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MAIA Biotechnology's Phase 2 Study Of THIO In Non-Small Cell Lung Cancer Shows Positive Interim Survival Benefits

Benzinga

By Meg Flippin, Benzinga MAIA Biotechnology Inc. (NYSE: MAIA), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted immunotherapies for cancer, reported positive interim survival benefits in a phase 2 study of THIO, its lead therapy to fight advanced non-small cell lung cancer (NSCLC). NSCLC is a disease in which cancer cells form in the tissues of the lung. It’s the most common form of lung cancer in the U.S., accounting for 81% of lung cancer diagnoses. The five-year survival rate for this type of cancer is 28%. In the phase 2 clinical trial dubbed THIO-101, MAIA is evaluating THIO sequenced with Regeneron Pharmaceuticals Inc.’s (NASDAQ: REGN) immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced NSCLC who failed two or more standard-of-care therapy regimens. As of August, 16 patients had survival follow-ups surpassing 12 months, including 9 patients in their third line of treatment. Interim median survival follow-up in third-line patients was 10.6 months. Three of the trials' earliest patients enrolled are nearing 17-month survival benefits. “THIO is showing a survival benefit for patients with advanced NSCLC. We’re on track to achieve our survival goals in third-line therapy,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “THIO’s outperformance to date supports our thesis that our telomere targeting agent could become a treatment option for people suffering from advanced NSCLC.” Attacking Cancer Spreading Telomeres THIO targets and attacks telomeres which play a key role in helping cancer cells live and spread. Telomerase is made from DNA sequences and proteins and sits at the end of chromosomes, capping and protecting them. Telomerase expression most often occurs in the early stages of growth and development in humans and in a few cells of adults. But in nearly all cancers, telomerase is present, allowing cancer cells to divide and spread. More than 80% of NSCLC tumors have telomerase expression. THIO induces telomerase-dependent telomeric DNA modification, DNA damage responses and selective cancer cell death. All The Data Coming Together The 12-month survival data corresponds to MAIA’s most recent data from THIO-101 demonstrating favorable disease control and overall response rates. In June, the company presented new efficacy data that showed a favorable overall response rate (ORR) of 38%, a disease control rate (DCR) of 85% and a median progression-free survival (PFS) of 5.5 months from THIO + CPI in third-line treatment. The data was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024. The primary objectives of the THIO-101 phase 2 trial are to examine the safety and tolerability of THIO as an anticancer drug and as an immune system primer and to examine the clinical efficacy of THIO in the form of ORR. “All exceptional measures of efficacy in our trial to date have exceeded our own expectations and outperformed standard of care treatments,” said Vitoc when the data was released. “The data presented at ASCO advances THIO’s excellent clinical profile as a strong, safe, and highly effective alternative for patients who progressed following chemotherapy and other available treatments. We eagerly anticipate full efficacy data from THIO-101 in the second half of this year.” THIO seems to be showing promise in fighting one of the most common forms of lung cancer, but that’s not all. If this treatment proves effective, as the company believes, MAIA plans to use THIO in treating other forms of cancer, such as hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and malignant gliomas – indications to which THIO has been granted Orphan Drug Designation by the U.S. FDA. With the size of the cancer treatment market poised to hit $521 billion by 2033, growing at a CAGR of 8.9% over 2023-2033, MAIA may be one company to pay attention to. Featured photo by motorolka on Shutterstock. 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 11, 2024 08:45 AM Eastern Daylight Time

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Armed With Its Patent Portfolio, BioRestorative Therapies Has Success In The Laboratory And At The Negotiating Table: Is Profitability Close Behind?

Benzinga

By Anthony Termini BioRestorative Therapies (NASDAQ: BRTX) is a clinical-stage biotechnology company involved in various clinical trials involving its patented approach for using stem cell therapy to treat a number of disorders. The company has, in recent months, issued updates on its earnings and operations, and it is developing a promising treatment program to treat diabetes and obesity. Quarterly Report Highlights The company issued its second quarter 2024 business update in August, and a number of announcements accompanied their reported financials. BioRestorative announced that preliminary clinical data related to its “Disc/Spine Program” showed meaningful signals and no notable safety markers in patients enrolled in a clinical study of BRTX-100 as a treatment for chronic lumbar disc disease. Also, following manufacturing/clinical process enhancements made by BioRestorative that tripled its monthly trial capacity, it guided that it was targeting completion of patient enrollment in the phase 2 BRTX-100 study in chronic lumbar disc disease (cLDD) by the end of 2024. The company also plans to provide additional preliminary data updates by then. Furthermore, BioRestorative said that it has also laid the foundation for the commercialization of its BioCosmeceuticals business, which could begin generating significant revenues this year. The company noted that it inked an agreement to supply its proprietary cell-based biologic serum to Cartessa Aesthetics, LLC. An analysis of the company’s June 30, 2024 Form 10-Q revealed a 19% improvement in year-over-year operations, with net loss narrowed to $2.5 million compared to a $3.1 million loss in the prior period. BioRestorative’s balance sheet showed some $14.7 million on hand at the end of June. Lance Alstodt, BioRestorative’s Chief Executive Officer, noted that these accomplishments “will provide additional financial flexibility” and bolster the company’s strategy to execute and accomplish important long-term goals. The quarterly report also discussed BioRestorative’s expansion of its core preclinical program for ThermoStem®. “Metabolic Program” Addresses Important And Lucrative Markets One of the more significant opportunities that BioRestorative is pursuing is related to its ThermoStem platform. Currently in preclinical testing, the intended therapy is to target obesity and metabolic disorders (like diabetes) using stem cells to generate a type of body fat that regulates metabolic homeostasis. A recent report from the Centers for Disease Control and Prevention demonstrates that nearly 42% of adults in the United States suffer from obesity. Those diagnosed with severe obesity were just over 9%. Furthermore, research conducted at Harvard University and George Washington University concluded that “adults with obesity spend an average of $1,861 more a year on medical costs than someone who doesn’t have obesity. People with severe obesity spend an average of $3,097 more.” According to investment firm Goldman Sachs, the worldwide market for obesity drugs could be $100 billion by 2030. And there is a link between obesity and diabetes. The American Heart Association says that obesity contributes to up to half of new diabetes cases annually in the United States. Treating this disease also represents a significant market opportunity for BioRestorative. Precedence Research expects the global diabetes drug market to reach about $132 billion by 2034. The combined market for obesity and diabetes drugs creates a significant opportunity for BioRestorative’s ThermoStem over the next decade. It is important to note that ThermoStem is not restricted to being only a standalone treatment. It may be used with drugs like Novo Nordisk’s (NYSE: NVO) Ozempic or Wegovy, or Eli Lilly’s (NYSE: LLY) Mounjaro, which are already approved for use to treat both obesity and diabetes. “We believe that ThermoStem has immense potential to develop both best-in-class and first-in-class therapies,” said Alstodt. Other Developments Related To BioRestorative’s Intellectual Property Portfolio Also accompanying BioRestorative’s business update announcement were comments related to its broad intellectual property portfolio. Previously published data from a study conducted at the University of Utah School of Medicine showed significant reductions in weight, triglyceride, and blood glucose levels compared to controls. The study also demonstrated that BioRestorative’s 3D scaffold was capable of retaining viable transplanted cells for at least five weeks post-implantation. In June, BioRestorative published a press release announcing that it had received notice of allowance from the Japanese Patent Office for a patent application related to ThermoStem. This is the fifth Japanese patent issued for the ThermoStem technology platform. “We are proactively expanding the already formidable ThermoStem intellectual property estate to help ensure long-term market exclusivity…” and “…this is demonstrated by this new patent allowance,” Alstodt remarked. The company also announced that it is currently involved in substantive discussions with at least one (undisclosed) regenerative medicine company regarding ThermoStem licensing. This, along with the Cartessa agreement, is why the company said that it “is poised to potentially enter into a stage of anticipated rapid growth.” Featured photo by qimono on 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 11, 2024 08:35 AM Eastern Daylight Time

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News Release

Aclarion, Inc.’s (NASDAQ: ACON) Emerging Role in the Back Pain Management Sector

ACON

As the healthcare technology sector advances, companies are making significant strides in addressing widespread health challenges. One area experiencing notable innovation is the diagnosis and management of chronic low back pain (cLBP), a condition that affects millions globally and incurs substantial healthcare costs. Aclarion, Inc. (NASDAQ: ACON) is emerging as a key player in this field with its groundbreaking Nociscan platform. Nociscan is an advanced diagnostic tool designed to address the global challenge of chronic low back pain, which impacts approximately 266 million people worldwide. This condition is a major driver of healthcare expenditures, with U.S. costs alone reaching up to $134.5 billion annually. Aclarion’s Nociscan platform stands out as the first evidence-supported software-as-a-service (SaaS) solution that uses Magnetic Resonance spectroscopy (MRS), proprietary signal processing techniques, and augmented intelligence algorithms to noninvasively differentiate between painful and nonpainful discs in the lumbar spine. The Nociscan system operates through a cloud-based platform that processes MRI data to quantify chemical biomarkers associated with disc pain. This data is then analyzed using proprietary algorithms to provide physicians with crucial insights into the potential sources of pain. By integrating Nociscan with traditional diagnostic methods, healthcare providers can achieve greater diagnostic precision and enhance treatment planning, leading to improved patient care. Aclarion, Inc. (NASDAQ: ACON) has recently achieved a significant milestone with its Nociscan platform, announcing the completion of the first Nociscan exams in the LIFEHAB trial. This randomized control trial, conducted in Norway, is pivotal in comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation for chronic low back pain. The trial involves 202 patients and utilized Nociscan’s advanced diagnostic technology to assess how MRS biomarkers can correlate with treatment responses. The LIFEHAB trial began enrollment in Q2 of 2024, and as of late August, six patients have completed their Nociscan exams. Brett Ness, Aclarion’s CEO, highlighted the significance of this development: ““We are excited to see the LIFEHAB Trial progressing on schedule and look forward to the results of the study and to the role we expect Nociscan data to play in not only helping physicians determine which discs to treat but in potentially helping to predict which treatment option is optimal for a particular patient.” This latest achievement showcases ACON’s commitment to advancing chronic low back pain management and demonstrates the growing adoption of Nociscan in research settings. The LIFEHAB trial’s integrations of Nociscan tech represent a crucial step in validating its effectiveness and aligning with Aclarions broader goals of enhaving treatment and outcomes. As ACON continues to make strides, the company has also expended presence in the US market. On August 14, 2024, the company announced a key commercial agreement with Sheridan Community Hospital in Michigan. This partnership marks Aclarion’s entry into central Michigan and involves collaboration with Dr. John Keller, a leading neurosurgeon. This agreement aims to further validate Nociscan’s clinical effectiveness and demonstrates the platform's potential to advance noninvasive, cost-effective diagnostics for disc pain. Building on its success in the UK, where ACON has secured insurance coverage, the company is now focused on achieving similar coverage in the U.S. This is a critical step towards increasing Nociscan’s accessibility and adoption within the American healthcare system. Further expanding its reach, ACON has introduced Nociscan to the personal injury and workers’ compensation markets in New Jersey. Announced on August 29, 2024, this initiative involves Dr. Justin Kubeck, an orthopedic spine surgeon, working to enhance the evaluation of chronic low back pain in these complex legal and insurance settings. This effort aims to provide objective data to support treatment decisions and compensation claims, leveraging Nociscan’s ability to measure biomarkers correlated with pain and structural integrity. In addition to its commercial agreements, Aclarion has launched two major clinical trials to substantiate Nociscan’s benefits. The Clinical Utility and Economic (CLUE) Trial, announced on August 21, 2024, aims to assess how Nociscan’s AI-generated biomarker data impacts surgical treatment decisions. By comparing surgeons’ initial treatment plans with those adjusted after reviewing Nociscan data, the trial seeks to provide valuable real-world evidence of the platform’s effectiveness in improving surgical outcomes. Complementing this, the CLARITY trial—a gold-standard, multicenter, prospective randomized study—will provide definitive evidence on the advantages of incorporating Nociscan data into surgical decision-making processes. Aclarion’s innovative approach has recently garnered industry recognition. On September 5, 2024, ACON was added to the PRISM Emerging Medical Devices Index. This inclusion highlights Aclarion’s position as a leading innovator in the medtech sector. Being part of the PRISM Index validates Aclarion’s technological advancements and can increase its market visibility, credibility, and attractiveness to investors. As the U.S. medical devices market is projected to grow to nearly $315 billion by 2032, Aclarion’s Nociscan is well-positioned to capture a portion of the $40 billion lumbar spine diagnostics and treatment market. ACON’s efforts to address chronic low back pain through innovative, noninvasive technology underscore its potential to make a significant impact in the healthcare sector. With its expanding clinical partnerships, ongoing trials, and recent industry recognition, ACON is positioning itself strongly within the healthcare technology market. 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 performances are not statements of historical fact and 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 that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the 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 investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated to assist in the production and distribution of this content. 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 http://razorpitch.com

September 11, 2024 06:00 AM Eastern Daylight Time

PathAI Launches MET Predict on AISight to Enhance NSCLC Assessments

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced the launch of MET Predict † on the AISight Ⓡ † Image management system (IMS). MET Predict is an AI-powered algorithm designed to help pathologists identify non-small cell lung cancer (NSCLC) tumors that may be more likely to have MET exon 14 skipping (METex14) or MET amplification, directly from an H&E whole slide image. NSCLC accounts for approximately 85% of lung cancers 1, with 3–4% of these cases involving METex14 2. Today, approved targeted therapies are available for patients with NSCLC who harbor METex14 mutations. Additionally, MET amplification occurs in 1–6% of NSCLC cases 3 and is emerging as a potential biomarker in lung cancer. Traditional molecular testing for MET alterations such as exon 14 skipping or amplification is often hindered by high costs, time- and tissue-consuming procedures, and the need for specialized equipment and trained personnel. These factors limit its accessibility and scalability, prompting the need for more efficient and cost-effective methods to assess MET alterations. “The integration of MET Predict into AISight marks a significant leap forward in utilizing AI to enhance the efficiency of NSCLC tumor assessments, particularly in identifying those with potential genetic alterations,” said Andy Beck, MD, PhD, co-founder and CEO of PathAI. “By providing rapid and precise biomarker insights directly from H&E images, MET Predict equips pathologists with the essential information needed to drive timely and accurate NSCLC evaluations.” MET Predict has the potential to significantly improve the efficiency of biomarker evaluation and molecular testing paradigms. The algorithm identifies >90% of MET altered tumors while additionally providing insights that may preserve tissue in 30% of cases where the likelihood of MET alteration is low. With the addition of MET Predict, AISight expands its toolset with the latest technology to assist pathologists in lung cancer assessments. This innovation addresses a crucial gap in pathology labs — the need for accessible, rapid, and comprehensive molecular tools that provide actionable insights from biopsy samples. †:MET Predict and AISight are for Research Use Only. Not for use in diagnostic procedures. References: 1 American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/lung-cancer/about/what-is.html 2 Frampton, G. M., et al. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer discovery, 5(8), 850-859. 3 Wolf J., et al. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787. PMID: 32877583 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. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

September 10, 2024 10:00 AM Eastern Daylight Time

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This Company Is Betting On Innovation To Make A Splash In Multiple Healthcare Markets And It Hit Multiple Milestones This Year

Benzinga

By James Blacker, Benzinga Therma Bright Inc. (OTC: TBRIF), a growing player in the healthcare industry, is making visible strides with its diverse portfolio of innovative medical devices and diagnostic solutions designed to address unmet clinical needs. With its flagship product the Venowave VW5, a product designed to enhance blood circulation, Therma Bright is aiming to capitalize on a deep vein thrombosis (DVT) treatment market expected to grow to $1.62 billion by 2032. Beyond this, the company’s ambitions expand to developing cutting-edge technology to tackle a variety of health challenges, from respiratory disease management to pain relief. Over 2024, Therma Bright secured multiple milestones that indicate the growing attention it is receiving. The Venowave: A Potential Game-Changer in DVT Prevention The Venowave VW5 is an FDA-approved circulation booster designed to improve circulation in the lower extremities. Worn on the calf, the lightweight device stimulates blood flow with wave-like motions that massage the leg, forcing blood from the feet and legs back to the heart and preventing the formation of blood clots. This is particularly effective in cases of DVT, a condition that affects up to 900,000 people in the U.S. and that, if left untreated, can lead to serious complications such as a pulmonary embolism. Beyond just DVT, the Venowave has a range of other healthcare applications, such as managing symptoms of post-thrombotic syndrome, preventing primary thrombosis and treating lymphedema. In an encouraging sign for the product, Therma Bright announced on 27 August that it has secured a nationwide U.S. distribution partner for Venowave. Subject to the success of an initial sales program, this unnamed partner has committed to acquiring inventory worth $2.38 million. Also in August, Therma Bright received the permanent Healthcare Common Procedure Coding System (HCPCS) code from the U.S. Department of Health & Human Services' Centers for Medicare and Medicaid Services (CMS). This crucial designation increases the product’s credibility and could be a key catalyst to help propel Therma Bright to a leadership position in the DVT treatment market. Preva®: Clot Retrieval For Stroke Treatment The global coronary stents market was estimated to be $8.82 billion in 2022 and is expected to grow at a compound annual growth rate of 7.82% to reach $16.14 billion by 2030. Positioning itself to take a share of this growing market, Therma Bright has added to its diverse portfolio of late-stage products by investing in Inretio, the developer of the Preva® clot-retrieval device. The company hopes this device will revolutionize ischemic stroke treatment by improving effectiveness and preventing complications during thrombectomy procedures. The technology, which recently completed its third successful human trial, promises to offer a new approach to clot retrieving that reduces the need for repeated maneuvers and minimizes the risk of embolization. With more than 690,000 ischemic stroke patients in the U.S. each year, this potentially game-changing device could be the breakthrough in clot retrieval needed to significantly improve their lives. Another Growth Opportunity In The COPD Market Another of Therma Bright’s ventures that may hold promise is its stake in InStatin, a company developing inhaled statin therapies for conditions such as asthma and chronic obstructive pulmonary disease (COPD). Unlike traditional oral therapies, InStatin targets the lungs directly, and the company hopes to provide a more effective treatment option for a range of respiratory conditions that affect millions of people worldwide. With the COPD market alone estimated to be worth over $16 billion annually, Therma Bright could stand to benefit from InStatin’s growth trajectory as its therapies advance through pre-clinical trials. Therma Bright previously owned a 17% stake in InStatin, but this percentage is set to increase as the company recently announced that it has expanded its investment. More In The Pipeline Therma Bright’s innovation pipeline doesn’t stop there. Other products in development include a Digital Cough Test app developed in partnership with AI4LYF. The app uses AI to monitor respiratory diseases based on the sound of a person’s cough. The cough data is reviewed by a doctor via an AI dashboard who can use the information to then treat the patient. Other products in Therma Bright’s portfolio include the Benepod™ Hot & Cold Contrast Therapy Device for Pain Relief, the AcuVid™ COVID-19 Rapid Antigen Test Solution, InterceptCS™ for at-home cold sore prevention and the TherOZap™ thermal therapy for insect bite relief. Why You May Want To Keep An Eye On Therma Bright With the global DVT market expected to reach $1.5 billion by 2032 and other innovations like the Preva® device and inhaled statins addressing multi-billion-dollar markets, Therma Bright could be well-positioned to capture a significant market share in multiple growing markets. Investors may want to keep an eye on this small company with a current market cap of about $20 million whose stock has rallied over 350% this year (as of Sep. 5) as it expands its presence in industries worth billions of dollars. Featured photo by Narupon Promvichai 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

September 10, 2024 08:58 AM Eastern Daylight Time

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Syntekabio Appoints Joonhyuk Choi, Former Target Health CEO, as Head of US Operations

Syntekabio, Inc.

Syntekabio (KOSDAQ: 226330), a leading artificial intelligence (AI)-driven drug development company, is pleased to announce the appointment of Joonhyuk Choi, former CEO of Target Health, as Head of US Operations. Joonhyuk brings over 25 years of extensive experience in the pharmaceutical industry, underpinned by his academic background in electrical and computer engineering from Rutgers University in New Jersey. His prominent career is distinguished by a strong track record in developing clinical trial software, navigating the US FDA’s drug and medical device approval processes, managing clinical trials, and leading business development success. Prior to joining Syntekabio, Joonhyuk served as CEO of Target Health, a US-based contract research organization (CRO). There, he played a pivotal role in clinical operations and drove business development, spearheading sales and marketing teams while overseeing the development and maintenance of validated software solutions for clinical trials and data management for over two decades. Syntekabio anticipates that Joonhyuk, with his deep understanding of the drug development process from AI-driven drug discovery and clinical trials to drug approvals as well as business development, coupled with his extensive knowledge of the US market, will significantly enhance the company’s strategic partnership and revenue-generating initiatives. “I am honored to join Syntekabio at such a pivotal moment in the company’s journey,” said Joonhyuk Choi, newly appointed Head of US Operations. “I am committed to leveraging strategies tailored to the unique dynamics of the US pharma and biotech market to enhance the global reach and impact of Syntekabio’s AI drug discovery platform.” Jongsun Jung, PhD, CEO of Syntekabio, remarked, “With Joonhyuk’s appointment, Syntekabio is now strategically positioned to collaborate with potential partners across the entire drug development spectrum, from AI-driven candidate screening to clinical trials. His extensive expertise and experience in the US market will be crucial in driving our global expansion and enhancing our competitiveness, positioning us for achieving sustained business success.” About SyntekabioSyntekabio 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 - Laurie Doyle MC Services AG +1 339-832-0752 syntekabio@mc-services.eu Company Website http://www.syntekabio.com/

September 10, 2024 08:00 AM Eastern Daylight Time

Valant Announces Platform Updates Offering Behavioral Healthcare Practices Increased Operational Efficiency

Valant

Valant, a leading EHR for behavioral healthcare practices, unveiled new platform updates for behavioral health practices today. New capabilities supporting operational efficiencies, workflows, and revenue collection include Valant Treatment Plans and Valant Custom Forms. Automating workflows, which previously were manual processes, ensures practices can be efficient, meet payer obligations, and cover legal liabilities as they bring on new patients. Valant Treatment Plans Valant’s new Treatment Plans feature solves complex payer documentation requirements through one efficient and flexible system. Meeting the evolving needs of payers through treatment plan types with customizable fields and reminder-based review cycles, practices can now create a consistent treatment experience with research-backed content libraries of 1000+ preset problems, goals, objectives, and interventions. Additionally, it helps set operational guardrails, ensuring clinicians meet payer requirements without manual oversight, so practices have peace of mind when they receive their next audit request. Valant Custom Forms Valant’s Custom Forms empowers practices to build advanced automated forms and segment intake flow by program, routing the right consent documents to new patients based on the services they seek. Practices can auto-assign different packets to new clients seeking adult psychotherapy versus new patients being seen for adolescent psychiatric evaluations. “Collecting patient data and consent is a time-consuming, tough-to-track process that often involves multiple external solutions, manual data entry, and for larger practices, a dedicated intake team,” said Ram Krishnan, CEO of Valant. “We aim to make this process fast, trackable, and easy to use so practices work start to finish in Valant.” Valant is designed specifically for behavioral health professionals in group and solo private practices, offering an integrated solution that allows practices to provide better care, run a smoother and more efficient operation, and remain compliant. To learn more, visit valant.io. About Valant Valant is a cloud-based integrated EHR software suite that supports the administrative operations of behavioral healthcare practitioners, agencies, and clinicians. The software offers features including individual and group appointment scheduling, treatment planning, medication management, patient engagement, billing, and reporting. Valant collects and organizes data from patients and providers, documents them using guided protocols, and stores them securely. Actionable insights and reports are also generated based on the data collected. Valant is built for large outpatient practices and solo providers including psychiatrists, nurse practitioners, psychologists, therapists, and counselors. To date, thousands of organizations across all 50 states utilize Valant to decrease costs and manage ever-changing compliance requirements. Learn more at valant.io. Contact Details Jennifer Mirabile valant@trustrelations.agency

September 10, 2024 08:00 AM Eastern Daylight Time

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

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