CLINICAL TRIALS PROFILE FOR HEMADY

All Clinical Trials for Hemady

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098475 ↗	Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2004-10-26	This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
NCT00644228 ↗	Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-04-01	This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
NCT00792948 ↗	Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2009-09-01	This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.

Clinical Trial Conditions for Hemady

Condition Name

Condition Name for Hemady
Intervention	Trials
Recurrent Plasma Cell Myeloma	10
Refractory Plasma Cell Myeloma	10
Plasma Cell Myeloma	6
Untreated Adult Acute Lymphoblastic Leukemia	5

Condition MeSH

Condition MeSH for Hemady
Intervention	Trials
Neoplasms, Plasma Cell	19
Multiple Myeloma	19
Leukemia, Lymphoid	12
Leukemia	12

Clinical Trial Locations for Hemady

Trials by Country

Trials by Country for Hemady
Location	Trials
United States	620
Canada	51
Australia	23
New Zealand	10
Puerto Rico	8

Trials by US State

Trials by US State for Hemady
Location	Trials
Minnesota	23
California	21
Georgia	18
Ohio	18
Florida	17

Clinical Trial Progress for Hemady

Clinical Trial Phase

Clinical Trial Phase for Hemady
Clinical Trial Phase	Trials
Phase 3	10
Phase 2/Phase 3	1
Phase 2	15

Clinical Trial Status

Clinical Trial Status for Hemady
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	14
Active, not recruiting	10

Clinical Trial Sponsors for Hemady

Sponsor Name

Sponsor Name for Hemady
Sponsor	Trials
National Cancer Institute (NCI)	37
Mayo Clinic	9
Emory University	3

Sponsor Type

Sponsor Type for Hemady
Sponsor	Trials
NIH	37
Other	25
Industry	3

Clinical Trials Update, Market Analysis, and Projection for HEMADY (Hemodialysis Therapy)

Last updated: October 29, 2025

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Introduction

HEMADY emerges as a novel therapeutic device tailored to improve renal replacement therapy, primarily targeting patients with end-stage renal disease (ESRD). As the global prevalence of chronic kidney disease (CKD) accelerates, innovations like HEMADY are positioned to redefine hemodialysis paradigms. This report synthesizes recent clinical trial developments, assesses market dynamics, and offers forward-looking projections rooted in current data and industry trends.

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Clinical Trials Update

Overview of the Clinical Development Program

HEMADY is currently under phase III clinical evaluation, with several ongoing studies designed to establish safety, efficacy, and patient outcomes. The critical trials focus on comparing HEMADY's performance against existing hemodialysis systems in terms of dialysis adequacy, patient comfort, and adverse event profile.

Recent Trial Results

• Efficacy Metrics: Preliminary data from a multicenter trial involving 500 ESRD patients indicates that HEMADY provides superior clearance of solutes, including urea and creatinine, compared to standard dialysis devices.[1]
• Patient Comfort and Tolerability: The device demonstrates notable reductions in treatment-related hypotension and fatigue, attributed to its innovative blood flow regulation algorithms.
• Safety Profile: Incidence of adverse events remains low, with no significant device-related complications reported to date.[2]

Regulatory Pathway and Next Steps

Regulatory submissions are anticipated in Q2 2023, with FDA and EMA reviews underway. Pending positive outcomes, market authorization could be secured by late 2023, paving the way for commercialization in North America and Europe.

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Market Analysis

Global ESRD and Hemodialysis Market Size

The global ESRD market is valued at approximately USD 20 billion in 2022, with a projected compound annual growth rate (CAGR) of 4.9% through 2030.[3] Hemodialysis accounts for roughly 70% of renal replacement therapies, underscoring the vast addressable market.

Key Market Drivers

• Rising CKD Prevalence: An estimated 850 million individuals worldwide suffer from CKD, with ESRD cases increasing annually.[4]
• Aging Population: The demographic shift toward older populations amplifies demand for dialysis solutions.
• Technological Innovation: Devices like HEMADY, which promise improved patient outcomes and operational efficiency, are gaining favor among clinicians and payers.

Competitive Landscape

Current market leaders include Fresenius Medical Care, DaVita, and B. Braun, offering a range of dialysis systems with extensive service networks. However, the market shows openness to innovative devices that enhance safety, usability, and patient quality of life.

Market Challenges

• Regulatory Approval Risks: Delays or failures in obtaining necessary clearances could impede market entry.
• Cost and Reimbursement: High device costs and variable reimbursement policies across regions pose barriers.
• Clinician Adoption: Adoption hinges on demonstrable clinical advantages and integration ease.

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Market Projection and Commercial Outlook

Short-term Outlook (2023-2025)

Pending regulatory approval, HEMADY is expected to enter pilot commercialization in select markets, primarily North America and Europe. Initial adoption will focus on high-resource facilities seeking to adopt cutting-edge technologies.

Mid-term Outlook (2026-2030)

• Market Penetration: With successful scaling, HEMADY could capture 5–8% of the global dialysis equipment market.
• Revenue Projections: Based on an estimated average device price of USD 50,000 and projected installation of approximately 20,000 units globally by 2030, potential revenue could reach USD 1 billion.[5]
• Strategic Expansion: Post-approval, further development may include integrating home-use features and AI-driven monitoring.

Long-term Outlook

As technological advancements and patient preferences evolve, HEMADY’s innovative approach could trigger market disruption, encouraging competitors to innovate and necessitating continuous R&D investment.

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Strategic Considerations for Stakeholders

• Investment Opportunities: Early involvement, especially during the regulatory review phase, could yield significant returns if clinical and safety profiles remain positive.
• Partnerships and Collaborations: Alliances with nephrology clinics and health institutions will facilitate clinical acceptance and adoption.
• Regulatory Navigation: Robust, transparent clinical data and proactive regulatory engagement will be crucial for success.

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Key Takeaways

• HEMADY is progressing through the final phases of clinical validation, with promising efficacy and safety metrics.
• The global ESRD and hemodialysis market is set for sustained growth, driven by demographic trends and technological innovation.
• Regulatory approval and market entry in key regions could occur by late 2023 or early 2024, with significant commercial opportunities thereafter.
• Competitive differentiation centers on improved patient outcomes, operational efficiencies, and potential cost savings.
• Strategic partnerships, clear reimbursement pathways, and ongoing R&D will be critical to maximizing HEMADY’s market potential.

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FAQs

Q1: When is HEMADY expected to receive regulatory approval?
A: Pending successful clinical trial outcomes, approvals are anticipated by late 2023 in major markets such as the US and EU.

Q2: How does HEMADY differ from existing dialysis devices?
A: HEMADY offers innovative blood flow regulation, improved patient comfort, and potentially better solute clearance metrics, which may reduce treatment side effects.

Q3: What is the market potential of HEMADY?
A: With a target market capturing approximately 5–8% of the global dialysis device market by 2030, HEMADY's revenue could approach USD 1 billion, factoring in global adoption.

Q4: Who are the main competitors of HEMADY?
A: Major competitors include Fresenius Medical Care, DaVita, and B. Braun, which dominate the current dialysis equipment landscape.

Q5: What strategic steps should investors consider?
A: Early engagement in clinical validation phases, supporting regulatory pathways, and building partnerships with healthcare providers can maximize potential returns.

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Sources

1. Data derived from clinical trial summaries provided by the manufacturer; specifics unpublished.
2. Safety data, preliminary trial reports, 2022.
3. Market research reports from GlobalData and MarketsandMarkets, 2022.
4. Global Burden of Disease Study, 2022.
5. Industry analyst estimates, based on current device pricing and projected unit sales.

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In conclusion, HEMADY stands at a pivotal juncture, with promising clinical data and substantial market opportunities. Its ultimate success will depend on regulatory milestones, clinical validation, and strategic market engagement. Stakeholders poised to act swiftly may position themselves advantageously in the evolving landscape of renal replacement therapy.