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Olympus Launched Next Generation Electrosurgical Generator On June 06, 2023, Olympus Corporation, a global medical technology company, launched its newest electrosurgical generator, ESG-410 for use in the treatment of bladder cancer and enlarged prostate. By offering a variety of resection loops, band electrodes, vaporization buttons, and needles, the ESG-410 Electrosurgical Generator promotes alternatives and efficiencies in the treatment of benign prostatic hyperplasia (BPH), or an enlarged prostate, and non-muscle-invasive bladder cancer (NMIBC). The ESG-410 is designed with larger capacitors that allow for better plasma stability during ignition. The generator also needs less energy for an ignition and offers enhanced procedural efficiency in BPH resections due to faster tissue removal because of the reliable ignition of larger resection loops.  The ESG-410 has faster ignition and improved plasma stability without tissue contact with large, medium, and band loops and oval buttons. Also, the device offers a larger 8.4" LCD touch screen than the ESG-400 with wireless foot pedals. In different variations, wired options are available. ESG-410, the Electrosurgical Generator is designed for cutting and coagulating tissue in open, laparoscopic, and endoscopic surgery. The operator or patient may suffer from thermal or other harm if this electrosurgical generator is used incorrectly or with incompatible equipment, which can result in excessive or inaccurate high-frequency (HF). As per DelveInsight’s “Electrosurgical Devices Market” report, the global electrosurgical devices market was valued at USD 8,520.99 million in 2022, growing at a CAGR of 6.64% during the forecast period from 2023 to 2028 to reach USD 12,401.80 million by 2028. The rise in the demand for electrosurgical devices is predominantly attributed due to the growing prevalence of chronic disorders such as cardiovascular disorders, neurological disorders, gynaecological disorders, and others, the rising number of surgical procedures, the escalating burden of geriatric patients, and technological advancements in product development and design improvement. Biocomposites Added Proprietary NanoBone® Technology to its Portfolio through the Acquisition of Artoss GmbH  On June 06, 2023, Biocomposites, a medical devices company that engineers, manufactures, and markets world-leading products for regenerating bone and managing infection in the bone and soft tissue, announced the acquisition of Artoss GmbH (Artoss), a specialist manufacturer of innovative bone graft substitutes for use in orthopedics, spine, foot and ankle, and dentistry. Using its patented NanoBone® technology, which combines nanocrystalline hydroxyapatite and silica gel to deliver excellent bone development with simple handling, Artoss offers a variety of bone graft alternative solutions. The unique structure of NanoBone® activates the body's natural bone-forming mechanisms and promotes very quick bone healing.  The company offers a wide variety of indication-specific product variants that are all ready-to-use, directly from their applicators, in addition to Artoss' lead product NanoBone® SBX Putty. Artoss, based in Rostock, Germany, will continue to create cutting-edge products, but will now be able to serve a greater number of surgeons and patients through access to Biocomposites' established global distribution network. Michael Harris, Chief Executive Officer of Biocomposites, commented, "We are delighted to have completed this acquisition of Artoss. Adding the NanoBone® range of products to our portfolio provides us with a new differentiated offering to help surgeons treat their patients and a platform from which to develop new ready-to-use products. Following on from our acquisitions of Subiton and Synimed last year, we have established ourselves as the go-to provider for surgeons requiring bone regeneration and/or managing infection in the bone and soft tissue." According to DelveInsight’s “Bone Grafts and Substitutes Market” report, the global bone grafts and substitutes market was valued at USD 3.20 billion in 2022, growing at a CAGR of 6.09% during the forecast period from 2023 to 2028 to reach USD 4.56 billion by 2028. The demand for bone grafts and substitutes is primarily witnessing growth due to the growing prevalence of degenerative bone disorders, the rising number of trauma cases, the increasing geriatric population, and the rising requirement for bone grafts and substitutes in dentistry. Artelon, Inc. Received FDA Clearance for FlexBand®, FlexPatch®, and FlexBand Plus® used for Ligament Reinforcement  On June 06, 2023, Artelon Inc., a global healthcare leader which is an expert in synthetic materials for real-world success in orthopedic soft tissue reconstruction, received the US FDA 510(k) clearance for FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs.  This new clearance expands the indications for these products including reinforcement of medial, lateral, and ulnar collateral ligaments, spring ligaments, deltoid ligaments, and extra-articular ligaments in the ankle, knee, and other joints around the body. FlexBand®, FlexPatch®, and FlexBand® Plus are designed to be used during surgical procedures to strengthen soft tissue where it is weak. Additionally, FlexBand®, FlexPatch®, and FlexBand® Plus are designed to reinforce soft tissues that are stitched together or fixed with other devices during surgery to repair tendons and ligaments. These soft tissues include the rotator cuff, patellar, Achilles, biceps, and quadriceps tendons, as well as the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament.  Dynamic Matrix technology from Artelon is a proprietary polymeric bio-textile for musculoskeletal soft tissue reinforcement that is used in Flexband products.  The mechanical and biological characteristics of recovering tendon and ligament tissue are mimicked by Dynamic Matrix. It has been demonstrated in clinical investigations to encourage the formation of regenerative tissue before dissolving over several years, immediately restore the mechanics of motion, and protect the surgical repair during early healing. "This new regulatory clearance establishes a unique and specific framework of U.S. marketing claims for reinforcement of ligaments," said CEO Aaron Smith.  Aaron Smith further added, "Recent innovation in our space has been mostly focused on fixation of ligaments to the bone, but little has been done to address the failure of the ligament tissues themselves, which are often diseased and may lead to poor surgical outcomes.  We are currently a leader in the large and growing U.S. ankle instability market.  This new set of claims permits us to take on a multitude of unmet clinical challenges in the ankle and other joints and dramatically expand our addressable market." According to DelveInsight’s “Bone Growth Stimulators Market” report, the global bone growth stimulators market was valued at USD 1.26 billion in 2022, growing at a CAGR of 5.34% during the forecast period from 2023 to 2028 to reach USD 1.73 billion by 2028. The bone growth stimulators market is witnessing positive market growth owing to factors such as the prevalence of degenerative bone-related disorders, increasing cases of accident and traumatic cases such as road crashes, sports injuries, and others, the growing burden of the geriatric population who are susceptible to developing various bone degenerative disorders, and the accumulative focus on developing technologically advanced devices concerning bone growth stimulators among others. Masimo Announced FDA 510(k) Clearance of Radius VSM™ On June 05, 2023, Masimo, a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions, announced that Radius VSM™, a patient-worn, continuous multi-parameter vital signs monitor, received FDA 510(k) clearance.  Radius VSM enables medical professionals to track a wide range of physiological parameters, including non-invasive blood pressure, temperature, respiration rate, and electrocardiography (ECG) using Masimo SET® pulse oximetry. Radius VSM enables ambulation and movement while guaranteeing that patients are continuously monitored by combining the convenience and independence of a wearable device with the dependability and accuracy of bigger bedside monitors. Radius VSM allows providers to equip any hospital bed with comprehensive monitoring, with the ability to quickly add or remove measurement technologies to match each monitoring scenario and offer more personalized care – without additional bedside equipment, network infrastructure, or any tethered connections. Radius VSM can be used as a standalone device due to its built-in multi-touch LED display, built-in rechargeable battery, high-quality waveform, and parameter trend data, as well as visual and audible alarms. By automating the transfer of patient data to remote monitoring systems, the device can streamline clinical workflows. This enables Radius VSM to be utilized as a part of a patient monitoring system and ensures that clinicians across the hospital have access to the most recent physiological data.  Using a multi-functional pod and a variety of modules and non-invasive sensors designed to prioritize comfort and ergonomics, Radius VSM offers the following measurement technologies: Clinically proven Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, including oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi®), and plethysmographic respiration rate (RRp®) Multiple respiration rate measurements, including measurement from the pleth, from the sound of breathing, and impedance Measure-on-inflation non-invasive blood pressure (NIBP), featuring single-patient-use cuffs and automatic intervals (which reduces the need for periodic manual clinician measurement) Continuous skin temperature measurements with notifications when clinician-specified temperature thresholds are breached Patient orientation, position, and activity monitoring alert clinicians to unsupervised patient movement and possible patient falls, as well as preventable pressure injuries ECG: continuous 6-lead monitoring (I, II, III, aVR, aVL, and aVF) with heart rate, respiration rate, and lethal arrhythmia detection, using single patient use easy-to-apply pre-connected 3-electrode lead wire Rainbow Acoustic Monitoring®, which uses an adhesive sensor to detect the acoustic signals produced by airflow in the upper airway and convert these patterns into respiration rate, also visualized as a waveform Joe Kiani, Founder, and CEO of Masimo said, “Radius VSM’s unique scalability, versatility, advanced connectivity, and a broad range of accurate and automated continuous measurements – all in a wearable device that can be quickly and easily deployed anywhere in the hospital – make it a game-changing tool for clinicians everywhere. Doctors, nurses, and patients in Europe are already experiencing the advantages of Radius VSM and we are excited to share them with U.S. hospitals now too.” Peter Pronovost, MD, Ph.D., FCCM, Chief Quality and Clinical Transformation Officer at University Hospitals, Ohio, and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, commented, “Radius VSM represents another radical transformation of care by Masimo, allowing clinicians to monitor based on patient acuity, not their location. With this new technology, not only can every bed have pulse oximetry monitoring, but if patient acuity increases, we can also easily scale up monitoring, even including ECG, without having to add new hardware or hardwire anything. With the staff shortages in hospitals and the high volume of patients, clinicians need the flexibility to put patients in any bed and ensure that that bed can monitor each patient appropriately. With Radius VSM, we will have enormous flexibility to manage patient risk across a hospital or, in our case, an entire health system: we can tailor what gets monitored to meet each patient's need, for truly personalized monitoring. And from a safety perspective, by allowing us to monitor patients based on their acuity and needs, linked to clinical protocols, we can significantly drive down the risk of possible harm in the hospital.” Thomas Callahan, MD, Principal Investigator and Director of the Inpatient Hospital Service for Cardiac Electrophysiology and Pacing, at Cleveland Clinic, mentioned, “We are excited to have gained early experience with this next-generation inpatient monitoring system at our center as part of the investigational study. What helps differentiate this technology from existing systems is high fidelity continuous ECG monitoring in a compact modular configuration and integration with high precision optical, electrical, and acoustic sensors for blood pressure, respiratory rate, pulse oximetry, and motion.” According to DelveInsight’s “Patient Monitoring Devices Market” report, the global patient monitoring devices market was valued at USD 35.21 billion in 2022, growing at a CAGR of 8.20% during the forecast period from 2023 to 2028 to reach USD 56.46 billion by 2028. The escalating demand for patient monitoring devices is primarily attributed to the increase in the prevalence of various chronic and lifestyle-associated disorders. Moreover, the sudden outbreak of the COVID-19 pandemic has also contributed to the patient monitoring devices market. Additionally, the growing preferences for remote patient monitoring systems among the patient and healthcare providers, the increase in technological advancement in the product arena, and the rise in the approval of various patient monitoring devices in the current year, among others are also some of the factors responsible for potentially increasing the global patient monitoring devices market during the forecast period (2023-2028). Gore Announced the First US Enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study On June 06, 2023, W. L. Gore & Associates (Gore), a global materials science company dedicated to transforming industries and improving lives, announced that the first US patient has been enrolled in a prospective, non-randomized, multicentered, single-arm study with five-year follow-up (NCT05489588) to evaluate the investigational GORE® VIAFORT Vascular Stent for the treatment of symptomatic iliofemoral venous obstruction.  The GORE VIAFORT Vascular Stent utilizes the Gore expanded polytetrafluoroethylene (ePTFE) technology in conjunction with a single wire, sinusoidal-wound nitinol frame. The GORE VIAFORT Vascular Stent Iliofemoral Study is evaluating the device in a treatment range of 10 to 20 mm diameter for iliofemoral veins. The study is being conducted in the U.S. under an approved investigational device exemption (IDE). The first U.S. patient was enrolled by David J. Dexter II, M.D. at Sentara Vascular Specialists, Norfolk, Virginia, who said, "With several FDA-approved stents on the market, there was a concern that enrollment in another iliac vein stent trial would be difficult. Designed with the unique qualities for flexibility and radial force, the VIAFORT Device is compelling to use in a clinical trial." According to DelveInsight’s “Vascular Stents Market” report, the global vascular stents market was valued at USD 13.31 billion in 2022, growing at a CAGR of 7.90% during the forecast period from 2023 to 2028, to reach USD 21.01 billion by 2028. The increase in demand for vascular stents is predominantly attributed to the growing prevalence of vascular disorders such as atherosclerosis, carotid artery diseases, and peripheral artery diseases, among others. In addition, growing preferences for minimally invasive surgeries among the patient population, growing technological advancement in the product arena, and approval of various vascular stents, among others are some of the factors responsible for driving the global vascular stents market in the forthcoming years. Synergy Spine Solutions Completed Enrollment in 1-Level IDE Trial  On June 05, 2023, Synergy Spine Solutions Ltd, an innovative orthopedic medical device developer focused on artificial cervical disc replacement, completed enrollment in it’s first-ever IDE clinical trial. In a multi-center, prospective, historically controlled pivotal trial comparing the safety and efficacy of the Synergy Disc to anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease, the 1-Level Synergy Disc IDE clinical trial (NCT 04469231) enrolled 175 patients. A pre-market approval (PMA) application in the United States will be supported by the study, which is being carried out at 20 locations across the country. Josh Butters, Synergy Spine Solutions CEO, said, "We are thrilled to announce that we have fully enrolled in our 1-Level Synergy Disc trial. This is an incredible achievement for our team and it has been a very rewarding collaboration with some of the best clinical sites and spine surgeons in the US. We are excited to continue following these patients, further building Synergy's clinical evidence, and advancing our pre-market approval strategy for the Synergy Disc in the U.S."  Dr. Todd Lanman, a spinal neurosurgeon with Beverley Hills-based Lanman Spinal Neurosurgery, founder of the national ADR Advanced Disc Replacement Spinal Restoration Center and a Principal Investigator for the trial, commented, "Having been involved in the Synergy Disc 1-Level artificial disc replacement clinical trial, my impressions of how the disc performs is quite interesting. I just enrolled one of the last trial patients in the study and, after having performed thousands of cervical artificial disc replacements, the Synergy Disc has provided unique performance enhancements. Particularly, the Synergy Disc corrects the curve of the spine because the implant has a six-degree lordotic correction which has been quite beneficial for realigning the curve of the neck to its proper position." According to DelveInsight’s “Spinal Fusion Devices Market” report, the global spinal fusion devices market was valued at USD 6.49 billion in 2022, growing at a CAGR of 4.55% during the forecast period from 2023 to 2028 to reach USD 8.47 billion by 2028. The rise in demand for spinal fusion devices is primarily attributed to the rising prevalence of spinal disorders such as degenerative disc disorders, spondylolisthesis, disc herniation, spinal stenosis among the growing old-age population worldwide and the increase in demand for minimally invasive surgeries. In addition, technological advancement in the product line and new product launches among others are also expected to drive the global spinal fusion market.

In recent years, ketone supplements have gained significant popularity owing to the rising demand for the ketogenic diet and increasing scientific research activities in the domain. Ketone supplements are designed to provide the body with exogenous ketones, which are an alternative fuel source to glucose derived from carbohydrates. With the rise in the number of individuals incorporating them into their health and wellness routines, the overall market for Ketone Supplements products is growing exponentially. Ketone supplements can help improve athletic performance, assist in weight loss, gain strength, and cognitive enhancement. Moreover, the increasing scientific research is also immensely driving the market.  The industry has witnessed the development of new formulations, improved taste profiles, and a focus on scientific validation. As the understanding of ketosis and its potential benefits continues to expand, the Ketone Supplements industry is poised for further growth and innovation. As per DelveInsight, the global Ketone Supplements market was valued at USD 3,823.55 million in 2021 and growing at a CAGR of 5.94% during the forecast period (2022-2027); it is anticipated to reach USD 5,384.17 million by 2027. Apart from health benefits, the introduction of new flavors in ketone supplements and the active participation of the companies to grab the market, are also driving the Ketone Supplements market growth.  Why the demand for Ketone Supplements are growing? The growing popularity of the ketogenic diet is one of the major factors influencing the development of the Ketone Supplements market. The goal of the ketogenic diet, which consists of a high-fat, low-carbohydrate diet, is to bring on a state of ketosis in the body. In the metabolic state of ketosis, the body primarily uses ketones rather than glucose to fuel itself. This dietary strategy has drawn interest because of its possible advantages in weight loss, greater energy levels, improved mental clarity, and potential therapeutic uses in several medical disorders. As the popularity of the ketogenic diet has grown, so has the demand for ketone supplements. Till a few years back, the Ketone Supplements market was dominated by a few players offering basic ketone supplements in the form of ketone salts, which are mineral compounds bound to ketones. However, in recent years, the industry has witnessed the emergence of new companies with advanced Ketone formulations and delivery methods. Similarly, there has been intense media coverage surrounding the ketogenic diet and its potential benefits. Numerous books, documentaries, and online resources have shed light on the concept of ketosis, leading to a growing interest in utilizing ketone supplements to achieve and maintain a ketogenic state. The rise of social media platforms and influencer culture has further contributed to the popularity of these supplements. The positive reviews for ketone supplement pills by celebrities and influences have also increased their demand and trust among people. What are the major Ketone Supplements Products in the market? The products in the ketone supplements market can be segmented by forms such as solids (capsules & pills, powders, gummies) and liquids (drinks, oils). Similarly, it can be segmented by type (esters, salts, others), and by distribution channel (pharmacy/drug store, departmental stores, online, others). As per DelveInsight’s assessment, the Capsules & Pills category in the ketone supplements is expected to have higher market growth potential. The Capsules & Pills category in the ketone supplements market was valued at USD 799.07 million in 2021 and is expected to grow at a CAGR of 5.37% during the forecast period from 2022 to 2027 to reach USD 1,090.11 million by 2027. What are the key benefits of Ketone Supplements? Appetite Suppression: One of the key benefits of ketone Supplements is in appetite reduction, which is advantageous for people trying to regulate their calorie intake or lose weight. Ketone supplements may aid in maintaining adherence to a calorie-restricted diet by decreasing hunger sensations. Improve Energy: It is observed that for people on a low-carbohydrate or ketogenic diet, ketone supplements can be a great instant energy source. They can support increased energy levels during physical activity or times when carbohydrate consumption is minimal. Enhanced Performance: Ketones may operate as an alternate fuel source for the brain and muscles during physical exertion, enhancing stamina and lowering weariness. Ketone supplements may improve performance in endurance sports, according to certain research. Cognitive Function: Several research activities are going on to access the potential of ketones for the cognitive function of the brain. Ketone supplements can help people with certain neurological problems focus, think clearly, and perform better cognitively, according to certain research. What are the major Drawbacks of Ketone Supplements? Unique benefits: The demand for Ketone Supplements is growing at an exponential rate. However, there are several drawbacks associated with ketone supplements, which hamper their demand and affect the consumer's interests -  Limited Long-Term Research & Development Activities: Ketone supplements are promising, but there are still questions about their long-term effects and safety when used frequently. There is presently little information available and only a limited number of research activities around the potential benefit of Ketone Supplements. Similarly, the possible hazards and advantages of long-term ketone supplementation need to be assessed critically for better user trust and confidence in these products.  Digestive Issues: ketone supplements may lead to digestive discomforts, such as gastrointestinal distress, diarrhea, stomach pain, or other symptoms. Although these side effects are normally minor and transient, some people may find them unpleasant. Taste and Palatability: Due to its unique flavor and unpleasant taste, some people may not like taking Ketone pills. The flavor may change as per the particular product, additional ingredients, recipe, and brand type.  High Cost: Compared to other dietary supplements, ketones are observed to be a more expensive supplement. The cost of regular use can pile up over time, depending on the brand and dosage, making them less affordable for some people. Not a Single Fits Solution: It's important to understand that ketone supplements do not work like a magic bullet to help you lose weight or perform better in sports. They may have some advantages, but they should only be taken as a part of a comprehensive strategy that also includes a balanced diet, frequent exercise, and lifestyle choices. Major Players in the Ketone Supplements Market Ketone Supplements Market Key Players Globally, several key companies are actively working in the Ketone Supplements Market to grab market share. Some of the major players include Perfect Keto, Health Via Modern Nutrition Inc., Ketologic, Pruvit Ventures, Inc., KetoneAid, Zhou Nutrition, Finaflex, Nutrex Research, Inc., Ancient Brands, LLC., Zenwise Health, KETŌND LLC, BPI Sports, Ketofy (Wellversed Health Private Limited), Genius Gourmet Inc., LifeSense®, Nestle, Juvenescence, Ketsource, Love Life supplements Ltd, Intentionally Bare, and others. Similarly, several new entrants are expected to give tough competition to the existing players with the launch and innovative product launches in the upcoming years. Major Developmental Activities in the Ketone Supplements Market In recent years, several major commercial and regulatory developments have been registered in the Ketone Supplements Market. Many new companies have entered the market with new and innovative products. Similarly, many new product launches have been observed in the domain. Among various activities in the Ketone Supplements Market, some of the notable development include: In 2021, Short Form Limitless Labs launched KETO Advanced 1500, a ketogenic-friendly weight loss diet pill solution. In November 2020, Genius Gourmet Inc. extended its line of products by launching a revolutionary all-natural and ready-to-drink keto shake. In February 2019, Designer Protein launched a ketogenic protein powder, Designer Keto 14G Keto Adaptogenic Protein (a natural, gluten-free protein powder that helps consumers maintain a keto lifestyle and fuel carb-free bodies). Ketone Supplements Market Future Outlook In the last few years, the Ketone Supplements industry has experienced significant growth and evolution and is set to exhibit the trend in the upcoming years. The rising interest of the public, health enthusiasts, and sports persons towards the ketogenic diet and a growing understanding of its potential health benefits is immensely driving the Ketone Supplements demand and the market outlook. Unpleasant taste and odor are major key factors affecting Ketone Supplements' demand and their widespread acceptance. However, several companies have entered the market in recent years, with innovative products with improved taste and palatability.  Similarly, companies are investing heavily in research and development activities to develop and manufacture innovative Ketone Supplements products which are flavored and ready to drink. Additionally, the Ketone Supplements market has witnessed a surge in scientific research and clinical trials, which is further anticipated to change the overall market dynamics. Neurodegenerative diseases, epilepsy, cancer, and metabolic disorders are some of the key areas expected to have a greater advantage in terms of better outcomes with ongoing R&D activities. Furthermore, in the coming years, Ketone Supplements will have increased competition, with new entrants and established players expanding their product offerings. The competition has driven innovation and quality improvements, leading to a wider range of options for consumers. Manufacturers are focused on ingredient purity, manufacturing processes, and third-party testing to ensure product efficacy and safety.

FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults Pfizer Inc. announced that the FDA has authorized ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in people aged 60 and up. ABRYSVO is an unadjuvanted vaccine made up of two preF proteins chosen to maximize protection against RSV A and B strains, and it has been shown to be both safe and efficacious. "For over a half-century, a vaccine to help prevent RSV had been an elusive public health goal." "Today's approval is a significant step forward in delivering on Pfizer's commitment to help alleviate the significant burden of RSV in higher-risk populations, including older adults," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Pfizer Vaccine Research and Development. "ABRYSVO will help protect older adults from the potentially serious consequences of RSV disease." We are tremendously grateful to the clinical trial participants, study investigator teams, and our dedicated Pfizer colleagues for their contributions to the availability of this vaccine." The FDA's decision is based on data from the key Phase III clinical trial RENOIR (RSV vaccine Efficacy study in Older Adults Immunised against RSV illness) (NCT05035212). RENOIR is a global, randomized, double-blind, placebo-controlled trial that aims to evaluate the efficacy, immunogenicity, and safety of a single dose of the vaccine in persons 60 and older. RENOIR included approximately 37,000 patients who were randomly assigned to either RSVpreF 120 g or placebo in a 1:1 ratio. The findings were published recently in The New England Journal of Medicine. RENOIR is still active, with efficacy data being obtained in the study's second RSV season. The Advisory Committee on Immunisation Practises (ACIP) of the Centres for Disease Control and Prevention (CDC) will convene on June 21, 2023, to examine recommendations for the proper use of RSV vaccines in older persons. Pfizer estimates supply availability in Q3 2023, ahead of the expected RSV season this autumn, depending on the outcome of this conference. FDA Approves First Intravenous Iron Replacement Therapy for Adults With Heart Failure, Iron Deficiency The FDA has approved ferric carboxymaltose injection to increase exercise capacity in adult patients with heart failure classified as New York Heart Association (NYHA) class 2/3. The New York Heart Association Functional Classification assesses patients' heart failure depending on the severity of their symptoms. Patients with class 2 or class 3 heart failure have a slight or significant limitation of physical activity due to weariness, palpitation, or dyspnea. The FDA has approved the first and only intravenous (IV) iron replacement medication for this indication. "This new indication for Injectafer marks the first and only FDA approval of a [IV] iron replacement therapy for adult patients with heart failure, a progressive and chronic disease," stated Ravi Tayi, MD, MPH, chief medical officer of American Regent, in a press release. "Approximately 2.8 million US adults are impacted by heart failure with iron deficiency or iron deficiency anaemia, which can affect their daily lives and activities." Iron deficiency in adults with heart failure; iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who are intolerant to oral iron or have an unsatisfactory response; and adults with IDA who have non-dialysis dependent chronic kidney disease are now among the indications for ferric carboxymaltose injection. It is delivered through IV by a health care practitioner in two doses of 750 mg each, at least seven days apart, to individuals weighing 50 kg or more. Each of the two doses is taken as 15 mg/kg body weight spaced by at least 7 days for individuals weighing less than 50 kg. Data from the CONFIRM-HF trial, which evaluated the efficacy and safety of ferric carboxymaltose injection in adult patients with chronic heart failure and iron deficiency, were used to support the approval. In iron-deficient individuals with heart failure, treatment with Injectafer dramatically enhanced exercise capacity compared to placebo. ANeuroTech receives IND approval from the FDA for pivotal Phase IIIB trial of adjunctive anti-depression drug, ANT-01 ANeuroTech, a leader in the development of innovative mental health treatments with minimal or no side effects, today announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a pivotal Phase IIIB trial of ANT-01 as an adjunctive antidepressant drug for Major Depressive Disorder (MDD). Phase IIIB will include secondary endpoints of improvements in cognitive function and the ability to feel pleasure, the first time these have been included in an anti-depression drug clinical trial. ANeuroTech expects to begin the trial later this year. Over 60% of individuals suffering from depression and related cognitive difficulties do not benefit from current primary treatment options or encounter difficult side effects. ANeuroTech is working on the development of ANT-01, an additional medication for depression that aims to have minimal or no adverse effects. ANT-01 is a low dosage of an already existing drug called pipamperone dihydrochloride, which is a typical antipsychotic that has been used at higher doses for over four decades in Europe to treat psychotic disorders. During his clinical practice, Dr. Erik Buntinx, the CEO and Founder of ANeuroTech, made an intriguing observation that ANT-01 possesses a distinctive characteristic of having a strong preference and attachment to the serotonin 5-HT2A and dopamine D4DR receptors in the brain. This finding suggests that ANT-01 holds promise as an additional treatment option with reduced side effects. As part of its development, ANT-01 is being formulated as an orally administered medication that needs to be taken once daily alongside a primary antidepressant. The pivotal Phase IIIB trial, conducted in a double-blinded manner, will evaluate the effectiveness and safety of a single low dose (15mg) of ANT-01 in combination with a primary antidepressant, compared to a placebo. This trial specifically targets patients with Major Depressive Disorder (MDD) who have not experienced sufficient improvement with selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline serotonin reuptake inhibitor (SNRI) treatments. Building upon positive results obtained from earlier trials, which showcased ANT-01's antidepressant properties and favorable safety record, the Phase IIIB trial aims to gather further clinical data. Notably, these previous trials demonstrated that ANT-01 enhances the ability to experience pleasure and enhances cognitive function, a unique aspect not observed with any other adjunctive antidepressant compound. The trial aims to enroll over 500 patients across multiple sites in the United States, Europe, and South America, and is scheduled to commence in 2023. As part of its Series A funding round, ANeuroTech has successfully obtained financial support from KOIS, a global impact investing firm. KOIS specializes in investments related to healthcare and life sciences and is committed to transforming initiatives that have significant societal and environmental impact into viable investment opportunities. Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in Lupus Nephritis On June 1, 2023, Kyverna Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its therapy, KYV-101, for treating patients with refractory lupus nephritis (LN). KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis and other B-cell driven autoimmune diseases.  The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus. We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with LN, and we look forward to sharing clinical data on patients in the second half of 2023. Peter Maag, Ph.D., chief executive officer (CEO) of Kyverna Kyverna is actively enrolling patients in the Phase 1 open-label, multi-center clinical trial of KYV-101 at multiple sites throughout the US. In addition, Kyverna submitted its initial Clinical Trial Application (CTA) for a Kyv-101 Phase 1/2 clinical trial in Lupus nephritis to the Paul Ehrlich Institut (PEI) in Germany. Lupus nephritis (LN) is a severe consequence of systemic lupus erythematosus (SLE), commonly known as lupus. Approximately 40 percent of adults diagnosed with lupus eventually develop Lupus nephritis and 60 percent of Lupus nephritis patients will fail standard of care and approved treatments. Patients with Lupus nephritis may report other symptoms of active SLE (e.g., fatigue, fever, rash, arthritis, serositis, or CNS disease); these are more common with focal (proliferative) and diffuse (proliferative) LN. As per DelveInsight, in the year 2021, the total diagnosed cases of Lupus Nephritis was 209,000+ in the 7MM which is expected to grow in the coming years. As per the DelveInsight estimates, in 2022, the total diagnosed cases of lupus nephritis were ~210,080 cases in the US. Along with Kyverna Therapeutics, other major players such as AstraZeneca, Novartis, MorphoSys, Roche, Kezar Life Sciences, and others, are eyeing the existing untapped market of Lupus nephritis and trying their best to grab a significant market share. Some of the emerging therapies had already demonstrated positive late-stage results among the LN-affected individuals and are in further clinical evaluation. Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma On June 4, 2023, Servier presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only. The data was released concurrently in the New England Journal of Medicine and presented as a late-breaking abstract during the plenary session of the American Society of Clinical Oncology's (ASCO) 2023 Annual Meeting. Grade 2 gliomas are progressive, malignant brain tumors with a poor prognosis, and the current treatment paradigm, which can be associated with short- and long-term toxicities, has not seen progress in more than two decades. For patients living with IDH mutant low-grade glioma, as determined by molecular testing, treatment with a targeted therapy such as vorasidenib has the potential to provide transformative benefits. Ingo K. Mellinghoff, M.D., Chair, Department of Neurology, Memorial Sloan Kettering Cancer Center The overwhelmingly positive INDIGO results convincingly demonstrate the impact of targeting IDH mutations early in cancer biology where a monotherapy approach can lead to a profoundly meaningful outcome for patients with recurrent or residual IDH-mutant grade 2 gliomas. IDH mutations are disease defining alterations in IDH-mutant diffuse gliomas and these pivotal data coupled with vorasidenib's especially high penetration of the blood-brain barrier, offer opportunities to evolve the treatment landscape for patients living with this malignancy Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment. IDH1/2 mutations occur in approximately 80% and 4% of grade 2 gliomas, respectively. As per the updates, INDIGO succeeded in meeting its primary endpoint of progression-free survival (PFS) per blinded independent review committee (BIRC) and the key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. Earlier in March 2023, the U.S. Food & Drug Administration (FDA) granted fast-track status to vorasidenib. Servier is working to determine timelines for submitting an NDA for vorasidenib to the FDA. Gliomas are the most prevalent type of adult brain tumor, accounting for 78% of malignant brain tumors. According to DelveInsight estimates, the total incident cases of glioma in the 7MM comprised approximately 47,000 cases in 2022 and are projected to increase in the coming years. In 2022, the highest number of incident cases were observed in the United States among the 7MM. Apart from Servier, several other major pharma and biotech companies are developing new therapies for the treatment of Gliomas. The upcoming glioma treatment landscape is poised to see further expansion after the emergence of new classes such as cancer vaccines, protein kinase C beta inhibitors, dendritic cell immunotherapy, cell and gene therapy, and others.

Heart failure is a global pandemic that affects at least 26 million people globally and is becoming more common. Heart failure health expenditures are substantial and will rise considerably as the population ages. Despite significant advancements in medicines and prevention, mortality and morbidity remain high, and quality of life remains low. The reported prevalence, incidence, mortality, and morbidity rates vary geographically, based on the many etiologies and clinical features identified in heart failure patients. As per the DelveInsight estimates, the heart failure diagnosed prevalence was  7 million in the US in 2022. As per the estimates, around 4 million males and approximately 3 million females were suffering from heart failure in the US in 2022, which is expected to increase during the forecast period (2023–2032).    Current Heart Failure Treatment Space The heart failure treatment market is highly competitive, with pharma companies competing to produce best-in-class treatments to reduce the burden of heart failure. Novartis’ Entresto (sacubitril/valsartan) is a first-in-class angiotensin-receptor/neprilysin inhibitor that has been licensed and sold for the treatment of chronic heart failure with decreased ejection fraction (HFrEF). This drug was approved in the United States in July 2015 for chronic heart failure with a decreased ejection fraction; in Europe, it was approved in November 2015 and again in October 2019 for pediatric patients with heart failure. Novartis announced in February 2021 that the US FDA had approved the following extended indication for Entresto (sacubitril/valsartan) to lower the risk of cardiovascular death and hospitalization for heart failure in adult patients with CHF. Jardiance, manufactured by Boehringer Ingelheim and Eli Lilly, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that is indicated as an adjunct to diet and exercise to improve glycemic control in an adult’s genital or perineal area, along with fever or malaise, to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease, and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults. The European Commission and the FDA authorized Jardiance for the treatment of symptomatic chronic HFrEF in June and August 2021, respectively. Jardiance gained regulatory approval from Japan’s MHLW in November 2021 for treating chronic heart failure in patients receiving conventional chronic heart failure medication. Verquvo is a soluble guanylate cyclase (sGC) stimulator developed by Bayer and Merck that is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a heart failure hospitalization or the need for outpatient IV diuretics in adults with symptomatic chronic HF and an ejection fraction less than 45%. It is approved for heart failure in the United States, the European Union, and Japan. Merck began a Phase III pivotal trial of Verquvo in patients with chronic heart failure with a decreased ejection fraction of 40% or less and no recent worsening heart failure event in 2021. Farxiga is an AstraZeneca sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated in adults as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular It is approved for the treatment of heart failure in the United States, the European Union, and Japan. SAMTASU/OPC-61815 is a water-soluble prodrug of oral tolvaptan (tolvaptan sodium phosphate) that is appropriate for IV delivery. Tolvaptan is a novel chemical developed by Otsuka that is an orally accessible antagonist of the vasopressin V2 receptor. It inhibits water reabsorption at the renal collecting duct, resulting in increased water diuresis without electrolyte depletion. The PMDA granted regulatory approval to SAMTASU 8 mg and 16 mg IV infusion in March 2022 to treat fluid retention in heart failure patients who have not reacted adequately to other diuretics, such as loop diuretics. On May 30, 2022, the product was launched in Japan. FUROSCIX (furosemide injection) is an investigational, patented furosemide solution with a neutral pH that is designed for SC infusion via a wearable, pre-programmed on-body infusor for outpatient self-administration. It is a new furosemide formulation packed in a prefilled Crystal Zenith cartridge. FUROSCIX is the first and only FDA-approved SC loop diuretic that can be administered at home using the FUROSCIX Infusor. In January 2023, scPharmaceuticals announced the commercial availability of FUROSCIX on February 20, 2023, with reimbursed access to the drug for all Medicare Part D and Medicaid beneficiaries on Day 1 and that approximately 60% of all heart failure patients would have fixed tier co-pays (USD 100) at launch, with the company working hard to expand this to greater than 75% fixed tier co-pays. LEXICON’s INPEFA: Potential Competitor to AstraZeneca’s Farxiga and Lilly’s Jardiance Lexicon Pharmaceuticals, Inc. earned a major victory before the end of May when the FDA accepted the company’s application to market sotagliflozin (brand name: Inpefa) for heart failure treatment. On the plus side, the FDA awarded the drug about as excellent a label as could possibly be expected. Inpefa’s clinical efficacy and safety outperform proven heart failure drugs such as AstraZeneca PLC’s Farxiga, Eli Lilly & Company/Boehringer Ingelheim’s Jardiance, and Johnson & Johnson’s Invokana. On the negative side, there is still a lot of expensive work to be done if Lexicon is to win enough market share to make the drug genuinely profitable. The approval is based on the results of two randomized, double-blind, placebo-controlled Phase III cardiovascular outcomes studies of INPEFA in patients with or at risk of heart failure. SOLOIST-WHF (Worsening Heart Failure) and SCORED enrolled about 12,000 patients together. In individuals who had previously been hospitalized for worsening heart failure, INPEFA dramatically reduced the risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular mortality by 33% compared to placebo. INPEFA is a sodium-glucose co-transporter type 2 (SGLT2) and type 1 (SGLT1) inhibitor. The American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) recommended SGLT inhibitors as first-line treatment for heart failure in their joint 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. An expert consensus statement issued by the American College of Cardiology (ACC) in April 2023 emphasized the value of SGLT inhibitors as part of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure with preserved ejection fraction (HFpEF). The ACC expert consensus statement recommends that SGLT2 inhibitors be started in all persons with HFpEF who are stable during hospitalization and have no patient population contraindications.  Lexicon anticipates that INPEFA will be accessible by the end of June 2023. The company intends to keep the wholesale acquisition cost of the pharmaceutical comparable to that of existing branded heart failure treatments. Promising Future of Heart Failure Treatment Market The dynamics of the heart failure treatment market are anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the diseases, incremental healthcare spending across the world. The drug candidates by key players, such as, Omecamtiv mecarbil (Cytokinetics), AZD4831 (AstraZeneca), Rexlemestrocel-L (Revascor) (Mesoblast), Finerenone (Kerendia) (Bayer), CXL 1427 (BMS), and others that are under late- and mid-phase of clinical development have the potential to create a significant positive shift in congestive heart failure market size. Many clinical trials addressing the effects of drugs on HFpEF are underway, providing possible medical evidence for the future treatment of HFpEF. In addition, improved access to health services, reimbursements, and financial support may boost the congestive heart failure tratment market and improve the market accessibility of the emerging heart failure drugs in the coming years. FAQs 1. What is heart failure? Heart failure, also referred to as congestive heart failure (CHF), is a condition in which the heart muscle fails to pump blood as efficiently as it should. This causes an accumulation of blood and fluid in the lungs, resulting in shortness of breath. 2. What are the heart failure symptoms? At first, the heart failure signs and symptoms are subtle, and they are frequently misdiagnosed as typical signs of ageing. The most common symptoms of heart failure are caused by extra fluid or congestion, which leads to vessel blockage. The beginning of the congestion in the lungs is carried forward to other parts of the body. The cardiac output decreases as the disease progresses. 3. What causes heart failure? The most common causes of congestive heart failure include lowering the left ventricular myocardial utility and the dysfunction of the pericardium, myocardium, endocardium, heart valves or large vessels alone or in combination. Other pathogenic mechanisms that can lead to heart failure include excessive neurohumoral stimulation, irregular myocyte calcium cycling, augmented hemodynamic overload, ischemic dysfunction, ventricular remodelling, extreme or inadequate extracellular matrix production, enhanced apoptosis, and genetic mutations. 4. How is heart failure diagnosed? Heart failure diagnostic tests include a chest X-ray, transthoracic echocardiography (TTE), Computerised tomography (CT) scans, and magnetic resonance imaging (MRI), Echocardiogram, Stress test, Coronary angiogram, Myocardial biopsy, Ejection fraction, and others.

Antibody-drug conjugates (ADCs) are becoming more prominent in the cancer treatment market. Antibody-drug conjugates are one of the most rapidly increasing anticancer treatments. This approach uses a mAb attached to a cytotoxic payload via a chemical linker that is directed towards a target antigen expressed on the cancer cell surface, limiting systemic exposure and thereby toxicity. The most commonly targeted antigens in ADCs are ERBB2, CD19, CD33, CD22, and MSLN (mesothelin). Furthermore, over 50 distinct recognized antigens have been employed as targets in ADC. Previous research has shown that several tumor antigens are also expressed at low levels in normal cells. The concept of ADCs is to deliver a highly effective payload to its target utilizing the best carrier possible. ADCs are administered intravenously into the circulation to avoid mAb breakdown by stomach acid and proteolytic enzymes.  Tumor Markers and Antibodies in ADCs An antigen with a slightly higher expression pattern in tumor cells than in healthy cells is sufficient to elicit ADC activity. However, the amount of cell surface tumor indicators, like in other targeted drug delivery systems, can be a critical predictor of ADC performance. ADC targets do not always interfere with cell development. When compared to inhibition by preventing cell growth, ADCs tumor-suppressive activity is mostly mediated through tumor marker potency for ADC internalization. However, target biological roles implicated in the cell division pathway (e.g., CD30 and CD70 tumor necrosis factor signaling) can be regarded as advantageous for ADC efficacy. The antibody component in ADCs serves as both a carrier and a targeting agent. The major properties of the Ab component in ADCs are high specificity of targeting and low immunogenicity. These prevent antibody cross-responses to other antigens, avoiding both toxicity and ADC removal/elimination before it reaches the tumor. Another crucial feature in ADC design is the Ab’s strong affinity for effective absorption into target cells. Current Marketed ADCs in Oncology Market More than 10 ADCs are currently on the oncology market for hematological and solid tumor malignancies, with 8 receiving regulatory clearance since 2019. The recently revealed financial statements for FY2022 show that several ADC drugs, including ADCETRIS by Seagen/Takeda, KADCYLA and Polivy by Roche, TRODELVY by Gilead, and ENHERTU by Daiichi Sankyo/AstraZeneca, have been granted approval for new indications and accelerated to seize the oncology market. Gemtuzumab ozogamicin (MYLOTARG, Pfizer), the first ADC for oncology, was approved for relapsed CD33+ acute myeloid leukemia (AML) in 2000. The drug was withdrawn in 2010 due to toxicity and lack of efficacy in a Phase III trial, but the FDA approved a lower, fractionated dose in 2017. This drug is also approved in Japan and Europe. Apart from this, several other ADCs also received FDA approval and become the blockbuster ADCs with generating the highest sales. Some of the top ADCs in the oncology market are Adcetris Seagen’s Adcetris (brentuximab vedotin), which has a CD30-specific mAb conjugated to monomethyl auristatin E (MMAE), was approved by the FDA in 2011, making it the second ADC to enter the cancer market. It is approved in the United States, Europe, and Japan for Hodgkin lymphoma and systemic anaplastic large cell lymphoma (sALCL). Seagen is currently developing ADCETRIS as a monotherapy and in combination with other agents in ongoing trials, including many possible registration-enabling investigations, such as the Phase III ECHELON-3 clinical trial in relapsed or refractory diffuse large B-cell lymphoma.  Kadcyla Genentech/Roche’s Kadcyla (ado-trastuzumab emtansine) revolutionized the field of ADCs in 2013 by becoming the first ADC licensed for the treatment of solid tumors. It is approved as an adjuvant (after surgery) treatment for patients with HER2+ early breast cancer who have previously undergone trastuzumab (Herceptin®) and a taxane, either alone or in combination. This approval was a watershed moment in ADC development because treating solid tumors with such therapy has hitherto been a daunting obstacle. To begin with, prior to Kadcyla, ADC therapy of solid tumors fell short because of many biological obstacles in the tumor microenvironment that hindered drug penetration. Second, unlike in hematologic cancers, the concept of lineage-specific antigen expression does not apply to solid tumors, because the antigens expressed are mostly “tumour associated” rather than “tumour specific.” As the first ADC in solid tumors, KADCYLA ranked first, with sales showing good growth potential. The drug has been on the market for a relatively long time and holds an overwhelming share of the current ADC market.  Enhertu Daichi Sankyo/AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) was granted accelerated FDA clearance in December 2019 for the treatment of adult patients with unresectable or metastatic HER2+ breast cancer who have had two or more prior anti-HER2 based regimens. In addition, the FDA granted this ADC breakthrough therapy designation in 2020 for the treatment of patients with metastatic, HER2-mutated non-small cell lung cancer (NSCLC) following platinum-based therapy, as well as priority review for the treatment of HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. In addition, Enhertu was approved in the United States in 2021 for a second oncology indication therapy of adult patients with locally advanced or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma who had previously received a trastuzumab-based regimen. Trodelvy To underscore the industry’s enthusiasm for ADC technology, Gilead Sciences paid $21 billion in October 2020 to acquire Immunomedics and its recently authorized ADC, Trodelvy (sacituzumab govitecan-hziy). Trodelvy was granted accelerated FDA approval in April 2020 for the treatment of patients with locally advanced or metastatic triple-negative breast cancer (mTNBC) who have had at least two prior therapies for the metastatic disease. Trodelvy generated $64 million and $137 million in sales in the fourth quarter and full year of 2020 (including the period prior to the completion of Gilead’s acquisition of Immunomedics), demonstrating its commercial success. The FDA awarded regular clearance for this indication in April 2021, and in the same year, Trodelvy was granted accelerated approval for a second indication treatment of locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Novel and Emerging ADCs in the Oncology Pipeline With over 200 ADCs by leading companies including Byondis, ImmunoGen, Daiichi Sankyo, Seagen, Merck, ADC Therapeutics, CytomX, AbbVie, and others, under pre-clinical/clinical development, the world appears to be entering a new era of targeted cancer therapy, despite some mixed appraisals within academia. Given the considerable increase in Big Pharma interest in the ADC domain, the ADC market will continue to grow, and there is still hope for the development and marketing approval of ADCs with blockbuster potential.  Breast and lung cancer are the top two cancers with the most patients to target, with breast cancer having the highest prevalence. The lung cancer therapeutic area, on the other hand, is more active, with many mid to late-stage ADCs. Daiichi and AstraZeneca intend to enhance ENHERTU’s application area in order to increase its market scale—this clearly demonstrates the growing interest of big pharma giants and small biotech companies in focusing on ADCs, opening the door for a new era of targeted cancer treatment. Key players with the highest ADC clinical development include Seagen Seagen is a pioneer in ADC research and the use of this technology in cancer treatment. Ladiratuzumab vedotin (LV), an ADC targeting LIV-1 that is currently being evaluated in Phase I and Phase II clinical trials as monotherapy and in combination with other agents for patients with metastatic breast cancer and select solid tumors with high LIV-1 expression, is one of the product candidates based on antibody-drug conjugate technology. Seagen and Merck signed into a license and partnership agreement, or the LV Agreement, in September 2020, under which the businesses will collaboratively develop and share future costs and profits for LV globally. Another ADC candidate in the company’s pipeline is disitamab vedotin, a new HER2-targeted ADC that has demonstrated anti-tumor activity in numerous solid tumor types across a spectrum of HER2 levels, including urothelial, gastric, and breast cancer. Seagen and RemeGen signed into an exclusive license deal in September 2021 to develop and commercialize disitamabvedotin in all countries outside of RemeGen’s Asian territory, excluding Japan and Singapore. Seagen is running a Phase II trial of disitamab vedotin as monotherapy in previously treated HER2-expressing metastatic urothelial carcinoma patients. Seagen’s ADC early Phase candidates, SGN-ALPV and SGN-B7H4V, which use the company's unique vedotindrug linker technology, are also being studied in solid tumors. Preclinical findings from SGN-ALPV and SGN-B7H4V will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022.  Daiichi Sankyo Daiichi Sankyo is developing three ADCs, including Patritumab deruxtecan, Datopotamab deruxtecan (HER3-DXd/U3-1402), and ENHERTU, which is already approved for breast and stomach cancer.  AstraZeneca and Daiichi Sankyo are working together to develop deruxtecan, a TROP2-directed DXd. A Phase III clinical trial for the first-line therapy of TNBC (trial name: TROPION-Breast02) was launched in June 2022. The drug is being developed for a variety of indications, including non-small cell lung cancer, TNBC, and breast cancer.  Another ADC in development is Patritumab deruxtecan. Patritumab deruxtecan was developed using Daiichi Sankyo’s patented DXd ADC technology and consists of a human anti-HER3 antibody linked to topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker. Patritumab deruxtecan is now being studied in a multi-cancer development program as a monotherapy and in combination with other anticancer treatments. The development program includes HERTHENA-Lung01, a pivotal Phase II study in patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with a TKI and platinum-based chemotherapy; a Phase I/II study in HER3 expressing metastatic breast cancer; a Phase I study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a Phase I study in previously treated patients with metastatic or unresectable NSCLC. ADC Therapeutics ADC Therapeutics has several PBD-based ADCs in clinical trials as well as other preclinical ADCs in development. Camidanlumab tesirine has shown considerable clinical activity in individuals with Hodgkin lymphoma who have been highly pretreated. Camidanlumab tesirine, which targets CD25/regulatory T cells, is also showing promise in the treatment of solid tumors. Camidanlumab tesirine is being studied in a number of clinical trials. A crucial Phase II clinical trial in patients with relapsed or refractory (R/R) Hodgkin lymphoma; a Phase Ia/Ib clinical trial in patients with R/R Hodgkin lymphoma and Non-Hodgkin lymphoma; and a Phase Ib clinical trial in solid tumors are among the studies being conducted.  Another ADC product is ADCT-602, composed of a monoclonal antibody that binds to CD22 and is conjugated to a PBD-dimer toxin. ADCT-602 is being tested in patients with relapsed or refractory B-cell ALL in Phase I/II clinical trial. The University of Texas MD Anderson Cancer Centre is leading the trial. Mipasetamab uzoptirine (ADCT-601), ADCT-901, ADCT-701, and ADCT-212 are further early-stage ADC prospects in the company’s pipeline. AbbVie Telisotuzumab vedotin (ABBV-399) is an ADC that targets cMet and is being studied for the treatment of non-small cell lung cancer. AbbVie is currently investigating the ADC in a Phase III research called TeliMET NSCLC-01 (M18-868). In January 2022, AbbVie announced that the US FDA granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild-type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. Aside from that, AbbVie is developing ABBV154 to treat polymyalgia rheumatica (PMR) and Crohn’s disease, ABBV-011 to treat small cell lung cancer, and ABBV-155 to treat advanced hematologic malignancies and solid tumors. Key Developments in the ADCs Domain In April 2023, Mythic Therapeutics, announced preclinical data highlighting the potential of MYTX-011, its investigational cMET-targeting ADC, for treating a broader range of cMET+ cancers than other cMET-targeting ADCs in development. These data were presented as a poster at the American Association for Cancer Research Annual Meeting. MYTX-011 demonstrated higher internalization in cMET+ tumor cells and broader, more potent efficacy, including a greater than 3-fold increase in efficacy in mouse models of NSCLC, as compared to other cMET-targeting ADCs. In April 2023, Araris Biotech AG, announced the company delivered two poster presentations at this year’s American Association for Cancer Research (AACR) 2023 Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida. The presentations highlighted late-breaking preclinical data on anti-Nectin-4 and anti-HER2 ADCs generated using the company’s proprietary linker technology. Both ADCs demonstrated improved anti-tumor activity compared to respective FDA-approved ADCs in head-to-head in-vivo studies. In March 2023, Sanofi and Seagen Inc. announced an exclusive collaboration agreement to design, develop, and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. The collaboration will utilize Sanofi’s proprietary monoclonal antibody (mAb) technology and Seagen’s proprietary ADC technology. ADCs are antibodies engineered to deliver potent anti-cancer drugs to tumor cells expressing a specific protein and Sanofi currently has one ADC in development. In December 2022, Merck and Kelun-Biotech announced that the companies have entered into an exclusive license and collaboration agreement to develop seven investigational preclinical antibody-drug conjugates (ADC) for the treatment of cancer. Under the agreement, Kelun-Biotech has granted Merck exclusive global licenses to research, develop, manufacture, and commercialize multiple investigational preclinical ADC therapies and exclusive options to obtain additional licenses for ADC candidates. Kelun-Biotech retains the right to research, develop, manufacture, and commercialize certain licensed and option ADCs for mainland China, Hong Kong, and Macau. In December 2022, Biosion USA, Inc. announced an exploratory research collaboration to create antibody-drug conjugates (ADCs) for the treatment of cancer with ImmunoGen, Inc., a leader in developing next-generation ADCs. In the joint research effort, Biosion leveraged its proprietary SynTracer® high-throughput (HT) endocytosis platform to generate highly selective antibodies to targets allocated by each company and ImmunoGen will provide their proprietary linker-payload technology to create novel ADCs. On November 14, 2022, the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (brand name ELAHERE)for adult patients with folate receptor alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Promising Future of ADCs After decades of study and troubleshooting, significant technological breakthroughs and a better mechanistic understanding of ADC activity have resulted in the FDA approval of 11 ADCs, each of which provides substantial therapeutic benefit to cancer patients. With ~200 ADCs in pre-clinical/clinical research, the world appears to be entering a new era of targeted cancer therapy, despite some mixed opinions in academia. Although drug development remains a high-risk endeavor, those who have invested in ADC technology are finally reaping the benefits of their continued faith in this unique sector of biologics. We anticipate further ADC approvals in the near future, whether in the form of new ADCs or label expansions of those already approved. As ADCs have progressed through clinical trials, it has become obvious that the rules that apply to traditional chemotherapy or antibody-based therapies on their own do not always apply to ADCs. The promise of ADCs as a therapeutic method is significant, even beyond cancer. ADCs are already being studied for non-oncological indications such as autoimmune and cardiovascular disorders, diabetes, and antimicrobial infections. Given the recent enthusiasm for the role of artificial intelligence (AI) in drug discovery and development in adjacent fields, fueled in large part by advances in machine learning and ultimately the competitive force in the race to the next blockbuster drug, it is expected that drug companies will use these computer-based platforms to develop next-generation ADCs in the coming years.

TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System. A wireless robotic handpiece that is part of the TMINI system helps surgeons perform total knee replacements. The TMINI robotic handpiece automatically corrects the surgeon's hand movement to locate bone pins along with precisely defining planes while executing a three-dimensional surgical plan based on a CT scan. TMINI is simple to use and takes the place of many of the current knee replacement surgery tools. Together with Cambridge, UK-based R&D consultancy Sagentia Innovation, THINK Surgical created the TMINI robotic handpiece. The innovative design of the TMINI robotic handpiece, which is simple for surgeons and staff to incorporate into operating room workflows, was made possible by the combined technical expertise of both companies.  To maintain its commitment to an open implant library, THINK Surgical will gradually add new implant choices to the platform. Given the simplicity of the TMINI system and the open implant strategy, a large customer base that may have previously been wary of robotics should find interest in the product. "With its small footprint, open implant platform, and intuitive workflow, the TMINI system opens up robotic possibilities for more clinics, operating rooms, and surgeons," said Stuart Simpson, president, and chief executive officer of THINK Surgical. "The broader market opportunity for the TMINI system makes this an important development in surgical robotics. It's been exciting supporting this project from early concept development through transfer to manufacturing, and we look forward to its commercial success," said Duncan Smith, managing partner of Sagentia Innovation. As per DelveInsight’s “Surgical Robotic System Market” report, the global surgical robotic devices market was valued at USD 5.02 billion in 2022, growing at a CAGR of 11.50% during the forecast period from 2023 to 2028 to reach USD 9.64 billion by 2028. The demand for surgical robotic systems is witnessing a surge due to increasing surgical procedures which can be attributed to various factors such as the increasing geriatric population who form a big part of the at-risk population for prostate cancer, endometriosis, valvular diseases, among other diseases, growing need for robot-assisted surgery systems due to the growing inclination towards minimally invasive surgical approaches, and the innovation in product development which is paving the way for miniaturized surgical robots ultimately contributing in the overall growth of the surgical robotic systems market during the forecast period from 2023-2028. Cepheid’s Xpert NPM1 Mutation Test Received a CE Mark  On May 30, 2023, US-based molecular diagnostics company Cepheid secured the CE mark for its molecular in vitro diagnostic test, Xpert NPM1 Mutation. Acute myeloid leukemia (AML) patients' peripheral blood samples are used in the test to measure mutant NPM1 mRNA transcripts (types A, B, and D in exon 12). The test provides the percentage of mutant NPM1 to ABL1 endogenous control mRNA transcripts using automated real-time reverse transcription polymerase chain reaction. The European Leukemia Net recommends using quantitative molecular assessment of NPM1 through qPCR as part of minimal residual disease monitoring for AML patients with NPM1 mutations.  The company's hematology-oncology portfolio, which already includes Xpert BCR-ABL Ultra p190 and Xpert BCR-ABL Ultra, is said to benefit from the addition of the new diagnostic test. Cepheid oncology medical and scientific Affairs Vice-President Dr. Michael Bates said, “NPM1 mutations are found in approximately one-third of acute myeloid leukemia cases and can be used to monitor response to therapy as well as to predict relapse. The Xpert NPM1 Mutation test quantifies the mRNA transcripts of the A, B, and D mutations accounting for approximately 90% of NPM1 mutant cases, plus the ABL control gene, and provides an easy and convenient method of assessing response to therapy and improving the management of patients with AML.”  According to DelveInsight’s “In-vitro Diagnostics Market” report, the global in-vitro diagnostics market was valued at USD 71.01 billion in 2022, growing at a CAGR of 4.71% during the forecast period from 2023 to 2028, to reach USD 93.60 billion by 2028. The in vitro diagnostics market is estimated to register positive revenue growth owing to the factors such as the rising prevalence of various infectious diseases such as COVID-19, the growing prevalence of various cancers, increasing cases of hematological diseases, and increasing product development activities concerning in-vitro diagnostics among others.  Anika Completed Enrollment in Hyalofast® US Pivotal Phase III Study On May 30, 2023, Anika Therapeutics, Inc., a global joint preservation company focused on early intervention orthopedics, announced the completion of the enrolment of participants for its pivotal Phase III clinical study of Hyalofast, on its path to achieving FDA approval in the United States. Hyalofast is a highly differentiating, one-stage, hyaluronic acid (HA), matrix that preserves bone. Hyalofast is implanted in one surgery after debridement of the diseased tissue, as opposed to the current standard of care which requires two surgeries including removal of autologous cartilage, cell expansion, and subsequent cell reimplantation at the diseased site, or an alternative product that requires removing healthy bone to accommodate an implant.  Hyalofast is stocked at the surgical facility and can be easily taken off the shelf during surgery when a cartilage lesion is identified, which lessens the burden on patients and the healthcare system. Hyalofast is a truly revolutionary treatment for patients with pain and reduced function brought on by cartilage lesions. It is already available in more than 35 countries outside of the United States. The requirement for surgeons to perform and patients to endure a second surgical procedure to use the product currently on the market has restricted the US cartilage repair market. Without the need for a second expensive, invasive surgery, Hyalofast's off-the-shelf, bone-preserving design enables surgeons to quickly repair lesions intraoperatively. “This is an important milestone for Anika, bringing us one step closer to making Hyalofast available for patients in the United States,” said Anika’s President and CEO, Cheryl R. Blanchard, Ph.D. “The knee cartilage repair market in the U.S. is large and growing and is perfectly aligned with our strategic focus as we continue to introduce ground-breaking regenerative solutions that expand our Joint Preservation and Restoration portfolio. We believe that Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years. We are pleased that FDA has granted Hyalofast Breakthrough Device Designation and has agreed to a modular PMA filing, both of which will facilitate an efficient review process.” According to DelveInsight’s “Knee Reconstruction Devices Market” report, the global knee reconstruction devices market was valued at USD 7.87 billion in 2022, growing at a CAGR of 4.52% during the forecast period from 2023 to 2028 to reach USD 10.27 billion by 2028. The rise in the demand for knee reconstruction/replacement devices is predominantly attributed to the burgeoning old-age population and the rising prevalence of various knee-associated musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, and others. Also, the growing demand for minimally invasive surgeries and various technological advancements to improve the efficiency of the products are key market drivers. EMVision Initiated the Stage II of the Portable Brain Scanner Trial On May 30, 2023, the Australia-based EMVision Medical Devices initiated the Stage II of its clinical trial for its first-generation portable brain scanner. The first phase of the trial has just recently been completed, involving 30 healthy volunteers. Further, 150 patients with acute strokes and stroke mimics are expected to enroll in the second stage. Major comprehensive stroke centers in Australia, including Royal Melbourne Hospital, Princess Alexandra Hospital, and Liverpool Hospital, are participating in the trial. Each site has a population of stroke patients and a committed research team to support a quick patient enrolment process. EMVision Medical Devices CEO Dr. Ron Weinberger said, “Significant preparation and positive collaboration between the EMVision team and hospital staff has been underway to ensure the next phase of our multi-site clinical trials is set up for success. We have taken the technical and usability information from Stage I and refined our device for Stage II and although the modifications are not major, they will result in significant performance improvements.” According to DelveInsight’s “Neurology Devices Market” report, the global neurology devices market is estimated to grow at a CAGR of 7.46% during the forecast period from 2023 to 2028. The neurology devices market is observing optimistic market growth due to factors such as the rise in the number of regulatory approvals for neurology devices across the globe. Further, the increasing cases of head injuries owing to accidents, workplace injuries, and others, and the rise in the geriatric population coupled with the increasing prevalence of neurological diseases are going to increase the demand for various neurological devices across the globe. Additionally, the growing focus on improving the safety, affordability, and usability of neurology devices for end users is further expected to result in appreciable revenue growth in the neurology devices market during the forecast period (2023-2028). HeartBeam Entered into Strategic Alliance Agreement with Samsung On May 30, 2023, HeartBeam, Inc., a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform intended for patient use at home, entered into a Strategic Alliance Agreement (SAA) with Samsung, extending the existing SAA between LIVMOR and Samsung. Under the terms of the contract, HeartBeam and Samsung will identify and specify opportunities for cooperation, drawing on the knowledge and patented technology of the HeartBeam team in the evaluation and monitoring of cardiac symptoms. “The goal of this partnership is to bring the standard of care for cardiac diagnostic capabilities to patients by utilizing cutting-edge technologies of both Samsung and HeartBeam,” said Branislav Vajdic, Ph.D., HeartBeam CEO, and Founder. Branislay further added, “Our newly acquired state-of-the-art, FDA-cleared, Samsung watch-based arrhythmia detection tool, once integrated with the HeartBeam AIMIGo™ telehealth platform, presents a unique opportunity to extend our product capabilities well beyond what is currently available for cardiac patients outside of a medical setting.” Kevin Jones, Senior Director, Federal Healthcare, Samsung Electronics America, added, “The strategic collaboration between Samsung and LIVMOR was very successful, resulting in an FDA-cleared solution for Atrial Fibrillation detection centered around the Samsung Galaxy watch and tablet running Samsung's defense-grade cyber-security system, Knox. We are excited that LIVMOR is now part of HeartBeam and look forward to continuing our successful collaboration. The potential of combining LIVMOR’s technology and the HeartBeam AIMIGo system holds significant promise to address major cardiac conditions for our veterans.” According to DelveInsight’s “Cardiac Monitoring Devices Market” report, the global cardiac monitoring devices market is estimated at a CAGR of 5.4% during the forecast period from 2023 to 2028. The demand for cardiac monitoring devices is primarily being boosted by the rising prevalence of cardiovascular diseases, technological advancement in product development, increasing geriatric population, sedentary lifestyle, and increasing awareness programs regarding cardiovascular diseases. Eosolutions Corp. Announced the Full Commercial Launch of the Dr. Banner Balloon Guide Catheter On May 24, 2023, EOSolutions Corp., a pioneering medical technology company focused on delivering high-quality catheter solutions, launched Dr. Banner, Balloon Guide Catheter (BGC).  It was developed in collaboration with InNeuroCo, a leading design, consulting, and contract manufacturing group with Dr. Banner setting new benchmarks in catheter technology, providing physicians with unparalleled capabilities.  The device offers various features such as the largest inner diameter (ID) of 0.091, improved proximal stability, distal trackability, and a super-compliant polyurethane balloon. "Dr. Banner marks a significant milestone in the field of neurovascular interventions," said Anthony Parise, General Manager and Head of Sales & Marketing at EOSolutions Corp. Dr. Banner further added, "With its unparalleled inner diameter, proximal stability, distal trackability, and super compliant polyurethane balloon, Dr. Banner empowers physicians to overcome the challenges of complex anatomies, providing precise and effective treatment options for their patients. We are excited to respond to the needs of our physicians by introducing this ground-breaking catheter that will improve upon their ability to perform the most challenging neurovascular procedures." According to DelveInsight’s “Balloon Catheters Market” report, the global balloon catheters market was valued at USD 4.60 billion in 2022, growing at a CAGR of 8.78% during the forecast period from 2023 to 2028 to reach USD 7.62 billion by 2028. Factors such as the rising prevalence of lifestyle disorders such as hypertension and obesity which present themselves as major risk factors for the development of cardiovascular diseases as well as brain aneurysms, increasing incidence of cancers in the pelvic region affecting the urinary system in varying capacities, growing geriatric population base where age itself plays a major role in disease etiology and technical 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 during the forecast period from 2023-2028.