Connect with us
European Gaming Congress 2024

Fintech PR

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Published

on

alkermes-presents-clinical-and-real-world-data-at-36th-annual-psych-congress

Poster Presentations Highlight Company’s Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —

DUBLIN, Sept. 11, 2023 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company’s continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

“Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases. This year’s presentations further reinforce Alkermes’ leadership and experience in the field of neuroscience,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Highlights of the presentations include:

  • The first real-world data assessment of healthcare resource use in patients with schizophrenia or bipolar I disorder in the six months following initiation of LYBALVI® (olanzapine and samidorphan);
  • Findings from a meta-analysis using individual subject-level data across three randomized, double-blind, controlled clinical trials designed to assess changes in body weight as either a primary or secondary endpoint in patients who received LYBALVI compared to those who received olanzapine;
  • Three posters describing the first set of results from OASIS (Observational Study of Long-Acting Injectables in Schizophrenia), a prospective, noninterventional study evaluating the use of second-generation long-acting injectables (LAIs) in community clinics, including during the COVID-19 pandemic;
  • Post-hoc analyses of the ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study, in which patients with schizophrenia were randomized to receive either the two-month dose of ARISTADA® (aripiprazole lauroxil) initiated in an inpatient setting using ARISTADA INITIO® (aripiprazole lauroxil) plus a single 30 mg oral dose of olanzapine, or an active control of paliperidone palmitate; and
  • Results from a recently completed, structured qualitative interview study evaluating the diagnosis journey and symptoms of adults living with narcolepsy type 1 and narcolepsy type 2.

A full list of Alkermes’ presentations at Psych Congress follows:

  • Poster #18: Diagnosis and Symptoms of Narcolepsy from the Patient Perspective: Results from In-Depth Qualitative Interviews
  • Poster #86: Aripiprazole Lauroxil 2-Month Formulation for Acute Schizophrenia: A Post Hoc Analysis of PANSS Factor Scores in the ALPINE Study
  • Poster #88: Key Characteristics of the Atypical Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for the Treatment of Schizophrenia
  • Poster #91: Olanzapine/Samidorphan Effects on Weight Gain: A Meta-analysis of Phase 2 and 3 Randomized, Double-Blind Studies
  • Poster #147: Burden of Bipolar I Disorder on Clinical, Economic, and Humanistic Outcomes: Matched Analysis of US National Health and Wellness Survey Data
  • Poster #148: Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder
  • Poster #157: Baseline Demographics and Clinical Characteristics From OASIS: An Observational Study of Long-Acting Injectables in Schizophrenia
  • Poster #161: Treatment Patterns From OASIS: Observational Study of Long-Acting Injectables in Schizophrenia
  • Poster #163: Outcomes From OASIS: Observational Study of Long-Acting Injectables in Schizophrenia
  • Poster #158: Mental Health Comorbidities Among Patients With Chronic Medical Conditions and Alcohol Use Disorder
  • Poster #159: Opioid Antagonists: Clinical Utility, Pharmacology, and Safety and Tolerability

About LYBALVI® (olanzapine and samidorphan)
LYBALVI® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.

IMPORTANT SAFETY INFORMATION FOR LYBALVI® (olanzapine and samidorphan)

Boxed Warning: Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the
treatment of patients with dementia-related psychosis.

Contraindications: LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products.

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke, transient ischemia attack, and fatalities. See Boxed Warning above.

Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids: LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers.

Vulnerability to Life-Threatening Opioid Overdose: Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage.

Advertisement

Neuroleptic Malignant Syndrome, a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and close monitoring.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected.

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically.

Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered.

Orthostatic Hypotension and Syncope: Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease. 

Falls: LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI.

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases): Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors.

Dysphagia: Use LYBALVI with caution in patients at risk for aspiration.

Seizures: Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: Because LYBALVI may cause somnolence, impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely.

Advertisement

Body Temperature Dysregulation: Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Anticholinergic (Antimuscarinic) Effects: Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.

Hyperprolactinemia: LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Risks Associated with Combination Treatment with Lithium or Valproate: If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products. 

Most common adverse reactions observed in clinical trials were: 

  • Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache
  • Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor
  • Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): dry mouth, dyspepsia, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia

Concomitant Medication: LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy.

Renal Impairment: LYBALVI is not recommended for patients with end-stage renal disease (eGFR of <15 mL/minute/1.73 m2).

Please see full Prescribing Information, including Boxed Warning, for LYBALVI.

About ARISTADA® (aripiprazole lauroxil) Extended-Release Injectable Suspension, for Intramuscular Use
ARISTADA is an injectable atypical antipsychotic approved in four dose strengths and three dosing durations for the treatment of schizophrenia in adults (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months). Once in the body, ARISTADA converts to aripiprazole.

About ARISTADA INITIO® (aripiprazole lauroxil) Extended-Release Injectable Suspension, for Intramuscular Use
ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. The first ARISTADA dose may be administered on the same day as the ARISTADA INITIO regimen or up to 10 days thereafter.

Advertisement

IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® and ARISTADA® 

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. ARISTADA INITIO and ARISTADA are not approved for the
treatment of patients with dementia-related psychosis. 

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis.

Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing antipsychotics should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges.

Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

Advertisement

Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or ARISTADA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.

Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks. Avoid use of ARISTADA 662 mg, 882 mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 inhibitors. (See Table 4 in the ARISTADA full Prescribing Information.)

Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia. 

Injection-Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. Injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection-site pain and associated with the first injection and decreased with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) occurred at less than 1%.

Advertisement

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA INITIO and/or ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for ARISTADA INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.

Please see full Prescribing Information, including Boxed Warning, for ARISTADA INITIO, and full Prescribing Information, including Boxed Warning, for ARISTADA.

About Alkermes
Alkermes plc is a fully-integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

LYBALVI®, ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license.

Alkermes Contacts:

For Investors:

Sandy Coombs, +1 781-609-6377

For Media:

Marisa Borgasano, +1 781-609-6659

Advertisement

 

Logo – https://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg

Cision View original content:https://www.prnewswire.co.uk/news-releases/alkermes-presents-clinical-and-real-world-data-at-36th-annual-psych-congress-301922607.html

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Fintech PR

Richardson Sales Performance Announces Acquisition of Challenger, Uniting Two Industry Leaders to Redefine the Future of Sales Training

Published

on

richardson-sales-performance-announces-acquisition-of-challenger,-uniting-two-industry-leaders-to-redefine-the-future-of-sales-training

PHILADELPHIA and CHICAGO, Sept. 16, 2024 /PRNewswire/ — Richardson Sales Performance (Richardson), a leading global provider of sales training solutions, today announced its acquisition of Challenger, world-renowned for their research-based Challenger selling approach. This strategic acquisition unites two of the most influential names in the sales performance industry, creating an unparalleled powerhouse poised to deliver innovative, high-impact solutions for sales organizations worldwide.

The combination of Richardson’s expertise in developing role-based sales capabilities and Challenger’s distinctive approach to challenging conventional thinking in sales, marketing, and customer service teams will equip both companies’ customers for greater success. Together, the two companies will offer a more comprehensive suite of solutions designed to elevate sales teams’ performance and drive measurable business outcomes.

Richardson and Challenger’s joint capabilities will provide customers with expanded access to best-in-class methodologies, cutting-edge technology, rich analytics, and a broader range of learning experiences. By leveraging the strengths of both organizations, customers will benefit from a more holistic approach to sales training, encompassing everything from consultative, agile selling skills to disruptive, insight-driven selling strategies.

“The combination of Richardson’s proven track record in equipping sellers with a wide range of sales capabilities and Challenger’s expertise in message creation and challenging conventional thinking creates a unique opportunity for our customers to develop sales teams that are both agile and differentiated,” said John Elsey, CEO of Richardson Sales Performance. “We are excited to join forces with Challenger to provide an unmatched range of solutions that will empower sales professionals to thrive in an increasingly competitive environment.”

The acquisition also opens up new opportunities for employees of both companies. Together, Richardson and Challenger will foster a collaborative and innovative environment where employees can access broader professional development opportunities, leverage combined resources, and contribute to shaping the future of sales training and performance improvement.

Andee Harris, CEO of Challenger, commented, “I believe that our employees are key to driving strategic success. By joining forces with Richardson, we are unlocking critical resources and capabilities that will enable us to accelerate our long-term objectives. This acquisition positions us to enhance both our competitive edge and the opportunities we can offer our team members, strengthening our ability to deliver exceptional value to our customers.”

This transaction has been supported by Richardson’s financial sponsor, Truelink, which was launched in 2022 by Todd Golditch and Luke Myers to work with companies in the industrials and tech-enabled services sectors. The firm’s senior team brings decades of experience to their portfolio company partners, an extensive history of creating value together, and well-established strategies to improve processes, fuel growth, and enhance earnings.

Houlihan Lokey served as the exclusive financial advisor to Challenger.

About Richardson Sales Performance
Richardson is how leading sales organizations around the world are getting better results from their investment in sales training. For far too long, companies have had to deal with a big disconnect between their training and their real results in the field. We connect metrics to behaviors, training to outcomes and sellers to their best performance. For more information, visit www.richardson.com 

About Challenger
Challenger is the global leader in training, technology, and consulting to win today’s complex sale. The company delivers a comprehensive portfolio of solutions to sales, marketing and customer service teams. Challenger’s training and consulting is provided through in-person workshops, eLearning and workflow tools, diagnostic and assessment offerings, and other sales acceleration modules. Underpinned by the world-renowned, research-based Challenger™ methodology, Challenger’s solutions help enterprises adopt, develop, communicate and implement more effective commercial strategies on a global scale. For more information, visit www.challengerinc.com.

Advertisement

Media Contact:
Andrea Grodnitzky
Chief Marketing Officer
Richardson Sales Performance
215-940-9255
[email protected]

Logo – https://mma.prnewswire.com/media/1178731/Richardson_Sales_Performance_Logo.jpg

Cision View original content:https://www.prnewswire.co.uk/news-releases/richardson-sales-performance-announces-acquisition-of-challenger-uniting-two-industry-leaders-to-redefine-the-future-of-sales-training-302248218.html

Continue Reading

Fintech PR

Blockchain Market to Reach $403.36 Billion by 2030, Driven by Rising Demand for Secure and Transparent Transactions in the BFSI Sector and Growing Popularity of Cryptocurrency – Exclusive Report by Meticulous Research®

Published

on

blockchain-market-to-reach-$403.36-billion-by-2030,-driven-by-rising-demand-for-secure-and-transparent-transactions-in-the-bfsi-sector-and-growing-popularity-of-cryptocurrency-–-exclusive-report-by-meticulous-research

REDDING, Calif., Sept. 16, 2024 /PRNewswire/ — According to a new market research report titled, ‘Blockchain Market by Type (Public, Private, Hybrid, Consortium), Platform (Ethereum, Hyperledger, Polygon, Solana), Organization Size, Sector (BFSI, Government, Healthcare, Professional Services, Manufacturing), and Geography—Global Forecast to 2030.

The blockchain market is projected to reach $403.36 billion by 2030, at a CAGR of 67.7% from 2023 to 2030.

Download FREE PDF Brochure Of Blockchain Market – https://www.meticulousresearch.com/download-sample-report/cp_id=5526

The growth of this market is mainly driven by the rising demand for secure and transparent transactions in the BFSI sector, the surging need to prevent data tampering in the healthcare sector, and the growing popularity of cryptocurrency. However, the high costs of blockchain implementation restrain the growth of this market.

Furthermore, SMEs’ focus on leveraging blockchain and the increasing adoption of blockchain among retailers are expected to create significant growth opportunities for the players in this market. However, regulatory uncertainties and the lack of interoperability between blockchain ecosystems are major challenges impacting market growth.

Get Insightful Data On Regions, Market Segments, Customer Landscape, And Top Companies (Charts, Tables, Figures And More) – https://www.meticulousresearch.com/request-sample-report/cp_id=5526

Increasing Need to Prevent Data Tampering Driving the Adoption of Blockchain Technology in the Healthcare Sector

The growing popularity of cryptocurrency and the need to prevent data tampering in the healthcare sector are key factors increasing the adoption of blockchain technology. Cryptocurrencies, such as Bitcoin, have gained traction in recent years, showcasing the potential of decentralized digital currencies that rely on blockchain technology for secure and transparent transactions. Data integrity and security are of paramount importance in the healthcare sector. Medical records, clinical trial data, and patient information must be protected from unauthorized access, tampering, or alteration. With blockchain technology, healthcare organizations can securely store and share patient records, ensuring the security and integrity of sensitive information. The distributed nature of blockchain technology eliminates the reliance on a single centralized authority, reducing the risk of data manipulation or tampering. The players in this market are focused on launching new offerings for healthcare applications. For instance, in October 2020, IBM Watson Health (U.S.) launched a blockchain-powered digital health pass. This digital health initiative was aimed at allowing users to share their verified health status without exposing the data used to generate it.

Explore the Key Market Segments Driving Growth (Download Free Sample) – https://www.meticulousresearch.com/download-sample-report/cp_id=5526

Blockchain Market Analysis: Key Findings

Advertisement
  • By Type: In 2023, the public segment accounted for the largest share of 66.9% of the blockchain market. However, the private segment is expected to register the highest CAGR of 70.3% during the forecast period 2023–2030.
  • By Platform: In 2023, the Ethereum segment accounted for the largest share of 53.8% of the blockchain market. However, the Hyperledger segment is expected to register the highest CAGR of 71.0% during the forecast period 2023–2030.
  • By Organization Size: In 2023, the large enterprises segment accounted for the major share of 74.0% of the blockchain market. However, the small & medium-sized enterprises segment is expected to register the higher CAGR of 70.1% during the forecast period 2023–2030.
  • By Application: In 2023, the payments segment accounted for the largest share of 25.2% of the blockchain market. Also, the payments segment is expected to register the highest CAGR of 69.3% during the forecast period 2023–2030.
  • By Sector: In 2023, the BFSI segment accounted for the largest share of 41.2% of the blockchain market. However, the healthcare & life sciences segment is expected to register the highest CAGR of 80.2% during the forecast period 2023–2030.

Have specific research needs? Request a customized research report – https://www.meticulousresearch.com/request-customization/cp_id=5526

Blockchain Market Analysis by Segment with Projected CAGR (2023–2030)

Category

2023 Largest Share

% Share (2023)

Highest CAGR (2023-2030)

CAGR % (2023-2030)

By Type

Public Segment

66.90 %

Private Segment

Advertisement

70.30 %

By Platform

Ethereum Segment

53.80 %

Hyperledger Segment

71.00 %

By Organization Size

Large Enterprises Segment

74.00 %

Small & Medium Enterprises

Advertisement

70.10 %

By Application

Payments Segment

25.20 %

Payments Segment

69.30 %

By Sector

BFSI Segment

41.20 %

Healthcare & Life Sciences

Advertisement

80.20 %

 

Geographic Analysis:

Based on geography, the blockchain market is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. In 2023, North America accounted for the largest share of 38.9% of the blockchain market. This market is projected to reach $136. 4 Billion by 2030.

Financial service industries across North America are poised for transformative change, and leading corporations and start-ups are increasingly investing in fintech. The increasing use of technologies within business ecosystems, the growing number of financial firms, millennials’ preference for digital applications and services for task completion, the rising demand for high-speed apps, and the growing need for real-time data transfer capabilities are expected to support the growth of the blockchain market in North America over the forecast period.

Browse In-depth Report Now – https://www.meticulousresearch.com/product/blockchain-market-5526

Furthermore, the presence of several blockchain providers across North America has also contributed to the region’s large market size. For instance, North America is home to some of the most popular blockchain development companies around the globe, including IBM and Amazon Web Services Inc. These companies are actively focusing on the development of innovative blockchain products. Additionally, governments in the region have undertaken several initiatives to support the adoption and raise awareness regarding blockchain technology.

In 2023, the U.S. accounted for the dominant share of 95.4% of the blockchain market in North America. The country’s large market share is mainly attributed to the increasing demand for decentralized financial solutions, the presence of leading blockchain development companies, and the increasing implementation of blockchain technology across retail, government, and BFSI organizations.

Get A Glimpse Inside: Request Sample Pages – https://www.meticulousresearch.com/request-sample-report/cp_id=5526

The high potential for the widespread adoption of blockchain technology across the financial services sector, the increasing development of digital currencies and fast payment methods, and the emergence of cryptocurrencies such as bitcoin are driving the growth of the blockchain market in the U.S. Furthermore, research and investments in blockchain technology are creating notable brands such as Libra (Facebook), JPM coin (JPMorgan) and Gemini coin (Winklevoss brothers), broadening the scope of the blockchain market. Leading blockchain providers are implementing solutions across the U.S. to ensure safe & secure transactions. For instance, in April 2021, BitGo (U.S.) implemented blockchain solutions to enable security for CoinLoan (Estonia) clients across the U.S.

Advertisement

Asia-Pacific: The Fastest-growing Regional Market

Asia-Pacific is projected to register the highest CAGR of 71.5% during the forecast period. In 2023, China accounted for the largest share of the blockchain market in Asia-Pacific. Market growth in APAC is attributed to the surging demand for safe transactions across international borders, the growing number of crypto-related businesses, and rising disposable incomes. Government policies and initiatives incorporating blockchain technology in the public sector are also expected to create growth opportunities for the players in this market.

The Asia-Pacific region is a leading fintech powerhouse due to the presence of hotspots, including Hong Kong, Singapore, Melbourne, and Indonesia. The presence of Chinese fintech hubs across Beijing, Shanghai, and Shenzhen, the increasing number of fintech companies across India, and the growing demand for friction-free, peer-to-peer transactions are driving the growth of the blockchain market in APAC.

Governments in the region have recognized the potential of blockchain technology and have launched initiatives to support its development. For example, China has expressed a strong interest in blockchain and has invested heavily in research and development. Singapore has also created a conducive environment for blockchain start-ups through regulatory frameworks and funding. These government initiatives contribute to market growth in the region.

Need Insights on Regional Data? Check Out Our Detailed Analysis (Download Free Sample) – https://www.meticulousresearch.com/download-sample-report/cp_id=5526

The U.K. Continues to Dominate the Blockchain Market in Europe

In 2023, the U.K. accounted for the largest share of the blockchain market in Europe. Factors driving market growth in the U.K. include the strong presence of leading financial firms, supportive government initiatives, and advances in fintech.

Blockchain has driven innovation across industries in the U.K. The emergence of distributed ledger technologies, such as blockchain, is influencing industries in the U.K., owing to the rapid development and proliferation of blockchain applications across the country. For instance, in March 2021, the London Stock Exchange partnered with IBM Corporation (U.S.) to develop Turquoise, a blockchain-based platform for issuing digital securities. The platform streamlines post-trade processes, enhances transparency, and attracts new investors by leveraging the benefits of blockchain technology.

Furthermore, Walmart (U.S.) implemented a blockchain solution for tracking and tracing food products in its U.K. stores. This solution helps ensure food safety, improves efficiency, and builds consumer trust. Blockchain technology can also revolutionize healthcare systems by improving data management, patient privacy, and interoperability. In the U.K., the National Health Service (NHS) implemented blockchain in the MediLedger Project led by the NHS National Innovation Center (NIC). This project aims to leverage blockchain to share medical research data securely and efficiently. These factors contribute to market growth in the country.

Need Insights on Regional Data? Check Out Our Detailed Analysis (Download Free Sample) – https://www.meticulousresearch.com/download-sample-report/cp_id=5526

Advertisement

Blockchain Market: Competition Analysis

This report offers a competitive analysis based on an extensive assessment of the leading players’ product portfolios, geographic presence, and key growth strategies adopted over the past 3–4 years. Major companies in the blockchain market have implemented various strategies to expand their product offerings and global footprints and augment their market shares. The key strategies followed by leading companies in the blockchain market include product launches, expansions, mergers & acquisitions, agreements, collaborations, and partnerships. The key players operating in the blockchain market include IBM Corporation (U.S.), Microsoft Corporation (U.S.), Oracle Corporation (U.S.), Amazon Web Services, Inc. (U.S.), Infosys Limited (India), Accenture plc (Ireland), Wipro Limited (India), Blockchain.com (U.K.), Circle Internet Financial Limited (U.S.), Ripple (U.S.), Tata Consultancy Services Limited (India), Intel Corporation (U.S.), Chainalysis Inc. (U.S.), Coinbase (U.S.), and BitGo (U.S.).

Learn About the Top Companies Influencing Market Dynamics (Download Free Sample) –  https://www.meticulousresearch.com/request-sample-report/cp_id=5526

Blockchain Industry Overview: Latest Developments from Key Industry Players

  • In January 2023, Amazon Web Services (U.S.) launched Avalanche to help bring blockchain technology to enterprises and governments. Avalanche is the first blockchain integrated with Amazon’s cloud-computing platform.
  • In January 2023, Ava Labs (Brooklyn) partnered with Amazon Web Services (U.S.) to allow individuals and institutions to launch subnets that can operate as self-sufficient blockchain systems.
  • In November 2022, Accenture plc collaborated with NTT DOCOMO (Japan) to accelerate the adoption and application of Web3 for addressing social issues.
  • In October 2022, Oracle Corporation launched its Oracle Database 23c Beta, the new version of the world’s most widely used converged database that supports all data types, workloads, and development styles.
  • In August 2022, Infosys Limited partnered with VMware (U.S.) to launch a blockchain-based vital records management solution.
  • In May 2022, Keep Sea Blue (Athens), an international and independent association, collaborated with Oracle Corporation (U.S.) to use Oracle’s blockchain technology to fight plastic pollution and keep the Mediterranean clean.
  • In November 2021, Infosys Finacle (India), a wholly-owned subsidiary of Infosys, collaborated with IBM Corporation (U.S.) to make the Finacle Digital Banking Solution available on Red Hat OpenShift and IBM Cloud with blockchain technology for Financial Services.
  • In August 2021, IBM Corporation (U.S.) collaborated with NPTEL to offer a 12-week online course on blockchain architecture, design, and use cases.
  • In January 2021, IBM Corporation (U.S.) partnered with Thai Reinsurance Public Company Limited (Thailand) to launch ASEAN’s first reinsurance smart contract platform using its blockchain and hybrid cloud technology.
  • In January 2021, Microsoft Corporation (U.S.) collaborated with Invest India to empower tech start-ups. The start-ups shortlisted by Microsoft included Whrrl Fintech Solutions, a company that empowers farmers, traders, and producer companies on a blockchain platform to raise working capital to tide over lengthy crop cycles.

IMMEDIATE DELIVERY AVAILABLE | BUY THIS RESEARCH REPORT (Insights, Charts, Tables, Figures and More)- https://www.meticulousresearch.com/Checkout/43525727

Scope of the Report:

Blockchain Market Assessment—by Type

  • Public
  • Private
  • Hybrid
  • Consortium

Blockchain Market Assessment—by Platform

  • Ethereum
  • Hyperledger
  • R3 Corda
  • Polygon
  • Solana
  • BSC
  • Terra
  • Other Platforms

Blockchain Market Assessment—by Organization Size

  • Large Enterprises
  • Small & Medium-sized Enterprises

Blockchain Market Assessment—by Application

  • Digital Currency
  • Asset Protection & Transfer
  • Identity Protection
  • Payments
  • Data Reconciliation & Sharing
  • Track & Trace
  • Certification
  • Other Applications

Blockchain Market Assessment—by Sector

  • BFSI
  • Government
  • Healthcare & Life Sciences
  • Retail & E-commerce
  • Energy & Utilities
  • Professional Services
  • Media & Entertainment
  • Manufacturing
  • Other Sectors

Blockchain Market Assessment—by Geography

  • North America
    • U.S.
    • Canada
  • Asia-Pacific (APAC)
    • China
    • Japan
    • India
    • South Korea
    • Australia & New Zealand
    • Singapore
    • Rest of Asia-Pacific (RoAPAC)
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Sweden
    • Rest of Europe (RoE)
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America (RoLATAM)
  • Middle East & Africa
    • UAE
    • Israel
    • Rest of Middle East & Africa

Browse More Related Reports:

Blockchain in Manufacturing Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/blockchain-in-manufacturing-market-5016

Blockchain in retail market to hit $25.8 Billion by 2029, growing at 68.3% CAGR. Explore its impact on transaction management, supply chain. – https://www.meticulousresearch.com/product/blockchain-in-retail-market-5376

Blockchain Market to hit $403.36 Billion by 2030, growing at a 67.7% CAGR from 2023. Explore growth trends and future opportunities in this booming industry. – https://www.meticulousresearch.com/product/blockchain-market-5526

Blockchain gaming market is projected to reach $165.4 billion by 2030, at a CAGR of 51.7% during the forecast period 2024–2030 – https://www.meticulousresearch.com/product/blockchain-gaming-market-5540

Advertisement

Blockchain Market Research Report Summary

Report Metrics

Details

Base year considered

2022

Forecast period

2023-2030

CAGR

CAGR 67.70%

Market Size

Advertisement

$403.36 billion

Segments Covered

By Type (Public, Private, Hybrid, Consortium), Platform (Ethereum, Hyperledger, Polygon, Solana), Organization, Sector (BFSI, Government, Healthcare, Professional Services, Manufacturing), and Geography

Geographies covered

North America, Europe, Asia Pacific, Middle East & Africa, Latin America

Companies covered

 International Business Machines Corporation (U.S.), Microsoft Corporation (U.S.), Oracle Corporation (U.S.), Amazon Web Services, Inc. (U.S.), Infosys Limited (India), Accenture plc (Ireland), Wipro Limited (India), Blockchain.com (U.K.), Circle Internet Financial Limited (U.S.), Ripple (U.S.), Tata Consultancy Services Limited (India), Intel Corporation (U.S.), Chainalysis Inc. (U.S.), Coinbase (U.S.), and BitGo (U.S.).

 

Click here to: Get a Free Sample Copy of this report

Hot Industry Reports: Emerging Trends and Market Forecasts

Advertisement

Chromatography Syringes Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/chromatography-syringes-market-3242

VNA and PACS Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/vna-and-pacs-market-4440

Dental Materials Market by Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/dental-materials-market-3182

Pharmaceutical Storage And Material Handling Equipment Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/pharmaceutical-storage-and-material-handling-equipment-market-4364

Tooth Replacement Market by Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/tooth-replacement-market-3155

Electronic Lab Notebook Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/electronic-lab-notebook-eln-market-4341

Hydroponics Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/hydroponics-market-5434

Laboratory Informatics Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/laboratory-informatics-market-3945

Sorbitol Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/sorbitol-market-3019

Mice Model Market by Size, Share, Forecast, & Trends 2023 – 2030 – https://www.meticulousresearch.com/product/mice-model-market-4151

Advertisement

High Throughput Screening Market Size, Share, Forecast, & Trends 2031 – https://www.meticulousresearch.com/product/high-throughput-screening-market-3206

Veterinary Immunodiagnostics Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/veterinary-immunodiagnostics-market-2897

Life Science Equipment Market by Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/life-science-equipment-market-3937

Cell Culture Market Size, Share, Growth, & Trends 2029 – https://www.meticulousresearch.com/product/cell-culture-market-4788

Bakery Processing Equipment Market Size, Share, Report 2030 – https://www.meticulousresearch.com/product/bakery-processing-equipment-market-4854

Inspection Machines Market Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/inspection-machines-market-2571

Modified Starch Market Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/modified-starch-market-2718

Industrial Margarine Market Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/industrial-margarine-market-3837

Plasmapheresis Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/plasmapheresis-market-3092

Biopharmaceutical Processing Equipment and Consumables Market Size – https://www.meticulousresearch.com/product/biopharmaceutical-processing-equipment-and-consumables-market-4200

Advertisement

Lipid Nutrition Market by Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/lipid-nutrition-market-3045

Telehealth Market: Size, Trends & Forecast Analysis to 2029 – https://www.meticulousresearch.com/product/telehealth-market-4174

IVD Quality Control Market Size, Share, Forecast, & Trends – https://www.meticulousresearch.com/product/ivd-quality-control-market-3447

Population Health Management (PHM) Solutions Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/population-health-management-solutions-phm-market-3897

North America Telehealth Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/north-america-telehealth-market-4832

South East Asia Food Processing Equipment Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/south-east-asia-food-processing-equipment-market-4194

Chromatography Data Systems Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/chromatography-data-systems-market-2933

Healthcare Artificial Intelligence Market Growth and Trends – https://www.meticulousresearch.com/product/healthcare-artificial-intelligence-market-4937

Latin America Home Healthcare Market by Size, Share, Forecasts, & Trends Analysis – https://www.meticulousresearch.com/product/latin-america-home-healthcare-market-1287

Speech and Voice Recognition Market Size, Share, Forecast, & Trends Analysis – https://www.meticulousresearch.com/product/speech-and-voice-recognition-market-5038

Advertisement

Contact:
Mr. Khushal Bombe
Meticulous Market Research Inc.
1267 Willis St, Ste 200 Redding,
California, 96001, U.S.
USA: +1-646-781-8004
Europe: +44-203-868-8738
APAC: +91 744-7780008
Email- [email protected]
Visit Our Website: https://www.meticulousresearch.com/
Connect with us on LinkedIn- https://www.linkedin.com/company/meticulous-research
Meticulousblog.org | Top Market Research Reports Blog – https://meticulousblog.org/
Content Source: https://www.meticulousresearch.com/pressrelease/757/blockchain-market

Photo: https://mma.prnewswire.com/media/2506362/Blockchain_Market_Size.jpg
Logo: https://mma.prnewswire.com/media/1757980/Meticulous_Research_Logo_1.jpg

Meticulous Research

 

Cision View original content:https://www.prnewswire.co.uk/news-releases/blockchain-market-to-reach-403-36-billion-by-2030–driven-by-rising-demand-for-secure-and-transparent-transactions-in-the-bfsi-sector-and-growing-popularity-of-cryptocurrency—exclusive-report-by-meticulous-research-302249186.html

Continue Reading

Fintech PR

Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

Published

on

epitomee-medical-announces-fda-clearance-of-its-capsule,-weight-management-device

Epitomee’s Ingestible Capsule, Offers a Safe and Effective Prescription Solution for Adults with BMI of 25-40 looking for Alternative Drug Free Solutions for Their Weight Management Needs alongside diet and exercise.

CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ — Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially cleared the Epitomee® Capsule, a cutting-edge ingestible medical device designed to support weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m² alongside diet and exercise. This novel, drug-free treatment provides a new option for millions of health-conscious individuals in the U.S.

The Epitomee® Capsule represents an innovative prescription option in weight management solutions, offering a drug-free alternative that differs from injectable treatments. With FDA clearance extending to adults with a BMI starting at 25, Epitomee® Capsule is accessible to a broader range of patients looking for tolerable and easy to use weight management solutions. The Epitomee® device is encased in a standard size, self-administered ingestible capsule. Once the Epitomee® Capsule is swallowed, and reaches the stomach it absorbs water in the stomach and creates a three-dimensional matrix designed to occupy volume in the stomach creating a sensation of fullness, enabling weight loss. The Epitomee® Capsule mechanism of action is purely mechanical and does not involve any chemical activity. The capsule works directly in the gastrointestinal (GI) tract.

Epitomee® Capsule was cleared by the U.S. FDA following the RESET study: A prospective, randomized, double-blind, placebo-controlled, multi-canter trial. The study enrolled 279 overweight and obese adults with and without prediabetes. All 9 sites enrolled in the study were in the US, located across 9 different states. Eligible subjects were randomized to test or placebo arms. Subjects were to take one capsule of the investigational device or placebo twice daily , alongside diet and exercise, for a period of 24 weeks. The study demonstrated that both co-primary endpoints were successfully met. The RESET study demonstrated significantly better weight loss among the device group compared to the control group (P<0.0001). The co-primary endpoint of treatment responders was also achieved: the rate of Epitomee treatment group subjects whose total body weight was reduced by at least 5% at 24-weeks post randomization was 55.5% (CI; 46.1-64.6), significantly exceeding the threshold of >35% (P<0.0001).

The study demonstrated a favourable safety profile of Epitomee® treatment throughout the study duration. Epitomee® treatment was well tolerated, with fewer patient dropouts in Epitomee® group than the control group. There were no serious adverse device effects (SADEs) in the study. In addition, subjects treated with Epitomee® showed better improvement in quality of life in several items of the IWQOL-Lite-CT questionnaire.

The company also performed an additional study in 3 out of the 9 sites that participated in the RESET study, the ELECT study. In this study subjects from both the device group and the placebo group kept on taking the Epitomee® capsule for an additional 24 week period. The study demonstrated a favourable safety profile of Epitomee® treatment throughout the 48 weeks of the study duration for subjects in the device group.

Shimon Eckhouse PhD co-founder and chairman of the board, commented on the approval: “The FDA clearance of the Epitomee® Capsule marks a significant milestone in the field of weight management. Its innovative approach offers a safe and effective option for patients. The ability to manage weight through a simple, drug free capsule opens up new possibilities for those seeking to improve their health and quality of life.”

Dan Hashimshony PhD, CEO of Epitomee Medical Ltd., commented: “We are proud to have received FDA clearance for our Epitomee® weight management Oral, Drug-Free solution. This achievement is the result of the innovative approach we have taken to tackle the global obesity epidemic. Our capsule offers a safe, effective, and drug-free solution to the many millions of individuals struggling with weight management. As we move forward, we are eager to bring this groundbreaking product to the U.S. market and seek strategic partnerships to fully realize its commercial potential.”

About Epitomee Medical Ltd.
Epitomee Medical Ltd, a public company (TASE: EPIT), co-founded in 2005 by Shimon Eckhouse, PhD and led by CEO Dan Hashimshony PhD.  Shimon co-founded Syneron Medical Ltd. (Nasdaq: ELOS), Lumenis (formally ESC Medical) and co-founded Ventor Medical Technologies, which was acquired by Medtronic. Dan was the founding CEO of Dune Medical Devices, a surgical oncology company (acquired by Dilon Technologies). Prior to that, Dan was with X-Technologies (acquired by Guidant in 2003) and Sela Semiconductor (acquired by Camtek).

The company is a pioneering health solutions company, committed to advancing innovative therapies. With focus on safety, efficacy, and improving quality of life, Epitomee Medical strives to be at the forefront of transformative healthcare solutions.
The company is advancing two major fields: weight management and biologic drug delivery. In addition to its flagship weight management solution, Epitomee Medical is developing a cutting-edge platform focused on the oral delivery of biologics. This innovative platform is designed to transport drugs to the absorption site with enhanced bioavailability.

Advertisement

For more information about Epitomee Medical Ltd., please visit Epitomee Medical (https://epitomeemedical.com/)

For partnership inquiries and more information about the Weight-management capsule – contact:
Mr. Alon Heth
VP Sales and Marketing
[email protected]

Photo – https://mma.prnewswire.com/media/2506355/Epitomee_Medical.jpg
Logo – https://mma.prnewswire.com/media/2506356/Epitomee_Medical_Logo.jpg

 

Epitomee Medical Logo

 

Cision View original content:https://www.prnewswire.co.uk/news-releases/epitomee-medical-announces-fda-clearance-of-its-capsule-weight-management-device-302249169.html

Continue Reading

Trending