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Biotech Investing: How PRVs Can Unlock Major Opportunities

Raz

In the world of biotechnology investing, companies often struggle to bring new drugs to market. Developing treatments for rare diseases can be incredibly expensive, and because these conditions affect relatively few patients, the financial payoff isn't always clear. To help incentivize drugmakers, the U.S. government created the Priority Review Voucher (PRV) program in 2007. PRVs act as a powerful tool that can significantly speed up the FDA approval process, making them a highly valuable asset—especially to major pharmaceutical companies. A PRV is awarded when a company gains approval for a drug that treats a rare pediatric disease (RPD), a tropical disease, or serves as a medical countermeasure for serious public health threats. Normally, FDA drug approvals take around 10 months, but using a PRV shortens that timeline to just six months. This four-month head start can be a game-changer, allowing companies to get a competitive edge or generate extra sales from blockbuster drugs. Since these vouchers don’t expire and can be freely bought and sold, they often end up in the hands of big pharmaceutical companies willing to pay top dollar for the advantage. PRV prices have historically hovered around $100 million, but with uncertainty surrounding the renewal of the rare pediatric disease PRV program, recent sales have surged past $150 million. If the program isn’t renewed, PRVs could become even scarcer, potentially driving prices even higher. Big pharma companies are fiercely competing for these vouchers, particularly in lucrative fields like obesity treatments, where shaving months off a drug’s approval timeline could mean capturing billions in market share. For small biotech companies, receiving a PRV can be a major financial boost. Take Day One Biopharmaceuticals (NASDAQ: DAWN) as an example. The company was awarded a PRV after its pediatric cancer drug, OJEMDA (tovorafenib), received FDA approval. Rather than using the voucher itself, Day One sold it for $108 million, securing much-needed funding without diluting shareholder value. This kind of transaction highlights why PRVs can be a game-changer for biotech firms—providing an immediate cash infusion that can support further drug development. With PRVs becoming an increasingly hot commodity, investors should keep an eye on biotech companies with potential voucher-earning drugs in development. With PRVs becoming increasingly valuable, several biotech companies could be next in line to benefit. Let’s take a look at three stocks with potential PRVs on the horizon. OS Therapies: OS Therapies (NYSE-A: OSTX) is emerging as a strong contender for a Priority Review Voucher (PRV), a potential game-changer for the company. The company is developing OST-HER2, an immunotherapy designed to prevent the spread of osteosarcoma (OS), a rare and aggressive bone cancer that primarily affects children and young adults. Because OS Therapies holds a Rare Pediatric Disease Designation (RPDD) from the FDA, an approval for OST-HER2 would make it eligible for a PRV—potentially bringing in around $150 million in non-dilutive funding. For a small biotech company, this is a game-changing opportunity. "The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease," said CEO Paul Romness. If OS Therapies secures FDA approval, not only would it mark a major breakthrough for osteosarcoma treatment, but the PRV could also provide the financial runway needed for future expansion. OS Therapies has already hit a key milestone, achieving the primary endpoint in its Phase 2b trial for OST-HER2. The treatment demonstrated a 33% Event-Free Survival (EFS) rate at 12 months, compared to just 20% in historical controls. Even more compelling, 91% of patients treated with OST-HER2 were alive at the one-year mark, versus 80% in the control group. These results indicate a significant improvement over existing treatment options, which have remained largely unchanged for decades. With these promising results in hand, OS Therapies plans to file for FDA approval (Biologics Licensing Application, or BLA) in late 2025, with potential approval by mid-2026. If successful, the company would receive a PRV just before the program sunsets, making it one of the last biotechs to benefit from this lucrative incentive. Financial Stability and Growth Potential Despite being a small-cap biotech, OS Therapies has positioned itself well financially. Over the past six months, the company raised $13.1 million through an IPO and a subsequent private placement. These funds are earmarked for final clinical trial payments, commercial manufacturing, and regulatory expenses—all crucial steps toward bringing OST-HER2 to market. Moreover, OS Therapies recently acquired key clinical assets from Ayala, including two additional Listeria-based immunotherapy candidates for lung and prostate cancer. This acquisition not only expands the company’s pipeline but also significantly reduces future cash obligations, improving long-term financial prospects. The Bigger Picture Beyond osteosarcoma, OST-HER2 has potential applications in other HER2-positive cancers, including breast cancer and canine osteosarcoma, where it has already received conditional approval from the U.S. Department of Agriculture. Additionally, the company is advancing its tunable Antibody Drug Conjugate (tADC) platform, a next-generation cancer therapy designed to improve targeted drug delivery. With multiple clinical programs, a solid financial strategy, and a real chance at securing a PRV, OS Therapies stands out as a compelling investment opportunity in biotech. If OST-HER2 gains FDA approval, the PRV could provide a significant financial boost—offering the company valuable resources for further development and creating substantial upside potential for investors. SpringWorks Therapeutics: SpringWorks Therapeutics (Nasdaq: SWTX) is a biotech company focused on developing treatments for severe rare diseases and cancer. Its first FDA-approved drug, OGSIVEO® (nirogacestat), treats desmoid tumors, but the company’s next major opportunity lies with mirdametinib—a drug currently in development for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), a rare condition that causes tumors to form along nerves. In the ReNeu trial, mirdametinib showed impressive results in both adults and children, reducing tumor size and improving pain and quality of life. Because of these promising outcomes, the FDA has granted Priority Review status to the drug, with a decision expected by February 28, 2025. If mirdametinib is approved, SpringWorks could earn a Priority Review Voucher (PRV), which would be a highly valuable asset for the company. A PRV allows for a faster approval process, providing a significant advantage for drugmakers. The company could choose to sell the PRV for a substantial financial boost, potentially funding future drug development or pipeline expansion without diluting shareholder value. With SpringWorks poised to potentially earn a PRV through mirdametinib, 2025 could be a pivotal year for the company, positioning it as a leader in rare disease treatments. Investors should keep a close eye on SpringWorks as it works toward FDA approval for mirdametinib and the possible PRV windfall. PTC Therapeutics PTC Therapeutics, Inc. (NASDAQ: PTCT) is a biopharmaceutical company dedicated to developing innovative treatments for rare diseases. The company has two important drugs that could earn PRVs in the near future, each representing a valuable opportunity for investors. First, vatiquinone, a drug for Friedreich ataxia (FA)—a rare, progressive disease that affects the nervous system—has been submitted for FDA approval. The company believes this drug could fill a big gap in treatment for both children and adults with FA, as there are very few options available right now. Vatiquinone has shown strong results in clinical trials, with evidence of slowing disease progression and improving quality of life. If approved, it could earn PTC a PRV, which could then be sold for a significant financial boost. The second drug, Sepiapterin, is being developed for phenylketonuria (PKU), a rare metabolic disorder that can cause serious developmental issues. PTC recently submitted Sepiapterin for FDA approval, based on promising trial results showing it can help patients manage the disease and even reduce their reliance on strict diets. If this drug gets FDA approval, it could also bring in a PRV for PTC, providing an additional source of funding. With two drugs in the pipeline that have the potential to earn PRVs, PTC Therapeutics is an exciting company to watch. These PRVs could provide significant financial support, helping the company continue its important work in rare disease treatments. 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 by O S Therapies Inc to assist in the production and distribution of content related to OSTX. 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

February 05, 2025 07:00 AM Eastern Standard Time

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Wire Industries Partners with Birches Health to Create Safer, More Responsible Gaming Environment

WagerWire

Wire Industries, Inc., a technology and media company that owns and operates sports betting marketplace WagerWire, announced today that it has partnered with Birches Health, a leading behavioral healthcare company that specializes in the online and confidential prevention and treatment of problem gambling-related challenges. This partnership complements the work Wire Industries has already done to promote responsible gaming by redefining what it means for bettors to have control over their entertainment time participating in real-money gaming and daily fantasy sports. Through this partnership, Wire Industries will propel awareness of responsible gaming and increase bettors’ access to important guidance and tools to ensure they are better informed and aware of the signs of problem gambling and prepared to take steps to address it if they see themselves or others exhibiting those signs. Wire Industries and Birches Health will work together to create clinical materials tailored to the needs of the modern bettor. In addition, Birches Health clinicians will appear on Wire Industries Spaces interviews held live on X.com, Birches Health content will be integrated across the WagerWire app and specific Birches Health and WagerWire co-created resources and tools will live across each partner’s website. “Wire Industries was created with the sole purpose to empower bettors and create an environment of responsible gaming,” said Wire Industries CEO Zach Doctor. “By working with Birches Health, we join ourselves with another innovative company in the industry that is also doing whatever they can to create more awareness, tools and resources for the bettor all while reinforcing our commitment to responsible gaming. We hope others in the industry see this innovation as a way to better the modern bettor and follow suit.” Birches Health is a modern digital healthcare company specializing in the prevention and treatment of behavioral addictions, with a primary focus on gambling disorder and related mental health issues in the United States. Utilizing a three-tiered strategic approach—education, engagement, and treatment—Birches Health offers free online learning modules, self-assessments, tools, and educational content to promote Responsible Gaming and prevent problem behaviors. For individuals in need, personalized treatment plans are crafted and led by licensed, specialized behavioral health clinicians available 24/7. Dedicated to providing convenient and comprehensive care, Birches Health empowers individuals to address behavioral health challenges effectively. “We applaud WagerWire and their team for a focus on making resources and education available and empowering their users to make healthier lifestyle choices.,” said Elliott Rapaport, Founder of Birches Health. “Partnering with Wire Industries to make sure that treatment options through WagerWire, FantasyWire and its other platforms are available to those who may need them creates a culture of sustainable play for all participants.” As part of this initiative, WagerWire and Birches Health are also exploring opportunities to integrate AI-driven tools and personalized support pathways into the WagerWire platform, further enhancing user education and care accessibility. This partnership will also further Wire Industries as an innovative, forward-thinking disruptor in all aspects associated with the gaming world. About Wire Industries Wire Industries Inc was founded with the mission to bring a more efficient, open, and entertaining market to real money gaming of all types, unlocking value for the entire ecosystem. The company was established in 2021 and owns and operates Wire Technologies and Wire Media Group. Wire Technologies is the company’s marketplace division including WagerWire, FantasyWire, PonyWire and ContestWire, while Wire Media Group operates their media network and affiliate marketing division. You can download their flagship product WagerWire in the Apple App Store and Google Play, and find them @WagerWire on Twitter/X, TikTok and LinkedIn, or @WagerWireLive on Instagram. Wire Industries is dedicated to providing a responsible gaming environment. If you think you or someone you know may have a gambling problem, resources are available. Call 1-800-GAMBLER or reach out to their Chief Responsibly Officer Carolina Young directly at live@wagerwire.com. About Birches Health Birches Health provides modern, clinician-led solutions for Responsible Gaming and Problem Gambling care covered by insurance. For more information, visit Birches Health at bircheshealth.com or email partnerships@bircheshealth.com. Contact Details Sterling Randle srandle@hotpaperlantern.com

January 30, 2025 09:01 AM Eastern Standard Time

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Market Alert: PESG Releases New Report Highlighting Silexion Therapeutics as an Emerging Leader in the Multi-Billion Dollar Precision Oncology Industry

Global Markets News

PESG Research releases new market update: Silexion Therapeutics (NASDAQ: SLXN) * continues to strengthen its position in the precision oncology landscape with breakthrough preclinical data validating systemic administration of SIL-204, potentially opening new frontiers in treating KRAS-driven cancers. This development comes amid increasing industry appetite for innovative oncology assets, exemplified by recent multi-billion dollar acquisitions. Silexion's latest preclinical findings mark a significant advancement in RNAi therapeutics, with data showing 50% tumor growth reduction and complete necrosis in half of treated tumors after 30 days, sustained therapeutic levels for over 56 days from a single administration, and broad coverage of key KRAS mutations (G12D, G12V, G12R, Q61H, and G13D). These results build upon previous successes, including promising synergy with first-line chemotherapies and the strategic collaboration with Evonik for advanced PLGA microparticle formulation. The precision oncology landscape has witnessed unprecedented consolidation, with Pfizer's $43 billion acquisition of Seagen and AbbVie's $10.1 billion purchase of Immunogen exemplifying the industry's willingness to invest heavily in innovative cancer therapeutics. These transactions reflect a broader industry shift toward precision medicine, particularly in oncology, where targeted therapies command significant premiums. Silexion's emergence as a potentially compelling player stems from its differentiated RNAi approach to targeting one of oncology's most challenging problems, offering broader applicability across multiple KRAS mutations compared to competitors' small molecule inhibitors. The first-generation LODER™ platform has already demonstrated promising Phase 2 results, while the next-generation SIL-204 advances toward clinical trials with successful validation of systemic administration. Notable industry analysts seem to have taken notice, with Maxim Group initiating coverage with a "strong buy" recommendation in November 2024 and an updated price target of $9. As Silexion advances toward clinical trials with SIL-204 and explores expanded development strategies, several key catalysts may lie ahead and could be worth watching closely, including metastasis impact studies, advancement towards next phases of trials, data from additional indications, potential strategic partnerships, and more positioning the company uniquely in the precision oncology landscape at a time when the industry actively seeks innovative solutions for challenging cancers. Click here to Subscribe for more updates like this Read out Previous update regarding Silexion Therapeutics Read out Previous update regarding Silexion Therapeutics >> We Encourage you to read the source news from Silexion: Silexion Therapeutics Reports Strong Tumor Growth Reduction from Systemic Administration of SIL-204 in Preclinical Pancreatic Cancer Models (*)Important Disclaimers & Disclosures: This report is for informational purposes only and should not be considered financial or investment advice. The author is not a registered financial or investment advisor nor does he hold any type of license or engage in any activity that would require one. The content may include forward-looking statements and opinions that may not materialize. Investors should conduct their own due diligence and consult with a qualified investment professional before making any investment decisions. This report was produced by ‘PESG Research’, a content brand which is part of the Wall Street Wire network, a digital coverage and news distribution subscription service and platform operated for commercial, promotional and investor relations purposes. This report contains advertising/promotional content relating to Silexion Therapeutics. Please review our detailed disclosure and disclaimer linked below which details the subscription fees the operators of PESG and the network of brands it is a part of received from Silexion Therapeutics and other customers for coverage, distribution and news promotion services, in accordance with Section 17(b) of the Securities Act. Please review the full disclaimers and disclosures this report is subject to: https://redditwire.com/terms. Contact Details Wall Street Wire Reports Desk* ronald@futuremarketsresearch.com

January 29, 2025 09:24 AM Eastern Standard Time

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Centre for Neuro Skills Earns Accreditation in Applied Behavioral Analysis and Training at Three of its Locations

Centre for Neuro Skills

Centre for Neuro Skills (CNS), a leader in traumatic brain injury and stroke rehabilitation services, has been accredited by the Behavioral Health Center of Excellence (BHCOE) for demonstrating a commitment to the standards of excellence for applied behavior analysis services. The BHCOE Accreditation® distinguishes applied behavior analysis (ABA) therapy providers that demonstrate continuous improvement in applied behavior analysis and dedication. Three of CNS’ locations in Bakersfield and Los Angeles, California, and Irving, Texas have earned this accreditation and have been approved as training sites for behavior analysis students. Since 1980, Centre for Neuro Skills has treated thousands of people whose brain injury deficits include complex behavior challenges. Behavior analysts and therapists are trained in behavior skills, crisis prevention and management, and implementation of comprehensive, interdisciplinary rehabilitation programs. As an accredited training site, students and interns can learn from board-certified behavior analysts to help treat behavior problems. “We are thrilled that our behavior department and treatment program has been recognized as a standard of excellence,” said Chris Persel, Regional Director of Clinical Services and Director of Behavior Programming. “This accreditation opens up more opportunities for behavior analysis students and demonstrates the importance of providing behavioral analysis services to individuals facing a brain injury." *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, Twitter, LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

January 29, 2025 06:01 AM Pacific Standard Time

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Shareholder Group, Detransitioner to Call Out Gender Ideology Harm at Visa, Inc. Annual Meeting on Tuesday

NLPC

National Legal and Policy Center, an investor in Visa, Inc., will present a shareholder proposal at the payment processor’s annual meeting on Tuesday, Jan. 28. The measure asks the company to investigate risks related to its discriminatory pay and benefits policies – specifically addressing where employees affected by gender-switching advocacy have been psychologically or medically harmed, without providing remedial care – and reporting to shareholders why such compensation gaps exist in the company’s policies. Speaking at Visa’s meeting in support of the proposal will be Claire Abernathy, a 20-year-old detransitioner whose therapy, medical and health insurance providers steered her into drastic body altering procedures when she questioned her gender starting at age 12. Ms. Abernathy will address the company’s board of directors and executive leadership, explaining her difficulties in finding medical care and insurance coverage to attempt to repair the damage done to her body. An excerpt from Abernathy’s planned remarks: By age 12 therapists affirmed my feelings about my body and false identity, and made my parents feel like abusive bigots for not immediately affirming me. The therapy was covered by my parents’ health insurance. Alleged medical professionals put me on a menstrual suppression drug, and at 14 I was put on testosterone and underwent a double mastectomy. It took only 8 months between getting referred for therapy and getting my breasts removed. That is an ideological agenda in search of victims, in the name of medicine, and it’s wrong. “By failing to include detransition care, companies like Visa perpetuate the neglect of a vulnerable population,” said Abernathy. “True equity in healthcare means acknowledging the full range of outcomes in gender transitioning treatments, and ensuring that all individuals have access to the care that they need.” In its shareholder proposal, NLPC itemizes numerous graphic, ghastly body-altering procedures that are drawn from Visa’s employee health insurance coverage through CIGNA, which also covers their minor dependents. Besides early-teen mastectomies like what Abernathy was pressured into, Visa also pays for procedures including penectomies, vaginectomies, orchiectomies, and salpingooophorectomies. “Rather than affirming and funding radical medical experiments on workers and their children – which sound more like something out of a horror movie than legitimate health care – Visa needs to just eliminate this coverage,” said Paul Chesser, director of the Corporate Integrity Project for NLPC. “With detransitioner lawsuits spreading across the country against medical providers and health facilities, corporations that sponsor this ‘care’ won’t be far behind in finding themselves in court.” As NLPC points out in its shareholder proposal, the Equal Employment Opportunity Commission considers failure to provide equivalent pay and benefits based on categories including “gender identity” and “sexual orientation” as discriminatory. Even the Securities and Exchange Commission agreed with NLPC that de-transitioning individuals fit under such classifications when considering unfairness in corporate compensation practices, in a decision rendered last year regarding NLPC’s shareholder proposal at Disney. NLPC sponsored similar proposals last year at Johnson & Johnson and PepsiCo. You can read NLPC’s shareholder proposal for Visa at its website. Last year Chesser also composed commentaries for the New York Post and Real Clear Markets that further explained the proposals and their necessity. Founded in 1991, NLPC promotes ethics in public life and government accountability through research, investigation, education, and legal action. ### For more information or to schedule an interview with Paul Chesser, contact Dan Rene at 202-329-8357 or drene@nlpc.org. Please visit http://www.nlpc.org. Founded in 1991, the National Legal and Policy Center promotes ethics in public life through research, investigation, education and legal action. Contact Details National Legal and Policy Center Dan Rene +1 202-329-8357 drene@nlpc.org Company Website http://www.nlpc.org

January 28, 2025 09:00 AM Eastern Standard Time

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Groundwork BioAg and Sustainable Travel International Partner to Offer Carbon Dioxide Removal Credits for Tourism

Groundwork BioAg

Groundwork BioAg ®, the world’s largest producer of mycorrhizal inoculants, announced a new partnership with Sustainable Travel International, a global leader in sustainable tourism solutions, to offer travelers and businesses access to premium carbon dioxide removal (CDR) credits, based on the application of mycorrhizal fungi in cropland. Mycorrhizal inoculants are applied in agricultural soils to improve crop yields, save fertilizer, reduce plant stress, and improve soil health – but at the same time, these microbial products act as a natural pathway to permanently sequester carbon. This partnership aligns with Sustainable Travel International’s mission to provide programs that help travelers, businesses and destinations protect the environment, preserve cultural heritage and promote economic development. Groundwork BioAg's Rootella Carbon™ program offers high-integrity, high-volume, durable carbon credits that are independently certified and approved, providing a reliable solution for organizations seeking to meet their net-zero pledges responsibly. "By adding Rootella Carbon to our Climate Impact Portfolio, we reaffirm our commitment to promote holistic environmental stewardship so our members can visit – and protect – the places they love,” said Paloma Zapata, CEO of Sustainable Travel International. “This innovative, nature-based solution aligns with our mission to help the travel industry address its carbon liability while directly improving soil health around the world.” Sustainable Travel International’s Climate Impact Portfolio includes a wide variety of projects in different locations that generate carbon credits as they reduce or remove emissions. The portfolio includes a mix of high-quality forestry, clean/efficient energy, blue/teal carbon, and innovative climate tech projects. The demand for high-quality carbon credits is growing rapidly, with two-thirds of the world's largest companies with net-zero targets using carbon offsets to help meet their climate goals. Rootella Carbon credits stand out among durable CDR credits as a scalable solution that not only sequesters carbon in the soil but also improves crop yields, reduces chemical fertilizer use, mitigates plant stress and supports regenerative agricultural practices. Dan Grotsky, co-founder and chief growth officer of Groundwork BioAg, said, "This collaboration not only validates the effectiveness of our Rootella Carbon program but also demonstrates the travel industry's commitment to sustainable practices. Together, we are paving the way for significant carbon sequestration by enabling travelers and rewarding farmers around the world – while contributing to a healthier planet." Rooted in Groundwork BioAg’s history of helping growers improve the productivity and profitability of their farms, this partnership now gives travelers the opportunity to directly support farmers for their land stewardship while reducing their own carbon footprint. Currently under validation within the Verra VM0042 v2.0 protocol, Rootella Carbon offers farmers the opportunity to earn up to 70% of net proceeds from carbon credit sales, making it an attractive option for growers looking to diversify their income streams. This innovative approach unlocks compensation for regenerative growers who would otherwise be ineligible for carbon credits, while incentivizing conventional farmers to adopt regenerative practices. For more information about Groundwork BioAg and the Rootella Carbon program, visit GroundworkBioAg.com. About Groundwork BioAg Groundwork BioAg, a leading bioagriculture company, produces cost-effective mycorrhizal inoculants at scale to tackle food insecurity and climate change. Groundwork BioAg’s nature-based carbon dioxide removal solution leverages mycorrhizae as carbon’s main pathway into the soil and is supercharging permanent carbon sequestration on millions of hectares of commercial and regenerative farms globally. We envision the world’s cropland regenerating with mycorrhizae and every farmer benefiting from higher yields, healthier soils, fertilizer reduction, and verifiable, premium carbon credit revenue – without altering cultivation practices. Nature’s most potent carbon removal solution is now in every farmer’s hands. For more information, visit groundworkbioag.com or groundworkbioag.com/rootella-carbon. Contact Details AgTech PR for Groundwork BioAg Jennifer Goldston jennifer@agtechpr.com Company Website https://www.groundworkbioag.com

January 22, 2025 10:32 AM Central Standard Time

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Cortland Biomedical Secures FDA Registration, Expanding Role as a Trusted Contract Manufacturer for Medical Device OEMs

Cortland Biomedical

Cortland Biomedical, a full-service biomedical textile product development partner that provides access to a full spectrum of global engineering, design, and manufacturing capabilities, is proud to announce its FDA registration, marking a significant milestone in the company’s evolution. This new designation positions Cortland Biomedical as a full-service contract manufacturer and reinforces the company’s unwavering commitment to delivering the highest standards of quality, compliance, and service to its medical device customers. As an FDA-registered contract manufacturer, Cortland Biomedical will better support its clients in highly regulated markets, particularly in the orthopedic sector, where precision and reliability are critical. The FDA registration, partnered with ISO 13486:2016 compliance, ensures that Cortland Biomedical operates under a robust Quality Management System (QMS) that meets stringent regulatory requirements, offering its customers peace of mind in the safety and performance of their devices. “FDA registration is a game-changer for Cortland Biomedical and our customers,” said Tara Yunkunis, Senior Business Development Manager, Cortland Biomedical. “This milestone underscores our dedication to maintaining world-class quality systems and compliance practices. As a contract manufacturer, we can now take a more active role in helping our customers bring innovative medical devices to market faster and with greater confidence.” With extensive expertise in the design and production of advanced biomedical textiles, Cortland Biomedical specializes in creating tailored solutions for a range of applications, including orthopedics, sports medicine, cardiovascular, robotic surgery, general surgery, and others. This expanded capability allows it to now partner with OEMs from initial concept through full-scale manufacturing, providing a seamless, forward-integrated approach to medical device development. For more information about Cortland Biomedical and its expanded capabilities as an FDA-registered contract manufacturer, visit cortlandbiomedical.com or come see the team in booth 2127 at the upcoming MD&M West show in Anaheim, CA. Cortland Biomedical custom designs and manufactures high-performance biomedical textile structures leveraging years of experience in medical textile engineering methods including knitting, braiding and weaving. Its thoughtful design concepts challenge the status quo. Cortland Biomedical's unique combination of advanced equipment and technology, a seasoned medical textile-specific engineering team, and first-rate R&D capabilities allows it to tackle customers' complex challenges with the innovation and agility expected in the medical device industry. Learn more at cortlandbiomedical.com. Contact Details Jordan Bouclin, SVM Public Relations +1 401-490-9700 Jordan.bouclin@svmpr.com Company Website https://www.cortlandbiomedical.com/

January 22, 2025 10:00 AM Eastern Standard Time

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How Monogram’s (NASDAQ: MGRM) Dynamic Approach To Robotics Could Help Reshape the Future Of Orthopedics

Benzinga

By Meg Flippin Benzinga Robots are becoming increasingly more common in the operating room, but just how automated are they? Monogram Orthopedics Inc. (NASDAQ: MGRM) would argue we have a long way to go before the full potential of robotic technology is fully tapped. The proliferation of robotics and increasing utilization is, at this point, likely a foregone conclusion. After all, some estimates predict that 50% of all knee procedures will be robotic by 2027, up from 11% in 2019. Yet despite the proliferation of AI and fully autonomous robotics in nearly every aspect of daily life, the surgical equipment currently in use for common orthopedic procedures is still reliant on surgeon skill. Monogram’s mBôs robotic technology aims to increase automation and reduce reliance on user skills. As a pioneer in autonomous saw-based cutting, the company has applied decades of robotics experience to amass an extensive portfolio of innovation, including some 23 patent applications in process. The majority of procedures done today combine manual surgery with robotics. The process can still rely heavily on surgeon skill to safely execute the surgery. Monogram’s mBôs aims to minimize direct surgeon contact with the robot mounted tools and hopes to provide surgeons a more autonomous platform for precise surgical bone cuts based on preoperative planning. Monogram’s autonomous robotics platform captured the attention of investment bank Roth Capital Partners, which recently initiated coverage of the company, noting mBôs simplifies surgery as a likely direct challenge to the dominant players in the space. “While orthopedic surgeons remain characteristically conservative, the clinical case for robotics technology is building, and robotics are changing market dynamics,” according to an analyst report compiled by Roth Managing Director Jason Wittes. “We anticipate adoption surpassing 50% over the next five years, and thus see significant strategic value in emerging robotics platforms such as MGRM's mBôs that can challenge MAKO’s dominance.” In addition, Monogram reports its technology pipeline is robust. It plans to introduce mVision in the future, which could enable faster registration and further optimize surgical time compared to competitors. Combination Of Advanced Technologies To Deliver Results Monogram leverages AI and robotics to develop state-of-the-art robots that can assist surgeons with knee reconstruction and, in the future, other procedures like hips, shoulders, ankles and spine. Monogram’s robotic systems aim for precise virtual assessment of laxity values to determine the potential clinical impact of planned resections. Its technology enables surgeons to place implants virtually before cutting to assess the impact of various resections on knee laxity with a target to achieve submillimeter bone cuts. These tools could dramatically simplify the complexity of joint reconstruction in the future. Monogram hopes the mBôs automation could increase throughput and hopes to reduce clinical risk with a planned clinical study to validate. The goal is for the robot to be easy to use and to lower the learning curve for surgeons. With accurate robotics, precision machine cuts can help enable the use of press-fit implants, eliminating the need for cement. Unlike traditional implants, press-fit implants rely on the patient’s bone to hold the implant in place instead of relying on cement. Natural biologic fixation could reduce the risk of the implant becoming loose for younger active patients as the cement breaks down over time. Showing Off The Tech At HQ Monogram’s unique approach to robotics was on display during an analyst meeting and demo day held in 2024 at the company’s cadaver lab and headquarters in Austin, Texas. Monogram executives – including CEO Ben Sexson, Founder and Chief Medical Officer Dr. Douglas Unis, Chief Technology Officer Dr. Kamran Shamaei and Chief Financial Officer Noel Knape – were on hand along with other senior management team members to provide an overview of the company's progress in combining advanced machine vision, AI and next-generation robotics to improve surgeries and patient outcomes. “We were extremely impressed with the management team, including founder Doug Unis, and the successful product Demonstration of the mBôs Precision Robotic Surgical System in a world-class cadaver lab,” said Dallas Salazar, Doctor Group investor. “The hands-free, fully active system demonstrated to us the ease of use and simplicity that was operated by the founder’s 11-year-old daughter giving more confidence of commercialization and acceptance in the orthopedic robotics community once approved. We believe there is clearly a disruptor in this space that is now bringing a product solution architecture to enable patient-optimized orthopedic implants at scale utilizing artificial intelligence and next-generation robotics.” Market Direction The company believes that the future of the market for robotics is bright. With continued robotic adoption driven by patient outcomes and healthcare providers, it believes robotics are likely to become increasingly autonomous. Given the advancements made in AI and robotics, the systems in place today may still be relatively constrained by a reliance on the precision of individual surgeons. The full potential of robotics could be realized across myriad industries. With the anticipated growth in surgical procedures and critical patient and healthcare business outcomes at stake, coupled with a declining number of orthopedic surgeons, automation could be an answer to the growing demand. Monogram aims to introduce an approach to enabling true automated robotic precision that has the potential to transform the way surgeons around the world perform knee replacements and other orthopedic procedures. Featured photo by SOMKID THONGDEE 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

January 22, 2025 08:45 AM Eastern Standard Time

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Salignostics Advances Saliva-Based HIV Testing with Successful Clinical Trial in Ethiopia

Salignostics

Salignostics, a leader in saliva-based diagnostic innovation, proudly announces the successful completion of a clinical trial in Ethiopia for its groundbreaking saliva-based HIV rapid test. This major milestone brings Salignostics closer to providing a transformative solution for HIV testing, particularly in areas with limited access to healthcare infrastructure. The trial, conducted in November 2024, evaluated 50 saliva samples from individuals diagnosed with HIV alongside 50 samples from healthy participants. The results demonstrated exceptional accuracy, with sensitivity exceeding 90% and specificity surpassing 98%. These findings underscore the reliability of saliva as a diagnostic medium and highlight its potential to address critical healthcare challenges worldwide. Accurate, accessible HIV testing is vital for early detection and treatment, especially in underserved regions. Salignostics’ saliva-based test eliminates the need for blood draws and specialized equipment, offering a cost-effective and non-invasive alternative that can be deployed in homes, clinics, or community health settings. This innovation not only reduces barriers to testing but also empowers individuals to take control of their health with privacy and convenience. “This successful trial highlights the value of saliva as a diagnostic medium,” said Dr. Guy Krief, Co-founder and Deputy CEO of Salignostics. “By leveraging our technology, we aim to complement existing HIV testing methods and provide a reliable, accessible solution that meets the needs of diverse communities worldwide.” The global HIV diagnostics market is rapidly expanding, driven by increasing demand for decentralized and user-friendly solutions. The market is projected to reach $3.88 billion by 2021, with forecasts of further growth to over $7 billion by 2034 at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2034. Building on its success with saliva-based diagnostics, Salignostics continues to expand its portfolio. The company has a proven track record, including CE, UKCA, and TGA certifications for its Salistick pregnancy test, which has achieved over 500,000 units sold and ordered across markets such as the UK and Israel. Salignostics’ development pipeline also includes applications for oral cancer, respiratory conditions, and sexually transmitted infections, further demonstrating the versatility of saliva as a diagnostic tool. For Salignostics, the successful Ethiopian trial is a significant step forward in transforming global healthcare. By providing accurate and accessible HIV testing, the company is addressing critical gaps in public health while reinforcing its commitment to innovation and quality in diagnostics. About Salignostics Founded in 2017 in Jerusalem, Salignostics is a global leader in saliva-based diagnostics. The company’s proprietary technology has been successfully commercialized, with its Salistick pregnancy test achieving over 500,000 units sold and ordered in markets such as the UK and Israel. Now approved by CE, UKCA, and TGA, Salignostics is actively expanding its portfolio of innovative, user-friendly diagnostic solutions. For more information about Salignostics and its groundbreaking saliva-based diagnostics, visit www.salignostics.com Founded in 2017 in Jerusalem, Salignostics is a global leader in saliva-based diagnostics. The company's proprietary technology has been successfully commercialized, with its Salistick pregnancy test achieving over 500,000 units sold and ordered in markets such as the UK and Israel. Now approved by CE, UKCA, and TGA, Salignostics is actively expanding its portfolio of innovative, user-friendly diagnostic solutions. For more information about Salignostics and its groundbreaking saliva-based diagnostics, visit www.salignostics.com Contact Details Salignostics Guy Krief | Co-founder and Deputy CEO, Salignostics guykrief@salignostics.com Company Website https://www.salignostics.com/

January 21, 2025 05:15 PM Eastern Standard Time

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