Silk Road Medical exclusively offers the products available for use during the TCAR procedure. The TCAR system received approval from the U.S. Food and Drug Administration in 2015 and is backed by numerous clinical studies showing a lower risk of stroke and other complications compared to traditional open surgery.
The acquisition price is set at $27.50 per share, representing an enterprise valuation of roughly $1.16 billion based on approximately 46.0 million fully diluted shares and a net cash position of $101 million as of March 31, 2024.
Boston Scientific anticipates completing the transaction in the latter half of 2024, subject to customary closing conditions. Silk Road Medical anticipates achieving approximately $194-198 million in net revenue for 2024, reflecting 10-12% growth over the prior fiscal year. The transaction is expected to have an immaterial impact on Boston Scientific’s adjusted earnings per share in 2024 and 2025, becoming accretive thereafter. However, the impact on GAAP earnings per share may be less enhancing or possibly diluting due to amortization expense and acquisition-related net charges.
As per DelveInsight’s “Acute Ischemic Stroke (AIS) Market Report”, the Acute Ischemic Stroke Market was valued at USD 9.21 billion in 2023 and is growing at a CAGR of 4.0% during the forecast period from 2024 to 2030, to reach USD 12.24 billion by 2030. The cases of acute ischemic stroke is primarily associated with the growing incidence of acute ischemic & hemorrhagic stroke, integration of advanced technology, and rising awareness programs regarding stroke symptoms, risk factors, and the importance of seeking immediate medical attention contribute to earlier diagnosis and treatment, driving market growth.
Philips Introduced Duo Venous Stent System to Address Symptomatic Venous Outflow Obstruction
On June 12, 2024, Royal Philips, a global frontrunner in health technology, announced the first implantation of its Duo Venous Stent System. This implantable device is designed to treat symptomatic venous outflow obstruction in patients suffering from chronic venous insufficiency (CVI), following the premarket approval (PMA) granted by the U.S. Food and Drug Administration (FDA).
“Duo is the first stent that offers a differential design for the challenges of venous anatomy – a focal area that withstands the forces of compression as well as the flexibility to accommodate curvature of the vessel.” said Dr Kush Desai, a highly regarded Interventional radiologist and associate professor of Radiology, Surgery, and Medicine at Northwestern University in Chicago.
On June 11, Dr. Erin Murphy, a vascular surgeon at the Sanger Heart & Vascular Institute, Atrium Health, successfully used the Duo Venous Stent System outside of clinical trials for the first time. Deep venous disease, approximately affecting 25 million people globally, results from venous thromboembolism and is the third most common cardiovascular disease. This condition presents numerous mechanical challenges due to the complexities of deep venous anatomy and obstructions.
The Duo Venous Stent System is designed for the unique challenges of venous anatomy and obstructions and consists of Duo Hybrid and Duo Extend stents of varying sizes. The Duo Hybrid features an integrated design with multiple zones of differing mechanical properties, while Duo Extend overlaps seamlessly for long lesions. Together, they minimize the risk of stent fracture and corrosion and can be used in smaller caudal veins.
The VIVID study is a global clinical trial conducted in the U.S. and Poland, evaluating the Philips Duo Venous Stent System for treating nonmalignant iliofemoral occlusive disease. It enrolled 162 subjects across 30 centers with three patient groups which included non-thrombotic iliac vein lesion (NIVL), post-thrombotic syndrome (PTS), and acute deep vein thrombosis (aDVT). After FDA approval, it transitioned from an investigational device exemption (IDE) study to a post-approval study (PAS) under NCT04580160. The study achieved all primary safety and efficacy goals, with a 12-month primary patency rate of 90.2% (exceeding the goal of 77.3%) and a 12-month primary safety rate of 98.7% (exceeding the goal of 89%). Quality of life and venous function assessments, including CEAP, VCSS, Villalta, EQ-5D-3L, and VEINES scores, showed sustained improvements compared to baseline at 12 months.
The VIVID study was the first clinical trial to require intravascular ultrasound (IVUS) for lesion assessment and stent sizing before device implantation. Previous research has shown that IVUS improves the accuracy of venous disease diagnosis and alters treatment plans in 57% of cases compared to venography alone. Philips led this initiative, and IVUS is now used in over 70% of venous stent procedures.
“The launch of the Duo Venous Stent System represents another step forward in achieving our aspiration to innovate interventional procedures with advanced medical technology,” said Heather Hudnut Page, Vice President and Business Leader of Peripheral Vascular at Philips. “In this context, we look forward to bringing the combined offering of intravascular ultrasound and Duo to the interdisciplinary teams – from vascular surgeons to interventional radiologists and interventional cardiologists – who share our overarching goal of enhancing patient care.”
According to DelveInsight’s “Stent Market Report”, the global stents market is estimated to grow at a CAGR of 5.61% during the forecast period from 2024 to 2030. The stents market is witnessing positive growth owing to factors such as the increasing prevalence of chronic diseases, rise in the geriatric population, increasing demand for minimally invasive procedures, and increase in unhealthy lifestyles, thereby all factors contributing to the growth of the stents market during the forecast period from 2024 to 2030.
Akili’s EndeavorOTC Received FDA Clearance as the First Digital Therapy for Adult ADHD via Video Game Modality
On June 18, 2024, Akili, Inc., a leading company in digital therapeutics, announced that the U.S. Food and Drug Administration (FDA) granted clearance for EndeavorOTCⓇ as an over-the-counter treatment for adults diagnosed with attention-deficit/hyperactivity disorder (ADHD). EndeavorOTCⓇ is the sole FDA-authorized digital therapeutic for ADHD that can be obtained without a prescription.
“This FDA authorization of EndeavorOTC positions it as a scientifically and clinically validated digital therapy for adult ADHD patients, and we’re incredibly proud of pioneering a new tier of digital medicine,” said Matt Franklin, Chief Executive Officer at Akili. “This is the culmination of years of clinical studies and the collective effort of scores of technical, scientific, clinical, and regulatory professionals. We are particularly grateful to the patients who participated in the study that made this clearance possible.”
EndeavorOTC received FDA clearance via the 510(k) pathway. In a study of 221 adults with inattentive or combined-type ADHD who all received AKL-T01 (the investigational name for EndeavorOTC and EndeavorRxⓇ) for 6 weeks. 83% showed improved focus according to the TOVAⓇ attentional control score. Additionally, 72.5% reported enhanced quality of life on the Adult ADHD Quality of Life Scale (AAQoL), and nearly 46% achieved clinically meaningful improvement. Participants also demonstrated significant improvements in ADHD symptoms on the ADHD-RS inattention subscale and total scale scores (p<0.0001 for both). A responder analysis revealed that 32.7% achieved at least a 30% reduction in ADHD-RS total score. Only 5% reported treatment-emergent adverse events, including nausea (1.8%) and headache (1.4%), with no serious adverse events reported.
As per DelveInsight’s “Digital Therapeutics Market Report”, the global digital therapeutics market is estimated to grow at a CAGR of 22.73% during the forecast period from 2024 to 2030. The demand for digital therapeutics is being boosted by the increasing prevalence of chronic diseases such as diabetes, mental illness, cancer, and heart failure (HF), advancements in technology such as the continuous advancements in mobile technology, wearable devices, artificial intelligence, machine learning, and data analytics which had facilitated the development of more sophisticated and effective digital therapeutics market and driving the market growth during the forecast period from 2024 to 2030.
Roche Achieved FDA Clearance for Diagnostic Digital Pathology Solution
On June 18, 2024, Roche, received FDA Clearance for the Roche Digital Pathology Dx (VENTANA DP 200). The system’s purpose is to aid pathologists in the evaluation and interpretation of digital images from scanned pathology slides to diagnose patients.
“Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere,” said Jill German, Head of Pathology Lab for Roche Diagnostics. “This not only improves a pathology lab’s efficiency but also expands access to pathologists for people living in remote areas and increases opportunities for pathologists to collaborate on patient cases.”
The field of digital pathology involves the digitization of conventional pathology processes, from the initial scanning of slides to their visualization and subsequent analysis. This paradigm shift is significantly enhancing traditional histopathology by streamlining operations, providing more thorough analytical capabilities, and creating opportunities for collaborative efforts among pathologists. For example, after a slide scanner captures and converts stained tissue sections on glass slides into digital formats, these images can be efficiently managed, disseminated, and analyzed by pathologists to assist in the determination of cancer treatment plans.
“We are investing in innovative digital pathology solutions to enable the pathology lab’s digital transformation,” German said. “Artificial intelligence-based tools and our Roche Digital Pathology Open Environment are designed to drive greater adoption and promote innovation in this critical field.”
According to DelveInsight’s “Digital Health Market Report”, the global digital health market was valued at USD 178.37 billion in 2023 and is estimated to grow at a CAGR of 18.25% during the forecast period from 2024 to 2030 to reach USD 486.55 billion by 2030. The digital health market is observing remarkable market growth due to the growing awareness, adoption of digital healthcare, and the rising demand for IoT, AI, and others in the healthcare industry. Further, the increasing patient pool suffering from chronic disease and the rising burden of the geriatric population across the globe will increase the need for remote and virtual patient care, leading to the increased demand for digital health. Additionally, the growing demand for remote patient monitoring and mobile health applications, increasing penetration of smartphones in the healthcare industries along with the increasing product or service launches & approvals, and the presence of key players in the market, among others will create a requisite for the digital health in the market. Therefore, the market for digital health is estimated to grow at a substantial CAGR during the forecast period from 2024 to 2030.
atHeart Medical Reported Long and Short-term Clinical Data Support Bioresorbable Frame reSept ASD Occluder (Clinical Update)
On June 18, 2024, atHeart Medical, established a new benchmark in atrial septal defects (ASDs) closure, redefining the standard of care, and announced the positive outcomes of its reSept ASD Occluder. Data from three patient cohorts show positive efficacy and safety for reSept, the first ASD occluder with a bioresorbable, metal-free frame. It enables future transseptal treatment, a significant advancement for patients needing transcatheter septal closure.
The new reSept clinical data included positive ten-year outcomes from the first-in-human (FIH) trial, demonstrating the long-term efficacy and safety of the reSept device, promising two-year data showing complete closure in a case study from the University of Virginia (UVA) cohort of ASCENT ASD, the ongoing pivotal trial, and one-month reSept efficacy in patients with iatrogenic ASDs caused by mitral valve intervention, from Canada’s first-ever experience through Health Canada’s Medical Devices Special Access Program.
“Having pioneered reSept in its early days as part of ASCENT ASD in the USA, I am very pleased about the long-term outcomes from the earlier European FIH trial and the wealth of promising new data available,” said Dr. Saibal Kar, National Physician Director HCA Healthcare, USA, co-Principal Investigator of the ASCENT ASD trial. “They indicate how transcatheter ASD closure with a bioresorbable device could become an even less invasive procedure for patients long-term. This is a very exciting development for our patients.”
Approximately 100 patients with ASDs had been successfully treated in trials and through special access iASD adult use across Canada, France, Germany, Switzerland, and the USA. The ASCENT ASD pivotal study is currently enrolling patients at over 20 hospitals in the US and four hospitals in France, and will soon began treating patients in Canada and Switzerland after recent authorizations from Health Canada and Swissmedic.
“Around 100 patients have been implanted with reSept to date. While hospitals continue to enroll patients as part of ASCENT ASD in several countries, we are excited that these positive outcomes showcase the potential for receipt to soon be the new standard of care,” said Laurent Grandidier, atHeart Medical CEO.
According to DelveInsight’s “Heart Closure Device Market Report”, the global heart closure devices market was valued at USD 2.51 billion in 2023, growing at a CAGR of 6.85% during the forecast period from 2024 to 2030 to reach USD 3.99 billion by 2030. The demand for heart closure devices is primarily being boosted by an increase in the incidence of congenital heart defects, rising adoption of MRI procedures, growing recognition and awareness of children born with cardiac irregularities, and continuous innovation in product development among others, thereby contributing to the overall growth of the heart closure devices market during the forecast period from 2024-2030.
Bioretec Announced Successful Clinical Outcomes from U.S. Controlled Launch of RemeOs™ Trauma Screw: 100% Fracture Healing Confirmed in Surgical Procedures
On June 19, 2024, Bioretec Ltd., a pioneer in biodegradable orthopedic implants, announced that several cases have been successfully performed across the U.S. using the RemeOs™ technology. Follow-up results confirmed successful implantation and fracture healing in all cases. Surgeons have reported very positive feedback, noting that there is no change to existing surgical techniques when using an absorbable metal implant for their patients. Additionally, the added benefits of osteopromotion and bioactivity at the fracture healing site were cited as factors influencing surgeons’ choice to use RemeOs™ screws in these procedures.
“The controlled launch of the RemeOs™ trauma screw in the United States has progressed very much in line with our expectations. In my short tenure with Bioretec, these excellent results and surgeon feedback have given me confidence in our plans to increase our commercialization efforts in the U.S.”, said Alan Donze, CEO of Bioretec.
According to DelveInsight’s “Orthopedic Implants Market Report”, the global orthopedic implants market is estimated to grow at a CAGR of 5.46% during the forecast period from 2024 to 2030. The orthopedic implants market is slated to witness prosperity owing to factors such as the increasing prevalence of orthopedic diseases such as arthritis, osteoporosis, and others, a growing burden of the geriatric population, the rising number of road accidents associated and other injuries, and the growing focus on improving the safety, affordability, and usability of orthopedic implants for people are further expected to result in the appreciable revenue growth in the orthopedic implants market during the forecast period (2024 to 2030).
