Alcon Announces Launch of Dry Eye Treatment Device

On April 04, 2022, Alcon Inc. announced the launch of their latest dry eye innovation, the Systane® iLux2® Meibomian Gland Dysfunction (MGD) Thermal Pulsation System. It is an all-in-one handheld device equipped with new imaging technology to capture infrared photos and HD video of the meibomian glands which will allow patients to see the need for treatment and visualize their procedure, and experience results in as little as one week.

The Systane iLux2 MGD Thermal Pulsation System would further expand Alcon’s current dry eye treatment offerings and allow practitioners to tailor MGD treatment to the needs of each of their patients in eight to twelve minutes.

The device is equipped with imaging technology that allows patients to view both their meibomian glands and treatment through infrared imaging and HD video of the procedure.

ECPs can customize heat and compression across each easy-to-visualize treatment zone.

Systane iLux2 MGD Thermal Pulsation System can help Eye Care Practitioners build a strong, trusting relationship with their patients by boosting the credibility of their treatment recommendation through direct visualization of the disease and tracking the disease over time through stored meibomian gland images.

Fred Ellis, Vice President, U.S. Pharmaceutical and Dry Eye, Alcon mentioned, “Alcon is dedicated to the advancement of medical device technology and providing Eye Care Professionals (ECPs) with the tools needed to effectively treat their patients.” He further added “With the Systane iLux2 MGD Thermal Pulsation System, ECPs will be able to further patient trust and confidence because seeing is believing.” 

Eric D. Donnenfeld, M.D., FAAO, Ophthalmic Consultants of Long Island, NY, said, “The new Systane iLux2 MGD Thermal Pulsation System gives me the confidence to customize treatments based on my patients’ needs and help them see, understand and value their MGD treatment.”

As per DelveInsight analysis, the entry of such devices would help in better management of ophthalmic indications which would positively influence the growth of the ophthalmic devices market. According to DelveInsight’s “Ophthalmic Devices Marketreport, the global ophthalmic devices market was valued at USD 55.91 billion in 2021, growing at a CAGR of 4.12% during the forecast period from 2022 to 2027 to reach USD 71.23 billion by 2027. The demand for ophthalmic devices is primarily being boosted by the rising prevalence of myopia and growing geriatric population base which has resulted in the increased prevalence of ocular diseases of different etiologies, increasing number of ophthalmic surgeries, and technical innovation in product development which are expected to increase the product demand thereby contributing in the growth of the ophthalmic devices market during the forecast period from 2022-2027.

AI Medical Device Software by Paige Receives CE-IVD and UKCA Marks

On April 06, 2022, Paige received the CE-IVD and UKCA marks for Paige Breast Lymph Node which is a clinical AI application. 

The newly launched AI medical device software is aimed to help pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review. These CE-IVD and UKCA designations would enable the hospitals and laboratories in the European Economic Area, the UK, and Switzerland to use the product in the course of clinical diagnosis. 

Paige Breast Lymph Node is based on the same underlying AI technology as Paige Prostate and can be deployed in any laboratory or hospital setting that is on the Paige Platform.

Juan Retamero, M.D., Medical Director, Digital Pathology Transformation at Paige, mentioned, “Paige’s aim is to provide pathologists with innovative, care enhancing technology so they can provide the best possible insights to patients. Through Paige Breast Lymph Node, pathologists can more efficiently identify tumor metastases of any size, including small micrometastases,” He further added, “The CE-IVD and UKCA marks for Paige Breast Lymph Node are a vital step towards increasing the adoption of our new tool in European hospitals and laboratories.”

However, in the United States, the Paige Breast Lymph Node is available for “Research Use Only”.

According to DelveInsight analysis, the approval of such software as medical device would prove to be beneficial in cancer diagnosis and would help the cancer diagnostics market grow further in coming years.  As per the DelveInsight report, the global cancer diagnostics market was valued at USD 114.35 billion in 2020, growing at a CAGR of 9.43% during the forecast period from 2021 to 2026, to reach USD 185.08 billion by 2026. The increase in demand for cancer diagnostic products and services is predominantly attributed to the spike in the cancer cases reported worldwide. In addition, growing manufacturers focus to develop advanced cancer diagnostic products, the establishment of various cancer diagnostic labs, and rising government initiatives to raise awareness regarding early detection and management of cancer among the patients, and others are anticipated to drive the global cancer diagnostic market during the forthcoming years.

I-VASC Srl Obtains Series A Funding to Launch its Chronic Venous Insufficiency Device

On April 08, 2022, – I-VASC,  an Italy-based medical device company came up with new technology- Empty Vein Ablation (EVA) for the treatment of chronic venous insufficiency (CVI) and varicose veins and developed a device- VELEX based on the aforementioned technology. 

The company announced the successful completion of the Series A financing round. In addition to the 750K Euro tranche raised in the first half of 2021, the company had raised another 1.066M Euro tranche before the end of last year, for a total amount of 1.8M Euro in 2021. The proceeds from this round will be used by I-VASC to pay for post-market clinical studies of the VELEX ™ device (which has received CE Mark approval for the European market in May 2021), to move toward FDA regulatory approval for the US market.

VELEX™, is the first CE Mark approved device of the company offers the innovative solution of the Empty Vein Ablation (EVA) technology for treating CVI, which notably includes the varicose veins disease. The device consists of a percutaneous 3-balloon catheter that allows to perform a chemical ablation (schelotherapy) in to the portion of the vein to be treated after having isolated it and emptied it from blood.

Daniele Zanotti, newly appointed CEO of I-VASC, stated, ““I am thrilled to embrace this new professional adventure and put my experience at the service of a project which has the potential of representing a new paradigm in the largely underserved market of CVI and varicose vein. With the considerable efficacy, safety and usability improvements that VELEX can offer with respect to all alternative methods, we have the opportunity to offer a better option to millions of patients and create a huge new value in the vascular arena.” 

Mario Salerno, Founder and CMO of I-VASC, mentioned, “We are approaching a new and important phase of the project, which I started in 2015. Thanks to the investors, who have believed in our proprietary and innovative technology, and to our reinforced team, we are now on the verge to bring VELEX™ into the market and provide proof of the validity of our EVA (Empty Vein Ablation) procedure”.

According to DelveInsight’s analysis, owing to the increasing prevalence of chronic venous insufficiency and varicose veins, rising prevalence of lifestyle disorders due to worsening of lifestyle habits, as well as continuous research and development activities to develop better treatment strategies for these indications are expected to drive the demand for such devices in coming years and would provide a conducive environment for the market growth of vein ablation devices. 

TRUVIC Receives 510 (k) Clearance for the Prodigy™ Thrombectomy System

On April 11, 2022, Truvic Medical Inc, received 510(k) clearance from the FDA for the Prodigy™ Thrombectomy System, designed for the treatment of peripheral vascular thrombus. 

Mike Buck, CEO of Truvic, stated, “We are excited to receive FDA clearance for our first thrombectomy system. We look forward to working with experts in the field to translate Prodigy’s novel design elements and features into superb clinical outcomes.” He further added, “This represents our first regulatory milestone as part of our strategy to advance multiple programs designed to meet patients’ needs and bring more innovative technologies to the market, faster.” 

Fred Khosravi, Chairman and CEO of Imperative Care, said, “Imperative Care and Truvic share a culture of innovation and intense commitment to the needs of patients. I am pleased that these common values continue to help propel our development programs towards elevation of patient care.”

Truvic Medical Inc is the wholly-owned subsidiary of Imperative Care Inc.

According to DelveInsight’s analysis, the entry of new devices such as Prodigy thrombectomy system would offer physicians more options to choose from currently available devices and may help in conducting procedures with improved precision helping in better management of peripheral vascular diseases. The global peripheral vascular devices market was valued at USD 9.63 billion in 2021, growing at a CAGR of 7.88% during the forecast period from 2022 to 2027, to reach USD 15.13 billion by 2027. The demand for peripheral vascular devices is primarily being boosted by the rapid growth in the prevalence of cardiovascular diseases and peripheral vascular diseases, the approval of new and advanced products, and the rising incidence of lifestyle disorders such as diabetes and hypertension. Furthermore, the increase in the geriatric population is also likely to contribute to the peripheral vascular devices market growth.

Guardant Health Presents New Data Supporting Efficacy of Blood Test in Detecting Multiple Cancers

On April 11, 2022, Guardant Health presented new data demonstrating the ability of the company’s investigational next-generation Guardant SHIELD™ multi-cancer assay to accurately detect early-stage cancers. This assay is designed to analyze approximately 20,000 epigenomic biomarkers that are informative for detection of a wide range of solid tumors in a single blood test. The data for four cancer types were demonstrated as examples: colorectal, lung, pancreatic and bladder. 

Data from the presentation showed that the next-generation Guardant SHIELD multi-cancer screening assay achieved sensitivity (detection rates) of 90% (n=692) in stages I and II colorectal cancer (CRC) and 87% (n=55) in stages I and II lung cancer. For more advanced cancer (stages III and IV), sensitivity was 93% (n=582) for CRC and 93% (n=136) for lung cancer. Detection was assessed at 90% specificity (true negative rates) based on a cohort of patients without cancer. This performance is on par with current guideline-recommended screening methods. Current screening options for these cancers, while effective, are limited due to low compliance rates: 66% for CRC and 14% for lung cancer. A high-performance blood test that can be completed as part of a routine patient workup has the potential to improve screening rates and, ultimately, save more lives.

The investigational next-generation Guardant SHIELD multi-cancer test aims to detect early-stage cancer where there is a clinical benefit from early detection and treatment. In January 2022, Guardant Health initiated the SHIELD Lung study, a prospective, observational, multi-center basket study designed to enroll individuals undergoing cancer screening across multiple cancer types. The first cohort, or basket, will enroll nearly 10,000 individuals eligible for lung cancer screening and aims to evaluate the performance of the next-generation Guardant SHIELD test to detect lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe. 

AmirAli Talasaz, Guardant Health co-CEO, said, “These positive results show that the next-generation Guardant SHIELD multi-cancer assay provides sensitive detection of early-stage cancers with the ability to identify the tumor tissue of origin with high accuracy.” He further added, “Presentation of these positive results represents a major step forward in our commitment to offering clinicians and patients a highly sensitive blood-based multi-cancer screening test in select tumor types where we believe cancer screening can save lives.”

The extensive research and development activities in the liquid biopsy domain for the development of multi cancer detection assay, companion diagnostic tests among others are expected to transform the field for cancer diagnosis and treatment. According to DelveInsight’s “Liquid Biopsy in Cancer Diagnostics Market” report, global liquid biopsy in cancer diagnostics market was valued at USD 6,953.15 million in 2020, growing at a CAGR of 16.64% during the forecast period from 2021 to 2026 to reach USD 16,500.05 million by 2026. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand of precision medicine, technical innovation in product development among other factors are expected to drive the liquid biopsy in the cancer diagnostics market.

Alucent Biomedical Announces Enrollment of First Patient in First in Human Natural Vascular Scaffolding Clinical Trial

On April 12, 2022, Alucent Biomedical Inc. announced the enrollment of the first patient in ACTIVATE II, an Australia-based First-in-Human clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (AlucentNVS) technology. The therapy is designed to open vessels and maintain patency without the use of permanent implants for the treatment of peripheral artery disease (PAD) of the lower extremities. 

The Alucent NVS Vessel Restoration System with Photoactivated Linking combines standard angioplasty with linking of the structural proteins in the wall of a blood vessel. The device is designed to restore the vessel’s lumen and improve blood flow without introducing a foreign implant, such as a metallic stent. Alucent NVS photoactivated linking is also designed to mitigate the well-known adverse effects of angioplasty, such as vessel recoil. Treatment using this device is expected to provide sustained, improved blood flow thereby offering pain relief, limb preservation, and improved quality of life for patients.

The first patient in the ACTIVATE II study was enrolled by Dr. Chris Delaney at Flinders Medical Centre in Adelaide. In total, the trial will enrol up to 50 subjects with up to 12 research sites. The primary endpoints of the study are freedom from composite investigational device, procedure-related Major Adverse Events, Primary Patency as assessed by Doppler Ultrasound, and freedom from clinically-driven target lesion revascularization (CD-TLR) at one year.

ACTIVATE II follows the completion of enrollment for ACTIVATE I safety study of AlucentNVS within the United States. Pre-clinical testing of AlucentNVS in animal studies has shown acute and long-term safety and patency without the pro-inflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel. 

Dr. Myles Greenberg, Alucent Biomedical’s CEO, stated, “We want to change that by offering a whole new way to treat these patients with AlucentNVS. Alucent’s novel approach has the potential to change the way PAD is managed in the future.”According to DelveInsight’s analysis, the increasing prevalence of lifestyle disorders such as high cholesterol, hypertension,  growing prevalence of cardiovascular disorders, sedentary lifestyle habits are some factors collectively contributing to the increasing prevalence of peripheral artery disease. This in turn is motivating companies across the globe operating in this domain to bring forth innovative and advanced systems, thereby providing a positive growth outlook for the peripheral artery disease market.