Recently, medical imaging company Spectra has completed its Series B financing and raised $50 million (approximately RMB 356 million) in funding. It is understood that the funds raised in this round of financing will support the commercial expansion and product increase of Spectra 'Hypervue imaging system to benefit patients with coronary artery disease.

It is worth noting that this round of financing is led by Johnson and Johnson Innovation and supported by investors such as S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, and Heartwork Capital.

Spectrawave， The intravascular imaging system has been approved by the FDA

According to publicly available information, Spectra was founded in 2017 and is located in Massachusetts, USA. It is a medical imaging company focused on improving the treatment and prognosis of patients with coronary artery disease (CAD). The Spectral Medical Imaging Platform is the most advanced integration of mature imaging technologies, designed to help interventional cardiologists understand patients and optimize intervention measures.

In 2023, Spectra 'flagship intravascular imaging system HyperVue obtained 510 (k) approval from the US Food and Drug Administration (FDA).

This new intravascular imaging system combines two current technologies, including optical coherence tomography (OCT) on the left side of the figure, which can display the structure inside the lumen and vascular wall; The near-infrared spectroscopy (NIRS) on the right can perform spectral chemical analysis on the blood vessel wall to reveal areas of high lipid content, particularly identifying lipid core plaques associated with plaque rupture.

Afterwards, Spectra obtained FDA 510 (k) license to improve the HyperVue imaging system, including contrast free saline imaging, artificial intelligence (AI) algorithm support for identifying clinical structures such as calcium and outer elastic layer (EEL), and joint registration of hands-free angiography.

It is reported that the HyperVue toolkit includes artificial intelligence supported lipid, luminal, stent, and collateral detection, as well as a flushing free preprocessed Starlight imaging catheter designed specifically for efficient setup and image acquisition in complex lesions.

Spectral intravascular imaging, recommended by the European 1A guidelines

Intravascular imaging can be used to improve the prognosis of patients undergoing stent surgery for coronary artery occlusion. According to Spectra, the information provided by this technology can assist interventional cardiologists in making decisions regarding plaque modification, stent and balloon size, risk of adverse events, and more.

The latest research shows that using intravascular imaging in percutaneous coronary intervention surgery improves blood flow to the heart compared to using X-ray imaging for angiography.

The guidance for intravascular imaging has been supported by a large number of randomized clinical trials (RCTs), and recent meta-analyses of 22 RCT studies and approximately 16000 patients have compiled these results. This year, the efficacy of coronary stent implantation in patients was presented in The Lancet, and the evidence and widespread understanding of its impact have recently pushed intravascular imaging towards the 1A guideline recommendations in Europe, which the United States is expected to follow in due course

Namati stated that the company's system received positive reviews when it was first launched in the United States. Improving the functionality and usability of intravascular imaging systems is now crucial for expanding the use of imaging and improving care for these patients, "Namati said.

With the latest developments, the company's goal is to develop new software for HyperVue that will increase the ability to measure blood pressure drop within coronary arteries without using line based sensors, while also supporting its ongoing commercial operations.

Development of intravascular imaging technology

At present, coronary heart disease is still one of the main causes of death among residents in China, and the number of cases and deaths caused by coronary heart disease in China will continue to grow rapidly in the next 10 years. Faced with an increasing number of patients with coronary heart disease, how to accurately diagnose not only tests the diagnostic level of doctors, but also the accuracy of intravascular imaging detection equipment.

The "gold standard" coronary angiography for the diagnosis of coronary heart disease can only provide two-dimensional contour information of the vascular lumen to judge the degree of stenosis, and cannot accurately judge the structure of the arterial wall, especially the evaluation of the characteristics of atherosclerotic plaque. To compensate for the aforementioned shortcomings of coronary angiography, intravascular imaging techniques including optical coherence tomography (OCT) and intravascular ultrasound (IVUS) have emerged and rapidly developed.

In fact, optical coherence tomography (OCT) and intravascular ultrasound (IVUS), as the two most important intravascular imaging techniques in coronary intervention diagnosis and treatment, have been clinically applied for decades. OCT has higher resolution and can better compare plaque components; IVUS can penetrate the blood and has a deeper imaging depth. Both imaging techniques have become indispensable auxiliary means for cardiovascular interventional doctors.

However, both imaging techniques have their own shortcomings, with OCT imaging having limited penetration depth and IVUS having weaker spatial resolution. It is difficult for a single OCT or IVUS to provide complete anatomical information of blood vessels and plaques. By utilizing their complementarity, integrating OCT and IVUS imaging catheters into the same imaging catheter can achieve multimodal intravascular imaging of both, providing interventional doctors with more ideal histological and morphological information of plaques and vascular walls.

From the perspective of enterprises, Philips, Boston Scientific Volcano, InfraredX, Foreign companies such as Taiermao, among which Boston Scientific was the first to introduce IVUS technology to the market; At the same time, domestic enterprises such as Kaikai Medical, Quanta Hengsheng, Anglo American, Beixin Technology, and Yuanda Medical are accelerating their research and development in the field of IVUS. Among them, the panoramic Hengsheng intravascular imaging device integrates IVUS and OCT technologies, making it the first domestically approved "IVUS+OCT 2-in-1" intravascular imaging device.

Johnson&Johnson continues to invest in the cardiovascular field

It should be pointed out that in the current financing of Spectrave, its leading investor Johnson&Johnson Innovation has also received industry attention.

According to data, Johnson&Johnson Innovation was founded in 1979 with the aim of improving human health through innovation. With the help of its innovation center, external innovators can access a wide range of resources within Johnson&Johnson, including funding, research and development expertise, and more. As Johnson&Johnson's venture capital division, Johnson&Johnson Innovation has invested in pharmaceuticals, medical devices, and healthcare consumers.

Prior to investing in Spectra, an intravascular imaging company, Johnson&Johnson was also continuously increasing its focus on the cardiovascular field.

On August 20th, Johnson&Johnson announced a final acquisition agreement with V-Wave, planning to acquire V-Wave for a total transaction amount of $1.7 billion. The latter is a company dedicated to developing percutaneous implantation technology for patients with chronic failure, with its core product Ventura Interatrial Shunt atrial shunt.

In April of this year, Johnson&Johnson acquired Shockwave, a cardiovascular intervention company, for a premium of $13.1 billion. As a star enterprise in the global cardiovascular field, Shockwave's product, Intravascular Lithotripsy, is the world's first intravascular shock wave system that can solve the problem of coronary artery calcification.

In November of this year, Johnson&Johnson acquired Abiomed, a leader in the artificial heart field, for a high price of $16.6 billion, making it the largest merger and acquisition in the global medical device industry in 2022. It is reported that Abiomed has a product pipeline including Abiomed Breethe OXY-1 System cardiopulmonary support system (ECMO)&ECPella, preCARDIA, and Impella product combinations, which involve clinical indications such as high-risk PCI, cardiogenic shock, right heart failure, and severe lung failure.

From the perspective of performance, Johnson&Johnson's merger and acquisition strategy in the cardiovascular field has shown initial success. According to Johnson&Johnson's latest financial report, in the first half of 2024, Johnson&Johnson Medical Technology achieved revenue of $15.778 billion, a year-on-year increase of 3.3%. Among them, the cardiovascular business achieved a revenue of 3.679 billion US dollars, an increase of 17.8% year-on-year, becoming the business segment with the highest revenue growth of Johnson&Johnson Medical Technology.

Johnson&Johnson is aggressively entering the cardiovascular device business, and in an area with significant unmet demand, we have a huge opportunity to gain a premium for differentiated innovation.

As early as early 2023, Johnson&Johnson stated that the company plans to focus on transactions that add value to its cardiovascular product portfolio, and it is not ruled out that the company will invest more in cardiovascular medical equipment in the future; In December 2023, Johnson&Johnson reiterated its commitment to "continue expanding its business into high growth areas such as cardiovascular intervention.

Source: http://qixieke.com/Font/index/detailPage.html?id=3188-142