Haemonetics Cardiovascular Intervention Circuit invested $1 billion

                 Haemonetics Cardiovascular Intervention Circuit invested $1 billion

On April 1, 2024, Haemonetics Corporation, a global blood technology giant, announced that it has completed the acquisition of Attune Medical, a manufacturer of esophageal cooling devices. The acquisition includes an upfront payment of $160 million, as well as certain milestone payments.

Attune Medical's ensoETM esophageal cooling device, currently the only FDA-approved thermoregulatory device for esophageal protection during radiofrequency (RF) cardiac ablation, generated $22 million in sales for Attune Medical last year after less than a year on the market.

Haemonetics has made a number of acquisitions in recent years, having invested nearly $1 billion in cardiovascular interventions in a short period of time.

                              1. Only approved by the FDA to prevent fatal complications

The esophagus is anatomically located just behind the left atrium, separated only by the pericardium and a little fibrous connective tissue, and separated only a few millimeters at its thinnest point.

Due to this adjacent structure, energy delivery can be extended to the esophagus next to the posterior wall of the left atrium during radiofrequency (RF) ablation surgery. Heat damage can lead to the development of atrioesophageal fistula (AEF), a rare but fatal complication.

International reports from clinical centers have shown that the incidence of AEF after radiofrequency catheter ablation ranges from <0.1% to 0.25%. Although the incidence of AEF is low, the incidence of esophageal injury due to catheter ablation is high (about 2% to 21%). Some studies have even reported that after upper gastrointestinal endoscopy, about 77% of patients have pathological changes of esophageal injury after catheter ablation.

 ensoETM is a disposable silicone tube inserted into the esophagus that controls a patient's esophageal temperature by connecting to an external heat exchange device, such as a Blanketrol III medical thermometer.

During the procedure, ensoETM is delivered close to the core of the heart, near the large blood vessels and the left atrium, and the internal water circulation will effectively lower or raise the temperature of the esophagus, keeping the temperature of the esophagus stable.

Its advantages include:

High precision. It can monitor esophageal temperature in real time and provide accurate body temperature data.

It's safe. Effectively prevent and manage the risk of hypothermia or hyperthermia in patients.

Easy to use. Simple to operate and suitable for different types of surgery and clinical Settings.

Personalized treatment. Temperature management can be personalized according to the specific situation of the patient.

In addition to this function, ensoETM also acts as a gastric tube for gastric aspiration, feeding and medication. And for use in a range of medical scenarios involving patient cooling or heating, including during treatment such as intensive care, neurological intensive care, trauma, burn surgery, spinal surgery, and cancer surgery.

On September 14, 2023, Attune Medical announced that the function of the ensoETM system for cardiac ablation surgery has been granted an investigational Device Exemption (IDE) by the FDA for this indication via the de novo pathway.

The FDA's approval is based on preclinical studies, computer models, three randomized controlled studies, and data from tens of thousands of patients treated in the real world. Studies have shown a reduction in esophageal damage of up to 83%. In addition, ensoETM reduces the risk of esophageal fistula (AEF).

ensoETM was previously approved by the FDA to control body temperature in patients and has been used by more than 50,000 patients since it came on the market in 2015.

                                              2.$1 billion for cardiovascular therapy

Through this acquisition, in fiscal 2025, Haemonetics expects Attune Medical to contribute approximately $30 million to $35 million in revenue to the company.Haemonetics will fund the transaction through cash on hand and a $150 million drawdown under its revolving credit facility. Following this acquisition, Haemonetics estimates its net debt to EBITDA ratio (as defined by Haemonetics' existing credit agreement) to be approximately 2.4 times.

Haemonetics was founded in 1971, listed on the New York Stock Exchange in 1991, and is headquartered in Massachusetts, USA. As a global blood technology company, Haemonetics currently has multiple branches and offices worldwide, with products and services in the Americas, Europe, Asia and other regions. Ranked 63rd in the Top 100 Global Medical Device Companies 2023 by Medical Design & Outsourcing.

61. (Insulet) USA $1.305 billion /2,600

62, (NuVasive) USA $1,202 million /3,000

63, (Haemonetics)USA $1,169 million / 3,03,464, (Merit Medical Systems)USA $1,151 million /6,846, (Cochlear) Australia $1.141 billion / 45,065, (Embecta) USA $1.13 billion /2,00066,

67, Omron healthcare JAPAN $1.081 billion

68. (Konica Minolta, Medical business)JAPAN $1.048 billion

69, (Conmed)USA $1.045 billion /4,100

(Fukuda Denshi)JAPAN $1.024 billion

The company's products include blood collection equipment, blood separation and preparation equipment, blood transfusion equipment, automated blood processing systems, etc., which play a vital role in clinical applications. In addition to the products themselves, the company also provides training, consulting, technical support and other services to help medical professionals better apply and understand blood management technology and promote the continuous development of the medical field.

In recent years Haemonetics has begun to expand its presence in the cardiovascular intervention space.

$510 million into vascular closure

21 years to acquire VASCADE (VASCADE) company Cardiva Medical for $510 million, the latter's VASCADE MVP is the only FDA approved vascular closure device for use after cardiac ablation. The device includes proprietary collapsible disk technology and absorbable collagen patches to achieve hemostasis, eliminating the need for manual compressions and reducing walking time by 64%. Allow patients to get up and move a few hours earlier and significantly reduce discomfort.

$2.53 million for fiber leader

In October 2023, it acquired OpSens, a Canadian medical cardiac fiber optic sensor manufacturer, for $253 million, and acquired the company's flagship "OptoWire" pressure guide wire, which uses advanced fiber optic sensor technology to improve clinical outcomes through flow reserve fraction measurement (FFR) and diastolic pressure ratio (dPR). To assist clinicians in accurate coronary diagnosis, treatment, and outcome confirmation.

The product was approved by the FDA in 2015 and is now available in more than 30 countries worldwide, diagnosing and treating more than 150,000 patients.

Big investment, acquisition offer

In 2023, it also invested $30 million in Vivasure Medical, an Irish vascular closure company, to acquire an exclusive interest in the future acquisition of its vascular closure device PerQseal. Haemonetic will acquire Vivasure Medical once Vivasure Medical reaches its milestone.

Vivasure Medical has one PerQseal product on the market and two PerQseal+ and PerQseal Blue products in development.

The first generation of PerQseal is a sutured and fully absorbable synthetic implant for large aperture arterial vessel puncture. Its intravascular patch seals the blood vessels from the inside, returning the arteries to their natural state without leaving any trace of collagen, metal implants or sutures.

With the acquisition of Attune Medical, Haemonetics has invested nearly $1 billion in cardiovascular interventions.

Cardiovascular intervention has always been the second largest medical equipment circuit in the world. According to a recent report by Grand View Research, Inc., the global market size for cardiovascular interventional devices is expected to reach $16.11 billion by 2030, growing at a compound annual growth rate of 3.7% from 2022 to 2030. The demand for cardiovascular interventional devices continues to increase due to preferential reimbursement policies for coronary interventions, the rising prevalence of cardiovascular disease (CVD) and diabetes worldwide, and the launch of new product lines on the market. As a leading player in the blood space, Haemonetics is worth keeping an eye on.

From the House of Instruments