logo
Burn Pain Market to Reach New Heights in Growth by 2034, DelveInsight Predicts

Burn Pain Market to Reach New Heights in Growth by 2034, DelveInsight Predicts

Globe and Mail12-03-2025

The Key Burn Pain Companies in the market include - Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others.
DelveInsight's 'Burn Pain Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Burn Pain, historical and forecasted epidemiology as well as the Burn Pain market trends in the United States, EU4 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
Some of the key facts of the Burn Pain Market Report:
The Burn Pain market size is anticipated to grow with a significant CAGR during the study period (2020-2034)
In August 2024, MediWound Ltd. (Nasdaq: MDWD), a global leader in enzymatic therapeutics for tissue repair, announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients from newborns to 18 years old with deep partial- and full-thickness thermal burns. This approval expands NexoBrid's authorization for all age groups in the U.S., aligning with its approvals in the European Union and Japan.
In 2023, the US maintained the largest market share among the 7MM, reaching USD 140 million. Projections indicate that this trend will persist, with the US expected to further strengthen its market dominance and remain the leading player by 2034.
In 2023, Germany and the UK in the EU4 and the UK both achieved market shares exceeding USD 20 million, with France following closely behind. In contrast, Italy had the smallest market share among these regions during the same period.
Opioid analgesics dominated the current treatment market for both inpatient and outpatient care, with an estimated market value of approximately USD 130 million in 2023.
In 2023, the US recorded over 2 million incident cases of burns, with numbers expected to rise by 2034.
In 2023, approximately 0.4 million treated incident burn cases requiring pain management therapies were reported in the US, with expectations for change during the study period from 2020 to 2034.
The gender distribution indicates a male dominance across the 7MM, with around 0.29 million male cases and 0.26 million female cases reported in the US in 2023.
Key Burn Pain Companies: Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others
Key Burn Pain Therapies: Methoxyflurane (PENTHROX), Caldolor, JNJ-42160443, ACTIQ, and others
The Burn Pain epidemiology based on etiology-specific cases analyzed that Etiology Specific Incident Cases of Burns is classified into Flame, Contact, Scald, Electrical, Chemical, and Others
The Burn Pain market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Burn Pain pipeline products will significantly revolutionize the Burn Pain market dynamics.
Burn Pain Overview
An organic tissue injury known as a burn is mostly brought on by heat, radiation, radioactivity, electricity, friction, or chemical contact.
Get a Free sample for the Burn Pain Market Report -
Burn Pain Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Burn Pain Epidemiology Segmentation:
The Burn Pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalence of Burn Pain
Prevalent Cases of Burn Pain by severity
Gender-specific Prevalence of Burn Pain
Diagnosed Cases of Episodic and Chronic Burn Pain
Download the report to understand which factors are driving Burn Pain epidemiology trends @ Burn Pain Epidemiology Forecast
Burn Pain Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Burn Pain market or expected to get launched during the study period. The analysis covers Burn Pain market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Burn Pain Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Burn Pain Therapies and Key Companies
Burn Pain Market Strengths
The increasing incidence of patients with burns is expected to propel the treatment market in the future, adding opportunities for new pharma players
Burn Pain Market Opportunities
The rising incidence of burn pain indicates increasing pharmacological treatment demands, thereby crafting lucrative opportunities for new pharma players
Scope of the Burn Pain Market Report
Study Period: 2020–2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Burn Pain Companies: Medical Developments International, Cumberland Pharmaceuticals, Janssen Research & Development, Cephalon, and others
Key Burn Pain Therapies: Methoxyflurane (PENTHROX), Caldolor, JNJ-42160443, ACTIQ, and others
Burn Pain Therapeutic Assessment: Burn Pain current marketed and Burn Pain emerging therapies
Burn Pain Market Dynamics: Burn Pain market drivers and Burn Pain market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
Burn Pain Unmet Needs, KOL's views, Analyst's views, Burn Pain Market Access and Reimbursement
Table of Contents
1. Burn Pain Market Report Introduction
2. Executive Summary for Burn Pain
3. SWOT analysis of Burn Pain
4. Burn Pain Patient Share (%) Overview at a Glance
5. Burn Pain Market Overview at a Glance
6. Burn Pain Disease Background and Overview
7. Burn Pain Epidemiology and Patient Population
8. Country-Specific Patient Population of Burn Pain
9. Burn Pain Current Treatment and Medical Practices
10. Burn Pain Unmet Needs
11. Burn Pain Emerging Therapies
12. Burn Pain Market Outlook
13. Country-Wise Burn Pain Market Analysis (2020–2034)
14. Burn Pain Market Access and Reimbursement of Therapies
15. Burn Pain Market Drivers
16. Burn Pain Market Barriers
17. Burn Pain Appendix
18. Burn Pain Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.
Media Contact
Company Name: DelveInsight
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association's 85th Scientific Sessions
Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association's 85th Scientific Sessions

Cision Canada

time2 days ago

  • Cision Canada

Gan & Lee Pharmaceuticals Presented Multiple Results in Novel Diabetes Therapies at the American Diabetes Association's 85th Scientific Sessions

In a Phase 2a clinical trial, the GLP-1 RA bofanglutide injection demonstrated a favorable safety and tolerability profile after 23 weeks of once weekly treatment in patients with type 2 diabetes mellitus (T2DM), with significant HbA1c reductions alongside comprehensive benefits for body weight, blood pressure and blood lipid profiles. In a Phase 2b clinical trial, the bofanglutide injection showed superior HbA1c and body weight reduction than semaglutide (Ozempic ®) after 24 weeks of bi-weekly treatment in patients with T2DM, along with an acceptable safety and tolerability profile. In a Phase 2 clinical trial, the once-weekly insulin GZR4 injection demonstrated comparable efficacy and safety profiles in patients with T2DM after 16 weeks of treatment. Notably, GZR4 injection achieved superior HbA1c reduction in patients with inadequate glycemic control on prior basal insulin therapy compared to once-daily insulin degludec (Tresiba ®). BEIJING and BRIDGEWATER, N.J., June 21, 2025 /CNW/ -- Gan & Lee Pharmaceuticals (Gan & Lee, stock code: announced that the company presented multiple Phase 2 clinical study results of ultra-long-acting GLP-1 receptor agonist (GLP-1 RA) bofanglutide (research code: GZR18) injection and once-weekly basal insulin analog GZR4 injection during a poster presentation at the American Diabetes Association (ADA)'s 85th Scientific Sessions. Bofanglutide injection and GZR4 injection are investigational drugs that have not yet been launched in any country. Gan & Lee Pharmaceuticals does not recommend the use of any unapproved drugs/indications. Bofanglutide injection: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2a Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Bofanglutide (GZR18) Injection in Chinese Patients with Type 2 Diabetes Mellitus (T2DM) In this Phase 2a clinical trial (NCT06256523), 36 adults with T2DM who had inadequate glycemic control through diet and exercise and/or irregular use of antidiabetic medications, were randomized to receive either bofanglutide injection (N=27) or placebo (N=9) once weekly (QW) for 23 weeks, with a dose escalating from 1.5 mg to 13 mg. The key efficacy endpoint was HbA1c change from baseline to week 23. After 23 weeks of treatment, the mean HbA1c change from baseline in the bofanglutide groups was -1.81% compared to 0.12% in the placebo group, with an estimated treatment difference of -1.93% points *. The proportion of participants achieving an HbA1c target of <7.0% and ≤6.5% was 57.7% and 46.2%, respectively, compared to zero in the placebo group. In terms of weight management, participants treated with bofanglutide experienced a mean reduction in body weight of 6.92 kg from baseline, corresponding to a 9.3% decrease, compared to a minimal reduction of 1.2% in the placebo group. Furthermore, bofanglutide showed comprehensive improvements over placebo in multiple metabolic parameters, including fasting plasma glucose (FPG), glycated albumin (GA), waist circumference (WC), blood pressure, and lipid profiles. In terms of safety, bofanglutide was well tolerated in patients with T2DM. Consistent with known GLP-1 RAs, the most common adverse events were gastrointestinal-related, primarily observed during the early dose-escalation period with mostly mild to moderate in severity. No hypoglycemic events or investigational product-related serious adverse events were reported during the study. Bofanglutide injection: A Multicenter, Randomized, Open-label, Active comparator-controlled Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of bofanglutide Injection versus Semaglutide (Ozempic ®) in Chinese Patients with T2DM In this Phase 2b clinical trial (NCT06256549), a total of 272 eligible Chinese patients with T2DM, who had inadequate glycemic control either after lifestyle intervention or despite stable use of oral antidiabetic drugs (OADs) for at least 3 months, were randomized to receive bi-weekly (Q2W) 12 mg (N=55), 18 mg (N=54), 24 mg (N=55) bofanglutide injections, or once-weekly (QW) 24 mg (N=54) bofanglutide injections, or 1 mg semaglutide (Ozempic ®, N=54) for 24 weeks of treatment, including the dose-escalation period. The primary endpoint was HbA1c change from baseline to week 24. After 24 weeks of treatment, the mean reductions in HbA1c from baseline were 1.87%, 2.28%, and 1.94% in the bofanglutide groups at 12 mg, 18 mg, and 24 mg Q2W, respectively, and -2.32% in the 24 mg QW group. All these treatment regimens showed greater HbA1c reductions compared to the semaglutide group (-1.60%), with the 18 mg Q2W and 24 mg QW bofanglutide groups demonstrating statistically significant superiority (p<0.001) *. Among drug-naïve patients with inadequate glycemic control despite lifestyle interventions, the 18 mg Q2W bofanglutide group achieved a mean HbA1c reduction of 2.98%, which was significantly greater than that observed with semaglutide (-2.04%; p<0.001)*. The proportions of patients achieving HbA1c target of <7.0% were 63.0% to 73.6% in the Q2W bofanglutide group, 75.0% in the QW bofanglutide group, and 70.0% in the semaglutide group. For the HbA1c ≤6.5% target, the corresponding proportions were 58.2% to 67.9%, 69.2%, and 62.0%, respectively. Furthermore, the mean change in body weight for all bofanglutide groups from baseline to week 24 ranged from -4.26 to -6.54 kg, compared to -3.25 kg in the semaglutide group *. Bofanglutide also greatly improved FPG, blood pressure, lipid profiles, and other metabolic parameters. In this study, bofanglutide was g enerally well tolerated, with safety and tolerability consistent with other known GLP-1 RAs. The most common adverse events were gastrointestinal-related, mostly mild to moderate in severity, and no sever e hypoglycemic events were observed. GZR4 injection: A Multicenter, Randomized, Open-label, Active-controlled, Treat-to-target Phase 2 Clinical Study Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin degludec (IDeg, Tresiba ®) in Chinese patients with T2DM This Phase 2 clinical study (NCT06202079) enrolled a total of 83 Chinese patients with T2DM who had inadequate glycemic control on OADs (Part A), and 96 patients with inadequate control on OADs combined with basal insulin therapy (Part B). Participants were randomized to receive QW GZR4 injection (Part A: N=42; Part B: N=41) or once-daily IDeg (Tresiba ®) injection (Part A: N=48; Part B: N=48) for 16 weeks of treatment. The primary efficacy endpoint was the change in HbA1c from baseline to week 16. After 16 weeks of treatment, in patients from Part A, the mean change in HbA1c was comparable between GZR4 groups and IDeg groups (−1.50% versus -1.48%, p = 0.90). The proportion of participants achieving HbA1c target of <7.0% was 59.5% in the GZR4 group and 70.7% in the IDeg group, while the proportion achieving HbA1c target of ≤6.5% was 38.1% and 29.3%, respectively. In patients from Part B, GZR4 demonstrated significantly greater HbA1c reduction compared to IDeg (-1.26% vs -0.87%; p<0.01), with a higher proportion of patients achieving HbA1c targets of <7.0% and ≤6.5% (52.1% vs 29.2%; 25.0% vs 10.4%). In addition, improvements from baseline in FPG and time in range (TIR) were comparable between the GZR4 group and IDeg group. GZR4 achieved effective glycemic control without the need for a loading dose at the first administration, while the total weekly insulin dosage (mole) for GZR4 was approximately 40–50% of that for IDeg (p<0.001). In terms of safety, the incidence of adverse events was similar between the two groups. No severe hypoglycemic events or investigational product-related serious adverse events were reported during the study. * The clinical data were presented as mean (SE) value. The detailed results of the above Phase 2 clinical study will be published in a peer-reviewed journal. Conclusion and Future Direction The latest clinical results presented at this year's ADA conference highlight Gan & Lee Pharmaceuticals' leading position in the development of long-acting antidiabetic therapies. Building on these positive outcomes, the company will continue to advance the research and development of innovative treatments for diabetes. Currently, Gan & Lee has initiated and is accelerating large-scale Phase 3 clinical programs in China for bofanglutide injection and GZR4 injections for the treatment of type 2 diabetes, aiming to provide more effective treatment options for patients with diabetes. Forward-looking statements Forward-looking statements are based on our expectations and assumptions as of the date of the statements. Actual results may differ materially from those expressed in these forward-looking statements due to a variety of factors, and we can give no assurance that such results will be achieved in the future. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. About Gan & Lee Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin ®), fast-acting lispro injection (Prandilin™), fast-acting aspart injection (Rapilin ®), mixed protamine zinc lispro injection (25R) (Prandilin™25), aspart 30 injection (Rapilin ® 30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin ® 30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine ®). In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine ®) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee's competitiveness in both international and domestic markets. In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.

AI Tools That Talk, Scan, and Save Lives Are Reshaping the Investment Landscape Français English
AI Tools That Talk, Scan, and Save Lives Are Reshaping the Investment Landscape Français English

Cision Canada

time3 days ago

  • Cision Canada

AI Tools That Talk, Scan, and Save Lives Are Reshaping the Investment Landscape Français English

Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, June 20, 2025 /CNW/ -- Equity Insider News Commentary – Amid the wave of new AI-powered innovations in healthcare, so far ambient scribes have emerged as the breakout use case. As the range of AI uses for the healthcare sector continues to grow, experts are analyzing the potential ROI on their implementation, and how much they'll benefit early adopters. Healthcare leaders are already seeing improvements, such as slashed clinician workloads from voice AI, and the adoption of AI agents to increase efficiency and smarter care delivery. For investors looking for remaining early-mover advantages, there have been several publicly-traded companies with recent developments worthy of capturing their attention, including Avant Technologies, Inc. (OTCQB: AVAI), Spectral AI, Inc. (NASDAQ: MDAI), Palantir Technologies (NADSAQ: PLTR), GE HealthCare Technologies Inc. (NASDAQ: GEHC), and CeriBell, Inc. (NASDAQ: CBLL). Investor interest in private companies is surging, as venture capital continues to pour into the AI-in-healthcare space. In Q1 alone, AI firms accounted for more than half of all digital health funding. Recent raises include $45 million for Ellipsis Health and $28 million for Autonomize AI, both targeting next-gen clinical intelligence. From diagnostics to drug discovery, the pace of innovation is accelerating — and many of these rollouts are now catching the attention of retail investors. One example is the rollout of AI-powered screenings for diabetic retinopathy now underway across Costa Rica, Nicaragua, and Panama. Avant Technologies, Inc. (OTCQB: AVAI) and joint-venture partner Ainnova Tech have begun offering free Vision AI scans inside Grupo Dökka's Fischel and La Bomba pharmacy chains. The fast, non-invasive test detects early retinal changes—often before symptoms appear—and delivers secure results within minutes. By embedding the service in retail pharmacies and preparing for a parallel launch in Mexico, the partners are bringing care closer to patients while generating real-world data to support broader commercialization. "As we begin similar initiatives in Mexico, our goal is to close the patient care loop with timely treatment, connecting every step of the journey," said Vinicio Vargas, CEO of Ainnova Tech and board member of Ai-nova Acquisition Corp. "We are integrating pharma, retail, ophthalmologists, and our technology into a unified experience, all driven by one incentive, the well-being of the diabetic patient." The rollout also gives Avant a timely proof point as it moves to consolidate Vision AI under one roof. Earlier this month, the company signed a non-binding letter of intent to acquire 100% of Ainnova Tech —bringing leadership, data, and intellectual property together ahead of a scheduled FDA pre-submission meeting in July. Folding the joint venture into a single public entity would remove the current holding-company structure, streamlining everything from regulatory filings to revenue recognition. Management sees the unified cap table as a potential draw for both investors and strategic partners. While the legal teams work through due diligence, engineers are finalizing a low-cost, automated retinal camera built to work seamlessly with the Vision AI platform. Legacy fundus cameras can run into the tens of thousands and typically require skilled operators. Avant's prototype is fully automated, cloud-connected, and designed for a fraction of the cost. If performance holds up to internal testing, the system could enable large-scale diabetic screenings in clinics and low-resource settings—without the need for additional specialist staff. Vision AI is also expanding beyond diabetic eye disease. A patented dementia-risk module —pairing a five-minute blood test with AI pattern recognition—is now in validation, while cardiovascular-risk analytics are advancing through pilot studies across Latin America. Because every new use case plugs into the same software backbone, Avant looks more like a scalable platform than a single-product company. On the financial side, the planned merger would fold all outstanding Ainnova shares into Avant's public float, avoiding cash dilution and fully aligning the combined team's incentives. Management says any future fund-raising would be aimed at three priorities: completing the automated camera, widening pharmacy deployments, and supporting U.S. regulatory milestones. Taken together, the pharmacy roll-out, planned Ainnova acquisition, and imminent camera launch signal a turning point for Avant. What began as an AI incubator is fast becoming a full-stack diagnostics company, complete with proprietary hardware, an expanding library of predictive algorithms, and retail-level distribution partners. If execution matches vision, Vision AI could cut referral delays, open earlier treatment windows, and give resource-strained health systems specialist-grade insight at primary-care prices—turning headline-grabbing tech into tangible patient benefits. Spectral AI, Inc. (NASDAQ: MDAI) continues to advance its DeepView® System, an AI-powered wound imaging platform designed to assess burn healing potential without invasive biopsies. The company's technology was recently spotlighted at the British Burn Association Conference, where new clinical data from UK hospitals showed DeepView® improved detection rates from 61% to 89%. "UK investigators shared valuable advancements with DeepView during the BBA meeting," said Dr. Jeffrey Carter, M.D., Louisiana State University Health Science Center. "Their early clinical experience demonstrated promising sensitivity and specificity results, along with a positive patient experience and a comprehensive evaluation of TBSA (Total Body Surface Area) calculation methods." The system aims to accelerate triage decisions and reduce treatment errors in both civilian and military burn care. Palantir Technologies (NADSAQ: PLTR) has entered into a strategic partnership with TeleTracking Technologies to deliver AI-powered operational insights to hospitals and health systems. The collaboration combines TeleTracking's Operations IQ platform with Palantir's Foundry and AIP, offering real-time visibility into staffing, capacity, and patient flow. "This partnership with TeleTracking represents the AI revolution in healthcare we are in the midst of-where we continue to move closer to a world where all hospitals and health systems are embracing, implementing and operating with an AI-powered approach, helping to streamline operations allowing for increased focus on providing the best level of care," said Alex Karp, CEO at Palantir. According to both companies, the platform will unlock real-time visibility across health systems while easing the load on overburdened staff. Executives describe it as a foundational shift toward AI-native operations in healthcare. GE HealthCare Technologies Inc. (NASDAQ: GEHC) has partnered with Stanford Medicine to advance total-body PET/CT technology that incorporates AI into every stage of the imaging process. The system delivers high-resolution, full-body scans in a fraction of the time, while reducing radiation dose for patients. "Our total body PET/CT technology represents the next chapter in our enduring commitment to advancing medical imaging," said Jean-Luc Procaccini, President & CEO, Molecular Imaging and Computed Tomography, GE HealthCare. "We're proud to collaborate with world-class institutions to explore new clinical frontiers in oncology and beyond. Together with our MIM software solutions, we're designing flexible, AI-enhanced tools that not only aim to enhance diagnostic confidence and operational efficiency but also help clinicians deliver more precise, personalized care that can truly improve patient outcomes." Key to the innovation is a deep-learning reconstruction engine that enhances detail and enables exploratory insights across oncology, cardiology, and neurology. GE HealthCare sees the platform as a foundation for identifying novel biomarkers, guiding treatment, and supporting large-scale clinical research. CeriBell, Inc. (NASDAQ: CBLL) is gaining momentum with its Rapid Response EEG system, which uses artificial intelligence to detect non-convulsive seizures in critical care settings. The company reported over 54,000 patients monitored in Q1 2025 alone, with 70% of seizures identified outside neurology departments—highlighting its utility in high-pressure environments. "We are pleased with our strong start to the year as we further expanded our account base while benefiting from accelerated adoption of the Ceribell system," said co-founder and CEO Jane Chao, Ph.D. "We also look forward to offering our pediatric Clarity algorithm to customers while continuing to invest in our product development pipeline with the goal of ultimately making EEG a new vital sign." With multiple AI modules, including seizure triage and brain function trending, Ceribell is becoming a key player in real-time neurological diagnostics. CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

Zemcelpro® (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells Français
Zemcelpro® (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells Français

Cision Canada

time4 days ago

  • Cision Canada

Zemcelpro® (UM171 Cell Therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells Français

If approved, Zemcelpro ® is expected to: increase access to donor-derived stem cell transplantation, which offers a potentially curative option for haematologic malignancies, including leukemias and myelodysplastic syndromes be the first and only therapy in the European Union with marketing authorization for adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available Approval decision from the European Commission expected within approximately two months MONTREAL, June 19, 2025 /CNW/ - ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending granting conditional marketing authorization for Zemcelpro ® for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. The European Commission (EC) is expected to make a final decision within approximately two months following CHMP recommendation, and the decision will apply to all 27 European Union (EU) Member States, Iceland, Norway and Liechtenstein. Zemcelpro ®, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. If approved, Zemcelpro ® is expected to be the first and only therapy in the EU with marketing authorization for adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available. Every year in Europe there are over 10,000 new cases of patients with haematological malignancies, including leukemias and myelodysplastic syndromes, requiring bone marrow transplant, and a number of these patients do not have access to suitable donor cells for different reasons, including the absence or unavailability of suitably matched donors. The positive CHMP opinion was based on the conditional Marketing Authorization Application (MAA) for Zemcelpro ®. Additional filings are planned for Zemcelpro ® with other health authorities, including in the US, Canada, the UK, and Switzerland. "Each year, thousands of people in Europe are diagnosed with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation, and it's an upsetting reality that a number of them don't have access to suitable donor-derived stem cells," said Dr. Guy Sauvageau, CSO and Founder of ExCellThera. "With today's positive opinion, we are closer to bringing the life-changing potential of Zemcelpro ® to patients with at-risk haematological malignancies in the EU," said David Millette, CEO of ExCellThera. "We are proud to bring our transformative cell therapy innovation to patients who continue to have unmet medical needs." The safety of Zemcelpro ® is consistent with the well-characterized safety profile of conventional allogeneic blood stem cell transplantation for haematological malignancies following myeloablative conditioning. ExCellThera extends its sincere gratitude to the patients and investigators who have contributed to the clinical development of Zemcelpro ®. About Zemcelpro ® Zemcelpro ®, also known as UM171 Cell Therapy, is a novel cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. Zemcelpro ®, developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro ® has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA. Zemcelpro ® has been tested in Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible. The use of Zemcelpro ® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being explored. The product is not yet approved for marketing by the EMA and remains subject to European Commission decision. Its safety and efficacy have not been established by other regulatory agencies, such as the FDA and Health Canada. About ExCellThera and UM171 Technology ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera's proprietary Enhance ™ platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (HSCs) from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the Enhance ™ platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit and follow us on LinkedIn.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store