“Dr. Banner marks a significant milestone in the field of neurovascular interventions,” stated Anthony Parise, General Manager and Head of Sales and Marketing at EOSolutions Corp. “Dr. Banner empowers physicians to overcome the challenges of complex anatomies, providing precise and effective treatment options for their patients, with its unparalleled inner diameter, proximal stability, distal trackability, and super compliant polyurethane balloon.” We are thrilled to answer to our physicians’ requirements by providing this ground-breaking catheter, which will enhance their capacity to undertake the most difficult neurovascular surgeries.”
EOSolutions Corp. stays committed to pushing the boundaries of medical innovation and providing cutting-edge solutions to healthcare professionals globally. Dr. Banner represents the company’s commitment to developing innovative catheter technologies that enable physicians to provide greater patient care while driving favourable clinical outcomes.
As per DelveInsight analysis, the global balloon catheters market was valued at USD 4.60 billion in 2021 and is expected to increase at an 8.78% CAGR from 2023 to 2028, reaching USD 7.62 billion by 2028. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity, which are major risk factors for the development of cardiovascular diseases as well as brain aneurysms, the increasing incidence of cancers in the pelvic region that affect the urinary system in varying capacities, the growing geriatric population base where age itself plays a major role in disease aetiology, and technological innovation in product development such as the manufacture of drug-coated balloon catheters aimed at drug delivery at the site of action among other factors are expected to drive the balloon catheters market.
US FDA Approves The Cyltezo® Pen, A New Autoinjector Option, Ahead of July 1 Commercial Launch
The Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira® (adalimumab), was approved by the U.S. Food and Drug Administration (FDA). Cyltezo was initially licensed as a pre-filled syringe to treat a variety of chronic inflammatory disorders. On July 1, 2023, the 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four-, and six-pack sizes.
“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “We’re thrilled to be able to provide patients with the Cyltezo Pen as an additional option when Cyltezo launches on July 1.”
The pen’s patient-centered design includes a one-button, three-step activation, 100% medication visibility, and a shielded needle. The Cyltezo Pen has been designated as an “Ease of Use” product by the Arthritis Foundation.
CYLTEZO is a medication used in the field of rheumatology and gastroenterology. It is a biosimilar of the drug certolizumab pegol, which is a tumor necrosis factor (TNF) inhibitor. CYLTEZO is designed to treat various inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis.
As a biosimilar, CYLTEZO is highly similar to the reference product, certolizumab pegol, in terms of quality, safety, and efficacy. Biosimilars undergo rigorous testing to ensure that they have a comparable clinical profile to the original biologic drug. They are developed to offer patients more affordable treatment options while maintaining therapeutic effectiveness.
Orlucent Receives FDA Breakthrough Device Designation for Handheld Mole Imaging System
On May 22, 2023, Orlucent announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Orlucent® Skin Fluorescence Imaging System. Orlucent system is a handheld point-of-care molecular imaging system designed to noninvasively identify and clinically evaluate the presence of biological tissue remodeling activity linked to the emergence of atypical moles in adults.
In order to determine a clinical course of action and detect melanoma at its very earliest stages, the Orlucent system in conjunction with a traditional clinical visual skin examination can greatly assist physicians to get information on the patient’s skin type, and medical history. The Breakthrough Device Designation will allow Orlucent technology to have a collaborative and streamlined review pathway with FDA to get the Orlucent system in the market faster.
“We are excited the FDA has recognized the Orlucent system as a Breakthrough Device. It’s estimated that anywhere from 2% to 53% of U.S. patients have moles that may be classified as suspicious, atypical, or dysplastic, and the Orlucent system will be an important tool to provide their physicians with information on a mole’s biological activity status as well as its potential to become melanoma.”
Catherine Shachaf, Ph.D., President of Orlucent
To use the Orlucent system for assessing an atypical lesion, a healthcare professional applies the reagent then uses the imager to capture both white light and fluorescent images. The system’s image analysis software is used to analyze and display the images as well as provide a probability score for the presence of tissue remodeling. A physician can decide whether to remove the mole and send it for biopsy or to leave it alone and possibly retest it with the Orlucent system in the future using the Orlucent system’s score in conjunction with their clinical evaluation.
US FDA Breakthrough Therapy Designation to Grünenthal’s Resiniferatoxin For Pain Associated With Osteoarthritis of the Knee
On May 22, 2023, Grünenthal announced that its investigational non-opioid medicine resiniferatoxin (RTX), currently undergoing clinical Phase III development, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for pain associated with osteoarthritis (OA) of the knee. The decision is based on clinical phase I and II data indicating significant pain relief and a favorable safety profile. Resiniferatoxin is a highly potent Transient Receptor Potential Vanilloid 1 (TRPV1) agonist with a well-validated mechanism of action. Resiniferatoxin has the potential to be a significant non-opioid therapeutic option if it is approved, offering long-lasting pain relief and improved joint function in addition to a positive safety profile.
“Millions of patients suffering from knee osteoarthritis are waiting for additional treatment options. Resiniferatoxin targets one of the most common and severe symptoms of this currently incurable disease: pain. The decision shows that the FDA considers osteoarthritis a serious disease and shares our assessment of resiniferatoxin’s potential to make a positive impact. We are hopeful that the Breakthrough Therapy Designation will help us to bring this non-opioid therapy option more quickly to patients.”
Jan Adams, M.D., Chief Scientific Officer, Grünenthal
Grünenthal is running a Phase III programme studying resiniferatoxin that will include more than 1800 patients with knee osteoarthritis who have insufficient pain relief with available nonsurgical treatment options. The program comprises three trials across Europe, the United States, Latin America, South Africa, and Japan to enable marketing approval for resiniferatoxin in the European Union, the United States, Japan, and other countries worldwide. As per the further updates, Grünenthal aims to submit the first Marketing Authorization Application in 2025, leading to a potential market entry of resiniferatoxin in 2025/2026. Grünenthal holds the global rights for resiniferatoxin since the acquisition of the Swiss biotech company Mestex AG in 2021 and has since been holistically developing the asset to maximize its positive impact on patients worldwide.
Osteoarthritis can be defined as a group of distinct but overlapping diseases. It is the most common joint disease in people aged 65 and over. Globally, over 360 million people are estimated to be affected by Osteoarthritis of the knee. In 2021, approximately 38 million cases of Osteoarthritis in the US. As per the analysis, a higher percentage of mild cases of Osteoarthritis was observed in the US, followed by moderate Osteoarthritis in 2021. The total number of diagnosed Osteoarthritis cases in the US is expected to rise in the coming yeast.
Element Science Completed Enrollment in the Jewel IDE Study Evaluating the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
On May 23, 2023, Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients transitioning from hospital to home, completed the enrollment in its Jewel IDE Study, designed to evaluate the safety and effectiveness of the Jewel P-WCD to monitor heart rhythms and treat subjects with defibrillation as needed.
Jewel P-WCD, a low-profile wearable defibrillator is intended for the detection and treatment of life-threatening arrhythmias in patients with a high temporary risk for SCA by continuously monitoring the patient’s heart
It offers continued protection during normal daily activities, including showering, sleeping, and moderate exercise. The Jewel Mobile App transmits therapy information to the patient’s medical team in near real-time and enables timely patient care.
The study results which are expected to be released in the fall of 2023 are going to be submitted for the US regulatory approval.
The initial results have demonstrated the therapeutic benefit of Jewel P-WCD in numerous patients where it successfully recognized lethal arrhythmias and restored a normal heart rhythm after a single therapeutic shock.
“We are delighted to have partnered with leading physicians across the country to conduct this study to demonstrate the safety and effectiveness of the Jewel P-WCD and its usefulness in bridging patients to important decision points in their lives,” said Uday N. Kumar, MD, Founder, President and CEO, Element Science. Uday Kumar added, “By truly continuously protecting patients from SCA, the Jewel P-WCD is enabling patients, their families, and their physicians to have the time they need to engage in meaningful discussions about the optimal long-term care pathway best for them. Everyone at Element Science is grateful to be able to play a role in improving the overall patient care journey for these patients.”
“We are grateful to the study participants and clinical research professionals for their commitment and contributions to the Jewel IDE Study. Completing enrollment is an important milestone toward reaching our goal of changing the paradigm of treatment for cardiovascular patients so they can safely return to their normal daily lives without fear or discomfort,” commented Zubin J. Eapen, MD, MHS, Element Science’s Chief Medical Officer.
As per DelveInsight’s “Defibrillator Market report, the global defibrillator market was valued at USD 10.19 billion in 2022, growing at a CAGR of 3.11% during the forecast period from 2023 to 2028, to reach USD 12.24 billion by 2028. The demand for defibrillators is primarily associated with the growing incidence of cardiac disorders, integration of advanced technology, increasing investments by government and private manufacturers, and rising awareness programs regarding cardiovascular disorders and the usage of defibrillators, among others.
A.Menarini Diagnostics Announced Release of the PRIME MDx Platform
On May 23, 2023, A.Menarini Diagnostics S.r.l., announced the commercial launch of its PRIME MDx platform: a sample-to-result, all-in-one, fully-automated molecular diagnostics platform for the processing of various testing portfolios through real-time PCR.
The molecular diagnostics market has been profoundly transformed by the Covid-19 epidemic, moving in the direction of seamless automation, usability, quick turnaround times, and test reliability.
With the innovative use of pre-filled plates and a universal extraction solution, PRIME MDx enables users to process a variety of sample types, with a maximum capacity of 240 samples per day. Each sample can run up to 5 distinct tests.
A faultless user experience is guaranteed by AI-driven software, from continuous sample loading to result interpretation.
The system will be introduced to the market with two panels of tests, one for viral infections of the upper respiratory tract and one for viral infections of transplants on a variety of sample matrices. To complete the offer, more testing panels are now being developed.
Fabio Piazzalunga, General Manager and Global Head of the Diagnostics Division in Menarini Group said, “We are proud to bring this innovative, all-in-one, molecular diagnostics solution to the market, which will allow us to address the needs of medium-to-high throughput laboratories internationally and strengthen the position of A. Menarini Diagnostics in the molecular space.”According to DelveInsight’s “Molecular Diagnostics Market report, the global molecular diagnostics market was valued at USD 16.94 billion in 2022, growing at a CAGR of 9.16% during the forecast period from 2023 to 2028, to reach USD 28.44 billion by 2028. The increase in demand for molecular diagnostics is primarily attributed to the growing incidence of infectious diseases such as the sudden outbreak of COVID-19 and the rising burden of cancers across the globe. Moreover, rapid technological advancement in the molecular diagnostic product arena and increasing demand for point-of-care diagnostics along with rising consumer awareness regarding quick diagnostics, among others, are some of the key factors responsible for the molecular diagnostic market growth during the forecasted period.
