| Over a week ago | ||||
Inari Medical announced… Inari Medical announced positive results from the FLAME study in high-risk/massive pulmonary embolism. The data was presented during the Late-Breaking Clinical and Investigative Horizons session at the 2023 ACC conference on March 5th by national Principal Investigator Mitchell Silver, DO, FACC, FVSM, RPVI, an interventional cardiologist and vascular medicine specialist at OhioHealth Riverside Methodist Hospital. FLAME is the largest prospective study of interventional treatment in high-risk PE, a patient population with a historical mortality rate of 25-50%. The study collected data on patients treated with FlowTriever and on those treated with other therapies in a context arm. The study was stopped early due to overwhelmingly positive outcomes in the FlowTriever patients. The primary endpoint measured a composite of meaningful in-hospital clinical outcomes, including mortality, major bleeding, clinical deterioration, and escalation to an alternate therapy. The endpoint was met in the FlowTriever arm, driven predominantly by a low mortality rate of 1.9%. This represented a 90% reduction compared to the 29.5% mortality rate seen in patients treated with other therapies in the context arm. "FLAME is yet another example of Inari's commitment to developing impactful, high-quality clinical evidence in VTE," said Thomas Tu, MD, Chief Medical Officer of Inari Medical. "The results of the trial will have an immediate impact on the treatment of high-risk PE patients and will ultimately change clinical practice guidelines for that population. Furthermore, the magnitude of the benefit seen in FLAME will undoubtably influence treatment decisions over a broader spectrum of PE patients." | ||||
Canaccord analyst William… Canaccord analyst William Plovanic raised the firm's price target on Inari Medical to $80 from $77 and keeps a Buy rating on the shares. The analyst said Inari seems very confident that its purpose built products for VTE will continue to be viewed as best-in-class and retain its large share in the market, which we assume in our forward estimates. | ||||
The company said,… The company said, "For the full year 2023, we are reaffirming our revenue guidance range of $470 million to $480 million." | ||||
Reports Q4 revenue… Reports Q4 revenue $107.77M, consensus $104.84M. "Crisp execution across all five of our growth drivers generated robust revenue growth in the fourth quarter," said Drew Hykes, CEO of Inari Medical. "We are especially pleased with the milestones we achieved across several clinical studies as well as two important new product launches. Our efforts continue to drive market expansion and uptake of our devices while further distancing Inari from both existing and future competition." | ||||
Canaccord raised the… Canaccord raised the firm's price target on Inari Medical to $77 from $76 and keeps a Buy rating on the shares. The analyst updated his model and raised our Q4 and 2023 revenue estimates to reflect Q4's preannounced revenues and FY23 guidance. | ||||
| Over a month ago | ||||
Truist analyst Richard… Truist analyst Richard Newitter lowered the firm's price target on Inari Medical to $65 from $75 and keeps a Hold rating on the shares as part of a broader research note previewing Q4 earnings in MedTech. The company offered positive guidance for FY23 revenue growth but the stock did not rebound amid mounting competition fears and concerns around sustainability of above 20% core VTE trajectory, the analyst tells investors in a research note. | ||||
BTIG analyst Ryan… BTIG analyst Ryan Zimmerman raised the firm's price target on Penumbra PEN) to $270 from $240 and keeps a Buy rating on the shares. Commentary from a key opinion leader Dr. Meisinger - a board-certified interventional radiologist and the Director of the Independent and Interventional Radiology Residencies at the UC San Diego Department of Radiology - indicated that he expects to switch nearly 100% of his share to the company's Lightning Flash in DVT cases while usage in PE will be more balanced between both Penumbra and Inari Medical (NARI), the analyst tells investors in a research note. BTIG further states that Dr. Meisinger had a difficult time getting access to Lightning Flash catheters initially due to inventory shortage. | ||||
In a regulatory filing,… In a regulatory filing, Inari Medical disclosed that its director William Hoffman sold 55K shares of common stock on January 17th in a total transaction size of $3.68M. | ||||
Inari Medical announced… Inari Medical announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled trial comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis treated with the ClotTriever System versus anticoagulation only. The trial is led by Principal Investigators: Dr. Xhorlina Marko, Interventional Radiologist at Beaumont Health; Dr. Steven Abramowitz, Chair of Vascular Surgery at MedStar Health; and Professor Stephen Black, MD, consultant vascular surgeon, Guy's and St. Thomas' Hospital, London. The first DEFIANCE patient was enrolled by Dr. Abdullah Shaikh, Interventional Radiologist at Allegheny Health Network, Pittsburgh, PA. DEFIANCE will enroll 300 DVT patients at up to 60 centers worldwide. DEFIANCE is Inari's second RCT, enrolling in parallel to the PEERLESS pulmonary embolism trial. "We're thrilled to enroll the first patient and officially kick off this important clinical trial," said Dr. Shaikh. "ClotTriever is fundamentally different than other DVT treatments. This trial is designed to produce definitive evidence to change standard of care." | ||||
Inari is providing… Inari is providing financial guidance for full year 2023 revenue of $470 million to $480 million, reflecting growth of approximately 23% to 25% over 2022. Further detail will be provided when Inari reports its financial results for the fourth quarter and full year 2022. | ||||
