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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…

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 …

“Maybe we’re overthinking it” — A tough call was the right call for this medtech developer

LimFlow’s ARC arterial catheter (pictured with needle extended) and the mesh V-Ceiver venous catheter [Image courtesy of LimFlow]

The challenges of developing the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) went beyond engineering and anatomical obstacles.

One of the biggest hurdles was downright emotional, Limflow leaders said in an interview with Medical Design & Outsourcing.

Vein-to-artery crossing is key to LimFlow’s unique FDA-approved system for chronic limb-threatening ischemia (CLTI) patients who have no other option than lower limb amputation.

To restore blood flow to an ischemic foot, the TADV system uses LimFlow’s ARC arterial catheter’s needle inside the tibial artery to puncture the adjacent tibal vein at the precise location of Limflow’s V-Ceiver venous catheter. A guidewire between the two catheters allows a physician to insert a self-…

How LimFlow’s foot-saving system prevents amputations in patients with no other options

LimFlow’s crossing stent diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]

LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD).

The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is now the only option other than amputation for ceratin CLTI patients who have lost blood flow below their knee. LimFlow’s TADV system won breakthrough device designation in October 2017 and secured FDA premarket approval (PMA) in September 2023.

“A lot of technologies come out of people fiddling with technologies that already exist, and then developing unique proprietary solutions after that,” LimFlow CEO Dan Rose said in an interview with Medica…

FDA approves LimFlow chronic limb-threatening ischemia treatment

The LimFlow System turns a vein into an artery to deliver blood flow down to an ischemic foot. This aims to prevent amputation, relieve pain and promote wound healing in patients with CLTI. [Image courtesy of LimFlow]LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI).

Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition.

France-based LimFlow designed its TADV (transcatheter arterialization of deep veins) system to reestablish blood flow in deep veins. It treats “no-option” CLTI patients who exhausted all other treatment methods. The therapy aims to prevent amputation and the associated complications, mortality and deterioration of quality of life.

This minimally invasive system bypasses blocked arteries in the leg and delivers oxygenated bloo…

LimFlow raises $40M for chronic limb-threatening ischemia treatment

LimFlow announced today that it closed an oversubscribed Series D financing round worth proceeds of $40 million (€36 million).

Paris-based LimFlow develops the LimFlow system for minimally invasive treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). The system uses a family of transcatheter products designed to optimize the perfusion of the critically ischemic foot to potentially avoid major amputation, resolve pain and promote wound healing.

According to a news release, the financing will be used for follow-up for the Promise II U.S. pivotal trial necessary for garnering FDA approval. LimFlow completed enrollment in the FDA investigational device exemption (IDE) trial last month. Proceeds will also support the commercialization of the system for deep vein arterialization.

New investors Longitude Capital, Soleus Capital Management and an undisclosed strategic investor joined the round. Existing major s…

LimFlow completes enrollment in pivotal trial for chronic limb-threatening ischemia treatment

LimFlow announced today that it completed patient enrollment in the Promise II pivotal trial of its LimFlow system.

Paris-based LimFlow designed its LimFlow system to reestablish materialization in deep veins for chronic limb-threatening ischemia (CLTI) — a severe form of peripheral artery disease (PAD) — patients who have exhausted other methods and face major amputation of their lower limbs.

The multi-center, prospective, single-arm Promise II study across multiple U.S. sites enrolled 105 no-option CLTI patients. Endpoints include amputation-free survival at six months, limb salvage and wound healing. Subjects will be followed out to three years.

LimFlow also completed enrollment in its CLariTI study of approximately 200 high-risk and no-option CLTI patients. That study will track the clinical progression of CLTI and incidence of death, amputation and revascularization attempts in patients undergoing standard medical management for the disease over a o…

20 medical device startups you need to know

The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention.

Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor

A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects.

From treating children with congenital heart disease to therapy that alleviates the effects of traumatic nightmares — and with plenty more innovations between — there is no shortage of intriguing medical devices and therapies coming up through the ranks.

“Even in the face of the COVID-19 pandemic, we continue to see tremendous energy in the medtech innovation ecosystem,” said Paul Grand, CEO of MedTech Innovator. “We are noticing a strong trend of minimally invasive medical devices that improve patient outcomes and require less time spent in th…

20 medical device startups you need to know

The medtech industry isn’t immune from COVID-19 troubles, but exciting innovation continues. These 20 medical device startups have grabbed our attention.

Tom Salemi, DeviceTalks Editorial Director and Sean Whooley, Assistant Editor

A number of medical device startups continue to make waves across the space, with new technologies and eye-watering fundraising rounds highlighting some exciting prospects.

From treating children with congenital heart disease to therapy that alleviates the effects of traumatic nightmares — and with plenty more innovations between — there is no shortage of intriguing medical devices and therapies coming up through the ranks.

“Even in the face of the COVID-19 pandemic, we continue to see tremendous energy in the medtech innovation ecosystem,” said Paul Grand, CEO of MedTech Innovator. “We are noticing a strong trend of minimally invasive medical devices that improve patient outcomes and require less time spent in th…