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No More Wisdom Teeth Horror Stories? TriAgenics' Alternative To Painful Wisdom Teeth Removal

Benzinga

By Mangeet Kaur Bouns, Benzinga For countless people, the prospect of wisdom teeth removal stirs a deep sense of dread. While many undergo the procedure without incident, the reality is that this “routine” surgery is fraught with risks that can turn a simple operation into a painful and protracted ordeal. Complications are not just possible – they’re common. Dry sockets, for example, occur when the blood clot that forms after extraction becomes dislodged, exposing the underlying bone and nerves. The pain from a dry socket can be intense – often radiating to the ear – and it can take weeks for full recovery. Nearly 30% of patients experience bleeding, which, if not properly managed, can lead to further complications. Nerve damage, though less frequent, can result in permanent changes in sensation, affecting the lower lip, chin and gums. Even more concerning are the cases where wisdom teeth removal leads to life-threatening outcomes. The tragic story of 17-year-old Jenny Olenick, who suffered fatal brain damage due to oxygen deprivation while under anesthesia for a wisdom tooth extraction, serves as a somber reminder that no surgery is ever truly routine. Despite the best efforts of medical professionals, Jenny’s surgery ended in tragedy, a stark example of the potential dangers inherent in this common procedure. Complications Beyond The Expected: A Risky Rite Of Passage While stories like Jenny Olenick’s are rare, they highlight the unpredictable nature of wisdom teeth removal. What starts as a straightforward procedure can quickly spiral into a series of complications that demand additional medical intervention, prolong recovery and increase costs. For many patients, the aftermath of surgery is marked by a litany of issues: swelling, pain and difficulty opening the mouth are common, sometimes persisting for weeks. Trismus, a condition characterized by painful jaw movement, is particularly prevalent among younger patients, especially those between the ages of 17 and 25. This condition can make it challenging to perform everyday activities such as eating and speaking, further complicating the recovery process. Infections are another frequent concern, often manifesting as persistent discomfort, swelling and, in severe cases, fever or yellow discharge from the extraction site. If left untreated, these infections can lead to more serious complications, requiring antibiotics or even additional surgery. Sinus complications can occur in cases where the upper wisdom teeth are involved, adding another layer of risk. If the tooth roots are close to the sinus cavity, the removal can create an opening between the tooth socket and the sinus. This condition, known as sinus communication, can cause ongoing discomfort and complicate the healing process. Anesthesia reactions, although rare, pose their own risks, ranging from mild nausea to severe allergic reactions. In extreme cases, these reactions can be life-threatening. Such incidents, while uncommon, underscore the need for thorough preparation and careful monitoring during any surgical procedure. Given these risks, there is a clear unmet need for a safer, more reliable alternative to traditional wisdom teeth removal practices. Triagenics And Zero3 TBA: A Game-Changing Solution? Enter TriAgenics, a company potentially on the cusp of revolutionizing dental care with its innovative Zero3 Tooth Bud Ablation (TBA) technology. This procedure promises a potential end to the painful and often risky process of wisdom teeth removal by preventing wisdom teeth from forming in the first place. Zero3 TBA treatment is designed for children ages 6 to 12, a time when the early signs of wisdom teeth can be detected. The procedure is minimally invasive and highly precise, targeting and neutralizing the developing tooth bud tissue before it can grow into problematic third molars. TriAgenics reports that the entire process takes only 60 to 90 seconds per tooth bud, with the full treatment, which involves four tooth buds, completed in about 30 minutes. The company says that what makes Zero3 TBA particularly compelling is the simplicity and effectiveness of the procedure. Traditional wisdom teeth extraction involves cutting into the gums and bone to remove the teeth, which often leads to significant pain and a lengthy recovery period. Zero3 TBA is quick, minimally invasive and comes with minimal recovery time. The procedure’s targeted approach means that the risks of complications such as dry socket, nerve damage and infection are significantly reduced if not entirely eliminated, says TriAgenics. Disrupting A Multi-Billion Dollar Market The potential market for TriAgenics’ Zero3 TBA technology is large. With approximately 85% of all wisdom teeth eventually requiring removal, the demand for a preventative solution is clear. The company estimates that its Zero3 TBA product could tap into a total addressable market of more than $2.5 billion annually. TriAgenics is already on its way to capitalizing on this opportunity. The company has completed extensive research and development, achieving a 100% success rate in animal trials in preventing wisdom tooth formation. This success has paved the way for the next critical step: obtaining FDA clearance. If approved, TriAgenics plans to begin commercializing Zero3 TBA in 2025, with licensed dentists treating patients. The process will involve dentists sending X-rays and prescriptions to TriAgenics, which will then produce custom 3TBA guides. These guides, designed specifically for each patient, will be sold to dentists at an estimated $350 per tooth bud treated. The company has already raised over $11.5 million in capital, a testament to the investor interest in its technology. Furthermore, TriAgenics has established a robust intellectual property portfolio, securing 32 U.S. and international patents, expanding patent coverage in Australia, Canada, Europe and Mexico. This IP position, combined with growing interest from oral surgeons and pediatric dental specialists, potentially positions TriAgenics as a frontrunner in the future of dental care. Potential To Transform Dental Care As TriAgenics advances toward FDA clearance and market entry, the company could be poised to disrupt the traditional approach to wisdom teeth management. Zero3 TBA offers a solution that could spare tens of millions from the pain, risks and costs associated with wisdom teeth removal. By preventing the formation of wisdom teeth, TriAgenics is not just offering a new product; it’s proposing a paradigm shift in how dental care is approached. “Dental practitioners have expressed tremendous excitement about the potential to eliminate all complications normally associated with wisdom teeth removal,” said Dr. Leigh Colby, TriAgenics CEO. “We believe this will be the industry standard of care by 2030.” The implications of Zero3 TBA extend beyond just a single procedure. If successful, the company believes this technology could set a new standard in preventative dental care, reducing the need for invasive surgeries and the associated complications that may come with them. This means less pain, fewer risks and significant cost savings for patients. For the dental industry, it could represent a major leap forward in how care is delivered. To explore how TriAgenics is shaping the future of wisdom teeth management, check out TriAgenics on StartEngine. Featured photo by S&B Vonlanthen on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 09, 2024 08:35 AM Eastern Daylight Time

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Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF): Major Approvals Make TBRIF A Stock To Watch

TBRIF

The medical device sector is experiencing rapid growth, driven by technological advancements and rising global healthcare needs. According to Statista, the global market is set to expand at an annual rate of 5.71%, reaching $673.10 billion by 2029. In 2024 alone, the United States is expected to generate $179.80 billion in medical device revenues, underscoring the sector’s substantial potential. In this burgeoning market, Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) stands out as an emerging leader. The company has made notable progress in diagnostics and health-tech solutions, with recent milestones such as the approval of reimbursement for its Venowave VW5 device. These developments highlight Therma Bright’s strong growth potential and its ability to open new revenue streams in the healthcare and medical technology sectors. Reimbursement Approval: A Game-Changer for Revenue On August 19, 2024, Therma Bright announced a landmark achievement with the U.S. Centers for Medicare and Medicaid Services (CMS) granting permanent Healthcare Common Procedure Coding System (HCPCS) code E0683 to its Venowave VW5 device. This approval signifies a major breakthrough, as it not only provides a specific reimbursement code but also sets a precedent for the device's integration into the U.S. healthcare system. Rob Fia, CEO of Therma Bright, expressed his enthusiasm about the development: "We're pleased that the Centers for Medicare and Medicaid have approved our permanent code request, as well as the reimbursement pricing and the new HCPCS Level II designation for our Venowave VW5 device." This approval ensures that Venowave VW5 will be reimbursed for up to $1,199 per device or $78.05 per month for rental, totaling up to $819.55 over 13 months. The device addresses critical circulatory issues, including deep vein thrombosis (DVT), a condition affecting over 900,000 U.S. citizens annually. The reimbursement approval opens a major revenue channel for Therma Bright. Market research projects that the global market for DVT-related treatments will reach $1.5 billion by 2032. With the Venowave VW5 device being the first of its kind to receive a permanent HCPCS code, Therma Bright is poised to capture a significant share of this expanding market. Strategic Investments and Expanding Market Reach In addition to the reimbursement milestone, Therma Bright has been actively expanding its footprint through strategic investments and partnerships. On August 22, 2024, the company announced the securing of a nationwide U.S. distribution partner for the Venowave VW5. This partner will launch an initial sales program to assess Medicare/Medicaid reimbursement timelines and billing procedures, with a commitment to acquire inventory valued at up to $2.38 million post-program success. The partnership is a testament to the confidence in Venowave’s market readiness and the anticipated success of the reimbursement process. Rob Fia highlighted the significance of this deal: "We are thrilled to welcome our nationwide distribution partner to our team... We expect the program to be successful, leading to a significant increase in Venowave orders on a monthly basis and accelerating our revenue growth." Innovative Technological Advancements Therma Bright’s innovative approach extends beyond Venowave. On August 16, 2024, the company revealed that its AI-powered Digital Cough Technology (DCT) is under consideration for a clinical trial involving a new chronic cough drug. This AI-driven platform aims to enhance data collection and clinical decision-making, showcasing Therma Bright’s commitment to advancing healthcare technology. Additionally, Therma Bright continues to make strategic investments in cutting-edge solutions. On August 6, 2024, the company increased its investment in InStatin, a firm developing an inhaled statin for chronic lung conditions. This move not only boosts Therma Bright’s stake but also positions the company to benefit from potential breakthroughs in asthma and COPD treatments. Leadership and Future Prospects The company’s progress is further supported by recent additions to its advisory board. On August 13, 2024, Therma Bright welcomed Michael Raimondo, a seasoned expert in medical sales and operations, to its advisory board. Raimondo’s extensive experience is expected to drive sales growth and navigate the complexities of U.S. healthcare reimbursement processes. Rob Fia commented on Raimondo’s appointment: "We are pleased that Michael has agreed to join Therma Bright's Advisory Board, where his skills and experience in sales and operations will aid in the company’s sales efforts of its health-tech and med-tech devices." Conclusion Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) is poised for significant growth following the approval of the HCPCS code for its Venowave VW5 device. This milestone opens up opportunities in the large DVT treatment market. With strategic investments, new partnerships, and technological advancements, TBRIF is well-positioned for future success, potentially making it a compelling stock for investors Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and has been compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website https://razorpitch.com/

September 09, 2024 06:00 AM Eastern Daylight Time

Syntekabio to Highlight its Cutting-edge AI-driven Discovery Solutions at BioTechX

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), an artificial intelligence (AI) based drug development company, today announced its participation at BioTechX USA, being held September 17-18, 2024 in Philadelphia, PA. Syntekabio is the Title Sponsor for the event and will give a keynote address and in-depth talk on its AI-driven solutions, as well as host a booth. “We look forward to meeting with potential clients at BioTechX and discussing how our AI-driven technologies can improve and accelerate their R&D activities,” said Jongsun Jung, PhD, CEO of Syntekabio. “We recently announced our ‘Develop Now, Pay Later’ offer that enables clients to test the validity of a target protein of interest without incurring any upfront costs. In addition to identifying potential hits and optimizing small molecule leads, we also have strong capabilities in antibody and cancer neoantigen discovery. We are excited to have the opportunity to highlight these technologies at the conference.” Meet us at BioTechX USA! Syntekabio has several activities planned at the conference. Schedule a meeting by clicking here or stop by our booth (#401) to meet the team and learn how our innovative AI-driven solutions can help solve your current pipeline challenges. Don’t miss out on the latest insights in AI presented in our talks! Tuesday, September 17 th 9:20 AM - Keynote presentation Addressing Data Scarcity in D rug Discovery with Physics-based AI Models Jonathan Witztum, PhD, CTO, Syntekabio USA 5:05 PM – AI in drug discovery presentation Flexible Molecular Docking for Neoantigen & Antibody Drug Prediction; Pre-Clinical Application Jongsun Jung, PhD, CEO, Syntekabio Recently announced Develop Now, Pay Later offer – drug discovery with no upfront fees Syntekabio’s Develop Now, Pay Later model enables pharmaceutical and biotechnology companies to test the validity of a target protein of interest without incurring any upfront costs. Should a project demonstrate viability, Syntekabio then employs its STB LaunchPad program, powered by its proprietary AI-driven DeepMatcher ® technology platform, to deliver hits and optimized leads as well as IND-enabled candidates. The client only pays for the work once the agreed upon validated results are obtained. For more information about Syntekabio, STB LaunchPad and Develop Now, Pay Later, please click here. Additional powerful tools enable novel antibody and cancer neoantigen prediction Additionally, the company will highlight its in silico biologics platforms, Neo-ARS TM and Ab-ARS TM, which enable personalized or universal neoantigen cancer vaccine and novel antibody drug prediction, respectively. These cutting-edge solutions address complex challenges in drug discovery, equipping researchers with powerful tools to develop novel and effective therapeutics. Syntekabio’s AI accesses over 10 billion known compounds as well as 1,400 in vitro/in vivo compatible drug targets covering over 70% of human diseases. This technology is powered by Syntekabio’s AI Bio-Supercom Center, which houses an immense infrastructure of 5,000 servers, 40,000 CPU cores, and 2,500 GPUs fueling the Company’s algorithms. The Company has a comprehensive suite of advanced proprietary tools designed to accelerate the drug discovery and development process. About Syntekabio Syntekabio Co., Ltd. (KOSDAQ: 226330) is a drug discovery company bringing together biology and AI/ML since 2009 and facilitating the discovery of first-in-class and best-in-class compounds, rapidly. The Company has its own supercomputer cloud, along with a global contract research organization network to complement and validate its computational results. Syntekabio offers clients a one-stop shop, with technologies and tailored services to rapidly generate and optimize drug candidates from target to IND-enabling. Syntekabio’s disease-agnostic physics-based platform generates a continual stream of hits, leads, and drug candidates that are readily available for purchase. The Company also undertakes client-specific projects to identify highly promising development candidates for specific targets and indications. Visit the Syntekabio website at www.syntekabio.com or follow the Company on LinkedIn for the latest updates. Contact Details Media inquiries US & Europe - MC Services AG Laurie Doyle / Dr. Cora Kaiser +1 339-832-0752 syntekabio@mc-services.eu Company Website http://www.syntekabio.com/

September 06, 2024 08:30 AM Eastern Daylight Time

Telomir Pharmaceuticals (NASDAQ: TELO) Featured In Local ABC Exclusive Showing Positive Outcomes Of Proposed Age Reversal Pill In Dogs

Benzinga

By Meg Flippin, Benzinga Turning back the clock on aging is a never-ending quest with people, large companies and startups pouring blood, sweat, tears – and tons of money – into finding a solution. One company that seems to be getting closer to its goal is Telomir Pharmaceuticals Inc. (NASDAQ: TELO), a pre-clinical pharma company seeking to lead developments in longevity science through treating age-related conditions. Its leading drug compound, Telomir-1, was featured in an ABC television news segment highlighting promising "age reversal" outcomes in a study with two senior dogs. Lengthening DNA’s Protective Caps Telomir-1, the company's leading drug compound, is designed to regenerate telomeres – the protective DNA structures at the ends of our chromosomes, often compared to the caps on shoelaces. Research has demonstrated that repairing these telomeres may extend biological age and reverse certain age-related conditions. By targeting telomere regeneration, Telomir-1 aims to slow down the aging process and combat diseases linked to telomere shortening. Telomir Pharmaceuticals says Telomir-1 is the first novel small molecule to lengthen the DNA’s protective telomere caps to potentially reverse age-related conditions. The novel molecule, which Telomir is testing with mice and dogs with an eye toward human clinical trials, binds to critical metals that wear down telomeres. By limiting the availability of metals and interrupting the enzyme function, Telomir-1 seeks to restore cellular metal homeostasis and reverse a person's or animal’s biological age. The oral therapy potentially provides what the company says is a safe and effective alternative to existing treatments with minimal side effects. Telomir-1 Gets Props In News Segment In the segment, "ABC7 Exclusive: New study reveals promising results for age reversal pill on dogs," the potential of Telomir-1 was on display through the stories of Zeus and Benson, two senior dogs from Donte's Den rescue organization in Myakka City, Florida. After being treated with Telomir-1, both dogs exhibited improvements in their health conditions, according to Telomir. Zeus, a 12-year-old German Shepherd, showed complete remission of terminal cancer, while Benson, a 12-year-old Newfoundland suffering from severe arthritis, regained his mobility, leading to what caretakers described as a miraculous recovery, reports Telomir. "The results of this study highlight the groundbreaking potential of Telomir-1. Our priority is to advance the rigorous scientific research required to bring this promising treatment to humans and pets through the regulatory process as swiftly and safely as possible," said Erez Aminov, CEO of Telomir. "At Telomir, we are dedicated to transforming the future of longevity science, and these early findings bring us one step closer to making that vision a reality." Aminov was named CEO earlier this month after the passing of Chairman of the Board and Chief Executive Officer Christopher Chapman, Jr., M.D. Aminov was most recently CEO of MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA). The positive preclinical trials have shown that Telomir-1 may have several applications in the veterinary market, which is large given that Americans are poised to spend $156 billion on their pets by the end of this year. The use of Telomir-1 in the two dogs was observed by Telomir's special advisor Dr. Michael Roizen, the former Chief Wellness Officer of the Cleveland Clinic and a leader in age-related medicine. In this small compassionate use program, remarkable improvements in the health and vitality of the dogs after treatment with Telomir-1 were noted, offering a glimpse into the potential future applications for humans, reported Telomir. "The preliminary results we're seeing with Telomir-1 are very encouraging. By lengthening telomeres, we believe Telomir-1 can promote cell regeneration and potentially reverse several aspects of aging or age-related conditions. I'm excited to continue working with Telomir to explore the full potential of this innovative therapy,” Roizen said. More Tests Underway Nobody wants to get old and that includes pets. With Americans pouring tons of money into keeping their pooches happy and healthy, they may someday have another tool: Telmoir-1. With encouraging results out of its study with two dogs and more positive results expected down the road, this may be a company worth paying attention to as the quest to reverse time continues. Featured photo by Simone Dalmeri on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 05, 2024 08:40 AM Eastern Daylight Time

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Mainz Biomed (NASDAQ: MYNZ) And Liquid Biosciences Team Up To Fight Pancreatic Cancer With Early Detection Tool

Benzinga

By Meg Flippin, Benzinga Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, has inked a collaboration deal with Liquid Biosciences, an AI-focused bio-analytics company, to potentially add pancreatic cancer detection to its colorectal cancer screening test ColoAlert®. Liquid Biosciences leverages its EMERGE AI analysis technology platform to help biopharma companies, diagnostics industries and academic institutions identify effective drugs and therapies. Mainz Biomed is developing PancAlert, a screening test that combines genetic and potentially microbiome biomarkers to detect pancreatic cancer. Research has shown that the microbiome – the mix of bacteria in the gut – plays a big role in how tumors develop and progress. The constitution of the microbiome can potentially hurt the immune system’s ability to recognize and attack cancer and render drugs less effective. By combining DNA and microbiome biomarkers, Mainz is betting early detection of pancreatic cancer is possible. Promising Early Results In the initial phase of the collaboration, the companies evaluated biomarkers from Mainz’s research program, co-funded by the German government, by applying a single algorithm developed by Liquid Biosciences using its EMERGE platform. Mainz said the results of the feasibility analysis were promising, giving both companies confidence that PancAlert could be added to ColoAlert in the future. ColoAlert is an early detection screening that spots bleeding and non-bleeding tumors through tumor DNA analysis, offering what the company says is a better early detection than fecal occult blood tests. In the second phase of the collaboration, Mainz and Liquid Biosciences will expand the biomarker evaluation to include microbiome biomarkers Mainz evaluated in 2023 and an expansion of the algorithm. The companies are targeting to complete this analysis in the fourth quarter of 2024. “We are excited by the opportunity to collaborate with Liquid Biosciences on PancAlert, which is being developed for early-stage disease detection with the goal of being a first-in-class screening test for this deadly form of cancer,” said Guido Baechler, Chief Executive Officer of Mainz Biomed. “Liquid Biosciences is already a key partner in our Next Generation colorectal cancer screening test. Expanding our partnership will allow us to bring the power of AI to this critical problem.” Pancreatic Cancer Is Deadly And Growing Pancreatic cancer is a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. It is now the third-leading cause of cancer deaths, and by 2030 it is expected to grow to second place, surpassing colorectal cancer deaths. This year alone, about 66,440 Americans will be diagnosed with pancreatic cancer, a record for this deadly form of cancer. What’s more, about 51,750 Americans are expected to die from the disease this year. Among cancers, pancreatic disease is a tough one to treat. It’s a highly aggressive form of cancer that attacks the pancreas, an organ needed for digestion. With limited treatment options, the five-year survival rate is just 13%. It doesn’t help that most people are diagnosed with pancreatic cancer in a late stage when it has already spread to other parts of the body. That’s particularly true with pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer that’s created from the cells that line the ducts of the pancreas. It's one of the most lethal forms of pancreatic cancer. Given the difficulty in treating pancreatic cancer and the increasing incidents, a lot of medical research is directed toward earlier detection and better treatments. As a result, the global pancreatic cancer market is projected to reach $7.4 billion by 2032, growing at a CAGR of 13.7% over 2023-2032. Mainz’s collaboration with Liquid Biosciences is the latest in the company’s collaborations to bring its next-generation diagnostics technology to the masses. By combining biomarkers, Mainz is seeking to demonstrate a better and more effective way to spot deadly cancers that currently go undetected and untreated until it's too late. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 05, 2024 08:35 AM Eastern Daylight Time

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Helping Redefine Medicine: AJNA BioSciences’ Path For FDA-Approved Plant Medicines

Benzinga

By Anthony Termini, Benzinga AJNA Biosciences is currently raising funds to bring its natural solutions to market! Click here for details. Back in the 1960s, a British pharmacologist discovered that aspirin had an effect on blood platelets that could reduce the risk of heart attacks and strokes. Unfortunately for patients, aspirin manufacturers couldn’t say that because of labeling requirements of the U.S. Food and Drug Administration (FDA). While the FDA is a vital part of providing patients and consumers with safe products, there are also more archaic aspects of the administration. Despite the reality that botanical solutions have been around and trusted for thousands of years, botanical or natural drugs have long been excluded from FDA-approval. It was only in 2016 that the Center for Drug Evaluation and Research developed guidelines for new drug applications for botanicals. It described the process pharmaceutical and biotechnology companies should follow to get a botanical drug approved by the FDA. AJNA’s Mission To Bring Natural Options To Market AJNA BioSciences is among the biotech companies seeking FDA approval for its botanical product. The company is working to develop the world’s first FDA-approved full-spectrum cannabinoid drug and a robust pipeline of other plant medicines. However, the path to launching a new FDA-approved drug can be long. According to management consultants McKinsey & Company, it takes about 12 years to bring a drug to market. To optimize the process, McKinsey suggests that drug makers need to be nimble and agile. AJNA BioSciences CEO Joel Stanley points out that “the botanical category is so new that only four FDA-approved botanical drugs exist to date.” Ajna hopes to break the mold and eventually introduce many FDA-approved botanical drugs to the market. “AJNA BioSciences is the first biotech company to be working with botanicals under a DEA Schedule-1 license,” says Joel Stanley, the company’s CEO. This is a significant milestone for the company because FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective. Additionally, FDA approval helps inform the Centers for Medicare & Medicaid Services, which is a critical step to getting a drug included on insurance reimbursement schedules. The company firmly believes in providing patients with a variety of options that are not only safe but affordable and available through insurance. Another one of AJNA’s goals is to make botanical drugs an accepted component of a physician’s and patient’s routine treatment options. Demand for botanical solutions has been increasing for years, and AJNA’s strategy is to follow the same blueprint as large pharmaceutical companies that bring new drugs to market. Herbal medicine products are not considered a distinct regulatory category in the U.S., unlike Europe or Canada. Instead, a botanical drug is defined by its intended use in the treatment cycle of disease – like all other medicinal drugs. However, until recently, strict regulatory policy blocked the development of prescription drugs made from plants – this has now changed. Obtaining FDA approval helps lead to greater physician advocacy. In other words, doctors have more tools at their disposal to help treat patients and are able to impact positive structural change to evolve treatment options. AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.” Stanley says that this is part of why AJNA is “the first company to receive a plant variety protection patent for cannabis.” The company also understands that FDA approval will make more patients feel comfortable with trying a more unconventional approach to treatment; for patients who have only been exposed to synthetic drugs, botanical drugs may seem unfamiliar, but FDA approval minimizes those hesitations. How Investors Might Evaluate AJNA’s Business AJNA’s mission is to bring natural options to the pharmaceutical industry, and it is bringing a number of proprietary strengths to the proposition. The company reports that it enjoys a wide economic moat that serves as a barrier to potential competitors. Having already raised over $250,000 from a venture capital firm, the company is currently hosting a raise to help further its vision. AJNA has established rigorous research and development processes with a strong team behind it. Its research facilities are registered with the FDA, with scientists from Harvard Medical, Johns Hopkins and NYU. Stanley is also an experienced CEO who has taken a similar company public. Chief Medical Advisor Orrin Devinsky helped obtain the first FDA approval for a cannabis-derived drug. Furthermore, AJNA’s research team has successfully shepherded more than 500 drug applications through the FDA process. While the company is not looking to replace big pharma, it wants to offer patients more solutions. As Stanley points out, “By investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had. We come from nature, not a lab.” More information is available on the Wefunder website. Featured photo courtesy of AJNA BioSciences. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 04, 2024 08:45 AM Eastern Daylight Time

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PathAI Collaborates with GoldPath to Elevate Digital Pathology Capabilities with AISight Image Management System

PathAI

PathAI, a global leader in digital pathology, announced today that GoldPath, an independent pathology service provider based in Duarte, California, has adopted the AISight Ⓡ1 Image Management System (IMS). In a competitive and evolving pathology landscape, where the demand for accurate and timely diagnostics is ever-increasing, the integration of digital pathology is becoming a critical differentiator for independent laboratories. GoldPath selected AISight after an extensive evaluation of various image management systems, recognizing it as the optimal solution to streamline workflows, enhance case management, and support a broad range of use cases. Through adopting AISight, GoldPath aims to reduce turnaround times for referring physicians and deliver cutting-edge pathology services. "As we continue to see a growing need for high-quality pathology services, integrating digital pathology is essential to maintaining our competitive edge and ensuring the best patient outcomes. AISight stood out for its robust capabilities, offering the versatility we need to manage our caseload effectively and improve efficiencies throughout our processes," said Gerardo De La O, CEO and Co-Founder of GoldPath. "The selection of PathAI's AISight Image Management System by a forward-thinking independent laboratory like GoldPath highlights the significant impact our technology can have on pathology operations. Their adoption of AISight demonstrates how our solution can enhance laboratory efficiency in the rapidly evolving field of digital pathology," said Andy Beck, MD, PhD, co-founder and CEO of PathAI. "We are excited to support GoldPath as they set new standards for pathology services." AISight, a cloud-native enterprise workflow solution, is central to PathAI's mission of revolutionizing the digital pathology ecosystem. Trusted by pathologists worldwide, AISight offers a comprehensive platform for case management, workload balancing, and image management, providing GoldPath with tools to address a wide array of histopathology use cases with exceptional versatility and efficiency. About PathAI PathAI is a leading provider of integrated AI and digital pathology solutions dedicated to transforming diagnostic accuracy and operational efficiency in pathology labs worldwide. Through innovative technologies and strategic partnerships, PathAI aims to enhance patient outcomes and drive the future of medical diagnostics. For more information, please visit www.pathai.com. About GoldPath GoldPath is an independent, fully accredited pathology laboratory in “the City of Health” Duarte, California, dedicated to providing exceptional patient care, cutting-edge technology, and outstanding customer service. With a highly trained team of medical professionals and client relations specialists, GoldPath offers fast, accurate, and personalized laboratory services and a full range of ancillary support and practice management solutions. Footnote 1:AISight is for research use only. Not for use in diagnostic procedures. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

September 03, 2024 10:00 AM Eastern Daylight Time

Early Cancer Detection Saves Lives - This Biotech Has A Promising New Test

Benzinga

By Johnny Rice, Benzinga Bill Caragol, CFO of Mainz BioMed (NASDAQ: MYNZ), was recently a guest on Benzinga’s All-Access. Mainz BioMed, maker of clinical laboratory tests, says it is committed to saving lives and reducing healthcare costs through early disease detection and prevention. For cancer and chronic conditions, patients can now live longer, healthier lives thanks to advances in diagnostic technology. Genetic and genomic tests are at the forefront of this progress. By revealing patients' unique genetic profiles, these tests can allow doctors to tailor treatments more effectively, ushering in an era of personalized medicine. Caragol spoke about promising data from recent trials. Watch the full interview here: Featured photo by National Cancer Institute on Unsplash Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 03, 2024 09:00 AM Eastern Daylight Time

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Mainz Biomed Seeks FDA Approval For Colorectal Cancer Test It Says Is Nearly Twice As Sensitive As Others – A Look At Pipeline And Milestones

Benzinga

By Anthony Termini, Benzinga In August 2020, popular actor Chadwick Boseman succumbed to colorectal cancer at the age of 43 after a four-year battle with colon cancer. The untimely death of the Black Panther star saw many fans overcome with grief but also brought attention to the danger posed by such cancers. Colorectal cancer is the second leading cause of cancer death in the United States, with more than 100,000 cases diagnosed so far in 2024. Mainz Biomed (NASDAQ: MYNZ), a German company whose U.S. offices are in Berkeley, California, believes the threat can be mitigated by technology and is working on a predictive test that may be more effective than solutions currently on the market. Benzinga recently sat down with the company’s CFO, Bill Caragol, to discuss the challenge and all the work the company is doing to help address it. The Available Options For Detecting Colorectal Cancer The standard of care for detecting colorectal cancer has since 1969 been the colonoscopy. The procedure is invasive and not very pleasant. In 2014, the fecal immunochemical test (FIT) received FDA approval. The test analyzes a person’s DNA to detect advanced adenomas, the pre-cancerous polyps that “may be the most valid…marker for present and future colorectal cancer risk,” according to research published by the National Library of Medicine. Blood-based tests are also available to detect colorectal cancer risk. However, some in the medical community are cautious about their use. According to David Lieberman, MD, chair of the American Gastroenterological Association’s Colorectal Cancer Workshop, “blood tests are neither as effective or cost-effective" as established colorectal cancer screening tests – something that Mainz’s Caragol testifies to, as well, stating that doctors continue to prescribe stool-based tests over blood tests because of the clinical differentiation since stool-based tests are better at detecting early-stage cancer, despite the “yucky factor.” He added,”Remember, [with] colorectal cancer – you detect late-stage, there’s a roughly 10% survival. When you catch it in early-stage, there’s 90% survival.” Mainz’s Breakthrough Device Leads To Next-Generation Screening Test Mainz has developed a molecular diagnostic solution to detect colon cancer risk. In July, Mainz submitted an application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for a non-invasive colorectal cancer product that includes a portfolio of mRNA biomarkers. Studies conducted by Mainz revealed that its mRNA-powered test showed a sensitivity for detecting precancerous polyps that is double that of products currently on the market. In those studies, competitors’ tests “demonstrated efficacy of detecting advanced adenomas in the 40% range,” says Bill Caragol. Caragol added that readouts from the three clinical studies Mainz conducted between 2023 and 2024, “demonstrated consistent accuracy above 80%, a quantum leap...over the other stool-based tests.” Mainz says its flagship product, ColoAlert®, misses far fewer cases than its competitors’ tests. Mainz puts the number at up to 60% fewer cases. Its next-generation FIT test is an enhancement of ColoAlert and was submitted to the FDA in July for Breakthrough Device designation. The next-generation FIT test is complemented by a proprietary algorithm that uses artificial intelligence and machine learning to identify mRNA biomarkers in order to better detect the early warning signals of potential colorectal cancer. Mainz said the test is “a new gold standard for noninvasive detection of advanced adenomas.” The company is scheduled to conduct an FDA pre-market approval study in 2025 for its next-generation test. A focus of the study is to distribute the next-generation test kit through the currently existing network of FDA-approved national reference testing laboratories in the United States. This differs from other products currently on the market in that the companies that make those test kits also control the testing process. As Caragol describes it, “every test [is] manufactured by them, sent out by them, returned to them [for analysis], test results delivered.” As a result, says Caragol, Mainz will have “the only product that will fit into the largest distribution.” Milestones Mainz Is Focused On For The Year Ahead Mainz has a clear strategy for approaching the market. Caragol said that they realize that as a small company targeting a large market, they will have to strategically align themselves with larger companies. The company is looking to partner with a PCR provider as well as one of the national reference labs. PCR labs specialize in blood, urine and other molecular testing to detect pathogens, commonly used for diagnosing infections like COVID-19. National reference labs offer a wide range of high-accuracy diagnostic services, including PCR, serving as centralized hubs for specialized testing across various locations. Having these partnerships in place is necessary for Mainz to conduct its FDA pre-market approval study. Importantly, they will also be important allies if the company receives approval to sell the kits. They will be integral components of Mainz’s commercial go-to-market strategy. At that point, Mainz’s commercial roadmap will focus on creating partnerships and awareness within physician networks and health care professionals about the differentiating benefits of the ColoAlert mRNA powered test. Investment Drivers For Companies Like Mainz Biomed If the company can meet each of its milestones, then it could set a course for future growth. The U.S. market for colorectal screening “is over $30 billion a year,” according to Caragol. He notes that the market is double that worldwide. There are a number of companies competing domestically for colorectal screening, the most notable of which is Exact Sciences Corp. (NASDAQ: EXAS). Caragol says Exact has about a 10% share of U.S. sales. As such, there may be an opportunity for Mainz if its next-generation test receives FDA approval in the next few years. The company says that a successful launch could open the door to other products, including test kits for pancreatic and other gastrointestinal cancers – significantly expanding its addressable market. For more information about Mainz Biomed listen to the conversation Bill Caragol had with Benzinga’s Zunaid Suleman. Featured photo by Furiosa-L from Pixabay. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 03, 2024 08:35 AM Eastern Daylight Time

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