Creative Medical Technology (CELZ)
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Creative Medical Technology (CELZ) - 2025 Q1 - Quarterly Report
2025-05-09 20:45
[PART I – FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 detail the company's first revenue, widened net loss, and strengthened cash position [Unaudited Condensed Consolidated Balance Sheets](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets increased to **$8.35 million** due to higher cash, with liabilities decreasing and equity growing Consolidated Balance Sheet Summary | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **ASSETS** | | | | Cash | $7,702,867 | $5,940,402 | | Total Current Assets | $7,844,011 | $6,135,303 | | **Total Assets** | **$8,347,274** | **$6,669,143** | | **LIABILITIES & EQUITY** | | | | Total Current Liabilities | $286,387 | $327,644 | | **Total Liabilities** | **$286,387** | **$327,644** | | **Total Stockholders' Equity** | **$8,060,887** | **$6,341,499** | | **Total Liabilities & Equity** | **$8,347,274** | **$6,669,143** | [Unaudited Condensed Consolidated Statements of Operations](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, the company generated its first revenue of **$3,000**, but increased operating expenses led to a widened net loss Statement of Operations Summary (Q1 2025 vs Q1 2024) | Metric | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Revenues | $3,000 | $ - | | Gross Profit | $1,800 | $ - | | Research and development | $743,304 | $422,392 | | Selling, general and administrative | $888,397 | $671,484 | | Operating loss | $(1,660,478) | $(1,123,147) | | **Net Loss** | **$(1,638,097)** | **$(1,041,544)** | | **Net Loss Per Share** | **$(0.83)** | **$(0.73)** | [Unaudited Condensed Consolidated Statements of Cash Flows](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operations was **$1.59 million**, offset by financing activities, leading to a net cash increase and an ending cash balance Cash Flow Summary (Q1 2025 vs Q1 2024) | Cash Flow Activity | For the Three Months Ended March 31, 2025 | For the Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,591,535) | $(896,864) | | Net cash provided by investing activities | $ - | $6,520,191 | | Net cash provided by (used in) financing activities | $3,354,000 | $(82,796) | | **Net Increase in Cash** | **$1,762,465** | **$5,540,531** | | **Ending Cash Balance** | **$7,702,867** | **$9,007,398** | [Unaudited Condensed Consolidated Statement of Stockholders' Equity (Deficit)](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholder'%20Equity%20(Deficit)) Stockholders' equity increased from **$6.34 million** to **$8.06 million** in Q1 2025, driven by warrant exercises and offset by the net loss Changes in Stockholders' Equity (Q1 2025) | Description | Amount | | :--- | :--- | | Equity at Dec 31, 2024 | $6,341,499 | | Proceeds from exercise of warrants | $3,700,000 | | Offering costs | $(336,000) | | Net loss | $(1,638,097) | | **Equity at March 31, 2025** | **$8,060,887** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=4&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, business risks, and financial items, including licensing agreements and a warrant exercise inducement - The company is a commercial-stage biotechnology firm focused on immunotherapy, endocrinology, urology, neurology, and orthopedics. Its commercial operations are primarily through the sale of CaverStem® and FemCelz® disposable kits[15](index=15&type=chunk)[17](index=17&type=chunk) - In March 2025, the company entered into warrant exercise inducement letters, resulting in the exercise of 837,104 warrants for approximately **$3.7 million** in gross proceeds. In exchange, new 'Inducement Warrants' will be issued pending shareholder approval[55](index=55&type=chunk)[56](index=56&type=chunk) Licensing Agreements Rollforward (Q1 2025) | Licensing Agreements Rollforward | Assets | Accumulated Amortization | | :--- | :--- | :--- | | Balances at December 31, 2024 | $1,060,000 | $(530,559) | | Amortization | - | $(30,577) | | **Balances at March 31, 2025** | **$1,060,000** | **$(561,136)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=9&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's progress as a commercial-stage biotech firm, highlighting pipeline advancements, increased net loss, and strong liquidity - The company is advancing multiple clinical programs, including CELZ-201 for Type I Diabetes and AlloStemSpine® for Chronic Lower Back Pain, both of which have received FDA clearance for Phase I/II trials[73](index=73&type=chunk)[78](index=78&type=chunk) - In March 2024, the company received Orphan Drug Designation (ODD) from the FDA for its ImmCelz™ (CELZ-100) platform for the treatment of Brittle Type 1 Diabetes[76](index=76&type=chunk) - The company has initiated a program combining artificial intelligence (AI) with its proprietary iPSC platform to diagnose and treat patients exposed to biological and chemical weapons[83](index=83&type=chunk) Results of Operations Comparison (Q1 2025 vs Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Gross Revenue | $3,000 | $0 | N/A | | SG&A Expenses | $888,397 | $671,484 | +32% | | R&D Expenses | $743,304 | $422,392 | +76% | | **Net Loss** | **$(1,638,097)** | **$(1,041,544)** | **+57%** | Liquidity Summary | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and equivalents | $7,702,867 | $5,940,402 | | Working Capital | $7,557,624 | $5,807,659 | [Quantitative and Qualitative Disclosures About Market Risk](index=12&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Creative Medical Technology Holdings has elected not to provide typical market risk disclosures - The company has opted out of providing market risk disclosures as permitted for a smaller reporting company[102](index=102&type=chunk) [Controls and Procedures](index=12&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[103](index=103&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control[105](index=105&type=chunk) [PART II – OTHER INFORMATION](index=13&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=13&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material lawsuits or legal proceedings at this time, though ordinary course of business matters may arise - The company may be involved in ordinary course of business lawsuits but reports no specific material legal proceedings at this time[108](index=108&type=chunk) [Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=13&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section discloses the company's share repurchase activity, including the buyback of 5,000 shares in March 2025 under its **$2 million** program - The Board of Directors authorized a share repurchase program for up to **$2 million** of common stock, which commenced in August 2023[109](index=109&type=chunk) Issuer Purchases of Equity Securities (March 2025) | Period | Total Shares Purchased | Average Price Paid per Share | Approx. Dollar Value Remaining in Plan | | :--- | :--- | :--- | :--- | | March 1 - 31, 2025 | 5,000 | $2.00 | $1,549,084 | [Exhibits](index=13&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, CEO/CFO certifications, and XBRL data files - The report includes standard exhibits such as corporate governance documents (Articles of Incorporation, Bylaws), CEO/CFO certifications (Rule 13a-14(a)/15d-14a(a) and Section 1350), and XBRL data files[112](index=112&type=chunk)
Creative Medical Technology Holdings, Inc. (CELZ) Upgraded to Buy: What Does It Mean for the Stock?
ZACKS· 2025-03-25 17:01
Core Viewpoint - Creative Medical Technology Holdings, Inc. (CELZ) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on changes in earnings estimates, tracking EPS estimates from sell-side analysts through a consensus measure known as the Zacks Consensus Estimate [2]. - The company is projected to earn -$2.03 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 45.3% [9]. - Over the past three months, the Zacks Consensus Estimate for Creative Medical Technology Holdings has increased by 9.4% [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [5]. Zacks Rank System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Creative Medical Technology Holdings to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].
Is Creative Medical Technology Holdings, Inc. (CELZ) Stock Outpacing Its Medical Peers This Year?
ZACKS· 2025-03-25 14:40
Group 1 - Creative Medical Technology Holdings, Inc. (CELZ) is currently outperforming its peers in the Medical sector with a year-to-date performance increase of approximately 14.3%, compared to the sector average gain of 5% [4] - CELZ has a Zacks Rank of 2 (Buy), indicating a positive outlook based on earnings estimates and revisions [3] - The Zacks Consensus Estimate for CELZ's full-year earnings has increased by 9.4% over the past quarter, reflecting improving analyst sentiment [4] Group 2 - CELZ is part of the Medical - Biomedical and Genetics industry, which includes 509 stocks and currently ranks 74 in the Zacks Industry Rank [6] - The Medical - Biomedical and Genetics industry has seen an average gain of 6% year-to-date, indicating that CELZ is performing better than the industry average [6] - Another stock in the same industry, 89BIO (ETNB), has also shown strong performance with a year-to-date increase of 17% and a Zacks Rank of 2 (Buy) [5][6]
Creative Medical Technology Holdings Secures FDA Clearance for Expanded Dose Escalation in the Clinical Trial of CELZ-201-DDT for Chronic Lower Back Pain
Newsfilter· 2025-03-20 11:50
Core Insights - The U.S. FDA has cleared an expanded dose escalation for Creative Medical Technology Holdings' ongoing Phase 1/2 trial of StemSpine® using AlloStem™ (CELZ-201-DDT), a proprietary allogeneic cell therapy for chronic lower back pain due to degenerative disc disease [1][4] - Interim blinded data shows statistically significant pain reduction and improved mobility among trial participants, reinforcing the therapy's potential efficacy [1][2][8] Trial Details - The study utilizes a minimally invasive ultrasound-guided injection of CELZ-201-DDT in an outpatient setting, with a 4:1 treatment-to-placebo ratio [2] - No dose-limiting toxicities or serious adverse events have been reported in the first half of the trial, indicating a strong safety profile [2][8] - The FDA's authorization allows for expanded dosing, which aims to optimize therapeutic outcomes [2][8] Company Perspective - The President and CEO of Creative Medical Technology Holdings emphasized that the FDA's clearance is a significant step towards maximizing safety and efficacy, potentially accelerating the pathway to a pivotal Phase 3 trial for Biologics License Application submission [4] - The company is committed to advancing regenerative medicine solutions to address critical unmet needs in pain management and tissue regeneration [4][6] Product Information - CELZ-201-DDT is designed to target the underlying pathology of degenerative disc disease, offering a non-surgical approach to reduce pain and enhance tissue health without radiation exposure [5][6] Future Outlook - Enrollment in the trial remains on track, with final data expected to influence future clinical and regulatory strategies [8]
Creative Medical Technology (CELZ) - 2024 Q4 - Annual Report
2025-03-14 20:30
Clinical Trials and Efficacy - The company received FDA clearance to initiate a Phase I/II clinical trial for AlloStemSpine® Chronic Lower Back Pain (CELZ-201 ADAPT), enrolling 30 individuals[26]. - The company reported a 93% overall efficacy in treated patients with Type 2 Diabetes using CELZ-001, demonstrating at least a 50% reduction in insulin requirement after one year[25]. - The FDA cleared the company's Type I Diabetes (CELZ-201 CREATE-1) IND application, allowing the start of a Phase I/II clinical trial[20]. - The company achieved a significant milestone by generating human iPSC-derived islet cells that produce human insulin, with potential for clinical translation[28]. - The company reported positive three-year follow-up data for the StemSpine® pilot study, showing continued efficacy for treating chronic lower back pain[21]. - The Data Safety Monitoring Board (DSMB) endorsed the continuation of the CELZ-201 ADAPT clinical trial, confirming the safety profile of CELZ-201[39]. - The first cohort of the CELZ-201 ADAPT clinical trial included 10 participants, with 8 receiving CELZ-201-DDT and 2 receiving placebo, showing no dose-limiting toxicities or serious adverse events[33]. - Preliminary blinded data from the CELZ-201 ADAPT trial suggest potential therapeutic benefits in alleviating chronic back pain associated with degenerative disc disease[39]. - The AlloStemSpine® treatment for chronic lower back pain has received FDA approval for a Phase I/IIa study, with initial data showing no serious adverse events in the first cohort of 10 participants[45]. - The StemSpine® procedure has shown a continued efficacy rate of 87% in treating chronic lower back pain over a three-year follow-up period[57]. - The OvaStem™ technology for treating infertility has demonstrated significant efficacy in a pilot study, resulting in the successful birth of healthy babies[63]. - The CELZ-201 CREATE-1 therapy for Type I Diabetes is currently in a Phase I/IIa FDA study, with a treatment group of 12 and a control group of 6[44]. Intellectual Property and Licensing - The company has a robust intellectual property portfolio with four issued patents and fifty pending applications related to stem cell therapies[68]. - The company acquired U.S. Patent No. 9,598,673 for the use of various stem cells in treating lower back pain, with an initial payment of $100,000 made in cash and stock[75]. - The company has made various payments to CMH totaling $300,000 related to the patent agreement, with the remaining obligations settled through stock issuance[77]. - The company entered a Patent License Agreement with Jadi Cell, LLC, granting access to proprietary processes for expanding master cell banks, with an initial license fee of $250,000 paid in stock[78]. - The company has trademark registrations for CaverStem®, StemSpine®, AlloStemSpine®, and FemCelz®, with pending applications for several other brands[81]. - The company has multiple pending patent applications in immunology, including 15/617,813 for immunotherapy of recurrent spontaneous abortions and 63/340,450 for protection from ovarian failure[71]. - The company intends to comply with all applicable FDA regulations to avoid potential enforcement actions that could impact operations[115]. - The company has established a framework for royalty payments of 5% from gross sales of products derived from its patents, ensuring ongoing revenue from successful commercialization[79]. Regulatory Compliance and FDA Interaction - The FDA regulates the company's stem cell treatments under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, requiring compliance with stringent regulations[86]. - The company’s CaverStem® and FemCelz® procedures are exempt from FDA premarket review under the Same Surgical Procedure Exception, while ImmCelz™ requires standard drug approval[91]. - The FDA has broad regulatory authority over drugs and biologics marketed in the United States, including research, clinical testing, manufacturing, and distribution[93]. - The process for FDA approval of a drug or biologic typically involves multiple phases of clinical trials, including Phase 1, Phase 2, and Phase 3, which can take many years and require significant resources[96][102]. - Approval of a New Drug Application (NDA) or Biologics License Application (BLA) requires demonstrating that the product is safe and effective for its intended use[95]. - The FDA may expedite the review of NDAs and BLAs through programs such as Fast Track, Breakthrough Therapy, and Priority Review, which can significantly shorten the review timeline[105][108]. - The FDA requires that post-marketing clinical trials may be necessary to confirm the effectiveness of a product candidate after approval[97]. - Medical devices are classified into three classes based on risk, with Class III devices subject to the highest regulatory scrutiny and requiring premarket approval[112][113]. - The FDA premarket clearance and approval process for medical devices can take from three months to several years, depending on the type of submission[114]. - Compliance with Current Good Manufacturing Practices (cGMP) is essential for products regulated as drugs, biological products, or devices to ensure quality and safety[116]. - The FDA can impose various enforcement actions for non-compliance, including fines, product seizures, and criminal prosecutions, which could materially adversely affect the company[104][117]. - Non-compliance with FDA regulations can lead to severe enforcement actions, including fines and product recalls, which could materially affect the company[92]. - The FDA regulates the entire lifecycle of drugs and biological products, including research, clinical testing, and manufacturing processes[93]. - The approval process for drugs typically involves multiple phases of clinical trials, with Phase 3 requiring statistically significant evidence of efficacy[100]. - If products are regulated as drugs or biological products, significant resources will be needed for regulatory compliance, and the approval process can be lengthy and unpredictable[102]. - The company must submit an IND to begin clinical trials, and an NDA or BLA for marketing approval, which requires demonstrating safety and efficacy[94]. - Phase 4 clinical trials may be required post-approval to address safety issues identified by the FDA[97]. - Changes to approved applications require submission and approval of new NDAs or BLAs, which can involve extensive clinical data[98]. Financial Performance and Investments - The company secured approximately $1.6 million in net proceeds from a registered direct offering and concurrent private placement of common stock[34]. - Research and development expenses for the year ended December 31, 2024, totaled $2,400,777, an increase from $1,970,639 in 2023, reflecting ongoing clinical trials and product development efforts[124]. - The company sold 418,552 shares of common stock at $4.42 per share, generating net proceeds of approximately $1.6 million from the offering[34]. - The company has ongoing obligations totaling $300,000 related to the patent, with payments made in cash and stock over several years[77]. - The company is competing with larger pharmaceutical and biotechnology firms in the regenerative medicine sector, which is rapidly evolving[82]. - The company has made significant investments in research and development, focusing on innovative therapies and technologies in the regenerative medicine field[84].
Creative Medical Technology Holdings Announces Agreements for Exercise of Warrants for $3.7 Million Gross Proceeds
Globenewswire· 2025-03-06 13:10
Core Points - Creative Medical Technology Holdings, Inc. has entered into agreements for the immediate exercise of existing warrants to purchase up to 837,104 shares of common stock at an exercise price of $4.42 per share, expected to generate approximately $3.7 million in gross proceeds [1][2][3] - Roth Capital Partners is acting as the financial advisor for this transaction, and in exchange for the immediate exercise, the company will issue new unregistered warrants for up to 1,674,208 shares at an exercise price of $3.75 per share, exercisable for five years post shareholder approval [2][3] - The transaction is anticipated to close on or about March 6, 2025, subject to customary closing conditions, with net proceeds intended for working capital and general corporate purposes [3][4] Company Overview - Creative Medical Technology Holdings, Inc. is a biotechnology company focused on advancing novel biological therapeutics in immunotherapy, endocrinology, urology, gynecology, and orthopedics, traded on NASDAQ under the ticker symbol CELZ [6]
Creative Medical Technology Holdings Announces Agreements for Exercise of Warrants for $3.7 Million Gross Proceeds
Newsfilter· 2025-03-06 13:10
Core Viewpoint - Creative Medical Technology Holdings, Inc. has entered into agreements for the immediate exercise of existing warrants, which will generate approximately $3.7 million in gross proceeds for the company [1][3]. Group 1: Warrants and Financial Details - The company has agreements with certain warrant holders to exercise up to 837,104 shares at an exercise price of $4.42 per share, originally issued in October 2024 [1]. - In exchange for the immediate exercise of existing warrants, the company will issue new unregistered warrants for up to 1,674,208 shares at an exercise price of $3.75 per share, exercisable for five years after shareholder approval [2]. - The transaction is expected to close on or about March 6, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the warrant exercise will be utilized for working capital and general corporate purposes [3]. Group 3: Regulatory Information - The new warrants and the shares issuable upon their exercise are offered in a private placement and have not been registered under the Securities Act of 1933 [4]. - The company plans to file a registration statement with the SEC for the resale of shares issuable upon the exercise of the new warrants [4]. Group 4: Company Overview - Creative Medical Technology Holdings, Inc. is a biotechnology company focused on advancing novel biological therapeutics in various medical fields, including immunotherapy and orthopedics, and is listed on NASDAQ under the ticker symbol CELZ [6].
Creative Medical Technology Holdings Applauds Presidential Initiative to Expand IVF Access, Showcasing OvaStem® Program's Success and Growth Potential
Newsfilter· 2025-02-20 13:00
Core Insights - Creative Medical Technology Holdings, Inc. supports President Trump's executive order to expand access to in vitro fertilization (IVF), aligning with its OvaStem® program which shows an 85% improvement in hormonal function and a 70% success rate in delivering healthy babies using a patient's own eggs [1][4] Group 1: Company Overview - Creative Medical Technology Holdings, Inc. is a biotechnology company focused on regenerative medicine, particularly in reproductive health through its OvaStem® program [1][5] - The company has filed for Orphan Drug Designation for Primary Ovarian Insufficiency (POI), highlighting its commitment to fertility innovation [2] Group 2: OvaStem® Program - OvaStem® offers a personalized alternative to traditional IVF by utilizing a patient's own cells, significantly improving the chances of conception for patients with POI, who typically have only a 5-10% chance of spontaneous pregnancy [2] - The next-generation OvaStem® integrates the AlloStem® platform, which is currently involved in two FDA-cleared clinical trials [2] Group 3: Executive Order Impact - The executive order mandates recommendations to lower out-of-pocket IVF costs, which currently range from $12,000 to $25,000 per cycle, potentially increasing access to advanced fertility technologies [3] - The administration's plan aims to remove financial barriers, facilitating greater adoption of fertility treatments [3] Group 4: Leadership Statements - The President and CEO of Creative Medical Technology Holdings expressed enthusiasm for the executive order, emphasizing the company's expertise in regenerative medicine and its potential to redefine reproductive health [4] - The Director of Clinical Operations highlighted the goal of providing safe, effective, and affordable infertility solutions, positioning OvaStem® at the forefront of this movement [4] Group 5: Future Commitment - Creative Medical Technology Holdings is committed to advancing innovative solutions in regenerative medicine, aiming to empower families and enhance shareholder value as federal efforts to expand fertility care progress [4]
Creative Medical Technology Holdings Applauds Presidential Initiative to Expand IVF Access, Showcasing OvaStem® Program's Success and Growth Potential
Globenewswire· 2025-02-20 13:00
Core Insights - Creative Medical Technology Holdings, Inc. supports President Trump's executive order aimed at expanding access to in vitro fertilization (IVF), aligning with the company's vision to enhance reproductive health through its OvaStem program, which shows an 85% improvement in hormonal function and a 70% success rate in delivering healthy babies using a patient's own eggs, with no safety concerns reported up to five years post-treatment [1][4]. Group 1: OvaStem Program - OvaStem provides a novel, personalized alternative to traditional IVF for patients with Primary Ovarian Insufficiency (POI), who typically have only a 5-10% chance of spontaneous pregnancy and often rely on donor eggs [2]. - The next-generation OvaStem integrates the AlloStem platform, which is currently utilized in two FDA-cleared U.S. clinical trials, and the company has filed for Orphan Drug Designation for POI, reinforcing its leadership in fertility innovation [2]. Group 2: Executive Order Impact - The executive order mandates the Domestic Policy Council to deliver recommendations within 90 days to lower out-of-pocket IVF costs, which currently range from $12,000 to $25,000 per cycle, making treatment inaccessible for many families [3]. - By removing financial barriers, the administration's plan is expected to facilitate greater adoption of advanced fertility technologies [3]. Group 3: Company Commitment - The company expresses its commitment to providing the safest, most effective, and affordable infertility solutions, positioning OvaStem at the forefront of the fertility care revolution [4]. - With a robust portfolio of proprietary technologies and clinical programs, the company aims to address pressing medical challenges and drive shareholder value as federal efforts to expand fertility care progress [4].
Creative Medical Technology Holdings Announces Mid-Term Follow-up Study Data Reporting Significant Reduction in Opioid Use by Chronic Lower Back Pain Patients Undergoing StemSpine® Procedure using AlloStem™
GlobeNewswire News Room· 2025-02-14 12:00
Core Insights - Creative Medical Technology Holdings, Inc. announced positive mid-term follow-up data from its StemSpine® pilot study, which utilizes AlloStem™ cells for treating chronic lower back pain [1][2] Study Results - The pilot study showed a significant reduction in opioid dependency, with over 90% of patients reporting no opioid use for pain management three years post-procedure [2] - Pain scores decreased by 80%, and there was a greater than 60% improvement in Oswestry Disability Index scores [2] - Only one patient required reintervention at the three-year follow-up, and no serious adverse events were reported, indicating a favorable safety profile for the StemSpine® procedure [2] Technology Overview - StemSpine® is a patented, non-surgical, ultrasound-guided procedure that employs AlloStem™, an allogenic cell therapy developed by the company [3] - The patent for StemSpine® includes the use of both autologous and allogenic cells, enhancing its clinical applicability [3] Company Vision - The results highlight the safety and clinical efficacy of AlloStem™ in the StemSpine® procedure, promoting repair and improved vascularization in affected areas [4] - The company aims to provide innovative, non-surgical solutions for individuals suffering from chronic lower back pain [4] - The positive findings from the pilot study are expected to drive strong enrollment in the ongoing FDA-cleared Phase 1/2 ADAPT clinical trial for CELZ-201-DDT [4]