Inari Medical has positive ClotTriever data

The ClotTriever system. [Image from the Inari Medical website]Inari Medical (Nasdaq: NARI) + announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system.

Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum.

Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a news release. Data demonstrates the safety, effectiveness and long-term outcomes of ClotTriever in real-world DVT patients.

Inari designed ClotTriever to capture and remove large clot burden from big vessels. Treating patients in one single session, it eliminates the need for thrombolytic and a stay in the intensive care unit. The company hopes to make it the standard of care for DVT patients.

Patients showed a low incidence of indep…

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Inari Medical closes LimFlow acquisition

The LimFlow System. [Illustration courtesy of LimFlow]Inari Medical (Nasdaq: NARI) + announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow.

The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of $250 million in cash at closing.

Contingent consideration of up to $165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close from existing cash resources.

LimFlow designed its system for transcatheter arterialization of deep veins. It diverts blood from a diseased tibial art…

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Inari Medical plans to buy LimFlow Medical for up to $415M

The LimFlow System for Transcatheter Arterialization of Deep Veins diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]Inari Medical (NASDAQ: NARI) + today announced a definitive agreement to purchase LimFlow Medical for up to $415 million.

The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI).

San Jose, California–based Inari said it expects to complete the acquisition by the end of 2023. Inari will pay $250 million in cash at closing, plus up to $165 million based on certain commercial and reimbursement milestones.

Medical Design & Outsourcing: How LimFlow’s foot-saving system prevents amputations in patients with no other options

Inari CEO Drew Hykes said the LimFlow acquisition “is closely aligned …

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Inari Medical launches RevCore, Triever16 Curve catheters

Inari Medical today announced it launched two new catheters for venous stent thrombosis and venous thromboembolism.

The Irvine, California-based company launched its RevCore thrombectomy catheter and the Triever16 Curve catheter. RevCore is a mechanical thrombectomy device for venous in-stent thrombosis, and Triever16 Curve is for pulmonary embolism and peripheral thrombectomy.

“We are thrilled to announce the commercial launch of these two products, which reinforce our unwavering commitment to addressing unmet needs with purpose-driven innovation,” CEO Drew Hykes said in a news release. “We continue to push the boundaries, and we are excited about the potential impact we can make on patients’ lives with these products and beyond.”

More about RevCore

RevCore has a unique diameter-controlled coring element that is designed to safely engage thrombus within stents. Inari Medical has developed a solution for an entirely new patient population.

“…

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Analysts are bullish on Inari Medical following Q4 results

Inari Medical (Nasdaq:NARI) shares dipped today despite fourth-quarter results that left analysts excited for the coming year.

Shares of NARI fell 3.5% at $55.34 apiece in midday trading today.

The Irvine, California-based thrombectomy device developer posted losses of $4 million. That amounts to 11¢ per share on sales of $107.8 million for the three months ended Dec. 31, 2022. Losses per share came in 5¢ ahead of expectations on Wall Street, while sales narrowly topped projections by 0.2%.

Inari reported a bottom-line slide into the red from profits of nearly $1 million a year ago. However, sales grew for the fourth quarter year-over-year by 29.5%. The company attributed its sales growth to U.S. expansion, increased procedure adoption and the introduction of new products.

Analysts excited by Inari’s results

According to BTIG analyst Marie Thibault, Inari “came out swinging” on competition from Penumbra’s Lightning Flash la…

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Inari Medical enrolls first patient in ClotTriever system trial for treating deep vein thrombosis

The ClotTriever system. [Image from the Inari Medical website]Inari Medical (Nasdaq:NARI) today announced that it enrolled the first patient in its Defiance trial for evaluating the ClotTriever system.

In August 2022, Inari Medical announced the launch of its Defiance trial for comparing ClotTriever to anticoagulation. Those enrolled in the trial (300 patients total) only have iliofemoral deep vein thrombosis (DVT). The trial spans 60 centers around the world.

Principal investigators Dr. Xhorlina Marko, Dr. Steven Abramowitz and Dr. Stephen Black lead the trial. Marko is based at Beaumont Health, Abramowitz at MedStar Health and Black at Guy’s and St. Thomas’ Hospital (London).

Dr. Abdullah Shaikh of Allegheny Health Network (Pittsburgh, Pennsylvania) enrolled the first patient. He said Inari and the investigators designed the trial to change the standard of care.

“We’re thrilled to enroll the first patient and officially kic…

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Inari Medical rises on Street-beating Q3, increased guidance

Inari Medical (Nasdaq:NARI) shares ticked up after hours today on third-quarter results that topped the consensus forecast.

The Irvine, California-based thrombectomy device developer posted losses of $10.2 million. That equals 19¢ per share on sales of $96.2 million for the three months ended Sept. 30, 2022.

Inari registered a more than $7 million bottom-line deeper in the red on sales growth of 31.9%. The company attributed its sales growth to U.S. commercial expansion, increased procedure adoption and new product introductions.

The company’s losses per share of 19¢ came in 6¢ ahead of Wall Street projections. Sales beat The Street, too, as analysts expected revenues of $90.4 million.

“Our aggressive investment in our growth drivers is paying off for our mission,” Inari Medical CEO Bill Hoffman said in a news release. “We launched two new products, our fifth and sixth of 2022, and presented three new data sets as late-breaking clinica…

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Inari Medical reports positive outcomes from FlowTriever study

The Inari Medical FlowTriever device. [Image from Inari Medical]Inari Medical (Nasdaq:NARI) announced today that the FLASH registry evaluating its FlowTriever produced positive results.

The company designed its FlowTriever for device retrieval and aspiration system designed to treat pulmonary embolism (PE). FlowTriever non-surgically removes clot from peripheral blood vessels. Its uses include treatment for PE and clot in transit in the right atrium. It received FDA 510(k) clearance in 2018.

Dr. Catalin Toma of the University of Pittsburgh Medical Center (UPMC) presented data at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) conference. Results from the 800-patient FLASH registry were simultaneously published in EuroIntervention.

Study outcomes

The registry is evaluating real-world patient outcomes after treatment of PE with FlowTriever. It has a primary endpoint of major adverse events comprising device-related mortality or major ble…

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Inari Medical launches trial to assess ClotTriever system in deep vein thrombosis

Inari Medical (Nasdaq:NARI) announced that it will conduct a trial for its ClotTriever system for iliofemoral deep vein thrombosis (DVT).

The Irvine, California-based company’s Defiance trial will compare ClotTriever to anticoagulation only for patients with iliofemoral DVT.

Defiance will enroll 300 patients across up to 60 centers around the world. It represents Inari’s second randomized controlled trial, running in parallel to the Peerless trial. Peerless compares the FlowTriever to catheter-directed thrombolytics in pulmonary embolism.

According to an Inari news release, the primary endpoint is a hierarchical composite of treatment failure and PTS severity at 6 months.

Dr. Xhorlina Marko, co-principal investigator and interventional radiologist at Beaumont Health, said in the release that Defiance is the first randomized controlled trial that compares mechanical thrombectomy to anticoagulation for the treatment of DVT.

Dr. St…

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Inari Medical to promote COO into CEO spot

Inari Medical COO Drew Hykes will become CEO. [Image courtesy of Inari Medical]Inari Medical (Nasdaq:NARI) announced this week that Drew Hykes will succeed Bill Hoffman as the company’s CEO.

Hykes, who currently serves as COO at the venous-specific devices company, will succeed Hoffman, effective Jan. 1, 2023. He will also join Inari’s board, while Hoffman will continue to serve on the board as well.

“Drew is a talented leader, and he is the single best problem solver I’ve ever seen. More important, he is committed to the beautiful simplicity of our mission to impact the lives of our patients and their families in extraordinary ways, and to take care of our people along the way,” Hoffman said in a news release. “Drew has established the scalable and repeatable systems that have produced best-in-class growth in patient treatments and revenue, and he has developed the cross-functional processes that have resulted in the explosion of new products and new …

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Inari Medical to bring in up to $186.3M in stock offering

Inari Medical (Nasdaq:NARI) announced that it priced an underwritten public offering worth up to $186.3 million in proceeds.

Irvine, California-based Inari Medical’s offering includes 2 million shares of its common stock at a public offering price of $81 per share before underwriting discounts and commissions. The company granted the underwriters a 30-day option to purchase up to 300,000 additional shares of common stock at the public offering price.

All shares in the offering will be sold by Inari Medical, with the company expecting the offering to close on or about March 15, 2022, subject to customary closing conditions, according to a news release.

Inari Medical did not list an intended use of proceeds for the offering. The company develops the ClotTriever system for thrombectomy in the peripheral vessels in patients suffering from deep vein thrombosis and the FlowTriever system for treating pulmonary embolism. Both minimally invasive catheter-b…

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Inari Medical to raise $156m in upsized IPO

Inari Medical (NSDQ:NARI) announced that it upsized its initial public offering of common stock shares for total gross proceeds of approximately $156 million.

Earlier this week, the venous disease treatment developer announced that it launched the roadshow for its initial public offering (IPO) of shares of its common stock, planning to offer 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.

The previously priced offering estimated shares to sell between $14 and $16, but the company upsized the offering to more than 8.2 million shares at a price of $19 per share. Inari also granted underwriters a 30-day option to purchase up to more than 1.2 million additional shares.

Inari Medical said in a news release that it expects to begin trading on the NASDAQ market today and anticipates that the IPO will close on May 27.

BofA Securities and Morgan Stanley ar…

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