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Minerva Surgical Launches Next Generation Symphion Fluid Management Accessory with Fluid Deficit Readout

Minerva Surgical, Inc.

Minerva Surgical, a manufacturer and distributor of minimally invasive gynecologic surgical technologies, today announced the launch of the Symphion Fluid Deficit Readout, an optional accessory that provides fluid deficit volume readings during operative hysteroscopy procedures. Operative hysteroscopy is a surgical procedure that requires precise fluid management to prevent complications. The Symphion Fluid Deficit Readout, which is intended for use with the Symphion Operative Hysteroscopy System, automatically calculates the fluid deficit during the procedure by measuring the weight of the saline bag throughout the procedure in real time and converting the weight measurement into fluid volume readings. Additional key features of the Symphion Fluid Deficit Readout include a fluid deficit accuracy within +/- 50mL, a user-friendly interface with an intuitive display for easy operation, and a compact design that allows for quick set up with the Symphion controller. “Continuous innovation with a focus on enhancing patient safety has always been the primary objective for Minerva Surgical. The Symphion Operative Hysteroscopy System is intended to volumetrically limit a patient’s exposure to fluid so the risk of fluid absorption and overload can be avoided. With the introduction of the Symphion Fluid Deficit Readout, the system has a new layer of procedural safety to complement the unprecedented precision during uterine cavity tissue resection.”, states Minerva Surgical Chief Medical Officer Eugene Skalnyi, M.D. Along with the Symphion Fluid Deficit Readout, Minerva Surgical is launching a compatible, next generation of Fluid Management Accessory called INFINITY. Together, the Symphion line extensions are the newest additions to the Minerva Surgical portfolio of minimally invasive technologies. The company is committed to advancing gynecologic surgery and providing solutions that enhance outcomes. About Minerva Surgical, Inc. Minerva Surgical is a technology enabled medical device company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct pelvic healthcare needs of women. The Company has established a broad product line of minimally invasive alternatives to hysterectomy, which include solutions to detect and address common causes of Abnormal Uterine Bleeding (AUB). The Minerva Surgical pelvic health solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the anatomy by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Kevin Tracey +1 855-646-7874 kevin.tracey@minervasurgical.com Company Website https://minervasurgical.com/

August 26, 2024 10:00 AM Eastern Daylight Time

Theriva Biologics Receives Rare Pediatric Drug Designation From FDA For Treatment Of Retinoblastoma

Benzinga

By Kyle Anthony, Benzinga The growing prevalence of cancer is not limited to adults; it is also afflicting children. An estimated 15,780 children between birth and 19 years of age are diagnosed with cancer each year in the U.S., according to the American Childhood Cancer Organization. Approximately 1 in 285 children in the U.S. will be diagnosed with cancer before their 20th birthday. Globally, there are more than 300,000 children diagnosed with cancer each year, and the rate of childhood cancer is slowly rising; cancer cases increased to 177 per million in 2019 from 165 per million in 2003. Recently, Theriva Biologics (AMEX: TOVX), the clinical-stage immuno-oncology company developing therapies for difficult-to-treat cancers, was granted Rare Pediatric Drug Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for VCN-01 for the treatment of retinoblastoma; the most common type of eye cancer in children. Retinoblastoma Presents Significant Treatment Challenges Retinoblastoma is a tumor that originates in the retina and accounts for approximately 2% of all childhood cancers. Some 200 to 300 children are diagnosed each year in the U.S., and the cancer is most common among infants and young children. The average age of a child when diagnosed is two years of age. Approximately three out of four children with retinoblastoma have a tumor in only one eye (known as unilateral retinoblastoma). When both eyes are affected it is known as bilateral retinoblastoma. Although the chances of developing retinoblastoma are statistically low, the challenge of preserving life while preventing the loss of an eye, blindness, and other severe consequences that diminish both lifespan and quality of life remains significant. Furthermore, in low-resource countries, children with retinoblastoma face a higher risk of losing their eyes and succumbing to metastatic disease. Recently, market research and industry consulting firm Spherical Insights assessed the global retinoblastoma treatment market size to be $2.5 billion in 2023; and it is expected to grow to $3.8 billion by 2033. Rare Pediatric Drug Designation For VCN-01 As the name suggests, the Rare Pediatric Drug Designation is a special status given to drugs explicitly developed for treating rare diseases that affect children. This designation is part of a broader effort to encourage the development of medications for conditions not commonly addressed due to the small number of patients, particularly in the pediatric population. For Theriva Biologics, this designation comes with a key incentive: if a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva says it may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed to receive a priority review for any subsequent marketing application or may be transferred or sold. PRVs have previously been sold by different companies for around $100M. “The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma. We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma,” said Steven A. Shallcross, CEO of Theriva Biologics. “Most recently, results from the investigator-sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need,” he said. With VCN-01 receiving RPDD from the U.S. FDA, this milestone speaks to the drug's efficacy and long-run potential. As such, the social benefit that Theriva Biologics provides could continue to grow and have increased industry resonance. Featured photo by Ani Kolleshi 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

August 26, 2024 08:45 AM Eastern Daylight Time

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Poster Presentations, Upcoming Human Trials, Recently Secured Funding And More: Glucotrack’s Plans To Transform The Continuous Glucose Monitoring Market

Benzinga

By Meg Flippin, Benzinga Managing diabetes has gotten an overhaul thanks to continuous glucose monitoring devices (CGM). Glucotrack Inc. (NASDAQ: GCTK), the Rutherford, New Jersey medical technology company that makes a continuous blood glucose monitoring (CBGM) device, is seeking to position itself to transform the glucose monitoring market. It is doing so through what it says is a game-changing medical technology that overcomes the challenges of the existing devices on the market, including the lack of real-time accuracy, the need for frequent sensor changes and concerns regarding comfort and wearability. Glucotrack’s implantable Continuous Blood Glucose Monitor (CBGM) measures glucose in the blood, something no other known competitor is offering to date. By measuring glucose in the blood instead of glucose in interstitial fluids – which is what most other devices measure – users get an accurate, real-time reading. Plus, Glucotrack’s implant can last up to three years, compared to less than one year for many of the continuous glucose monitoring (CGM) devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity, whether it's swimming or hot yoga. The CBGM, which also requires minimal calibration, eliminates the hassle and discomfort of a wearable that requires frequent replacement, the company said. Making The Rounds Glucotrack has been busy getting the word out about the potential of its CBGM. In June, it presented two posters at the American Diabetes Association (ADA) 84th Scientific Sessions discussing preclinical animal studies and a sensor longevity simulation modeling for its CBGM. The ADA Scientific Sessions is one of the premier diabetes conferences which provides a platform for the latest advancements in diabetes research, prevention and care. This annual meeting provides researchers and healthcare professionals with the opportunity to share ideas and learn about cutting-edge technologies and breakthroughs in diabetes research and diabetes-related conditions. Glucotrack also presented an emerging science industry poster at the Association of Diabetes Care and Education Specialists annual conference, which took place from Aug. 9 to 12. The poster presented market research data on the acceptance of the company’s CBGM concept among people with type 1 and type 2 diabetes. It highlighted that out of 757 respondents with type 1 and type 2 diabetes using a variety of insulin regimens, there was a positive sentiment towards the CBGM concept, with over 50% of potential users open to adopting the product. In other words, the CBGM concept could be a viable alternative to existing products on the market. PreClinical Trials In The Bag Glucotrack’s data so far seems to back up its claims, including its recent 90-day preclinical study demonstrating the sustained accuracy of its CBGM. The second long-term preclinical study for its CBGM showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, reports Glucotrack. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack. The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM’s sustained accuracy and performance. “We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials,” stated Paul Goode, PhD, president and CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for 3 years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution,” he said. Cashing In All of these developments seem to have brought Glucotrack investment money; in July, the company secured $4 million in funding from its leading shareholder to support its upcoming first in-human clinical trial. It also helps the company that it has a deep leadership bench and board with years of experience. Take Goode, for starters. He has decades of experience developing innovative medical technologies in the implantables and glucose monitoring space for big-name medical technology companies, including DexCom Inc. (NASDAQ: DXCM), a global continuous glucose monitoring company. Goode is a named inventor on over 150 issued patents, including over 100 relating to Dexcom’s continuous glucose sensing technology. Meanwhile, Mark Tapsak, Ph.D., VP of Sensor Technology, has held senior positions at diabetes management companies, including as senior scientist at DexCom. Further, the bench just got deeper with the appointment of Andy Balo – a former DexCom executive – to the board. Balo brings decades of regulatory, clinical and quality experience in the medical technology industry. In 2002, he joined DexCom as part of the original executive team where he remained for the next 22 years, playing a key role in shaping the company’s future. During his tenure, he was responsible for numerous glucose monitoring regulatory submissions and clinical trials worldwide, and coordinated quality activities across multiple manufacturing facilities. With a forecasted CAGR of 10.3% over 2024-2034, the continuous glucose monitoring market could be poised to take off, and Glucotrack wants to play a role in expanding options for patients with its technology. With preclinical trials already being in the bag, and human trials up next - the company feels its commitment to that goal is progressing steadily toward fruition. Featured photo by Mykenzie Johnson 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

August 26, 2024 08:30 AM Eastern Daylight Time

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RedHill's Opaganib Shows Diabetes And Obesity Potential With Positive In Vivo Results

Benzinga

By Meg Flippin, Benzinga A potential, previously unexplored pathway for fighting diabetes and obesity-related disorders may have been unveiled by RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company, and its partner Apogee Biotechnology Corp., who are busy developing what may be an interesting new approach in the obesity and diabetes market. The company is testing opaganib in a range of metabolic disease models designed to show its potential to prevent and treat type 2 diabetes and other obesity-related diseases and recently received positive in vivo results. The positive results of early trials are good news for RedHill Biopharma given the global obesity-diabetes drug market opportunity is huge, projected to reach $100 billion by 2030. It’s being driven largely by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk’s (NYSE: NVO) Ozempic and Wegovy (semaglutide), Eli Lilly’s (NYSE: LLY) Trulicity (dulaglutide) and Mounjaro (tirzepatide) and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim’s Jardiance (Empagliflozin), reports RedHill. If RedHill is right about opaganib, it could join those ranks. “Sphingolipid metabolism is implicated in insulin resistance, β-cell disruption, adipocyte function, inflammation and immune regulation, vascular complications and energy metabolism – all significant components of obesity, diabetes and their associated complications,” said Charles D. Smith, Ph.D. Founder and CEO of Apogee Biotechnology Corp., Redhill’s partner who led the testing of opaganib for the treatment and prevention of type 2 diabetes and other obesity-related disorders. “Opaganib’s ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells provides a strong rationale for evaluation of opaganib in obesity-related disorders.” Opaganib Slows Weight Gain Earlier this week RedHill announced that in vivo studies conducted by RedHill’s partner, Apogee, yielded positive results. The studies looked at the impact opaganib had on weight gain and glucose tolerance in a high-fat diet (HFD) model. They demonstrated opaganib suppressed HFD-induced body weight gain, loss of glucose tolerance and fat deposition. Additionally, opaganib reduced weight gain and restored glucose tolerance in an already obese HFD model, suggesting its potential for treating, not just preventing, obesity-related disorders, reports RedHill Biopharma. “Sphingolipid metabolism is a key pathway in many diseases, including obesity, but has not been adequately examined as a therapeutic target for human therapy,” said Dr. Mark Levitt, Chief Scientific Officer at RedHill. “Opaganib, which acts as a sphingosine competitor, is the first clinical drug to target three key enzymes in this pathway.” With multiple U.S. government collaborations ongoing, opaganib, RedHill Biopharma’s first-in-class new chemical entity with anti-inflammatory, anti-cancer and antiviral activity, is a host-directed, potentially broad-acting, orally administered small molecule drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection. More Than Fighting Diabetes But it’s not just in fighting diabetes and obesity-related disorders where RedHill is making progress. Adding to its commercialization by RedHill in the U.S., the company just launched Talicia (omeprazole magnesium, amoxicillin and rifabutin) in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori. The commercial launch of Talicia in the UAE triggers RedHill’s eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In a pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). “As one of the strongest risk factors for gastric cancer, H. pylori is a major public health concern,” said Rick Scruggs, President & Chief Commercial Officer at RedHill. “With 41% of the UAE population infected by H. pylori and the alarming failure rates of clarithromycin-based therapies, there is a significant medical need for a highly effective first-line H. pylori therapy. Our efforts to make Talicia available to patients in more countries continue as we work to explore additional opportunities with existing and potential partners.” From preventing diabetes and obesity-related diseases to fighting H. pylori, RedHill Biopharma seems to be making strides with its key drug compounds. Early testing shows promise, potentially making this a company worth watching. To learn more about RedHill Biopharma’s pipeline, click here. Featured photo by Diana Polekhina 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

August 23, 2024 08:30 AM Eastern Daylight Time

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News Release

Sector Spotlight: Top 4 Basket of Diagnostic Stocks (EXAS, GH, ILMN, LUDG)

LUDG EXAS GH ILMN

Big diagnostic companies soared during the pandemic thanks in part to mandated government testing, but once the at-home kits arrived and insurance companies were forced to foot the bill, diagnostic companies with COVID-19 revenues collapsed. Many diagnostic companies got caught in the downdraft because they thought the testing gravy train was going to continue and ramped up capacity instead of diversifying. The opportunity in the sector comes from diagnostic companies that chose to reinvent themselves by developing early cancer screening tests. During the pandemic, regular cancer screenings were put off to conserve medical resources toward COVID. Since the pandemic is over, it's worth reexamining beat-up diagnostic companies that were able to adapt and are now on the upswing. The top diagnostic stock to put on your radar is Exact Sciences (NASDAQ: EXAS). Most investors will recognize their at-home cancer screening kit is called cologuard which tests for colon cancer. Those primetime commercials you’ve likely heard mean they’ve established their brand along with a national audience. Testing volume dropped measurably during the pandemic as early cancer screening was pushed aside, but now their testing volumes are ramping back up and helping chew through the testing backlog created by the pandemic. It has taken a couple of years for EXAS testing volumes to return to pre-pandemic levels. In Q2 2024 the company had a record 1.0 million screenings and got back on its growth trajectory, helped by an expansion of cancer indications that include breast, prostate, and colon cancer. It also started its pipeline expansion into precision oncology. EXAS also made a move into a blood-based multi-cancer space when they purchased Thrive Early Detection Corp. for $2.15 billion. This purchase turned into a business vertical that not only does a deeper dive into the hereditary nature of the cancer but also profiles the tumor in such a way that it assists in the optimization of treatment regimens. The company has $2.6 billion in trailing revenues and a current market cap of $10.3 billion and is an overall leader in the diagnostic sector with solid earnings and a balance sheet for risk averse shareholders looking for a solid return from a company that consistently beats expectations. Guardant Health Inc. (NASDAQ: GH) has the first FDA-approved primary screening blood test for colorectal cancer (CRC). The test is called Shield and it is covered under the Medicare reimbursement program. Shield has a sensitivity of 83% and a 90% specificity (false positives) for advanced neoplasia (polyps that could turn cancerous). The company has $600 million in trailing revenues and a current market cap of $4.0 billion. They call it a non-invasive test, but you still have to get pricked. Another way to play the diagnostic market is to look at the top industry suppliers. llumina Inc. (NASDAQ: ILMN) is a medtech company that makes genetic testing equipment that enables the large-scale analysis of genetic variations. The company manufactures next-generation sequencing (NGS) platforms, microarrays, and bioinformatics software. Their machines are used in genomics research, clinical applications, and molecular diagnostics, which means their customers are research centers, pharma companies, academic institutions, and clinical research organizations. The company recently spun off their diagnostics business called Grail Inc. (NASDAQ: GRAL) which is an early cancer screening company for people that are not symptomatic, enabling a proactive approach to diagnosing cancer earlier. ILMN funded GRAL with a one-time cash payment of $923 million. The company's leading product is a multi-cancer early detection blood test called Galleri. The test screens for 50+ types of cancer by reading the DNA sequence. The backbone of the testing technology is from the Illumina platform and over 20,000 participants in large clinical trial studies. The test kits cost around $1100 each, and they are awaiting FDA approval for the test. Investors looking for a little more alpha should look at this diagnostic testing company disruptor and its game changing technology. Ludwig Enterprises Inc. (OTCMKTS: LUDG) is an exceptional OTC company in the diagnostic screening sector, boasting mRNA testing technology that has the potential to revolutionize the multibillion-dollar diagnostic screening industry with its less invasive tests. CEO Marvin S. Hausman MD stated, “mRNA is the language that interprets DNA and is the future of medicine.” Although the company currently has no revenue, it is gearing up for an exciting product launch in October, coinciding with Breast Cancer Awareness Month, which is expected to kickstart its revenue stream. To spearhead its viral marketing campaign, the company has enlisted a seasoned veteran. LUDG’s Lab Developed Test (LDT) will initially target breast cancer screening, but the technology can be easily adapted to other inflammatory-driven cancers. These LDTs are processed at the Genetics Institute of America, a CLIA lab, which allows for quicker product launches as they do not require FDA approval. The company has developed a unique cancer screening approach by measuring mRNA at the nucleotide level. Their test uses AI algorithms to create a personalized inflammatory index, comparing it to a database of over 3,200 mRNA samples collected from 40+ clinical centers over five years. This method, particularly for breast cancer, boasts a 97% test sensitivity, indicating when further evaluation is needed. The LUDG test kits will cost $249 and will follow proven successful direct-to-consumer viral marketing strategies driven by targeted machine learning algorithmic technologies. The CEO of LUDG Hausman has come out of retirement to lead this technology to commercialization. He is a Medical Doctor, Immunologist, and board certified Urological Surgeon. Investors in LUDG will have an experienced CEO at the helm with a proven track record of successful exits. One of his most notable exits was when he sold his NYSE company Medco Research to King Pharmaceuticals, which was ultimately acquired by Pfizer (NYSE: PFE). LUDG’s Revealia breast cancer test is very much like the EXAS Cologuard test. As investors move back into diagnostic stocks, these 4 represent a diversified basket every investor should put on their radar. 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 compensated to assist in the production and distribution of content related to LUDG. 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 Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://razorpitch.com

August 23, 2024 06:00 AM Eastern Daylight Time

Navigate your Investment Roadmap with Select Sector SPDR ETFs

Select Sector SPDR

In an era where market dynamics shift as swiftly as the winds, Select Sector SPDR ETFs remain a beacon for investors aiming to harness the potential of sector-specific investments. Tailored to meet the diverse needs of both individual and institutional investors, these ETFs chart a course for strategic portfolio management by distilling the vast S&P 500 into accessible segments. Focused Investment Across Diverse Sectors Select Sector SPDR ETFs stand out by offering a focused approach to investing, breaking down the broad landscape of the S&P 500 into key sectors. This segmentation allows investors to pinpoint their investments according to specific economic areas, aligning their portfolios with their investment goals, risk assessments, and market perspectives. Below is a glimpse into the diverse holdings that form the core of the Select Sector SPDR ETFs: Communication Services Select Sector SPDR Fund (XLC): Zooms in on the telecommunications and media sectors, capturing the pulse of digital communication. Consumer Discretionary Select Sector SPDR Fund (XLY): Targets the vibrant consumer goods and services sector, from retail giants to entertainment behemoths. Consumer Staples Select Sector SPDR Fund (XLP): Focuses on essential consumer goods and services, providing stability in fluctuating markets. Energy Select Sector SPDR Fund (XLE): Powers through with a dedicated look at the energy sector, from fossil fuels to renewable resources. Financials Select Sector SPDR Fund (XLF): Encompasses the robust banking, investment, and insurance industries, the backbone of economic infrastructure. Health Care Select Sector SPDR Fund (XLV): Centers on the pharmaceuticals, healthcare equipment, and services sectors, addressing global health needs. Industrials Select Sector SPDR Fund (XLI): Broadens the horizon with manufacturing, construction, and logistics firms. Materials Select Sector SPDR Fund (XLB): Covers the foundational chemicals, construction materials, and packaging industries. Real Estate Select Sector SPDR Fund (XLRE): Opens doors to commercial real estate services and REITs. Technology Select Sector SPDR Fund (XLK): Accelerates into the information technology and electronics sectors, powering innovation and connectivity. Utilities Select Sector SPDR Fund (XLU): Illuminates the path with utility companies, ensuring the flow of essential services. A Path for Strategic Investment By offering a lens through which to invest in specific sectors, Select Sector SPDR ETFs enable investors to steer their portfolios with confidence and clarity. The ETFs’ commitment to transparency and strategic focus empowers investors to adapt and thrive amidst the ebb and flow of market conditions. In the evolving landscape of the financial markets, Select Sector SPDR ETFs stand as a testament to the power of targeted investment. Through detailed sector analysis and dedicated portfolio exposure, these ETFs offer a distinguished pathway for those seeking to refine their investment strategies with sector-specific allocations. About Select Sector SPDR ETFs Select Sector SPDR ETFs are a series of exchange-traded funds designed to provide investors with an effective way to engage in sector-specific investment strategies. By segmenting the S&P 500 into distinct sectors, Select Sector SPDR ETFs furnish investors with the tools necessary for targeted and strategic investment decisions. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007734 EXP 10/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

August 22, 2024 05:00 AM Eastern Daylight Time

News Release

The Future of Medicine: Key Biotech Stocks to Watch

OSTX ATNM PBYI CRBP

In today's rapidly advancing healthcare landscape, biotech companies are playing a crucial role in addressing some of the most challenging medical conditions. With a focus on innovation and precision, these companies are developing next-generation treatments and therapies that offer new hope for patients and present compelling opportunities for investors. Unlike many traditional sectors, biotech operates at the cutting edge of science and technology, often driving significant progress in areas such as targeted therapies, immunotherapies, and genetic research. As these companies push forward with their groundbreaking work, they not only stand to revolutionize patient care but also present promising prospects for those looking to invest in the future of medicine. Let’s take a closer look at four biotech companies making waves in the industry. OS Therapies, Inc. (NYSE-A: OSTX) OS Therapies, Inc. (NYSE-A: OSTX) is carving out a unique position in the oncology landscape with its innovative approaches to treating cancer. The company, still in its clinical stage, focuses on developing therapies for osteosarcoma and other solid tumors. Their flagship product, OST-HER2, utilizes a novel immunotherapy platform that leverages the immune-boosting properties of Listeria bacteria to target the HER2 protein—a key player in several cancers. The company's pipeline includes OST-HER2, an immunotherapy currently in a Phase 2b trial targeting resected, recurrent osteosarcoma. With the trial fully enrolled and results expected in the fourth quarter of 2024, investors are keenly awaiting data that could significantly impact the stock’s trajectory. OST-HER2 has already garnered notable designations such as Fast-Track, Orphan Drug, and Rare Pediatric Disease from the FDA, underscoring its potential to address unmet medical needs. In addition to OST-HER2, OSTX is advancing its tunable Antibody Drug Conjugate (tADC) platform. This next-generation technology employs pH-sensitive silicon-based linkers, known as SiLinkers, designed to deliver multiple therapeutic agents directly to tumors, minimizing harm to healthy cells. Early preclinical data from this platform shows promise, positioning OS Therapies as a company with innovative solutions that could transform cancer treatment. Recent milestones further highlight the company’s growth potential. OSTX successfully raised $6.4 million in its initial public offering (IPO) on July 31, 2024. This funding not only bolsters their financial position but also supports ongoing and upcoming clinical trials. Additionally, the company has entered into Johnson & Johnson Innovation – JLABS, which could enhance its development capabilities and expand its research network. Financially, OSTX has made significant strides. The conversion of outstanding preferred shares and debt into equity, alongside the successful IPO, positions OS Therapies with a solid cash runway extending into mid-2025. This financial stability is critical as they approach key clinical milestones and seek further regulatory approvals. On August 2, 2024, OS Therapies announced the formation of a Patient Advocacy Advisory Board (PAAB) dedicated to its osteosarcoma program. The PAAB, composed of key figures from the osteosarcoma community, including Miriam Cohen (Osteosarcoma Collaborative) and Mac Tichenor (Osteosarcoma Institute), will provide valuable insights and feedback as the company seeks regulatory approvals for OST-HER2. This board will meet quarterly to review clinical progress and guide discussions with the FDA regarding a potential Biologics License Authorization (BLA). Additionally, on August 6, 2024, OS Therapies introduced its Scientific and Medical Advisory Board (SMAB). This board includes leading experts in osteosarcoma from institutions such as Texas Children’s Hospital and the Cleveland Clinic. The SMAB will support the company in evaluating OST-HER2’s safety and efficacy compared to current standards of care, playing a crucial role in the company’s regulatory strategy and potential BLA submission. OS Therapies’ approach to addressing significant cancer challenges through its innovative platforms presents an intriguing opportunity for investors. With strong initial results, a promising pipeline, and a strategic partnership with JLABS, the company is well-positioned for future growth. For those looking to invest in a company at the forefront of cancer immunotherapy and antibody drug conjugates, OSTX offers a compelling proposition. Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) CRBP is making notable strides in oncology with its innovative approach to addressing serious diseases. The company's diversified pipeline includes CRB-701, CRB-601, and CRB-913, each with unique mechanisms and promising potential. Corbus’ lead asset, CRB-701, is a next-generation antibody drug conjugate (ADC) targeting Nectin-4. Recently presented at the American Society of Clinical Oncology (ASCO) Annual Conference, the Phase 1 trial results have been promising. The study, conducted with CSPC Pharmaceuticals Group, is assessing CRB-701's safety and efficacy across multiple doses. Data through April 2024 reveals a 44% overall response rate and a 78% disease control rate in metastatic urothelial cancer, and a 43% ORR and 86% DCR in cervical cancer. The drug has been well tolerated, with manageable side effects including a few cases of skin rash and peripheral neuropathy, and no dose-limiting toxicities observed up to 4.5 mg/kg.. For the quarter ending June 30, 2024, Corbus reported a net loss of approximately $10.0 million, an increase from the previous year. This rise in loss is attributed to increased clinical trial costs for CRB-701 and drug manufacturing costs for CRB-913. The company ended the quarter with $147 million in cash, which, combined with recent fundraising, is expected to sustain operations through Q3 2027. Corbus also appointed Winston Kung to its Board of Directors as of August 16, 2024. Kung’s extensive experience in both the pharmaceutical industry and investment banking is anticipated to provide valuable insights and guidance as Corbus advances its pipeline. The company also announced the resignation of Avery “Chip” Catlin from the Board, after over ten years of service. Corbus Pharmaceuticals is advancing through significant clinical and corporate milestones. The encouraging data for CRB-701 and the progress in other pipeline assets position the company for potential growth. Continued development and forthcoming data releases will be crucial in determining the long-term impact of these promising therapies. Puma Biotechnology, Inc. (NASDAQ: PBYI) Puma Biotechnology is dedicated to advancing cancer treatment, with a focus on its lead drug, NERLYNX. Approved for HER2-positive breast cancer, NERLYNX has faced fluctuating sales performance. In Q2 2024, the drug generated $44.4 million in revenue, a 14% decrease from the previous year, but still managed to beat analyst expectations despite a sequential decline of 24.2%. The product’s total prescriptions rose by 3% sequentially but fell 14% year-over-year. In addition to NERLYNX, Puma is developing alisertib, an aurora kinase A inhibitor. This drug, licensed from Takeda in 2022, is being evaluated in several trials. The Phase I/Ib study presented at the 2024 ASCO Annual Meeting demonstrated alisertib’s potential when combined with osimertinib for treating osimertinib-resistant EGFR-mutant non-small cell lung cancer (NSCLC). The study showed an 81% disease control rate and a median progression-free survival of 5.5 months. Notably, alisertib was more effective in patients with TP53 wild-type mutations, prompting Puma to adjust the trial focus accordingly. PBYI reported a net loss of $4.53 million for Q2 2024, a stark contrast to the profit of the same quarter last year. The drop in revenue and increased operating costs have been concerns, though the company’s revenues from NERLYNX and royalties met expectations. Looking ahead, Puma’s pipeline, particularly the alisertib studies, could be pivotal in shaping its future performance. With trials like ALISCA-Lung1 for small cell lung cancer and the upcoming ALISCA-Breast1 study, Puma aims to address significant gaps in cancer treatment. While current financials reflect challenges, the potential breakthroughs in its pipeline offer a promising outlook for long-term growth. Actinium Pharmaceuticals Inc. (NYSE-A: ATNM) ATNM focuses on targeted radiotherapies for oncology patients who have not responded to conventional treatments. Its primary products, Iomab-B and Actimab-A, are aimed at treating relapsed and refractory acute myeloid leukemia (AML), offering substantial growth potential if the company’s clinical trials continue to yield positive results. The company's most advanced candidate, Iomab-B, is in a Phase 3 SIERRA trial for AML patients undergoing bone marrow transplants. Despite a setback regarding its Biologics License Application (BLA), where the FDA requested an additional randomized trial, Iomab-B has shown promising results. The SIERRA trial met its primary endpoint of durable complete remission (dCR) with a p-value of less than 0.0001. This success places Actinium in a strong position, though further validation through additional trials will be key to unlocking its full market potential. Actimab-A, another late-stage candidate, is being tested as a targeted radiotherapy both as a single agent and in combination with other therapies for AML. These ongoing trials could drive stock performance, especially as the company expands its reach into various cancer therapies. Additionally, Iomab-ACT, a newer agent, shows promise in the growing gene and cell therapy space. The targeted radiotherapy conditioning approach of Iomab-ACT could revolutionize how treatments like CAR-T and gene therapies are delivered. The CAR-T market, currently valued at over $3.5 billion in annual revenue, is projected to grow at a compound annual growth rate of 11%. If Iomab-ACT proves successful, it could capture a significant portion of this expanding market, potentially contributing blockbuster-level revenue by 2030. Actinium’s intellectual property portfolio supports this potential, with patent protection for Iomab-B and Iomab-ACT extending until 2040. The company’s ability to further develop these products, particularly in collaboration with institutions like Columbia University, presents a compelling investment case as it seeks to expand into high-demand areas like sickle cell disease and stem cell therapies. 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 compensated by OS 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

August 21, 2024 05:00 AM Eastern Daylight Time

Minerva Surgical Appoints Darin Hammers as Chief Executive Officer and Member of the Board of Directors

Minerva Surgical, Inc.

Today, Minerva Surgical announced the appointment of Darin Hammers as the new President and Chief Executive Officer and Member of the Board. With a 30-year proven track record of success and excellence, Mr. Hammers brings a wealth of expertise and leadership to the company as it continues to develop and commercialize minimally invasive gynecologic technologies that improve patient outcomes. Most recently, Mr. Hammers served as President and Chief Executive Officer of EndoGastric Solutions (EGS), which was acquired by Merit Medical in July. Prior to EGS, he served as Chief Executive Officer of DYSIS Medical and President and Chief Executive Officer of Cogentix Medical, a company that was acquired by Laborie in 2018. Mr. Hammers was formerly Vice President of Sales for the Bard Medical Division of C.R. Bard, and he spent over twelve years in leadership positions with the Urology and Gynecology division at Boston Scientific Corporation. During his tenure in the medical device industry, Mr. Hammers consistently demonstrated the ability to build high-performing organizations and teams that deliver exceptional results. Minerva Surgical Chairman Dr. Uri Geiger said: “We are delighted to welcome Darin as our new President and Chief Executive Officer. Mr. Hammers is a dynamic business leader with exceptional strategic capabilities, proven operational effectiveness and strong experience in women’s health. The Board looks forward to working with Darin as we grow Minerva’s platform of exceptional products for women’s care.” Mr. Hammers stated: “I am delighted to join Minerva Surgical and build a company that will develop new and innovative technologies to improve the quality of life for women. The core portfolio of products is as effective as any on the market when it comes to treating uterine cavity conditions, and the goal is to expand our footprint in the gynecology space and become a market leader.” Darin Hammers holds an MBA from Emory University’s Goizueta School of Business and a Bachelor of Science degree in marketing from the University of Southern Indiana. About Minerva Surgical, Inc. Minerva Surgical is a commercial-stage medical technology company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. The Company has established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of Abnormal Uterine Bleeding (AUB) in most uterine anatomies. The Minerva Surgical solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the uterus by avoiding unnecessary hysterectomies. For more information about the innovative medical devices of Minerva Surgical, please visit www.MinervaSurgical.com. Contact Details Minerva Surgical Kevin Tracey +1 855-646-7874 media@minervasurgical.com Company Website https://minervasurgical.com/

August 19, 2024 10:00 AM Eastern Daylight Time

PathAI Announces Launch of AI-based Measurement of Metabolic Dysfunction-Associated Steatohepatitis ("AIM-MASH") on the AISight Image Management System

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, is proud to announce the launch of its AIM-MASH 1 product on the AISight Ⓡ 1 Image Management System (IMS). This product provides advanced AI-based measurement (AIM) to support the analysis of MASH Clinical Research Network (CRN) Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Activity Score (MAS) component grades and fibrosis staging. The launch of AIM-MASH on AISight aims to increase the reproducibility and scalability of pathologists' assessments and management of MASH cases, which are projected to reach 27 million in the US alone by 2030 2. PathAI's AIM-MASH AI-based measurement tools have been utilized in over 20 presentations and publications, demonstrating their effectiveness in assisting pathologists with MASH CRN scoring in clinical trials; bringing them to the AISight IMS enables a seamless connection between trial and laboratory settings. These tools have been rigorously evaluated via a comprehensive multi-site analytical validation study using diverse datasets from four different trials 3. They have proven to be reliable and effective in helping pathologists make MASH assessments with: Highly Sensitive and Specific Review: AIM-MASH's model overlays have been validated by multiple pathologists for their high specificity and sensitivity in guiding reviews of MASH biopsies and accurately highlight key areas such as artifact, steatosis, hepatocellular ballooning, lobular inflammation, and fibrosis 3. Repeatable and Reproducible Assessments: AIM-MASH algorithm outputs have shown higher repeatability and reproducibility compared to intra- and inter-pathologist agreement for manual reads, confirming its precision in measuring the CRN scoring system components in liver biopsies from MASH patients 3. Increased Scoring Confidence: Validation studies have shown that AIM-MASH algorithm outputs are comparable to pathologist assessments, providing accurate first reads equivalent to those of expert pathologists to aid pathologists in their final assessment. 3 Global Collaboration: The AISight digital IMS allows expert GI Liver pathologists to review cases regardless of their location. This eliminates the need for time-consuming and costly shipping of glass slides and provides opportunities to utilize the MASH experts. The practical application of AI in MASH assessments was highlighted in a recent case study conducted by PathAI Diagnostics (now Ameripath, at its Memphis, TN-based laboratory) 4. This study demonstrated the synergy between traditional pathology and AI, showcasing how AI-assisted pathology can enable more precise evaluation of histologic features relevant to MASH, including steatosis, lobular inflammation, and fibrosis. "We are thrilled to introduce AIM-MASH on the AISight IMS platform," said Andy Beck, MD, PhD, CEO of PathAI. "This product is a game-changer for drug development, as it supports pathologists in making high-quality, reproducible MASH assessments. With AIM-MASH on AISight, pathologists can increase their confidence in pathology reads and decision-making, as if they have the world's expert liver pathologists assisting with every slide, helping with simplifying the complex task of scoring and evaluation." Dr. Arun J Sanyal, Professor and Interim-Chief of the Division of Gastroenterology, Hepatology, and Nutrition at Virginia Commonwealth University and co-investigator of the AIM-MASH analytical and clinical validation study, adds: "The data supports the use of AIM-MASH by pathologists in clinical trials as a method to resolve the accuracy and precision gaps in MASH assessment while guiding pathologists in an efficient evaluation to result in a standardized and reproducible score." The addition of AIM-MASH broadens the set of tools available through AISight to assist pathologists in making reproducible and efficient assessments of MASH. This announcement addresses a crucial gap in pathology labs — the lack of a standardized system that ensures consistent, accurate, and reproducible assessments, particularly for challenging conditions like MASH. With AIM-MASH on AISight IMS, PathAI aims to provide digital and AI tools to assist pathologists in making precise and reproducible assessments at scale, along with workflow optimization features, empowering pathology labs worldwide. References: 1: AIM-MASH and AISight are for Research Use Only. Not for use in diagnostic procedures. 2: Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133. https://doi.org/10.1002/hep.29466. Epub 2017 Dec 1. PMID: 28802062; PMCID: PMC5767767. 3: Pulaski, Hanna, et al. “Analytical and Clinical Validation of AIM-NASH: A Digital Pathology Tool for Artificial Intelligence-Based Measurement of Nonalcoholic Steatohepatitis Histology.” MedRxiv (Cold Spring Harbor Laboratory), 29 May 2024, https://doi.org/10.1101/2024.05.29.24308109. Accessed 22 July 2024. 4: Kinsey, S., Reed, M., Parsell, T. “Practical Clinical Application of Artificial Intelligence in Metabolic Dysfunction Associated Steatohepatitis (MASH) – A Case Study Highlighting the Synergy between Traditional Pathology and AI.” PathAI, 2024. 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 +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 13, 2024 09:00 AM Eastern Daylight Time

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