Creative Medical Technology Holdings, Inc. (CELZ): Business Model Canvas [11-2024 Updated]

Creative Medical Technology Holdings, Inc. (CELZ) is at the forefront of regenerative medicine, offering innovative solutions for chronic conditions and Type 1 diabetes. Their business model canvas highlights a strong foundation built on key partnerships with research institutions and clinical trial sites, alongside cutting-edge proprietary technologies like ImmCelz™ and AlloStem™. As CELZ navigates the complexities of the healthcare landscape, understanding their strategic value propositions and revenue streams reveals how they aim to transform patient care and drive growth. Dive deeper to explore the intricacies of their business model!

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Key Partnerships

Collaborations with Greenstone Biosciences for iPSC development

Creative Medical Technology Holdings, Inc. has established a partnership with Greenstone Biosciences, focusing on the development of induced pluripotent stem cells (iPSCs). This collaboration aims to enhance the production of iPSC-derived products, which have potential applications in regenerative medicine. The partnership is pivotal in accelerating research and development timelines, enabling CELZ to leverage Greenstone's expertise in stem cell technology.

Partnerships with clinical trial sites and CROs

CELZ has engaged with various clinical trial sites and Contract Research Organizations (CROs) to facilitate its clinical studies. Notably, in June 2024, the company contracted with a CRO to initiate the clinical trial site for the AlloStemSpine™ Chronic Lower Back Pain (CELZ-201 ADAPT) study. This trial is designed to evaluate the safety and efficacy of AlloStem™ (CELZ-201-DDT) for treating chronic lower back pain, with a total enrollment of 30 individuals. The partnership with CROs is crucial for managing the logistics and regulatory compliance associated with clinical trials, which can be complex and resource-intensive.

Engagement with research institutions for technology validation

Creative Medical Technology Holdings works closely with various research institutions to validate its technologies. These collaborations are essential for ensuring that the scientific basis of CELZ's therapies is robust and credible. For instance, in March 2024, CELZ secured FDA authorization for an expanded access therapy, utilizing the CELZ-201 platform to manage abnormal glucose tolerance and potentially prevent Type I Diabetes. Such partnerships not only enhance the company's reputation but also facilitate access to cutting-edge research and development resources.

Partnership Type	Partner Name	Focus Area	Key Milestones
Collaboration	Greenstone Biosciences	iPSC Development	Enhanced production methodologies
Clinical Trials	Various CROs	Clinical Research	Initiated CELZ-201 ADAPT trial in June 2024
Research Engagement	Multiple Research Institutions	Technology Validation	FDA authorization for CELZ-201 therapy in March 2024

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Key Activities

Conducting clinical trials for various therapies

As of September 30, 2024, Creative Medical Technology Holdings, Inc. (CELZ) is actively conducting clinical trials, including the Phase I/II clinical trial of AlloStemSpine™ Chronic Lower Back Pain (CELZ-201 ADAPT). This trial, which is designed to evaluate the safety, efficacy, and tolerability of AlloStem™ (CELZ-201-DDT), is set to enroll 30 individuals suffering from chronic lower back pain. The company has also received FDA clearance for this trial in September 2023.

Research and development of stem cell technologies

Research and development (R&D) expenses for CELZ totaled $581,796 for the three months ended September 30, 2024, compared to $992,272 for the same period in 2023. For the nine months ended September 30, 2024, R&D expenses reached $1,928,937, up from $1,621,231 in the previous year, marking a 19% increase. Significant investments are being made in various clinical trials, including the CELZ-201 CREATE-1 trial for Type 1 Diabetes, which accounted for $508,268 of the R&D expenses.

Marketing and distribution of medical kits

CELZ markets and sells disposable kits for stem cell concentration, such as CaverStem® and FemCelz®, which are used in autologous procedures for treating erectile dysfunction and female sexual dysfunction. For the nine months ended September 30, 2024, CELZ reported revenues of $8,000, a slight increase from $6,000 in the same period the previous year. The company has also implemented a share repurchase program with a maximum dollar value of $2 million to support its stock price, which indirectly aids in maintaining investor confidence during its marketing efforts.

Activity	Details	Financial Impact (Q3 2024)
Clinical Trials	Phase I/II trial for AlloStemSpine™	FDA clearance; 30 patients enrolled
R&D Expenses	Focus on stem cell technologies and clinical trials	$581,796 (Q3 2024)
Marketing of Medical Kits	Sales of CaverStem® and FemCelz®	$8,000 revenue (9M 2024)

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Key Resources

Proprietary stem cell technology platforms (ImmCelz™, AlloStem™, etc.)

Creative Medical Technology Holdings, Inc. has developed proprietary stem cell technology platforms, including ImmCelz™ and AlloStem™, which are integral to its therapeutic offerings. ImmCelz™ focuses on utilizing a patient’s own immune cells, reprogrammed to enhance regenerative properties, while AlloStem™ targets chronic lower back pain through advanced stem cell applications. In March 2024, the company secured FDA authorization for expanded access therapy using CELZ-201, aimed at managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals.

Experienced management and scientific team

The company's management team comprises seasoned professionals with extensive experience in biotechnology and clinical research. The scientific team is well-versed in stem cell technology and therapeutic development, facilitating the advancement of innovative treatments. For instance, the company's recent initiatives include the successful generation of human induced pluripotent stem cells (iPSC)-derived Islet Cells, demonstrating its commitment to cutting-edge research.

Intellectual property portfolio

Creative Medical Technology Holdings holds a robust intellectual property portfolio, crucial for its competitive advantage. As of September 30, 2024, the company reported licenses, net of amortization, amounting to $553,198. This portfolio includes U.S. Patent No. 9,803,176 B2 concerning methods for clinical derivation of allogenic cells, acquired through a licensing agreement with Jadi Cell, LLC. The company also maintains various patents related to its stem cell technologies and treatment methodologies, bolstering its market position.

Key Resource	Description	Financial Metrics
ImmCelz™	Proprietary platform utilizing reprogrammed immune cells for regenerative therapies.	FDA authorization for CELZ-201 in March 2024.
AlloStem™	Targeted treatments for chronic lower back pain using advanced stem cell applications.	Initiated Phase I/II clinical trial in September 2023.
Intellectual Property	Comprehensive portfolio of patents and licenses supporting therapeutic development.	Licenses valued at $553,198 as of September 30, 2024.
Management Team	Experienced professionals in biotechnology and clinical research.	Recent advancements in iPSC-derived therapies.

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Value Propositions

Innovative therapies for chronic conditions and Type 1 diabetes

Creative Medical Technology Holdings, Inc. (CELZ) focuses on developing innovative therapies for chronic conditions, particularly in the field of Type 1 diabetes. In March 2024, the company secured FDA authorization for an expanded access therapy using CELZ-201, aimed at managing abnormal glucose tolerance and preventing Type 1 diabetes in high-risk individuals. This therapy is notable as it potentially represents a first in medical history for such a preventive approach .

Personalized medicine approach targeting individual patient needs

The company's personalized medicine strategy is exemplified by its ImmCelz™ platform, which utilizes a patient's own immune cells that are reprogrammed with optimized stem cells. This approach is designed to tailor treatments specifically to individual patient needs, enhancing efficacy and minimizing side effects. The ImmCelz™ platform demonstrated a reduction in required donor patient cells by 75% compared to industry standards, while maintaining a product purity greater than 95% .

Potential for significant cost reduction in treatment processes

CELZ aims to significantly reduce treatment costs through its innovative production processes. The ImmCelz™ platform's efficiency allows for the manufacture of clinical products at a lower cost. This advancement is expected to accelerate clinical applications and foster collaborations, ultimately benefiting patients with immune disorders .

Key Metrics	2024 (YTD)	2023 (Comparative)
Gross Revenue	$8,000	$6,000
Cost of Goods Sold	$3,200	$2,400
Gross Profit	$4,800	$3,600
Research and Development Expenses	$1,928,937	$1,621,231
Selling, General and Administrative Expenses	$1,846,177	$2,161,599
Net Loss	$3,639,407	$3,608,000
Cash Balance	$6,260,438	$4,507,108

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Customer Relationships

Direct engagement with healthcare providers

Creative Medical Technology Holdings, Inc. (CELZ) focuses on establishing strong connections with healthcare providers to facilitate the adoption of its innovative therapies. The company primarily markets its CaverStem® and FemCelz® kits, which are essential tools for physicians conducting autologous procedures aimed at treating erectile dysfunction and female sexual dysfunction, respectively.

Focus on building trust through successful clinical outcomes

CELZ emphasizes the importance of clinical outcomes in fostering trust with healthcare providers. In March 2024, the company secured FDA authorization for CELZ-201, aimed at managing abnormal glucose tolerance and preventing Type I Diabetes in high-risk individuals. This personalized medicine approach has been recognized as a groundbreaking development in the field . The efficacy of CELZ-001 in treating Type 2 Diabetes was demonstrated with a 93% efficacy rate in a study involving 30 patients .

Ongoing support and education for medical professionals

Ongoing education and support are crucial aspects of CELZ's strategy to maintain strong relationships with healthcare providers. The company is committed to providing comprehensive training on the usage of its products and updates on clinical trials and research findings. For instance, the Phase I/II clinical trial of AlloStemSpine™ for chronic lower back pain commenced in September 2023, which is expected to enhance the knowledge base and practical application of their therapies among medical professionals .

Metric	Value
FDA Authorizations	CELZ-201 for Type I Diabetes (March 2024)
Clinical Trial Success Rate (Type 2 Diabetes)	93% efficacy with CELZ-001
Revenue (Nine Months Ended September 30, 2024)	$8,000
Research and Development Expenses (Nine Months Ended September 30, 2024)	$1,928,937
Selling, General and Administrative Expenses (Nine Months Ended September 30, 2024)	$1,846,177
Net Loss (Nine Months Ended September 30, 2024)	($3,639,407)

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Channels

Distribution through healthcare providers and clinics

Creative Medical Technology Holdings, Inc. (CELZ) primarily distributes its medical products through healthcare providers and clinics, focusing on the use of its patented technologies in the treatment of erectile dysfunction and female sexual dysfunction. The company markets its CaverStem® and FemCelz® kits, which are utilized by physicians for autologous procedures. In the nine months ending September 30, 2024, CELZ reported revenues of $8,000, a slight increase from $6,000 in the same period the previous year.

Direct sales of medical kits (CaverStem®, FemCelz®)

Direct sales of medical kits, such as CaverStem® and FemCelz®, form a crucial part of CELZ's revenue model. These kits are marketed directly to clinics and healthcare providers, allowing for streamlined access to the products. The company has not generated significant revenue from these sales, reporting no revenues in the last quarter of September 2024, compared to a gross profit of $3,600 in the same quarter of 2023.

Item	Q3 2024 Revenue	Q3 2023 Revenue	Change
Gross Revenue	$0	$6,000	-100%
Cost of Goods Sold	$0	$2,400	-100%
Gross Profit	$0	$3,600	-100%

Participation in medical conferences and trade shows

CELZ actively participates in medical conferences and trade shows to promote its products and technologies. These events provide opportunities for networking with healthcare professionals and potential partnerships. In the nine months ended September 30, 2024, the company incurred selling, general, and administrative expenses totaling $1,846,177, representing a 15% decrease from $2,161,599 in the same period of the previous year. The participation in such events is crucial for raising awareness about its innovative therapies and for potential collaborations in research and development.

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Customer Segments

Patients with chronic back pain and Type 1 diabetes

Creative Medical Technology Holdings, Inc. (CELZ) focuses on patients suffering from chronic back pain and Type 1 diabetes. As of 2024, the chronic pain market is projected to reach approximately $67.5 billion globally by 2025, with treatments for back pain being a significant portion of this market. The prevalence of chronic back pain affects around 31 million Americans, creating a substantial target population for CELZ's therapeutic offerings. In addition, Type 1 diabetes affects about 1.6 million people in the U.S., necessitating innovative treatment options like CELZ-201, which aims to manage and potentially prevent the onset of complications associated with the disease.

Healthcare providers and clinics specializing in regenerative medicine

CELZ targets healthcare providers and clinics that specialize in regenerative medicine. This segment is growing rapidly, with the global regenerative medicine market expected to reach around $38.7 billion by 2026. The increasing adoption of stem cell therapies and regenerative treatments among healthcare professionals presents a significant opportunity for CELZ's products, such as the AlloStemSpine™ and ImmCelz™ platforms. As of 2024, approximately 3,000 clinics in the U.S. are engaged in regenerative practices, providing a broad customer base for CELZ.

Research institutions focused on stem cell therapies

Research institutions represent another crucial customer segment for CELZ. The global stem cell research market is projected to grow to approximately $23.6 billion by 2025. CELZ collaborates with various research institutions to advance its stem cell therapies and clinical trials. These institutions are essential for validating treatments and conducting further research into the efficacy of CELZ's products, including ongoing trials for CELZ-201 targeting chronic back pain and Type 1 diabetes.

Customer Segment	Market Size (2024)	Key Statistics	Potential Revenue Impact
Chronic Back Pain Patients	$67.5 billion	31 million Americans affected	High demand for innovative therapies
Type 1 Diabetes Patients	$23.6 billion	1.6 million people in the U.S.	Need for effective management solutions
Healthcare Providers	$38.7 billion	3,000 clinics in the U.S.	Growing adoption of regenerative treatments
Research Institutions	$23.6 billion	Significant growth in stem cell research	Collaboration opportunities for clinical validation

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Cost Structure

Research and Development Expenses

Research and development (R&D) expenses for the three months ended September 30, 2024, totaled $581,796, down from $992,272 in the same period of the previous year. For the nine months ended September 30, 2024, R&D expenses were $1,928,937, an increase from $1,621,231 for the same period in 2023. This increase was primarily attributed to costs associated with the CELZ-201 ADAPT Chronic Lower Back Pain clinical trial, which saw an increase of $508,268.

Period	R&D Expenses (USD)	Change from Previous Year (USD)
Q3 2024	$581,796	-$410,926
9M 2024	$1,928,937	+$307,706

Clinical Trial Costs and Regulatory Compliance

The costs associated with clinical trials are significant for Creative Medical Technology Holdings, Inc. As of September 30, 2024, the company had incurred substantial expenses related to various trials, including payments of $200,000 for a Phase 1-2 clinical trial and other associated costs with ongoing research efforts. Regulatory compliance costs are embedded within the R&D expenses but are crucial for maintaining progress in clinical stages.

Administrative and Marketing Expenses

Selling, general and administrative expenses for the three months ended September 30, 2024, were $498,607, compared to $531,042 for the same period in 2023, reflecting a decrease of $32,435. For the nine months ended September 30, 2024, these expenses totaled $1,846,177, a decline from $2,161,599 in the previous year. This reduction was primarily due to decreases in marketing expenses by $140,339 and public company-related expenses.

Expense Category	Q3 2024 (USD)	Q3 2023 (USD)	9M 2024 (USD)	9M 2023 (USD)
Administrative Expenses	$498,607	$531,042	$1,846,177	$2,161,599
Decrease in Expenses	-	-	-	$315,422

Creative Medical Technology Holdings, Inc. (CELZ) - Business Model: Revenue Streams

Sales from disposable stem cell concentration kits

Creative Medical Technology Holdings, Inc. generates revenue through the sale of its proprietary disposable kits, including CaverStem® and FemCelz®. These kits are designed for autologous procedures aimed at treating erectile dysfunction and female sexual dysfunction, respectively. For the nine months ended September 30, 2024, the company reported gross revenues of $8,000, compared to $6,000 for the same period in 2023 .

Period	Revenue	Cost of Goods Sold	Gross Profit
9 Months Ended September 30, 2024	$8,000	$3,200	$4,800
9 Months Ended September 30, 2023	$6,000	$2,400	$3,600

Potential licensing fees from intellectual property

The company has entered into various licensing agreements which may yield significant future revenues. One notable agreement is with Jadi Cell, LLC, where Creative Medical Technology Holdings is subject to a $250,000 initial license fee and ongoing royalties of 5% on net income . As of September 30, 2024, the carrying value of the licenses was reported at $553,198 . Additionally, the company anticipates further revenues from the commercialization of its patents as it progresses through clinical trials.

License Agreement	Initial Fee	Ongoing Royalties	Carrying Value (as of Sep 30, 2024)
Jadi Cell, LLC	$250,000	5% of Net Income	$553,198

Future revenues from successful therapy commercialization

Looking ahead, Creative Medical Technology Holdings expects to generate substantial revenue from the commercialization of its therapies, particularly those utilizing its CELZ-201 technology. As of March 2024, the company secured FDA authorization for an expanded access therapy aimed at managing abnormal glucose tolerance and preventing Type I Diabetes . The potential market for such therapies is significant, with increasing demand for innovative treatments in immunotherapy and regenerative medicine. The company has outlined various milestone payments related to clinical trials that could further enhance its revenue streams .

Milestone Payment	Amount	Condition
Initial Payment	$100,000	Upon signing IRB agreement
Completion of IRB Trial	$200,000	Upon completion
Commercialization without Clinical Trial	$300,000	Upon commercialization

Updated on 16 Nov 2024

Resources:

1. Creative Medical Technology Holdings, Inc. (CELZ) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Creative Medical Technology Holdings, Inc. (CELZ)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Creative Medical Technology Holdings, Inc. (CELZ)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.