to transmit through the nephrons, reducing downstream hydrostatic pressure. Controlled pressure reduction allows for effective filtration and selective …

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From Novartis to Pfizer: A closer look at novel cell and gene therapy pricing and reimbursement strategies

[Image: Adobe]

Cell and gene therapies are upending the treatment of a growing number of diseases by addressing the underlying causes of genetic disorders. Yet the high costs associated with these therapies, sometimes costing multiple millions of dollars for a single treatment, pose significant challenges for patients, payers and healthcare systems. To address this matter, a growing number of companies are pioneering novel pricing and reimbursement strategies such as outcomes-based agreements and risk-sharing models to help ensure patient access while mitigating financial risks.

Spotlight on Beqvez: A promising hemophilia therapy

In that vein, Pfizer recently announced the FDA approval of Beqvez, a one-time gene therapy for adults with moderate to severe hemophilia B. In tandem with the launch, Pfizer revealed a novel warranty program “based on durability of patient response to treatment.” The firm n…

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Align Technology announces $150M repurchase program

Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $150 million of its own common stock.

The open-market repurchase falls under the company’s $1 billion stock repurchase program approved in January 2023.

Align Technology executed a $250 million repurchase in February 2023 with Citibank. In October, the company triggered another $250 million repurchase in an accelerated program. Then, a month later, Align made a $100 million repurchase.

Tempe, Arizona-based Align plans to execute its repurchases based on market conditions and other factors. That includes stock price, trading volume, general business and market conditions and capital ability.

It expects to complete the repurchases by the end of July 2024, funding them with cash on hand. As of March 31, 2024, Align had approximately 75.3 million shares outstanding. It had $902.5 million in cash, cash equivalents and short-term and long-term marketable securities.

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4WEB Medical wins regulatory clearance for Anterior Spine Truss System

4WEB Medical this week announced it received regulatory clearance for its Anterior Spine Truss System with Anchor Fixation (ASTS-AF).

The Dallas-based orthopedic implant company’s current anterior lumbar implant offering includes a traditional interbody with the option of an integrated plate and a standalone interbody with screw fixation. The regulatory clearance expands the company’s portfolio to deliver anchor fixation through a less invasive surgical approach instead of traditional integrated spacers.

Anchor fixation allows for easier implantation in challenging patient anatomy. According to 4WEB, it provides comparable mechanical stability to traditional standalone ALIF systems with screw fixation and allows multiple options for securing the interbody to the vertebrae.

“Adding anchor fixation to 4WEB’s existing product offering will allow the company access to a new market segment, providing opportunity for growth,” 4WEB…

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LivaNova says cybersecurity breach included personal info for U.S. patients

LivaNova (NASDAQ: LIVN) + provided additional info regarding a cybersecurity incident first brought to light in late 2023.

In November, the company disclosed a cybersecurity breach that disrupted portions of its information technology systems and business operations. This incident came shortly after another large medtech company, Henry Schein, experienced a significant breach as well.

London-based LivaNova now says that, promptly after detecting the issues last fall, it began an investigation. That investigation enlisted external cybersecurity experts and coordinated with law enforcement. The company took action to remediate the issue, including taking certain systems offline.

The company eventually resumed manufacturing and, through the investigation, found that an unauthorized party first accessed its systems around Oct. 26, 2023.

On April 10, 2024, LivaNova discerned that the unauthorized party obtaine…

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Report: Abbott files trio of patent lawsuits over CGM tech in Europe

The FreeStyle Libre 3 continuous glucose monitor. [Image courtesy of Abbott]Abbott (NYSE:ABT) filed three patent lawsuits against SiBionics and its distribution partner in Europe, JUVE-Patent reports.

The lawsuits include patent infringement allegations centered around continuous glucose monitoring (CGM) devices, according to the report. Abbott filed them against China-based SiBionics and its sales partner Umedwings at the Unified Patent Court.

SiBionics develops, manufactures and distributes CGM and other monitoring technologies. It received CE mark approval for its GS1 continuous glucose monitoring (CGM) system last fall. Umedwings, a Dutch company, serves as its distribution partner in Europe.

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

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FDA approves Medtronic’s Inceptiv closed-loop rechargeable spinal cord stimulator

The Inceptiv spinal cord stimulation system. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + announced today that it received FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS) system.

Inceptiv treats chronic pain and represents Medtronic’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy in harmony with the motions of daily life.

The medtech giant also labeled it the world’s smallest and thinnest fully implantable SCS device. Medtronic plans to begin a U.S. market launch in the coming weeks. The system already has availability in Japan and Europe, with CE mark approval coming last August.

“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said …

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The $5-7B generative AI opportunity biopharma can’t afford to ignore

[Adobe Stock]

Yes, generative AI is hyped. And yes, the technology has shortcomings. But the landscape is swiftly changing. Bloomberg Intelligence estimated that the GenAI market would grow from $40 billion in 2022 to $1.3 trillion by 2032. A recent study from Deloitte Consulting estimates that for a top 10 biopharma company with $65-75 billion in revenue, the peak value that could be captured by scaling AI over 5 years is $5-7 billion.

While it is easy for individuals to dabble with the technology, quantifying the actual enterprise value for biopharma firms is often less clear. “We kept hearing the same question over and over again from the C-suite: What’s the value to my company? What’s the size of the prize?” said Adam Israel, managing director at Deloitte Consulting, and co-author of the report, “Realizing Transformative Value from AI & Generative AI in Life Sciences.”

The answer…

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Edwards Lifesciences beats the Street in Q1 and increases sales outlook

Edwards Lifesciences (NYSE: EW) + reported first-quarter results that exceeded Wall Street expectations after market close today.

The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading.

Irvine, California–based Edwards Lifesciences earned nearly $351 million, or 58¢ per share, off of $1.6 billion in revenue during the quarter that ended March 31, 2024. Compared to Q1 2023, sales were up 9% year over year and profits increased 3%.

Adjusted to exclude one-time items, earnings per share were 66¢. The result beat the expectations of The Street, where analysts predicted EPS of 64¢ and revenue of $1.57 billion.

“Edwards is positioned to extend our leadership and deliver sustainable …

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