Inspira Technologies Signed Strategic OEM Agreement with Terumo Cardiovascular

On December 27, 2023, Inspira Technologies, a ground breaking respiratory support technology company, announced that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement with Terumo Cardiovascular, a division of Terumo Corporation, a leading global medical device company. 

Terumo Corporation operates in over 160 countries and regions around the world, providing patients in a variety of medical settings with over 50,000 products and services. Oxygenation devices, heart-lung machines, and monitoring systems are areas of expertise for Terumo Cardiovascular. 

This agreement calls for the creation of a flow mechanism that will be incorporated into Inspira Technologies’ products and used to circulate blood extracorporeally while it is being oxygenated. This may potentially entail incorporation into the INSPIRATM ART system, which aims to bring a novel approach to acute respiratory treatment by rapidly increasing oxygen saturation levels with modest blood volumes. With the help of the INSPIRA ART system, patients can be treated while they are awake and breathing on their own, nullifying the need for intrusive mechanical ventilation.

Joe Hayon, Inspira Technologies’ Co-Founder and President, stated, “This is a very important agreement for the Company, and we believe that it is in line with our strategy towards developing collaborations with the largest medical device companies to join in on our journey to market.”

As per DelveInsight’s “Extracorporeal Circulation System Market” report, the global extracorporeal circulation system market is expected to grow in the coming years owing to the rising demand for effective diagnostic cardiovascular devices due to a rise in the incidence of cardiovascular diseases (CVDs) across the globe. Further, the rising demand for extracorporeal circulation systems, the increasing number of cardiac surgery, and new product launches in the market, among others, will also contribute to the growth of the extracorporeal circulation system.

Burning Rock Received FDA Breakthrough Device Designation for its OverC™ Multi-Cancer Detection Blood Test 

On January 3, 2023, Burning Rock, a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, announced that its OverC™ Multi-Cancer Detection Blood Test (MCDBT) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA), which is the third of its kind globally.

Certain medical devices that enable more effective treatment or detection of fatal or permanently disabling diseases or conditions, such as cancer, are given the Breakthrough Device Designation under the FDA’s Breakthrough Devices Program. By accelerating their creation, evaluation, and review, this initiative aims to give patients and healthcare professionals quick access to medical devices that have received the designation.

For individuals of either sex, aged 50 to 75, who are at average risk for cancer, OverCTM MCDBT is designed to provide early identification of a variety of cancer types, including oesophagus, liver, lung, ovarian, and pancreatic cancers. In the case-control research THUNDER, OverCTM MCDBT showed a 69.1% sensitivity and 98.9% specificity, and it will be further validated in prospective interventional trials in asymptomatic populations. Results from “Detected” in the top one or two expected tissues of origin of cancer-associated signals may point to the presence of cancer and should be followed up by diagnostic procedures advised by licenced medical professionals in accordance with professional standards. The presence of cancer is not ruled out by test results of “Undetected,” thus people should keep getting the standard of care screening tests advised by guidelines.

Liquid biopsy has the potential to improve cancer detection accuracy and enable early diagnosis and treatment, enhancing patient survival and quality of life while lowering the financial burden of the disease on society. Burning Rock began working on a DNA methylation-based multi-cancer early detection system in 2016. Since then, the system’s validation data and technical developments have been presented at ESMO, ASCO, and other medical conferences, as well as in journals like Nature Biomedical Engineering. These studies show the system’s high tissue specificity, sensitivity, and accuracy. 

Burning Rock got the CE mark in May 2022 for their OverCTM MCDBT, which was produced in both US and Chinese factories. In May 2022, Burning Rock received CE mark for its OverC™ MCDBT manufactured in both the US and China facilities. The FDA Breakthrough Device Designation granted for OverC™ MCDBT would pave the way for a clearer registration path through confirmative performance validation and utility establishment.

Mr. Yusheng Han, founder and CEO of Burning Rock, said, “We are very excited that our cfDNA methylation multi-cancer early detection technology has received FDA Breakthrough Device Designation. For cancer, early diagnosis and treatment are the key to the long-term survival of patients. Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now. Burning Rock has also launched two prospectively collected case-control studies, PREDICT and PRESCIENT, with more than 10,000 subjects to be enrolled, to continue developing OverC™ MCDBT to cover more cancer types. With our promising clinical research data, we believe that over time our collective effort is going to make significant impact towards the improvement of cancer patients’ lifespan and quality of life.“

According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market” report, global liquid biopsy in cancer diagnostics market was valued at USD 7.64 billion in 2021, growing at a CAGR of 16.64% during the forecast period from 2022 to 2027 to reach USD 19.24 billion by 2027. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand of precision medicine, and technical innovation in product development, among other factors, are expected to drive the liquid biopsy in the cancer diagnostics market. The liquid biopsy in the cancer diagnostics market witnessed a dip in the generated revenue due to implementing measures to curb the spread of the COVID-19 infection. One of the major steps during the COVID-19 surge was the suspension of numerous elective procedures and outpatient visits which reduced the demand for liquid biopsy products and services in the market as the healthcare system guidelines across the globe temporarily focused all their efforts on the management of COVID-19 infection patient load during the initial lockdown period.

Cook Medical’s Launched New Bipolar Electrodes Portfolio

On January 3, 2023, Cook Medical, launched a new, streamlined portfolio of urological bipolar electrodes in the U.S. This portfolio includes the products that urologists use most frequently to focus on daily electrode needs when performing procedures on the bladder and prostate. 

The bipolar electrodes portfolio includes a total of seven products. The portfolio is streamlined to include the most frequently used and in-demand products in this category. 

Six of the products are configurations indicated for use in transurethral resection, ablation and soft tissue removal of the prostate and bladder and where hemostasis is required:

  • A bipolar transurethral bladder loop, which is angled at 136° to accommodate the anatomy of the bladder
  • Four transurethral cutting loops—12° and 30° options, each available in medium and large sizes 
  • A bipolar transurethral needle electrode

The seventh product is the Bipolar Transurethral Plasma Disc, which is made for electro-vaporization in urological procedures to help with vaporization of the prostate and coagulation. The patented concentric, multi-tiered disc design by Omnitech Systems, Inc., provides concentrated current density to be more energy efficient while still supporting current flow and plasma ignition.

The distal wires of each electrode tip (except for the transurethral needle electrode) are made from a platinum-iridium alloy, which extends from the leading edge past the stabilizer. The platinum-iridium alloy is reinforced by being crimped deep into the body of the electrode for durability. The electrodes have a shelf life of five years, providing additional stock and supply benefits.

“We listened to physicians about obstacles they were facing when trying to perform resection and ablation procedures, such as benign prostatic hyperplasia (BPH). For example, we learned that most bladder loops on the market were difficult to use around the bladder, so we offer a bladder loop angled at 136° to improve efficiency of surgery. With the seven products in the streamlined bipolar electrodes portfolio, we aim to help physicians focus on treating patients with products they use frequently,” said Rob Faulkner, senior director of Cook Medical’s Urology specialty.

According to DelveInsight’s “Urology Devices Market” report, the global urology devices market was valued at USD 9.17 billion in 2021, growing at a CAGR of 6.78% during the forecast period from 2022 to 2027 to reach USD 13.56 billion by 2027. The urology devices market is witnessing an explosion in product demand due to numerous reasons, such as the increasing geriatric population who make up for a formidable share of the total population susceptible to developing various age-related indications such as benign prostatic hyperplasia in older men, increasing prevalence of kidney disorders such as kidney stones,  growing prevalence of lifestyle disorders such as hypertension and diabetes that may impact the health of organs in the urinary system such as kidneys over a long period of time. Additionally, product development activities in terms of product approvals, and regulatory support, such as assigning of special designations, also play a key role in establishing an upward growth trend in the urology devices market during the forecast period from 2022-2027.

Verana Health and Sight Sciences Collaborated on Glaucoma Research Using Curated Real-World Data from the IRIS Registry

On January 4, 2023, Verana Health, a digital health company elevating quality in real-world data (RWD)—and Sight Sciences, Inc., an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, announced a research collaboration designed to provide insights that may lead to improved outcomes for patients with primary open-angle glaucoma (POAG). 

To assess different aspects of its implant-free, minimally invasive OMNI Surgical System, which specifically addresses all three known points of resistance in the aqueous outflow system—the trabecular meshwork, Schlemm’s canal, and the collector channels—Sight Sciences will make use of Verana Health’s Qdata Glaucoma RWD module. The only known modifiable risk factor for glaucoma is intraocular pressure (IOP), and OMNI allows surgeons to lower IOP without using more aggressive surgical techniques or foreign body implants seen in traditional minimally invasive glaucoma surgery (MIGS) treatments. OMNI can be used prior to, in conjunction with, or after cataract surgery and is appropriate for canaloplasty followed by trabeculotomy.

A collection of eye conditions known as glaucoma, a leading cause of blindness globally, can cause vision loss or total blindness by damaging the optic nerve over time while initially showing minimal symptoms. With 2.7 million Americans suffering with POAG, it is the most prevalent kind of glaucoma in the country. Patients with POAG ultimately lose their peripheral vision, even though they may not initially exhibit any symptoms. POAG, if untreated, can result in blindness.

The American Academy of Ophthalmology’s (Academy) IRIS Registry (Intelligent Research in Sight), which collects real-world glaucoma data, powers Qdata Glaucoma, the only data module that documents the whole real-world glaucoma patient journey. This curated data module provides information for:

  • More than 5 million de-identified patients with linked closed claims
  • More than 341,000 glaucoma patients who received MIGS procedures
  • MIGS procedure details and IOP readings
  • An average of 2.9 years follow-up for glaucoma patients 

The IRIS Registry is the first comprehensive eye illness clinical registry in the United States and one of the largest specialty society clinical data registries in all of medicine. It was introduced in 2014 and has since collected data from more than 540 million patient visits, more than 75 million unique de-identified individuals, more than 60 electronic health records systems (EHRs), and more than 16,000 eye care specialists working in clinics around the country. The Academy’s sole end-to-end data curation and analytics partner for the IRIS Registry is Verana Health.

It is extremely challenging for researchers to pinpoint specific MIGS devices utilised using medical claims data alone due to shared CPT codes and the limited information that was obtained. However, Verana Health’s access to comprehensive patient journey information and advanced analytics allowed Sight Sciences to gain valuable insight into real-world, long-term evidence. In addition, the curated database includes de-identified patient outcomes data (such as IOP) that can’t be found anywhere else.

“We chose to collaborate with Verana Health both for the company’s access to curated ophthalmological data through the IRIS Registry and its suite of advanced analytics tools that enable insights into glaucoma treatments,” said Jaime Dickerson, PhD, vice president of strategic clinical evidence at Sight Sciences. Jaime added, “Verana Health shares our conviction that high-quality RWD allows researchers to assess questions such as the long-term efficacy, safety and cost-effectiveness of glaucoma treatments and procedures in the real world.”

Michael Mbagwu, MD, senior medical director for Verana Health, says, “Sight Sciences shares our goal of improving outcomes and treatments for people with glaucoma. Their research using RWD from our Qdata Glaucoma module could result in better treatment selections that could help ease the many burdens facing patients with glaucoma and improve their quality of life.”

According to DelveInsight’s “Ophthalmic Surgical Devices Market” report, the global ophthalmic surgical devices market was valued at USD 8.91 billion in 2021 and will grow at a CAGR of 5.09% during the forecast period from 2022 to 2027 in order to reach USD 11.97 billion by 2027. The ophthalmic surgical devices market is observing remarkable market growth due to the factors such as the growing prevalence of various ophthalmic disorders such as glaucoma, cataract, refractive errors, and others. Moreover, the rising burden of the geriatric population, the rising prevalence of diabetes, and other risk factors for ophthalmic disorders will aid in driving the market for ophthalmic surgical devices. Additionally, the rising awareness about vision impairment, surging technological advancements in the devices, along with the increasing product launches and approvals, the presence of key players in the market, and other factors will create a requisite for the ophthalmic surgical devices in the market. Therefore, the market for ophthalmic surgical devices is estimated to grow at a substantial CAGR during the forecast period from 2022 to 2027.

Cardiovascular Systems, Inc. Announced FDA 510(k) Submission of Innova Vascular, Inc.’s Thrombectomy System 

On January 4, 2023, Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced that Innova Vascular, Inc. (Innova) has submitted a 510(k) Premarket Notification to the U.S. Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.

To remove blood clots from veins and arteries, doctors undertake thrombectomy, an interventional technique that is rapidly gaining popularity. Each of the cutting-edge thrombectomy devices from Innova that target peripheral vascular disease will be purchased and made available for sale by CSI. The thrombectomy devices’ commercialization will be a great addition to CSI’s larger portfolio of cutting-edge technology for the treatment of cardiovascular disease.

In about 6 months, CSI might start to commercialize a range of aspiration catheters and clot retrieval devices for use in the peripheral vasculature, subject to regulatory approval in the US and the conclusion of the acquisition of the first Innova system. Following the conclusion of the related clinical trials and 510(k) clearances, the portfolio and associated indications for usage will be expanded to cover the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Enrollment for these trials is anticipated to start later in 2023.

In accordance with the terms of the agreements made with Innova, CSI has given that company financial support for the creation of thrombectomy devices. According to an acquisition option agreement, CSI will have the sole right to purchase the thrombectomy devices after Innova completes important technical, regulatory, and clinical milestones in the development programme, provided that the deal’s closing conditions are satisfied.

Scott R. Ward, Chairman, President and CEO, said, “CSI’s strong commercial presence, with over 150 peripheral sales representatives, will make thrombectomy an excellent fit as we seek to reach more patients and drive increased revenue through our sales channel beginning later this year.”

Sanjay Shrivastava, Ph.D., CEO of Innova, said, “The FDA submission of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of this thrombectomy system.”

According to DelveInsight’s “Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market” report, the global Neurovascular Thrombectomy Devices/Neurothrombectomy Devices Market was valued at USD 722.78 million in 2021, growing at a CAGR of 6.15% during the forecast period from 2022 to 2027 to reach USD 1033.33 million by 2027. The rise in demand for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices is predominantly imputed to the rising prevalence of neurovascular disorders across the globe which require Neurovascular Thrombectomy Devices/Neurothrombectomy Devices for their treatment, such as ischemic stroke and hemmorhagic stroke, the growing burden of old age population. In addition, shifting key players’ focus towards the development of technologically advanced products and initiatives to increase awareness regarding neurovascular diseases and their prevention are some of the factors among others that are likely to upsurge the market for Neurovascular Thrombectomy Devices/Neurothrombectomy Devices. 

liberDi Received FDA Regulatory Clearance for its Digital Dialysis System 

On January 4, 2023, liberDi Ltd., a portfolio company of The Trendlines Group Ltd., announced that it has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace, by themselves, monitored by their physician using the advanced telemedicine capabilities of the system.

Around the world, one in ten people have renal illness. Dialysis is the most popular treatment for people with the condition when it is advanced. Dialysis is a form of life support that adds 5 to 10 years to the normal lifespan. 90% of patients dialyze in clinics for the first half of their remaining lifetimes. With its self-care method, liberDi’s technology is poised to displace current full-service, in-clinic care for a large population of dialysis patients.

To establish the safety and efficacy of the Portable Peritoneal Dialysis system on patients needing dialysis, liberDi conducted two early clinical studies. Under the supervision of three Israeli medical facilities, 42 individuals underwent dialysis using the device. The findings of the research confirm the viability and safety of an automatic PD exchange using liberDi’s Digital Dialysis Clinic. Additionally, liberDi conducted a human factor validation research examining all user groups, including those who require dialysis, their caretakers, and medical specialists including nephrologists and dialysis nurses. The study demonstrated that anyone can use the system after just one 90 minute proper training session by simulating a real-world setting.

liberDi CEO, Hezkiah Tsoory remarked, “Receiving FDA clearance for our state of the art Digital Dialysis Clinic technology, is a huge achievement for liberDi. This is a big step forward in liberDi’s journey to improve the quality of life of people on dialysis. liberDi’s system is designed to provide these patients with ease of use, freedom of movement, automatic catheter connection flush technology and patient monitoring, while performing their daily dialysis activities from the comfort of their home or workplace. liberDi frees people from spending half of their lives in dialysis centers, which is a disruptive technology in the dialysis market.”

liberDi’s Chairman, Mr. Caroll Neubauer, former CEO of B. Braun USA, added, “We’re excited to start 2023 with FDA clearance allowing liberDi to bring its Digital Dialysis Clinic to the US market to improve treatment as well as the quality of life to dialysis patients and their families.”

Professor Edwina Brown, President of the International Society for Peritoneal Dialysis and Professor of Renal Medicine, Imperial College London, said, “This represents an exciting development for peritoneal dialysis and is the first for some years. It makes at-home peritoneal dialysis easier and quicker (due to the pump in the device), and with remote monitoring available for the dialysis center it will make dialysis at home more accessible for the many people globally who develop kidney failure.  The team developing liberDi should be congratulated.“

According to DelveInsight’s “Dialysis Devices Market” report, the global dialysis devices market was valued at USD 74.44 billion in 2021, growing at a CAGR of 4.84% during the forecast period from 2022 to 2027 to reach USD 98.84 billion by 2027. The demand for dialysis devices is witnessing a surge majorly due to the rising prevalence of kidney failure due to various reasons such as the rising geriatric population wherein age acts as a major risk factor for loss of kidney function, rising prevalence of diabetes in which hyperglycemia is linked with blood vessel damage in kidneys. Furthermore, hypertension is another key factor that is extensively linked with kidney failure. Additionally, technological advancements such as the development of continuous renal replacement therapy (CRRT) have also been a major influential factor in boosting the growth of the dialysis devices market during the forecast period from 2022-2027.