About Medical Device News Magazine

August 14, 2024

About Medical Device News Magazine | A Digital Publication Founded in 2008 & Located in the United States.

The publication is one of the industry’s leading sources of medical device and biotech industry updates.

Medical Device News Magazine is easily accessible 24/7/365 and is a fast 1, 2, 3 easy read!

Our purpose is threefold:

At Medical Device News Magazine, our purpose is threefold. Firstly, we aim to inform and educate medical specialists on breaking device news across various specialties including General Surgery, Interventional Cardiology, Interventional Radiology, Neurosurgery, OB-GYN, Ophthalmic Surgery, Orthopedic Surgery, Cardiothoracic Surgery, Urologic Surgery, and Vascular Surgery. Our coverage also extends to topics such as Artificial Intelligence, Diagnostic Modalities, FDA Updates, Executives on the Move, and Market Analysis Reports.

Secondly, we strive to keep the medical device industry informed by providing updates and breaking news from competitors. Our comprehensive coverage ensures that industry professionals stay up-to-date with the latest advancements, trends, and breakthroughs.

Lastly, we aim to inform the public about the latest devices that can treat various medical conditions, diseases, and other issues. By highlighting innovative solutions, we contribute to raising awareness and improving healthcare outcomes.

Whether you are a medical specialist, industry professional, or investor, Medical Device News Magazine is your go-to source for staying informed and connected. Join us as we continue to deliver reliable and insightful updates in the dynamic world of medical devices.

The publication is a division of PTM Healthcare Marketing Inc., which provides essential PR and marketing services to the medical industry.

Medical Device News Magazine, is a comprehensive platform for staying updated on the latest news, clinical trials, product launches, FDA announcements, and more in the medical device industry. Our publication is dedicated to providing medical specialists, industry executives, investors, and allied health professionals with accurate and timely information.

Through our extensive network and expertise in medical public relations and startup marketing, we are committed to delivering fact-checked updates in the fields of medical and biotech. Led by our experienced editor-in-chief, Pauline T. Mayer, our team works tirelessly to curate content that is relevant to startups, specialists, and investors alike.

Stay connected with us through various social media outlets and targeted subscriber emails to ensure you never miss an important update or industry breakthrough. Join us in this exciting journey as we strive to be your go-to source for all things related to the medical device industry.

“Working with the Medical Device News Magazine has been extremely helpful. Pauline and Helen have aided us with their great deal of experience. Their intelligent marketing solutions have produced incredible results, enhancing the visibility of our startup.” – Michael, Cardiovascular Medical Device Startup

What We Do
We’re dedicated to delivering our readers an understandable and engaging breakdown of complex subjects. We report everything from clinical trial updates to product launches, FDA announcements, and everything in between. In other words: if it’s related to the world of medical tech, we’ve got it covered. Our vital publication ensures medical specialists, investors and allied health professionals remain up-to-date on crucial developments in medical devices, biotechnology, and diagnostics. Each month we feature several key opinion pieces written by industry specialists, solidifying our role as an expert-led medical news outlet.

Why We’re Different
We’re proud to be one of the top-read, fast 1, 2, 3 easy online news outlets by medical specialists, investors, and allied health professionals. What sets us apart is our dedication to delivering important, understandable, and engaging breakdowns of complex subjects surrounding medical technology. Unlike other print publications, our purely digital approach allows us to deliver relatively important and timely updates the moment they happen.

Thanks to a lack of distracting sales forecasts and printing expenses, our sole focus is to bring you up-to-date on the latest news in biotech. Through web updates, various social media outlets, and e-newsletters, we invite our readers to enjoy an all-encompassing digital news solution. Simple!

“Medical Device News Magazine’s visibility on LinkedIn, Twitter, and Facebook has helped us find new customers for our medical device manufacturing business.” – June, Cloud Services Industry. Learn more about Medical Device News Magazine or contact us at mdnewsmagazine@infomeddnews.com.

Medical Device

WHO Definition: A medical device is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life.

A medical device is any apparatus, implement, machine, appliance, software, material, or other article whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

Diagnosis, prevention, monitoring, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap
Investigation, replacement, or modification of the anatomy or of a physiological process
Supporting or sustaining life
Disinfection of medical devices
Control of conception
Providing information by means of in vitro examination of specimens derived from the human body

Medical devices vary according to their intended use and indications. Medical device examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers that assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of mechanical engineering. (Wikipedia).

Bikini Area Whitening: Tips and Treatments for Confident Beach Days

August 12, 2024

Bikini Area Whitening: Are you ready to step onto the sandy shores with confidence and a radiant glow? Achieving a bright and even skin tone in your bikini area is a goal for many, and it’s completely understandable. Whether you’re gearing up for a beach vacation or simply want to feel more confident in your own skin, bikini area whitening can help you achieve that extra boost of self-assurance.

In this blog, we’ll explore five tips and treatments to help you on your journey to a more confident you.

5 Proven Tips and Treatments for Bilkini Area Whitening

The following tips and treatments are considered effective in treatments for confident beach days:

Tip #1: Professional Consultation

The first step in your journey towards bikini area whitening is to seek professional guidance. Finding a reputable med spa near you is crucial, as they can offer expert advice and customized solutions. During your consultation, you can discuss your goals, skin type, and any concerns you may have. Professionals at a med spa can recommend the most suitable treatment options for your unique needs.

Tip #2: IPL Treatments

IPL (Intense Pulsed Light) treatments are a popular choice for bikini area whitening. These non-invasive procedures use broad-spectrum light to target pigmented areas, effectively reducing hyperpigmentation, uneven skin tone, and unwanted dark spots. IPL treatments can be performed at a med spa near you, ensuring your safety and comfort throughout the process.

Tip #3: Topical Lightening Creams

In addition to professional treatments, you can complement your bikini area whitening regimen with topical lightening creams. These creams are designed to fade dark spots and even out your skin tone over time. When used in conjunction with med spa treatments, you can maximize the effectiveness of your whitening journey. Look for creams at your local beauty stores or inquire about them at the med spa near you.

Tip #4: Chemical Peels

Chemical peels are another effective method for bikini area whitening. These peels use various acids to exfoliate and remove the top layers of skin, revealing brighter, smoother skin beneath. It’s important to consult a professional at a med spa near you before considering this option, as they can recommend the right type and strength of peel for your skin type.

Tip #5: Home Care and Maintenance

Maintaining your bikini area’s whitening results is just as important as the initial treatments. To keep your skin looking its best, ensure you have a good skincare routine in place. Consider using gentle exfoliants, moisturizers, and sunscreen to protect your skin from further discoloration. If you’re searching for products or services to aid in your home care, remember to search for “intimate bleaching near me” to find local options that align with your needs.

In conclusion, achieving a beautifully whitened bikini area is a journey that can boost your confidence and have you feeling your best on beach days. The key to success lies in a professional consultation at a med spa near you, where expert guidance and customized treatments can set you on the right path. By incorporating IPL treatments, topical lightening creams, chemical peels, and maintaining a strong home care routine, you can enhance the results and keep your skin looking radiant.

Pneuma Systems Infusion Technology Accepted by FDA’s Highly Selective Safer Technologies Program (STeP)

August 12, 2024

Pneuma Systems Corporation announced the acceptance of its PneumaFlow™ Controller and Administration Sets into the U.S. Food and Drug Administration’s Safer Technologies Program (STeP) for Medical Devices. STeP is an accelerated regulatory review process to give patients more timely access to innovation by expediting the development, assessment, and review of 510(k) documentation.

“This is a tremendous milestone,” says Pneuma Systems Founder and CEO Jeffrey Carlisle. “Not just for Pneuma, but for the infusion pump industry and, most importantly, for patients and nurses everywhere.”

The STeP initiative was launched by the FDA in 2021 with a rigorous application process to expedite the development and review of innovative medical devices that offer a significant advantage over currently available options. As of the end of 2023, just 35 devices had been selected for STeP. FDA will collaborate with Pneuma through interactive and frequent communications, real-time feedback, and regulatory support leading to the Company’s 510(k) submission.

Peggy McDaniel, BSN RN, Pneuma’s Director of Clinical Support shares, “I have been in the trenches with infusion devices, fellow nurses, and patients for decades. Our team is ready to prove and quantify significant improvements in patient care, infusion safety, and nurse efficiency. We are grateful the FDA has given us the chance to verify this innovative approach.”

There have been more than 50 FDA recalls of infusion systems in the last 10 years to protect patient safety. Seeing an industry plagued with these recalls and safety issues, Pneuma’s approach eliminates legacy problems and transforms the standard of care for patients and nurses with its patented technologies, modern components, and cutting-edge software. The PneumaFlow™ Controller provides significant reduction in electromechanical complexity and vastly improved reliability compared to infusion pumps currently on the market.

Beyond improvements to the underlying flow control technologies, Pneuma is focused on addressing the unmet needs of clinicians and patients who directly interact with these devices. Safer, more reliable technology that measures both flow rate and fluid volume offers opportunities to measurably improve fluid flow, workflow, information flow, and cash flow.

Aethlon Medical Receives Second Ethics Committee Approval for Hemopurifier Cancer Trial

August 12, 2024

Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that, on August 6, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a 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 Merck’s Keytruda® (pembrolizumab) or Bristol Myers Squibb’s Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study).

The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia.

“We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application. Dr. Matos and his research team have a proven track record of enrollment in device trials in oncology patients that provides momentum to these trials,” stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. “This is the second ethics committee approval we have received for our oncology trial in Australia after receiving approval from the ethics committee for Royal Adelaide Hospital in June.”

Dr. LaRosa continued, “The next step is to receive approval from the Research Governance Office at each hospital which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment may proceed.”

Currently, only approximately 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. 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 in cancer patient plasma samples.

The primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trial is safety. The trial 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 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.

Scaling with Demand: Requirements for Success in Medical Device Manufacturing | By Laura Beckwith, Director of Product Management, Configit

August 9, 2024

Historically, medical device companies have provided value by producing equipment for diagnosing and treating patients worldwide. However, contemporary challenges such as heightened pricing pressures, regulatory compliance, supply chain volatility and operational inefficiencies have significantly changed the landscape for these companies.

To secure their market standing and guarantee sustained profitability, manufacturers must prioritize the integration of their product and process configuration to enhance delivery lead time, minimize information handovers and eradicate invalid orders. Establishing a single source of configuration truth, via a Configuration Lifecycle Management (CLM) approach, enables manufacturers to maintain a consistent and reliable revenue stream, along with prolonged opportunities for upselling over time.

Challenges in medical device manufacturing

New and evolving regulations and compliance requirements are challenging to navigate. For instance, the FDA recently provided draft guidance for medical device manufacturers, called Section 524B. These are updates to the FDA’s Premarket Cybersecurity Guidance document and, while not yet binding, herald changes that will likely become legal requirements. This section proposes that any manufacturer submitting an application for a new medical device must include a detailed cybersecurity plan for the device, its software and any other internet-connected technology.

These companies also need to pay attention to new guidelines, such as those recently released by the Connectivity Standards Alliance (CSA) for IoT devices. It aggregates a number of international regulations into one specification.

Supply chain resilience is also an issue. Medical device makers have struggled with unprecedented supply chain shortages for the past three years, including a dearth of raw materials, leading to product delays and other challenges. This reality highlights the need for such companies to develop more resilient supply planning and risk mitigation approaches that enable better visibility into and insight about inventory. That will help to improve forecasting, planning and right-sizing of orders.

The U.S. Producer Price Index (PPI) for healthcare-related equipment and supplies manufacturing has risen since last year. Medical device makers also face lower-cost options from global competitors, higher interest rates, ongoing economic instability and reduced budgets across healthcare systems. All of these issues affect spending on medical technologies. In addition, these highly competitive companies are trying to navigate an environment that’s frowning upon raising prices for the critical devices they make. They need to reduce their costs so they can still turn a profit, which is leading them to take another look at their product portfolios to eliminate excess costs and redundancies.

There are also challenges related to operational inefficiencies, including manual documentation processes, lack of visibility into supplier performance, and difficulty managing changes throughout the product lifecycle that can lead to delays, errors and increased costs.

The need for aligned data

Engineering, sales and manufacturing need to have insight into the same data sets so they can understand what actually can be manufactured and offered to customers. CLM fits this need; it creates a unified repository of all possible product configurations so that medical device manufacturers have confidence that their whole organization is operating from the same data.

With CLM in place, the manufacturing function experiences faster and more accurate delivery times. The engineering function has more time for innovation, and the sales team never sells a non-compliant product. The manufacturer also experiences a fast and accurate response to the supply chain in real time, since it takes just hours to make and deploy changes instead of coordinating various departments and systems. Manufacturers get a better understanding of how compliance issues will affect them by leveraging both a digital thread of customer’s orders and the original source data.

In addition, enabling users from various business functions to use a shared source of configuration truth for collaboration offers a higher degree of transparency so they can capture costs from engineering hours, order handling flow, routing and drawing maintenance, inventory replenishment and more.

Greater value, less disruption

When data is connected across functions, not only are errors due to siloed information eliminated but the development, manufacture and sale of products and services is accelerated. The company gains more operational efficiency by having a shared source of configuration truth. The internal value of this shared truth manifests as lower costs and higher sales. The external value manifests as greater brand loyalty and customer experience.

This results in a process that is free of errors, creating competitive advantage, long-term stability, greater customer satisfaction and higher profit margins.

Manufacturing success

Today’s medical device manufacturers have a lot to contend with. Supply chain issues, cost pressures and evolving regulations are making it more difficult to produce affordable, quality devices in a timely manner. To attain or maintain competitive advantage and remain profitable long-term, these manufacturers need to create a single source of configuration truth via CLM. This unifies both their process and their product configurations, empowering them to experience stable, ongoing revenue and to scale their businesses.

Paragon 28 Appoints Chadi Chahine

August 8, 2024

Paragon 28, Inc. (NYSE: FNA) (“Paragon 28” or “Company”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced that Chadi Chahine has been appointed Chief Financial Officer and Executive Vice-President of Supply Chain Operations, effective August 5, 2024. The Company also reported financial results for the quarter ended June 30, 2024, and narrowed its 2024 net revenue guidance.

Recent Business Updates

Strengthened executive leadership team with appointment of Chadi Chahine as CFO & EVP Supply Chain Operations, effective August 5, 2024
Recorded global revenue of $61.0 million in the second quarter, representing 19.6% and 19.7% reported and constant currency growth compared to the prior year period, respectively
Drove 840 basis point improvement in operating expense as a percent of revenue in the second quarter compared to the prior year period
Initiated an operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preserving cash without compromising revenue growth opportunities
Narrowed 2024 net revenue guidance of $249 million to $255 million, representing 15.1% to 17.8% reported growth compared to 2023
Filed an amended Form 10-K/A for the 2023 fiscal year and an amended Form 10-Q/A for the quarter ended March 31, 2024 in connection with the financial restatement detailed in the Form 8-K filed July 30, 2024

Appointment of Chadi Chahine as Chief Financial Officer

The appointment of Chadi Chahine concludes an extensive search process conducted by the Company. Mr. Chahine will succeed Kristina “Krissy” Wright who has been serving as Interim CFO since April 3, 2024.

“We are thrilled to welcome Chadi to our executive team,” said Albert DaCosta, CEO and Chairman of Paragon 28. “Chadi’s extensive experience in orthopedics and finance combined with his strategic vision and proven ability to drive growth and operational efficiency will be invaluable as we continue to expand our presence in the foot and ankle market and further scale our business operations. We also extend our sincere gratitude to Krissy Wright for her exceptional leadership as interim CFO and look forward to her continued contributions on our Board.”

Chadi Chahine brings over 25 years of extensive global experience in finance and business operations, including a proven track record in the orthopedic industry, to Paragon 28. Before joining Paragon 28, Mr. Chahine served as Group CFO of the Global Business Group for Zimmer Biomet Holdings Inc. (“Zimmer Biomet”), where he oversaw $7 billion in revenue and had full P&L, balance sheet, and commercial finance responsibilities, across all geographic regions. During his tenure at Zimmer Biomet, Mr. Chahine helped drive record revenue and profit in 2022 and 2023 and identified additional efficiencies in inventory and research & development investments.

Prior to his tenure at Zimmer Biomet, Mr. Chahine served as COO and CFO of Global Stanley Security at Stanley Black & Decker prior to the business’s $4.1 billion sale. He also previously served as CFO at CIRCOR International, leading takeover defense efforts and implementing significant cost-saving measures. Earlier in his career, he held divisional CFO roles at Smith+Nephew responsible for International Markets and the US where he led initiatives to accelerate sustainable growth. Mr. Chahine holds a Bachelor of Commerce in Accounting from Université du Québec à Montréal and a Bachelor of Science in Math and Economics from Université de Montréal.

“Paragon 28 is a truly unique business in the world of orthopedics. The Company’s commitment to innovation and excellence in foot and ankle aligns perfectly with my professional values and goals,” said Chadi Chahine, CFO. “I am excited to join Paragon 28 at such a critical time and look forward to contributing to its continued growth and success.”

Chadi Chahine’s appointment as CFO & EVP Supply Chain Operations marks a significant step forward for Paragon 28 as it strengthens its leadership team and positions the Company for continued growth and success in the foot and ankle market.

Second Quarter 2024 and Six Months Ended June 30, 2024 Financial Results

Consolidated net revenue for the second quarter of 2024 was $61.0 million, representing 19.6% and 19.7% reported and constant currency growth, respectively, compared to the second quarter of 2023. Consolidated net revenue for the six months ended June 30, 2024 was $122.1 million, representing 18.5% reported and constant currency growth compared to the six months ended June 30, 2023.
- U.S. net revenue for the second quarter of 2024 and six months ended June 30, 2024 was $49.7 million and $100.8 million, respectively, representing 17.6% and 15.5% reported growth, respectively, compared to the prior year periods.
- International net revenue for the second quarter of 2024 and six months ended June 30, 2024 was $11.3 million and $21.3 million, respectively, representing 29.4% and 35.1% reported growth respectively, compared to the prior year periods.
Gross margin was 75.0% for the second quarter of 2024 compared to 77.3% in the second quarter of 2023. Gross margin was 76.2% for the six months ended June 30, 2024 compared to 78.8% for the six months ended June 30, 2023.
Operating expenses were $56.5 million for the second quarter of 2024, an increase of 9.7%, compared to $51.5 million for the second quarter of 2023. Operating expenses were $118.9 million for the six months ended June 30, 2024, an increase of 16.1%, compared to $102.4 million for the six months ended June 30, 2023.
Net loss was $13.8 million for the second quarter of 2024, a $0.6 million increase, compared to a net loss of $13.2 million for the second quarter of 2023. Net loss was $31.2 million for the six months ended June 30, 2024, a $7.1 million increase, compared to net a loss of $24.1 million for the six months ended June 30, 2023.
Adjusted EBITDA was a $3.0 million loss for the second quarter of 2024, a $2.4 million improvement, compared to a $5.4 million loss in the second quarter of 2023. Adjusted EBITDA was a $10.7 million loss for the six months ended June 30, 2024, a $2.6 million decrease compared to a $8.1 million loss for the six months ended June 30, 2023.

“We are pleased with our results this quarter and continue to see strong momentum in the U.S. driven in part by the energy around our recent new product launches,” said Albert DaCosta, Chairman and Chief Executive Officer. “Further, we have made significant progress on our cost optimization plans resulting in an 840 basis point year-over-year improvement to operating expenses in the quarter, with more planned in the second half of 2024 and into 2025.”

Operational Efficiency Strategy

The Company also announced an operational efficiency strategy targeted at optimizing the organizational structure, minimizing costs and preserving cash without compromising revenue growth opportunities. This strategy was initiated in the second quarter of 2024 and is expected to result in durable savings for the rest of 2024 and in 2025. Management has determined that this operational efficiency strategy will not result in the Company incurring material charges. This operational efficiency strategy includes:

An approximately 7% reduction in work force expected to take place in August of 2024, and is intended to result in up to $8 million in annualized savings offset by approximately $1 million in severance costs;
Detailed review and optimization of functional costs and controls;
An inventory burn-down plan; and
One-time realignment of executive compensation for 2024

“Our company has consistently demonstrated strong growth and we remain committed to sustaining that momentum by making thoughtful strategic adjustments,” said Albert DaCosta, Chairman and Chief Executive Officer. “Although these processes are never easy, this initiative is critical to enhance efficiency, minimize costs and preserve cash without compromising our growth initiatives or our high-quality product portfolio.”

2024 Net Revenue Guidance

The Company narrows its prior 2024 net revenue guidance and expects net revenue to be $249 million to $255 million, representing 15.1% to 17.8% reported growth compared to 2023.

The Company’s 2024 net revenue guidance assumes foreign currency translation rates remain consistent with current foreign currency translation rates.

Restatement

As previously announced in our Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on July 30, 2024, on July 30, 2024, the Audit Committee (the “Audit Committee”) of the Board of Directors and in consultation with management, concluded that its audited consolidated financial statements for the fiscal year ended December 31, 2023 and its unaudited condensed consolidated financial statements for the periods ended March 31, 2023, June 30, 2023, September 30, 2023, and March 31, 2024 could no longer be relied upon as a result of material accounting errors identified by management. Accordingly, the consolidated financial statements as of and for the fiscal year ended December 31, 2023 have been restated in the Company’s Annual Report on Form 10-K/A filed on August 8, 2024 to reflect the correction of identified errors in the calculation of excess and obsolete inventory, as well as its accounting for inventory variances, which resulted in a net overstatement of inventory as of March 31, 2023, June 30, 2023, September 30, 2023, and December 31, 2023, and a net understatement in cost of goods sold for the respective interim periods ended on such dates and for the fiscal year ended December 31, 2023. Additionally, the unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2024 have been restated in the Company’s Quarterly Report on Form 10-Q/A filed on August 8, 2024 to reflect the correction of identified errors in the calculation of excess and obsolete inventory, as well as its accounting for inventory variances, which resulted in a net overstatement of inventory as of March 31, 2024 and a net understatement in cost of goods sold for the three months ended March 31, 2024. In connection with the presentation of comparative prior period financial statements in the amended Form 10-K/A for the fiscal year ended December 31, 2023, the Company revised the consolidated financial statements for the year ended December 31, 2022 and the condensed consolidated financial statements for the interim periods for such year, each as presented in the amended Form 10-K/A for the fiscal year ended December 31, 2023, to correct errors identified that were determined to be immaterial both individually and in the aggregate.

NEC Bio Therapeutics and AGC Biologics Announce Collaboration to Manufacture Personalized Cancer Vaccines

August 8, 2024

NEC Bio Therapeutics and AGC Biologics have announced a partnership to advance the production of NECVAX-NEO1, an orally delivered, bacteria-based DNA vaccine designed to target patient-specific tumor neoantigens. This important and promising collaboration aims to enhance the production of personalized cancer treatments by leveraging the biotechnology strengths of both companies.

Advancing Personalized Cancer Treatment

NEC Bio Therapeutics, a Mannheim based German company focused on clinical development of innovative drugs by using proprietary AI, is developing NECVAX-NEO1, a personalized cancer vaccine that uses cutting-edge AI/machine learning technology to target specific tumor neoantigens that are unique to each patient. NECVAX-NEO1 relies on powerful and flexible plug and play bacteria-based platform technology and is convenient for patients due to its oral delivery. Unlike traditional treatments, NECVAX-NEO1 requires tailored manufacturing capacities and is produced by cost-efficient microbial fermentation at a small scale and with a quick turnaround time.

New Phase1/2 clinical trials for NECVAX-NEO1 are slated to begin in cancer patients throughout 2024 and 2025. These trials will play a crucial role in validating the efficacy and safety of this novel treatment, potentially offering new hope to countless individuals battling cancer.

Expert CDMO Collaboration for Global Manufacturing

AGC Biologics is well-equipped to support the current supply chain needs of NECVAX-NEO1, ensuring timely delivery for clinical trials.

As a global Contract Development and Manufacturing Organization (CDMO), AGC Biologics will use its state-of-the-art Heidelberg, Germany facility, a site with almost 40 years of microbial fermentation expertise, to perform a technology knowledge transfer, implementation and qualification of analytical methods, preparation for large scale clinical manufacturing, engineering and batch execution with Good Manufacturing Practices (GMP), and drug product release testing.

“Personalized medicines have the potential to innovate how a treatment can address specific traits of a disease in a patient and give them a better quality of life. That is truly a remarkable endeavor, and the Heidelberg site is proud to have this opportunity to help NEC Bio Therapeutics on its mission of combining AI and machine learning with traditional biologics and personalized care,” said Dieter Kramer, General Manager, AGC Biologics Heidelberg. “We are eager to begin work and to collaborate with our new partners on this important journey.”

AGC Biologics is the large molecule arm of the AGC Life Science Company, the life science division of AGC Inc. AGC Biologics offers end-to-end services for protein biologics, cell and gene therapies, plasmid DNA and messenger RNA, with operations in Europe, North America, and Japan.

Collaboration Kickoff in Germany

The partnership between NEC Bio Therapeutics and AGC Biologics will commence with a focus on clinical development and GMP-compliant manufacturing in Germany. Both companies have strategically positioned teams in Heidelberg and Mannheim, close to each other, fostering a collaborative environment for advancing this critical initiative.

“We are thrilled to announce our collaboration with AGC Biologics to support the manufacturing of NECVAX-NEO1. This partnership represents a significant milestone in our commitment to delivering high-quality, affordable personalized cancer vaccines to patients. This collaboration underscores our dedication to improving global health outcomes in the oncology field. We look forward to the transformative impact this partnership will have on our operations and, more importantly, on the lives of the patients we serve,” said Dr. Heinz Lubenau, CEO, NEC Bio Therapeutics.

Optimizing Biopharma Workflows: Integrating AI to Enhance Research and Discovery | By Christian Olsen, Associate VP & Industry Principal for Biologics at Dotmatics

August 7, 2024

Much has been discussed about the potential of artificial intelligence (AI) to transform the biopharma industry as it becomes integrated into research and discovery workflows. AI’s capability to process enormous datasets and detect patterns that might elude human researchers can significantly speed up drug development, lower costs, and improve the accuracy of personalized medicine.

AI’s Wide Role in Biopharma Research

At the core of this promise is the potential to analyze and model complex biological data at unprecedented scale and speed. Traditional drug discovery processes, which often take over a decade and cost billions of dollars, are being optimized through AI’s capabilities in four major areas – drug target identification, compound screening, predictive modeling, and personalized medicine.

Drug Target Identification. By analyzing extensive genetic and proteomic data, AI can pinpoint potential drug targets with a speed and precision that surpasses traditional methods. Machine learning models excel at predicting interactions between various genes and proteins – spotlighting the most promising targets for research.

Compound Screening. AI plays an important role in managing the immense data sets generated by high-throughput screening techniques. These screenings are essential for identifying potential drug candidates. AI efficiently sifts through these data to predict the efficacy and safety of numerous compounds, ranking those with the highest likelihood of success.

Predictive Modeling. AI-driven models can accurately forecast a drug’s behavior in the human body by considering factors such as absorption, distribution, metabolism, and excretion (ADME). These predictive models enable researchers to design compounds with optimal pharmacokinetic properties, thereby reducing the risk of failures in the later stages of development.

Personalized Medicine. By analyzing patient-specific data, including genetic information, medical history, and lifestyle factors, AI holds the promise of tailored treatment plans. This personalized approach ensures that patients receive therapies suited to their unique needs, which improves outcomes and minimizes adverse effects.

Bioinformatics Challenges and Opportunities

Despite its potential, incorporating AI into biopharmaceutical R&D workflows faces several challenges, especially in the realm of bioinformatics.

Effectively functioning AI algorithms depend on high-quality structured and standardized data. Inconsistent or incomplete datasets can completely undermine the accuracy of predictions and the reliability of results. Therefore, the biopharma industry must invest in robust data curation and standardization practices before it can fully harness the benefits of AI.

Integrating AI into biopharma workflows requires interdisciplinary collaboration between biologists, chemists, data scientists, IT, and AI experts. Effective collaboration ensures that AI models are informed by comprehensive domain expertise and the technical know-how.

If AI is used downstream from R&D where patients are involved, AI-generated insights must adhere to strict regulatory standards to ensure the safety of the patient and the integrity of the data. Developing AI models that comply with these regulations involves navigating complex regulatory landscapes to ensure transparency in AI decision-making processes. Compliance is critical to maintaining acceptance, credibility, and trust with AI in the biopharma industry.

As R&D workflows are impacted by the rise of AI, new ethical considerations are surfacing related to data privacy, consent, and bias. Ensuring that AI systems are designed and implemented ethically is crucial for maintaining public trust and achieving equitable healthcare outcomes. Addressing these ethical concerns involves implementing measures to protect patient data, obtain informed consent, and reduce biases in AI models.

Real-World Healthcare Applications

The successful integration of AI into biopharmaceutical workflows has already led to significant advancements in healthcare. And several real-world applications demonstrate AI’s potential to transform the industry. One of the best recent examples stems from the severe acute respiratory syndrome human coronavirus (SARS-hCOV) pandemic.

During the pandemic, AI played an important role in accelerating vaccine development. Companies like Moderna used AI to quickly identify mRNA sequences that could be used in potential vaccines. During the development process, AI-driven simulations and predictive models helped optimize the vaccine candidates, which significantly reduced the time required for development and approval. This vaccine development example not only showcased AI’s capability to handle vast and complex datasets, but also highlighted its potential to address urgent global health crises in a timely fashion. AI proved itself to be a game changer.

AI is also revolutionizing cancer research by enabling the analysis of large-scale genomic data. The ‘IBM Watson Oncology Platform’ uses AI to analyze patient data and recommends personalized treatment plans. This system has been used in clinical settings to support oncologists make more informed treatment decisions. The ability of AI to process and interpret vast amounts of genetic data allows for more accurate and individualized approaches for cancer treatment, which leads to improved patient outcomes.

In addition to facilitating new drug discoveries, AI algorithms are being used to repurpose new uses for existing drugs. This can significantly reduce therapeutic development timelines and costs. For instance, AI-driven analysis of electronic health records (EHRs) and biomedical literature mining has led to the identification of many existing drugs with potential efficacy against neurological diseases like Alzheimer’s and Parkinson’s. By repurposing known and approved compounds, the biopharma industry can expedite the delivery of effective treatments to patients.

AI is also improving the diagnosis of rare diseases by analyzing genetic data and identifying patterns associated with these conditions. Platforms like ‘Face2Gene’ use facial recognition technology and AI to help clinicians diagnose rare genetic disorders based on facial features. This technology expedites the diagnostic process and enables earlier intervention, which is critical for managing rare diseases. AI’s ability to uncover subtle genetic patterns and correlations that humans can easily miss, enhances the accuracy and speed of diagnoses, offering new hope to patients with rare conditions.

Takeaway

The integration of AI into biopharmaceutical workflows holds immense potential to transform the industry, enhancing research and discovery processes, and ultimately improving patient outcomes. By addressing bioinformatics challenges and leveraging AI’s capabilities in drug target identification, compound screening, predictive modeling, and personalized medicine, the biopharma industry can achieve remarkable advances in drug development and healthcare delivery.

Realizing this potential requires concerted efforts to ensure data quality, foster interdisciplinary collaboration, navigate regulatory landscapes, and address the ethical considerations. As the biopharmaceutical industry continues to embrace AI, it’s poised to unlock new possibilities in the fight against diseases and pave the way for a future where personalized, effective treatments are available to all.

The integration of AI in biopharmaceutical workflows is not just a technological advancement, but a paradigm shift that promises to completely revolutionize how we research, understand, and treat diseases. By harnessing the power of AI, we can accelerate the pace of scientific discovery, improve the efficiency of drug development, and bring hope to millions of patients worldwide.

Editor’s Note: Christian Olsen is the Associate VP, Industry Principal of Biologics at Dotmatics, a leader in R&D scientific software connecting science, data and decision-making. Christian is a renowned bioinformatics scientist with deep expertise in infectious disease and public health, drug target selection, and drug resistance surveillance. He guides strategy and development for antibody discovery workflows within the Dotmatics Biology solution to radically improve the way scientists work.

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Bio-Rad Launches Annexin V StarBright Conjugates for Apoptosis Detection via Flow Cytometry

August 7, 2024

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, today announced the launch of annexin V conjugated to eight StarBright Dyes: SBUV400, SBUV795, SBV440, SBV515, SBV790, SBB675, SBB765, SBY800. The new Annexin V StarBright conjugates support detection of early apoptotic cells by flow cytometry, offering an increased range of fluorophore options.

Bio-Rad’s range of annexin V conjugates provides researchers with a variety of choices, especially important when including apoptosis detection in multicolor immunophenotyping panels in both conventional and full spectrum flow cytometry. Annexin V StarBright conjugates enable full utilization of all the common laser lines found in flow cytometers such that common viability dye and fluorescent protein emission wavelengths can be avoided. This, combined with the narrow excitation and emission of StarBright Dyes, reduces spillover and spreading to provide high-resolution data.

“Introduction of Annexin V StarBright Dye conjugates offers customers greater choice and flexibility when detecting apoptosis in both conventional and full spectrum flow cytometry,” said Hilary Mavor, Marketing Director, Life Science Group at Bio-Rad Laboratories. “Bio-Rad has one of the most comprehensive ranges of annexin V conjugates, allowing users to follow best practice and accurately detect apoptosis with minimum spillover with their viability dyes.”

TRIMEDX Receives International Organization for Standardization’s Highly Regarded Quality Management System Recertification

August 7, 2024

TRIMEDX―an industry-leading, independent clinical asset management company delivering clinical engineering services, clinical asset informatics, and medical device cybersecurity―has been recertified with the highly regarded International Organization for Standardization’s Medical Device Quality Management System (MD QMS) certification ISO 13485, a widely recognized international standard outlining best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle.

This recertification, now valid through Aug. 2027, reverifies that TRIMEDX continues its dedication to maintaining a comprehensive quality management system (business policies and procedures), ultimately impacting its service excellence to clients.

“This reaffirms our commitment to excellence for our clients, associates, and stakeholders,” says TRIMEDX CEO Henry Hummel. “Our quality of service standardizes work and contributes to continuous improvement as we progress. By verifying these processes, we aim to achieve best-in-class customer satisfaction, quality service, and ultimately impact clients’ ability to ensure patient safety.”

This standard analyzes and evaluates everything TRIMEDX does from a risk perspective, so risk control is included in all parts of the business. ISO 13485 outlines best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle. TRIMEDX was recertified by third-party registrar DEKRA.
The ISO 13485 certification couples with TRIMEDX’s Service Organization Control (SOC) 2 Type 2 and ISO 27001 certification (valid through Dec. 2026) to make up TRIMEDX’s Quality Management System covering MD QMS and Information Security Management System (ISMS) standards.

“Achieving this level of compliance requires a continued commitment and demonstrated ability to monitor system activity and quickly take corrective action with the people, process, and technology in place,” says Denisa Lambert, vice president of quality & regulatory compliance. “Our comprehensive approach to data protection and responsive action sets us apart in delivering service excellence to clients.”

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