Inari Medical to Acquire LimFlow SA for Up to $415 Million to Expand into CLTI Treatment

Nov 05, 2023 18:17 CST Updated 18:17

LimFlow

Medical Device Developer

Inari Medical

Cardiovascular Disease Treatment Device Developer

Recently,Inari MInari Medical announced an acquisition agreement with LimFlow SA, with the total transaction value reaching up to $415 million (approximately 3 billion RMB)., including $250 million in cash at closing and $165 million in commercial and milestone payments. The transaction is expected to close this quarter.

LimFlow is transforming the treatment of CLTI, a significantly underpenetrated market that affects more than 1.5 million patients globally each year, including approximately 560,000 patients in the United States. Following its acquisition by Inari Medical, LimFlow is expected to increase patient access to its LimFlow System for Trans-Deep Vein Arterialization (TADV), designed to restore deep vein blood flow in "no-option" CLTI patients who have no other suitable endovascular or surgical treatment alternatives and face major amputation.

Vascular Intervention SpecialistInari Medical

Inari Medical was founded in July 2011 in Delaware, with its headquarters in Irvine, California. It is a commercial-stage medical device company dedicated to developing, manufacturing, and selling interventional treatment devices for venous diseases.

In May 2020, Inari Medical was listed on the NASDAQ Stock Exchange in the United States with the stock code NARI. Inari Medical ranks among the top ten in the global medical device R&D investment list.The company's R&D expenditure was $66 million, accounting for 16.8% of its revenue. In addition, the company successfully ranked on the 2022 Global Medical Device Company Top 100 list.

On January 8, 2021, Inari Medical announced that its FlowTriever system for the treatment of pulmonary embolism and right atrial transfer thrombus received FDA 510(k) clearance in the United States.In addition, the ClotTriever system for the treatment of deep vein thrombosis has received FDA 510(k) clearance and CE mark certification.

Since then, Inari Medical has continued to expand its presence in this field, enriching its product portfolio. On June 7, 2023, the company launched two new products: the RevCore thrombolytic catheter and the Triever16 Curve catheter, addressing challenges in retrieving thrombi within venous stents and enhancing trackability for pulmonary embolism and right atrial transfer thrombi, respectively. Inari Medical claims that, compared to a 16Fr continuous aspiration catheter, the Triever16 Curve catheter offers unique advantages, including compatibility with FlowSaver blood return and the ability to easily connect to either a 20Fr or 24Fr catheter.

The Trieve Aspiration Catheter is a large-lumen catheter with high trackability that can be used with large-bore syringes to quickly aspirate large amounts of thrombus while minimizing blood loss. It is available in three sizes: Triever16, Triever20, and Triever24.

The FlowTriever catheter is a catheter with three self-expanding nitinol mesh disks, available in four sizes: S (6-10 mm), M (11-14 mm), L (15-18 mm), and XL (19-25 mm). It is designed to lyse thrombus and deliver it to the Triever20.

The ClotTriever system is another core product of Inari Medical, used for treating deep vein thrombosis (DVT). The system can fully conform to blood vessel walls with diameters of 6-16 millimeters, and its key components include the ClotTriever catheter, ClotTriever BOLD catheter, and ClotTriever sheath.

The ClotTriever catheter features a nitinol cutting element and a braided collection bag, designed to cut and collect thrombus from within the ClotTriever sheath. The cutting element is atraumatic, causing no damage to the vessel wall, and is capable of handling thrombi of varying degrees, including newly formed acute thrombi and long-standing chronic thrombi. The ClotTriever XL catheter is an "enlarged version" of the ClotTriever catheter, specifically designed for the efficient removal of various chronic thrombi in the inferior vena cava.

The radial force of the ClotTriever BOLD catheter is 30% higher than that of conventional thrombectomy devices. This allows ClotTriever to exert greater force on the vessel wall during expansion, enabling it to fit tightly against the vessel wall, thereby reducing flow resistance and thrombus formation. This component enhances the thrombus capture capability of the ClotTriever system, allowing it to capture thrombi of various sizes and hardness levels and remove them from the blood vessels, preventing their migration or re-obstruction.

ClotTriever Sheath is a catheter sheath specifically designed to maximize thrombus removal while minimizing blood loss. Its self-expanding nitinol funnel can fully conform to the vessel wall, enabling 360° thrombus clearance. The device features a one-handed hemostasis valve that minimizes blood loss during insertion and removal.

Recently, Inari Medical released its third-quarter earnings report, with revenue of $126.4 million, representing a year-over-year increase of 31.4%.Operating expenses totaled $109.8 million, with a net income of $3.2 million. The Irvine, California-based company also raised and tightened its full-year guidance, forecasting revenue between $490 million and $493 million, up from the previous estimate of $482 million to $492 million.

Inari Medical CEO Drew Hykes stated, "We are seeing meaningful contributions from our core VTE business, new product launches, and international regions. Our disciplined investment approach has resulted in positive operating income for the first time since Q4 2021. Our core business is thriving, and we are confident in our ability to sustain growth in the coming years. Most importantly, we remain fully committed to advancing our mission of addressing significant unmet patient needs. The acquisition of LimFlow aligns with this goal."

Why AcquisitionLimFlow？

LimFlow System is a minimally invasive technique designed to reroute blood around diseased arteries in the leg and deliver it into the tibial veins that supply blood to the foot, thereby transporting blood and oxygen to ischemic and hypoxic tissues in the foot. The abundant oxygen in the tissues can immediately relieve pain and promote chronic wound healing in many patients, improving their quality of life and enabling them to regain their favorite activities.

LimFlow SA is a medical technology company headquartered in France, focusing on the development and promotion of innovative technologies for the treatment of chronic limb-threatening ischemia (CLTI). The company's core product is an interventional device named the "LimFlow System."

LimFlow SA is committed to advancing the development and application of the LimFlow System through clinical research and partnerships. The company collaborates with medical institutions worldwide to conduct clinical trials assessing the safety and efficacy of the technology. It also partners with other medical device companies to drive innovation in the field of chronic limb-threatening ischemia.

In September this year,Paris-based LimFlow SA's breakthrough system for treating chronic limb-threatening ischemia (CLTI) has received FDA Premarket Approval (PMA), marking the first FDA-approved product of its kind for treating this severe form of peripheral artery disease (PAD).

The LimFlow System includes an endoluminal ultrasound catheter (arterial, venous) kit and ultrasound monitoring system; venous valve cutter; and配套 self-expanding covered stent锥形 covered stent, straight covered stent. Through the venous access at the ankle or foot sole, puncture from the artery to the venous segment is performed under ultrasound guidance. The push-type valve cutter retracts to remove the venous valve, and a straight extended covered stent is placed in the venous segment. Then, through the distal end of the covered stent, a tapered crossover covered stent is placed into the arterial segment.

The LimFlow Percutaneous Deep Vein Arterialization System is a minimally invasive technology designed to divert blood around diseased arteries in the leg and deliver it into the tibial veins that supply blood to the foot, thereby transporting blood and oxygen to ischemic and hypoxic tissues in the foot. The substantial increase in oxygen within the tissues can immediately alleviate pain and promote chronic wound healing in many patients, improving their quality of life and enabling them to regain their favorite activities.

According to a study published by LimFlow SA in The New England Journal of Medicine at the beginning of the year, 76% of patients with chronic limb-threatening ischemia (CLTI) retained their legs three years after surgery.

Specific research data:

76% limb salvage rate, more than three-quarters of the patients retained their legs and avoided amputation;

76% of patients had completely healed (25%) or were healing (51%);

The patients' pain was significantly reduced, with the average pain score decreasing from 5.3/10 before treatment to 3.0/10 six months after treatment.

The success rate of the surgery is as high as 99%, indicating that the surgery is reproducible across different locations and researchers.

The median operation time was 199 minutes, and there were no surgery-related adverse events;

It can be said that the LimFlow System is a very effective treatment technology that allows patients to have a normal quality of life.

"The acquisition of LimFlow is closely aligned with our mission to address significant unmet patient needs and adds another highly differentiated growth platform to our portfolio. We believe the CLTI market is poised for sustained growth, driven by compelling technology, outstanding clinical outcomes, and multiple expansion opportunities. Since early 2022, as a minority investor in LimFlow and a board observer, we have witnessed firsthand the life-changing impact of this technology on patients, as well as how complementary our two businesses are," said Drew Hykes, CEO of Inari Medical.

Vast Market Opportunities

Chronic Limb-Threatening Ischemia (CLTI) is the most severe form of peripheral artery disease (PAD) and often occurs in patients with coronary artery disease, diabetes, obesity, high cholesterol, and/or hypertension. Patients with CLTI frequently experience profound chronic pain and develop wounds or infections that lead to major amputations, and it is closely associated with increased mortality and reduced quality of life.

Image Source: LimFlow Official Website

Patients with chronic limb-threatening ischemia (CLTI) have few clinically effective treatment options. Statistics show that 15-20% of patients with chronic limb-threatening ischemia (CLTI) undergo amputation within one year of diagnosis, and 40% will die within two years after amputation surgery, with a mortality rate worse than heart failure, stroke, and most cancers.

According to statistics, there are as many as 4 million CLTI patients in the United States alone, with more than 150,000 patients having to undergo major amputation surgery each year to save their lives. At the same time, the U.S. spends up to $12 billion on medical expenses for this. Despite the high annual medical expenditure, the 5-year mortality rate of patients remains very high (with a mortality rate exceeding 50% at the 5-year mark).

LimFlow stated that it has trained and deployed a team of sales representatives in selected U.S. markets, who are now executing the rollout of the LimFlow therapy. Eyni estimated that there are approximately 55,000 CLTI patients in the U.S. each year who have no other treatment options besides amputation, representing an annual opportunity worth $1.5 billion for LimFlow devices in the United States alone.

Inari Medical's acquisition of LimFlow SA can be said to have expanded Inari Medical's product line from venous diseases to peripheral arterial PAD, forming a perfect complement to its previous venous disease product line. Peripheral artery and peripheral venous diseases are rapidly growing fields with many unmet clinical needs. A global patient population of nearly 150 million makes Inari Medical potentially poised to become an industry giant in the future.

丨Source: Medical Device Innovation Network

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