Wednesday, November 13, 2024

Breaking Cleantech Automotive Stock News: Worksport (NASDAQ: $WKSP) Reports Significant 581% YoY Revenue Growth in Q3 2024, Eyes Record 2025; @WorksportLtd

Breaking Cleantech Automotive Stock News: Worksport (NASDAQ: $WKSP) Reports Significant 581% YoY Revenue Growth in Q3 2024, Eyes Record 2025; @WorksportLtd

 

Company Announces Consecutive Surge in Quarterly Revenues; Provides Positive Outlook for Fiscal Year 2025; Ongoing Expansion and New Product Lines Fuel Momentum

 


West Seneca, New York - November 13, 2024 (Investorideas.com Newswire) Worksport Ltd. (NASDAQ: WKSP) (“Worksport” or the “Company”), a U.S.-based manufacturer and innovator of hybrid and clean energy solutions for the light truck, overlanding, and global consumer goods sectors today announced its Q3 2024 financial results. Worksport shares another consecutive quarter of revenue growth and positive outlook for financial year-end 2025.

 

Q3 revenue surged to $3.12 million—a 581% year-over-year increase compared to $458,433 in Q3 2023. This rapid growth reflects continued scaling of both B2B and B2C channels and the growing demand for Worksport’s innovative products. Following a 275% revenue increase from Q1 to Q2 2024, Q3 revenue grew another 63% from Q2 2024, underscoring the strength of the Company’s strategic investments and the success of its recent sales initiatives. Worksport believes it will exceed previous financial guidance of $6-8M by year-end 2024, and below issues guidance for year-end 2025.

 

Paid News dissemination for Worksport Ltd.

 

Read this news, featuring WKSP in full at https://www.investorideas.com/news/2024/11131WKSP-Revenue-Growth-Q3.asp

Steven Rossi, Worksport’s Founder & CEO, stated:

"Our Q3 results are just the beginning. With our robust product pipeline and aggressive market penetration strategies, we are on a trajectory for sustained growth. Our goal is to become cash flow positive in 2025, with a keen focus on EPS and EBITA. We are targeting revenue growth to $25-$34.5 million in 2025. We are excited about the significant impact our products, including the AL4 tonneau cover, SOLIS solar cover, and COR portable energy system, are expected to have as we enter next year."

 

Upcoming Products & Strategic Path to Profitability:

Worksport continues to expand its production capacity and expects to meet its next production target of making over 200 tonneau covers per day within 2025. This increase in capacity should enable the Company to meet growing demand while notably increasing margins, driven by new high-demand, high-margin product lines. In Q3, the Company maintained an inventory balance of $6.1 million, strategically positioned to support sustained revenue growth without the need for major capital investments. The Company believes it can increase its ability to produce beyond 200 covers without significant time or capital investment.

 

Additional Highlights Include:

B2C Sales Growth: Online sales increased from $21,599 in Q3 2023 to $1.59 million in Q3 2024, now making up 51% of total revenue.

 

 

Government Sales Traction: Worksport initiated sales to a U.S. government agency, positioning itself for potential future business development.

 

New Product Launches: The highly anticipated AL4 tonneau cover is set to debut in Q4 this year and is expected to contribute significantly to revenue growth in 2025, while the SOLIS and COR products are in Alpha testing, with a full market launch slated for Q2/Q3 next year.

 

Strategic Market Position and Forward Guidance

Worksport expects to exceed its previously issued revenue guidance of $6-8 million by year-end 2024.

 

Worksport’s growth is underpinned by its diversified portfolio, intellectual property, team experience, and its newly launched online presence. With the pickup truck market continuing to lead vehicle sales and Worksport’s first-to-market solar-integrated tonneau cover SOLIS on the horizon, the Company believes it is well-positioned to capture market share in both the automotive accessory and clean energy sectors. Complemented by the COR portable energy system, Worksport’s growth potential continues to become strong in 2025 and beyond.

 

For 2025, Worksport projects its existing product lines to generate $20 million in revenue, with new product launches, including its AL4 cover and COR and SOLIS systems, contributing up to an additional $18.5 million. Depending on timing and circumstances, these projections lead to a robust revenue outlook ranging from $25 million to $34.5 million in 2025, a pivotal year anticipated to drive Worksport towards cash flow positivity.

 

Worksport Q3 Earnings Call

For detailed insights on the quarter, and management commentary, please attend the Q3 2024 Earnings Call. It will occur at 4:30pm ET on Wednesday November 13, 2024. You may attend with this link: [Worksport Q3 2024 Earnings Call]

 

The prepared remarks will also be available at Worksport’s Investor Relations website.

 

Investor Inquiries May Be Directed To:

Investor Relations, Worksport Ltd.  

T: 1 (888) 554-8789 x128

W1: https://investor.worksport.com

W2: www.worksport.com   

E: investors@worksport.com

 

Worksport Quarter 3, 2024 Report, Item 1. Financial Statements

 




 



 

The Company has included the Financial Statements section below from the ‘Full Worksport Q3 2024' For Quarterly Period Ended: September 30, 2024. Investors are encouraged to read the full 10-Q along with the Prepared Remarks, both linked above.

 

Item 1. Financial Statements

The accompanying notes form an integral part of these condensed consolidated financial statements. Please click here to download the full 10-Q.

 

The link below will take you to the Worksport Investor Relations Website. You may download the full 10-Q and accompanying earnings call remarks there: Q3 2024 10 Q & Earnings Call Prepared Remarks - Download Here

 

Investor Inquiries May Be Directed To:

Investor Relations, Worksport Ltd.
T: 1 (888) 554-8789 x128
W1: https://investor.worksport.com
W2: www.worksport.com
E: investors@worksport.com

 

Key 2024 Press-Releases:

Read all Worksport press releases: [Link to All Press Releases].

 

Stay Connected

  • Investor Newsletter: Investors and customers are invited to follow Worksport's progress as it builds on this momentum and strives to redefine industry standards with each new corporate development. Link to Newsletter
  • Contact Information

 

Investor Relations, Worksport Ltd. T: 1 (888) 554-8789 -128 W: investors.worksport.com E: investors@worksport.com
W: worksport.com

 

About Worksport

Worksport Ltd. (Nasdaq: WKSP), through its subsidiaries, designs, develops, manufactures, and owns the intellectual property on a variety of tonneau covers, solar integrations, and NP (Non-Parasitic), hydrogen-based true green energy solutions for the sustainable, clean energy, and automotive industries. Worksport has an active partnership with Hyundai for the SOLIS Solar cover. Additionally, Worksport's hard-folding cover, designed and manufactured in-house, is compatible with RAM, Chevrolet, and GMC models from General Motors, as well as Ford, Jeep, Nissan, and Toyota pickup trucks. Worksport seeks to capitalize on the growing shift of consumer mindsets towards clean energy integrations with its proprietary solar solutions, mobile energy storage systems (ESS), and NP (Non-Parasitic), Hydrogen-based technology.

Terravis Energy's website is terravisenergy.com. For more information, please visit investors.worksport.com.

 

Connect with Worksport

Please follow the Company's social media accounts on X (previously Twitter), Facebook, LinkedIn, YouTube, and Instagram (collectively, the "Accounts"), the links of which are links to external third party websites, as well as sign up for the Company's newsletters at investors.worksport.com. The Company does not endorse, ensure the accuracy of, or accept any responsibility for any content on these third-party websites other than content published by the Company.

 

Product social media

Instagram
Facebook
YouTube

 

Investor social media

X (formerly Twitter)
LinkedIn
Link to Newsletter

 

Investors and others should note that the Company announces material financial information to our investors using our investor relations website, press releases, Securities and Exchange Commission ("SEC") filings, and public conference calls and webcasts. The Company also uses social media to announce Company news and other information. The Company encourages investors, the media, and others to review the information the Company publishes on social media.

 

The Company does not selectively disclose material non-public information on social media. If there is any significant financial information, the Company will release it broadly to the public through a press release or SEC filing prior to publishing it on social media.

 

For additional information, please contact:
Investor Relations, Worksport Ltd. T: 1 (888) 554-8789 -128 W: investors.worksport.com W: www.worksport.com E: investors@worksport.com

 

Forward-Looking Statements
The information contained herein may contain "forward looking statements." Forward looking statements reflect the current view about future events. When used in this press release, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," "project," "should," or the negative of these terms and similar expressions, as they relate to us or our management, identify forward looking statements. These statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) supply chain delays; (ii) acceptance of our products by consumers; (iii) delays in or nonacceptance by third parties to sell our products; and (iv) competition from other producers of similar products. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, including, without limitation, our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. The forward-looking statements made in this press release are made only as of the date of this press release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.

 

Worksport Ltd. (Nasdaq: WKSP) is a featured renewable energy/automotive stock on Investorideas.com

 

More info on WKSP at Investorideas.com Visit:  https://www.investorideas.com/CO/WKSP/

 

Disclaimer/Disclosure: Disclosure: Worksport Ltd. (Nasdaq: WKSP) is a paid featured company on Investorideas.com effective  October 18th 2024 for 2 months. lInvestorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. Contact management and IR of each company directly regarding specific questions. More disclosure info can be found here. More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

 

 


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Breaking Medical Technology News: Aethlon Medical (Nasdaq: $AEMD) Announces Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and Provides Corporate Update

 

Breaking Medical Technology News: Aethlon Medical (Nasdaq: $AEMD) Announces Financial Results for the Fiscal Second Quarter Ended September 30, 2024 and Provides Corporate Update

 

Achieves Key Milestone with Enrollment of First Two Patients in the Safety, Feasibility, and Dose Finding Study of Aethlon's Hemopurifier® in Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

 

Two Australian Sites Open For Patient Enrollment in Hemopurifier® Cancer Trial

 

Conference Call to be Held Today at 4:30 p.m. ET

 


SAN DIEGO, CA - November 13, 2024 (Investorideas.com Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal second quarter ended September 30, 2024 and provided an update on recent developments.

 

Company Updates

During the second quarter, and subsequently, the company advanced its oncology trial efforts in Australia, while implementing cost-cutting measures to streamline operations. Management is pleased to report positive progress on these initiatives, specifically:

 

Clinical Trials: The first two patients have now been enrolled at the Royal Adelaide Hospital in Adelaide, Australia. Additionally, Pindara Private Hospital, in the Gold Coast section of Australia, received ethics committee approval, was trained on Aethlon's Hemopurifier®, and is now open for patient enrollment. The company has also trained a third hospital in Australia, but has not yet received ethics committee approval for that institution and it has not yet begun patient enrollment.

 

In September, Aethlon received ethics committee approval from Medanta Medicity Hospital in Gurugram, India, for a similar nine to 18-patient, safety, feasibility and dose-finding trial of the Hemopurifier. The company is completing the necessary logistical steps before the site can open for patient enrollment.

 

Management Change: In October, Aethlon's board of directors appointed James Frakes to serve as the company's permanent Chief Executive Officer, after having served as Interim Chief Executive Officer since November 2023.

 

Operational Efficiency: Strategic cost-cutting initiatives have allowed for optimized resource allocation, enabling continued focus on high-impact areas of the oncology trial.

Paid News Dissemination of behalf of AEMD

 

Read this news in full and see financial charts at https://www.investorideas.com/news/2024/11131AEMD-Fiscal-Second-Quarter.asp

 

"During the second fiscal quarter and subsequent period, we continued advancing our oncology trials, earlier this week announcing enrollment of the first patient at Royal Adelaide Hospital, and now updating this news to report enrollment of a second patient. This represents a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have failed treatment with anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We now have two sites open for patient enrollment in Australia, have received ethics committee approval from a site in India, and we expect to continue to enroll subjects in our Hemopurifier cancer trial. As previously announced, we believe these studies will help inform future oncology efficacy trials. Additionally, we have made strategic cost-cutting measures to optimize company resources, in order to focus on the high-impact oncology trials in both Australia and India."

As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 antibody therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.

 

Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.

 

The company also continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in capturing viruses such as Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in India remains open to accommodate any potential COVID-19 admissions to the intensive care units at the two participating sites, Medanta Medicity Hospital and Maulana Azad Medical College. So far, one patient has been treated. The company is actively evaluating COVID-19 admissions and potential enrollment against the ongoing costs of maintaining the trial.

 

Financial Results for the Fiscal Second Quarter Ended September 30, 2024

As of September 30, 2024, Aethlon Medical had a cash balance of approximately $6.9 million.

 

Consolidated operating expenses for the fiscal quarter ended September 30, 2024 were approximately $2.9 million, compared to $3.2 million for the fiscal quarter ended September 30, 2023. This decrease of approximately $300,000, or 9%, in the 2024 period was due to a decrease of approximately $600,000 in professional fees, partially offset by an increase of approximately $200,000 in payroll and related expenses and an approximately $100,000 increase in general and administrative expenses.

 

The approximate $600,000 decrease in professional fees was primarily due to a $300,000 reduction in legal fees following a transition to a new legal firm, a $200,000 decrease in contract labor expenses due to project completions with contract manufacturing organizations and research and development consultants, and an $81,000 decrease in accounting fees.

 

The approximate $200,000 increase in payroll and related expenses was primarily due to an increase of $500,000 in separation expenses related to severance agreements following the termination of an executive and a reduction in workforce. This increase was partially offset by a $200,000 reduction in ongoing payroll expenses and a $100,000 decrease in stock-based compensation as a result of the completion of vesting of existing stock options and reduced headcount.

 

The $100,000 increase in general and administrative expenses in the fiscal quarter ended September 30, 2024 was primarily due a $200,000 increase in costs associated with the company's ongoing oncology clinical trial. This increase was partially offset by reductions in a number of general and administrative expense items, including decreases in U.S. clinical trial expenses.

 

As a result of the factors noted above, the company's net loss decreased to approximately $2.8 million in the fiscal quarter ended September 30, 2024, from approximately $3.0 million in the fiscal quarter ended September 30, 2023.

 

The consolidated balance sheet for September 30, 2024, and the consolidated statements of operations for the three- and six-month periods ended September 30, 2024 and 2023 follow at the end of this release.

 

Conference Call

Management will host a conference call today, Wednesday, November 13, 2024, at 4:30 p.m. ET to review the company's financial results and recent corporate developments. Following management's formal remarks, there will be a question and answer session.

 

Interested parties can register for the conference call by navigating to https://dpregister.com/sreg/10194285/fdebe88214. Please note that registered participants will receive their dial-in number upon registration.

 

Interested parties without internet access or unable to pre-register may dial in by calling:

 

PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741

PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

 

All callers should ask for the Aethlon Medical, Inc. conference call.

 

A replay of the call will be available approximately one hour after the end of the call through December 13, 2024. The replay can be accessed via Aethlon Medical's website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll free at 1-855-669-9658. The replay conference ID number is 10194285.

 

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

 

Additional information can be found at www.AethlonMedical.com.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to raise additional capital on terms favorable to the Company, or at all; the Company's ability to successfully complete development of the Hemopurifier; the Company's ability to successfully demonstrate the utility and safety of the Hemopurifier in cancer and infectious diseases and in the transplant setting; the Company's ability to achieve and realize the anticipated benefits from potential milestones; the Company's ability to obtain approval from the Ethics Committee of its third location in Australia, including on the timeline expected by the Company; the Company's ability to enroll additional patients in its oncology clinical trials in Australia and India, including on the timeline expected by the Company; the Company's ability to manage and successfully complete its clinical trials; the Company's ability to successfully manufacture the Hemopurifier in sufficient quantities for its clinical trials; unforeseen changes in regulatory requirements; the Company's ability to maintain its Nasdaq listing; and other potential risks. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

 

Company Contact:

Jim Frakes

Chief Executive Officer and Chief Financial Officer

Aethlon Medical, Inc.

Jfrakes@aethlonmedical.com

 

Investor Contact:

Susan Noonan

S.A. Noonan Communications, LLC

susan@sanoonan.com

 

Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com

 

More info on AEMD at Investorideas.com Visit: 

https://www.investorideas.com/CO/AEMD/

 

Get News Alerts on Aethlon Medical

 

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Tuesday, November 12, 2024

Medical Technology Stocks and First Patient Enrollment Milestones

 

 

 


 


 

Medical Technology Stocks and First Patient Enrollment Milestones

 


November 12, 2024 - Investorideas.com, a go-to investing platform, releases an industry snapshot  looking at the future of  medical technology as first patients are enrolled in potential breakthrough trials, featuring Aethlon Medical, Inc. (Nasdaq:AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.

 

According to Statista.com, “The Medical Technology market, which encompasses various markets, including Medical Devices, is anticipated to witness significant revenue growth in the coming years.”

 

“By 2024, the market is projected to reach a staggering US$597.00bn worldwide. Among these markets, Medical Devices are expected to dominate, with a projected market volume of US$508.00bn by 2024. Furthermore, the Medical Technology market is expected to demonstrate a steady annual growth rate of 5.29% from 2024 to 2029.”

 

As medical technology companies announce first patient enrollment, they take a significant step forward to the goal of bringing their technology to market.

 

Stocks mentioned in this article include Royal Philips (NYSE: PHG), Microbot Medical Inc. (Nasdaq: MBOT), BD (Becton, Dickinson and Company) (NYSE: BDX).

 

Yesterday, Aethlon Medical, Inc. (Nasdaq:AEMD) announced a key milestone with enrollment of the first patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.

 

Paid news dissemination for Aethlon Medical

 

Read this article, featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/11121AEMD-First-Patient-Enrollment-Milestones.asp

 

The Hemopurifier is an immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier has demonstrated the removal of harmful exosomes from biological fluids, utilizing its proprietary lectin-based technology.

 

From the news: The first patient completed screening activities confirming their eligibility on November 8, 2024, and has now entered a two-month run-in period, receiving anti-PD-1 therapy. During this time, concentrations of Extracellular vesicles (EVs) and anti-tumor T cell activity will be measured. If imaging after this two-month run-in period reveals no improvement in the patient’s tumor, they will be treated with the Hemopurifier, followed by monitoring to identify decreases in EV concentrations and improvements in T cell anti-tumor activity.

 

"Enrollment of the first patient represents the achievement of a critical milestone for Aethlon Medical in the clinical development of the Hemopurifier in Oncology,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “We are thrilled with the pre-screening activity being done to identify patients at Royal Adelaide, as well as the second site, Pindara Private Hospital in the Gold Coast. We are grateful to the patient for consenting to be part of this study. This trial is our initial step in determining if the Hemopurifier treatment can improve upon the 30-40% response rates to anti-PD-1 therapies such as Opdivo and Keytruda.” 

 

From the news: Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

 

The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

 

On November 4th, Royal Philips (NYSE: PHG) (AEX: PHIA), a global leader in health technology, announced enrollment of the first patient in the US THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device. Procedures that previously required the use of two different devices can now be performed in a single procedure using a single device, simplifying workflows and procedures and potentially reducing the risk and improving outcomes for patients who might otherwise face multiple complex interventions.

 

From the news: The Cardiovascular Institute of the South in Louisiana recently completed the first case using the new laser catheter. The care team there successfully treated a 78-year-old male with peripheral vascular disease using the Philips device.

 

“Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,” said Drs. Craig Walker, Pradeep Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana. “This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.”

 

From the news: This ground-breaking first procedure not only marks the launch of the THOR IDE trial. It also showcases how this innovative new technology, which resulted from Philips’ powerful in-house development capabilities, can ease the patient experience by streamlining complex interventions into a single procedure, potentially reducing the need for multiple interventions and hospital visits.

 

From the news: The goal of this pivotal study is to evaluate the safety and efficacy of using this unique laser device — a first-of-its-kind solution that integrates laser atherectomy and intravascular lithotripsy in a single device to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.

 

On October 15th, Microbot Medical Inc. (Nasdaq: MBOT), a developer of the innovative LIBERTY® Endovascular Robotic Surgical System, announced that it has successfully completed enrollment and follow up for all patients in its ACCESS-PVI human clinical trial. The Company remains on track to file its 510(k) submission with the U.S. Food and Drug Administration (FDA) by of the end of 2024.

 

The Company also announced that it is accelerating its go-to-market strategy. It expects to begin building out the commercial infrastructure, including the hiring of a seasoned healthcare executive to lead its sales efforts, upon the FDA clearance, which is expected during 2Q 2025.

 

This news follows up on developments since its first patient announcement in July when Microbot announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial.

 

From the news: The clinical trial at BWH was led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization.

 

“Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY® to U.S. physicians,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very pleased with the rapid pace of site activation, and I’m looking forward to enrolling additional patients in the near future.”

 

Earlier this year BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced the enrollment of the first patient in the investigational device exemption (IDE) study, "AGILITY," which will assess the safety and effectiveness of the BD Vascular Covered Stent for the treatment of Peripheral Arterial Disease (PAD).

 

The investigational Vascular Covered Stent is a self-expanding, low profile, polytetrafluoroethylene encapsulated nitinol implant. It is deployed from a delivery system that provides controlled stent release.

 

"When we're addressing advanced PAD, a self-expanding covered stent can play an important role," said Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic and National Principal Investigator of the AGILITY study. "We need a stent that can track to the lesion, apposes the vessel wall and ultimately provides long-term durability. We're excited to see how this technology performs."

 

From the news: According to BD, the global, prospective, multi-center, single-arm, non-randomized AGILITY clinical study will include 315 patients at up to 40 clinical study sites across the United States, Europe, Australia and New Zealand. Follow-up for all treated patients will be performed at various points after treatment — starting at one month and ending at 36 months.

 

Medical technology and devices offer a different approach to health than pharmaceuticals, and as is the case with Aethlon Medical, Inc. (Nasdaq:AEMD, and its Hemopurifier in Oncology, it offers a potential solution when other treatment has failed. 

 

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