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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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PayMedix and XO Health Announce Strategic Partnership that Redefines Healthcare Financing and Payments

PayMedix

PayMedix, a leading healthcare financing and payments solutions provider, and XO Health, a pioneering value-based care and benefits platform dedicated to transforming healthcare for self-insured employers, today announced a strategic partnership that expands access to PayMedix’s healthcare financing solution to XO Health’s extensive network of self-insured employers, TPAs, and value-based providers. XO Health members nationally will benefit from PayMedix’s interest-free payment plans that work for their unique financial situations and cover all in-network medical bills, up to their out-of-pocket maximum. All participating providers will benefit from prompt payment for both member and plan-pay portions of their claims. The partnership will help reduce costs and administrative inefficiencies. “Our mission has always been to improve people’s ability to access and afford healthcare when they need it, while simultaneously removing the complexity and administrative burden of bill collection and processing from providers, and simplifying billing for patients,” said Tom Policelli, CEO of PayMedix. “Our partnership with XO Health aligns with this mission. We’re disrupting the way people access and pay for healthcare together.” PayMedix creates a holistic healthcare payment experience and simplifies the process of billing for all parties involved – patients, providers, employers, and TPAs. Patients receive the benefit of flexible repayment plans that remove financial barriers to care. Providers benefit from prompt payment and a reduction in administrative costs. Employers benefit by improving their employees’ well-being, reinvigorating their benefits, and enhancing their employees’ medical experience through simplified statements. The result is employees across the credit spectrum access care earlier and more often, improving health equity and reducing overall cost. XO Health is redefining how healthcare is delivered and paid for by dramatically expanding access to value-based care with new advanced payment models and a modern tech platform that completely rewires health plan operations, delivering a better healthcare experience to self-insured employers, level-funded plans and TPAs. Key features of XO Health’s health plans include: provider networks built on trust and autonomy; secure, real-time data, and analytics powered by a cloud-native data and generative AI; a proprietary pricing and payments engine that enables the creation, pricing, and tracking of “smart care packages” in real time with full transparency into claims, pricing, and payments; and integrated member and provider tools that provide high-touch frictionless transactions and interactions for both plan members and providers. “At XO Health, we believe that bringing trust, transparency, and common sense to healthcare requires foundational changes to how we pay for care,” said Swati Mathai, Co-founder and CEO, XO Health. “Our partnership with PayMedix enables us to deliver on this vision by offering a more straightforward approach to billing that prioritizes simplicity and fairness for both members and providers. By eliminating meaningless complexities of healthcare payments, it allows providers and members to focus on what’s truly important, better care and better health.” About PayMedix PayMedix is the only company solving the problem of high out-of-pocket costs for all parties involved -- providers, patients, employers, and TPAs. PayMedix is changing how people access, use, and pay for healthcare by guaranteeing payments to providers and providing financing for all patients. PayMedix has processed more than $5 billion in medical payments for hospital systems and physician practices and can be implemented in conjunction with any network. About XO Health XO Health is a groundbreaking value-based care and benefits platform with a mission to bring trust, transparency, and common sense back to healthcare. Built on a foundation of real-time data and analytics and offering a broad solution set, the XO Health platform powers excellence across the entire healthcare ecosystem. With an unparalleled team of experienced leaders from diverse domains, XO Health is uniquely positioned to disrupt the healthcare landscape and deliver the transformative change the industry deserves. To learn more, please visit www.xohealth.com. Contact Details Brodeur Partners Sam LeCompte +1 603-660-9407 slecompte@brodeur.com PayMedix/TempoPay Hattie Ninteau hninteau@hps.md Company Website https://paymedix.com/

February 04, 2025 08:00 AM Eastern Standard Time

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Flash Names Jim Zeitunian Chief Technology Officer

Flash

Flash, the leader in parking and mobility technology, today announced the hiring of Jim Zeitunian as Chief Technology Officer (CTO). Over his decades-long career, Zeitunian has led the transformation of hardware and software firms into AI-forward technology innovators. As CTO of Flash, he will drive innovation and advancement of the digital parking ecosystem powering Flash’s parking management platform. "Now is a pivotal time in parking and mobility innovation, and Jim's track record of modernizing legacy industries through AI and cloud technologies aligns perfectly with Flash's vision," said Dan Sharplin, Flash's CEO and Chairman. "His expertise in scaling AI platforms will accelerate our transformation of the parking experience, from expanding our AI-enabled Vision camera network to deepening integrations with consumer apps like ParkMobile. Jim's leadership will be instrumental in building the intelligent mobility infrastructure of tomorrow." Zeitunian joins Flash with a distinguished career in technology leadership, including most recently as CTO of Powerfleet, where he transitioned a traditional fleet management business into a data-driven SaaS powerhouse. Earlier in his career, he developed enterprise SaaS platforms at Coupa Software and Thomson Reuters, gaining unique insight into scaling complex technology ecosystems for Fortune 500 businesses. "The parking industry is ready for an AI-driven revolution, and as a pioneer in parking and mobility technology, Flash has positioned itself to lead it," said Zeitunian. "We’re creating an intelligent parking network that will fundamentally change how people and vehicles move through urban spaces. The opportunity to join Flash's talented team to scale this vision globally is incredibly exciting." In the CTO role, Zeitunian assumes leadership of Flash's global engineering, product management and design, and quality assurance teams and reports to Flash president Chris Donus. Priorities include expanding Flash's AI capabilities across its product portfolio, scaling the company's cloud-based operating system to support growing transaction volumes, and accelerating the integration of parking, EV charging, and mobility services into a unified digital experience. About Flash Flash is a pioneering technology company bringing seamless parking and EV charging experiences to drivers through a first-of-its-kind digital ecosystem. Flash’s platform connects reservable parking and charging in the apps drivers use every day with garage, surface lot, event, and valet parking locations — connected and controlled via a cloud-based operating system with unrivaled intelligence. Customer-obsessed brands partner with Flash to deliver digital, easy-to-use, reliable, and increasingly frictionless experiences to drivers eager to pay for a solution that eliminates wasted time, excess emissions, and stress from driving. The solution has arrived. Visit www.flashparking.com to learn more. Contact Details Ray Young +1 512-694-6097 ray@razorsharppr.com Company Website https://www.flashparking.com/

February 03, 2025 12:00 PM Central Standard Time

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CAREABOUT HEALTH APPOINTS TWO NEW C-SUITE EXECUTIVES

CareAbout Health

CareAbout Health, a provider of management, resources, value-add services, technology and other support to a portfolio of medical groups and healthcare focused companies, announced today the appointment of two C-suite executives. Danielle Webb was named chief operating officer and Scott Robbins was appointed chief people officer. In her new role, Webb, will be responsible for overseeing CareAbout’s daily operations and optimizing processes across the national umbrella entities, which fall within the MSO. She will also drive strategic initiatives around enhancing patient care, improving operational efficiencies and achieving long-term growth. Prior to this appointment, Webb served as chief operating officer of Medical Specialists of the Palm Beaches (MSPB), a leading primary care-focused, multi-specialty physician group practice in South Florida. In this capacity, she headed day-to-day operations and was instrumental in optimizing MSPB’s performance and growth. Robbins, with two decades of healthcare human resources expertise, will lead and manage CareAbout’s centralized human resources function, including benefits, recruitment, employee engagement and other key tasks critical to its talent and workforce. Before joining CareAbout, Robbins spent five years serving as chief people officer at WellBe Senior Medical, a geriatric in-home healthcare provider, where he played a pivotal role in supporting Company’s growth by expanding the team from nine employees to 1,000+. His extensive experience includes establishing and enhancing HR frameworks for a range of entities, including start-ups, for-profit and non-profit companies and community-based healthcare organizations. “Danielle and Scott both have extensive, proven track records in their respective niches within the healthcare services arena. They each have demonstrated exemplary leadership and operational expertise, making them excellent candidates for these positions,” said Dr. Nedal Shami, chief executive officer at CareAbout Health. “As we grow CareAbout’s managed shared services (MSO) model, we need the right team in place to lead us to our goals of ensuring the delivery of the highest quality care while leveraging the benefits of unified, shared services across our medical group practices. Daneille and Scott round out that team, and we look to the contributions they will make in their new roles,” Dr. Shami stated. About CareAbout Health New York, NY-based CareAbout Health provides management, resources, value-add services, technology, and other support to a portfolio of medical groups and healthcare focused companies. The management services organization focuses on empowering providers, improving patient outcomes and advancing value-based care models, delivering scalable, efficient solutions while maintaining local medical care autonomy in key geographic markets. For more information, please visit www.careabout.com. Contact Details PAIRELATIONS Susan J. Turkell +1 303-518-7100 sturkell@pairelations.com Company Website https://careabout.com/

February 03, 2025 08:00 AM Eastern Standard Time

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Therma Bright Reaffirms Its Position As A Key Player In The $4.2 Billion Compression Market With New Venowave Orders

TBRIF

Last year was a pivotal year for cutting-edge diagnostic and medical device technologies developer Therma Bright Inc. (TSXV:THRM) (OTCQB:TBRIF) for many reasons. Its flagship product, Venowave VW5, a medical compression pump that is lightweight, compact, and battery-operated, which is designed to treat and alleviate the symptoms associated with poor circulation in the lower extremities, received the permanent Healthcare Common Procedure Coding System (HCPCS) code from the U.S. Department of Health & Human Services' Centers for Medicare and Medicaid Services (CMS). The company received the new Venowave VW5 permanent HCPCS Level II code E0683 for this first-of-its-kind solution, as well as a CMS pricing determination marking a critical milestone for the company. This FDA-designated Durable Medical Equipment (DME) device is currently the only Medicare-approved, reimbursable, mobile mechanical compression system available in the US under its HCPCS code E0683, which provides a simple and comfortable mobile treatment solution for patients needing to accelerate post-operative recovery periods while also managing longer-term pain and swelling issues. The codes went live on October 1st, and as expected, this attracted a lot of interest from a number of potential distributors across the country. The company engaged some of these distributors in pilot tests for nationwide launches of the initial Venowave sales program to gauge Medicare/Medicaid reimbursement timelines and billing procedures as well as any rejections that occurred. The distributors had success in the pilot trials, reaffirming the demand for Venowave. For instance, the DME Authority initially took up 25 units, which received 100% reimbursement, and later took 175 more units, which were all also reimbursed, illustrating the traction of Venowave in the market. For context, the DME Authority provides nationally exclusive niche therapy smart devices to hospitals and physician practices with the first-ever white-glove, turn-key, technology-driven capability that delivers true “hospital to home” continuum-of-care coverage. Following the pilot tests, Therma Bright announced it had signed a letter of intent (LOI) for a Venowave distribution program with DME Authority across the US. Through this distribution program, DME Authority would collaborate with multiple tenured and qualified network partners to establish no less than three comprehensive U.S. distribution agreements. As outlined in the LOI, these 'Premier Distributor Partner' contracts would require a minimum foundational inventory purchase of $2 million and collectively commit to a total inventory purchase of $6 million in Venowave VW5 devices within the first six months of 2025, with a minimum equal inventory purchase requirement between Q3 and Q4, 2025. On January 21, Therma Bright announced that it had secured a purchase order for 1,750 Venowave VW5 from the DME Authority, which would offer HCPCS code reimbursements that total about $1.43 million. This purchase order brings both companies one step closer to the outlined LOI that positions DME as a 'Premier Distributor Partner' for the company. Earlier in the year, Therma Bright announced that it had secured an initial purchase order for 100 Venowave VW5 units from another national distribution partner called Valor Medical. The initial purchase order was based on the success of the distributor's pilot tests around the HCPCS code reimbursement program and confirmation that Venowave was indeed a superior product compared to what was in the market. As a new national distribution partner of Therma Bright, Valor Medical looks to fill the immediate needs of its current network of medical practitioners and their patients. According to this distributor and its partners, they receive upwards of 100 doctor referrals per day for vascular compression therapy solutions and have seen great success in securing HCPCS code reimbursements within a normal 30- to 60-day timeframe. Valor Medical and its partners intend to place orders on a regular basis, perhaps every few weeks, as they build greater awareness of the Venowave VW5 solution with their end clients. This initial purchase order for 100 Venowave VW5 units offers HCPCS code reimbursements that total a minimum of $81,955. "We are excited to partner with Therma Bright in offering the Venowave VW5 to our national distribution network," shared Cindy Sebek Quick, Partner of Valor Medical Solutions. "This initial 100-unit purchase will fill the immediate demand of our partners, who anticipate early adoption of this special vascular compression therapy solution.” According to a report from Straits Research, the global compression therapy market was worth about $4.18 billion in 2024 and is projected to grow to $6.72 billion by 2033, representing a CAGR of 7.30%, which bodes well for Therma Bright. With 1,850 Venowave orders in the first month of this year alone and new distribution partners in the pipeline, the company is reaffirming its position as a key player in the US compression market. Moreover, the company’s second product is also helping position it as a key player in the medical device market and creating new potential areas for growth. Therma Bright is currently pursuing a U.S. Food and Drug Administration (FDA) 513(g) request to obtain information regarding the classification and regulatory requirements for its acoustic AI Digital Cough Technology (DCT) as a remote therapeutic monitoring solution. The DCT platform with partner AI4LYF is focused on supporting healthcare decision-making by improving the ability to collect, organize, and display cough and respiratory data for healthcare providers, as well as epidemiologists who are public health workers that investigate respiratory patterns. The company is also looking to get reimbursement codes through CMS that allow for this type of remote therapeutic monitoring device. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and has been compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website https://razorpitch.com/

February 03, 2025 07:00 AM Eastern Standard Time

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Therma Bright Inc. (OTC: TBRIF) Expands in $6.72 Billion Compression Market

TBRIF

In an aging world where healthcare costs are rising, the demand for cost-effective, non-invasive treatments is skyrocketing. One sector seeing a surge in interest is compression therapy, a market projected to grow from $4.18 billion in 2024 to $6.72 billion by 2033. Traditionally dominated by compression stockings and bulky pneumatic devices, the space is undergoing a technological shift toward portable, user-friendly solutions—opening the door for companies developing next-generation devices. One under-the-radar player making moves in this space is Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). The company’s Venowave VW5, an FDA-cleared, battery-powered compression device, has been gaining traction in the U.S. market, especially following recent reimbursement approvals from Medicare and private insurers. With a growing distribution network, strong early sales, and a huge addressable market, Therma Bright is quickly positioning itself as a compelling small-cap investment in a sector experiencing major tailwinds. With reimbursement momentum building and major distribution deals already in place, is Therma Bright an overlooked gem in the booming compression therapy industry? Let’s take a closer look at the opportunity. Therma Bright Inc.: Advancing Medical Innovation with Venowave VW5 Therma Bright Inc. is a developer and investment partner in advanced diagnostic and medical device technologies. The company focuses on delivering high-quality, innovative healthcare solutions to both consumers and medical professionals. Milestone Achievement: HCPCS Code Reimbursement Secured in Record Time Therma Bright and its nationwide U.S. distribution partners have successfully secured Medicare and Medicaid HCPCS Level II code reimbursements within just 60 days. Since October 1, 2024, over 110 Venowave VW5 units have been deployed across the U.S. in pilot tests, with 25 units already receiving full reimbursement through commercial health networks and federal healthcare programs. The remaining 85 units are anticipated to follow suit soon. Given these strong results, the company has initiated discussions on scaling sales, optimizing delivery logistics, and ramping up manufacturing with its distribution partners. "Our U.S. national distributors are highly impressed with the speed of CMS reimbursements for the Venowave VW5," said Rob Fia, CEO of Therma Bright. "Typically, brand-new HCPCS Level II codes require more time to process, but our code has been efficiently handled within 60 days. This sets a strong precedent for even faster reimbursements in the future and supports our commercialization efforts." Expanding U.S. Distribution with DME Authority Therma Bright has signed a Letter of Intent (LOI) with DME Authority, a Nashville-based distributor, to significantly expand Venowave’s reach. Under this agreement, DME Authority will establish at least three comprehensive distribution agreements, requiring an initial inventory purchase of $2 million. Collectively, these partners will commit to purchasing $6 million worth of Venowave VW5 units within the first six months of 2025, with an equal commitment for Q3 and Q4. DME Authority will also acquire Therma Bright’s remaining in-stock inventory as part of this agreement, ensuring seamless market expansion. "Our strategy to secure Venowave’s HCPCS code was crucial, and the timing couldn’t be better," said Erick Gosse, CEO of DME Authority. "Medicare patients have lacked a mobile mechanical compression solution—Venowave now fills that gap effectively." Product Overview: Venowave VW5 The Venowave VW5 is a compact, battery-operated peristaltic pump designed to improve vascular and lymphatic flow in the lower limbs. It qualifies for Medicare and Medicaid reimbursement under 10 medical indications and is the only Medicare-approved mobile mechanical compression system under HCPCS code E0683. Clinically Proven Benefits: Increases venous blood flow by 64% within 2 minutes and by 88% after 50 minutes of use. Enhanced Mobility: Lightweight (250g), discreet, and wireless, allowing patients to remain active during treatment. FDA-Designated Durable Medical Equipment (DME): Designed for repeated use across multiple patients. Major Purchase Orders Driving Market Expansion Therma Bright continues to strengthen its market presence through key purchase agreements: Valor Medical Solutions: Placed an initial order for 100 Venowave VW5 units following successful pilot trials. The purchase equates to a minimum of $81,955 USD in HCPCS code reimbursements ($117,952 CAD). Valor anticipates increasing its orders biweekly to meet growing demand. DME Authority: Confirmed a major purchase order of 1,750 Venowave VW5 units, totaling $1.43 million USD ($2.05 million CAD) in reimbursements. This milestone further solidifies DME’s role as a Premier Distributor Partner for Therma Bright. Market Outlook: Seizing a Growing Opportunity The global compression therapy market, valued at $4.18 billion in 2024, is projected to grow to $6.72 billion by 2033, representing a CAGR of 7.3%. Therma Bright is well-positioned to capitalize on this expanding market through strategic partnerships, timely reimbursements, and the increasing adoption of Venowave VW5. "With strong distributor commitments, rapid reimbursement processing, and increasing patient demand, we anticipate significant revenue growth in 2025 and beyond," added Rob Fia. Therma Bright remains committed to innovation, accessibility, and enhancing patient care as it scales its commercialization efforts for Venowave VW5 in the U.S. healthcare market. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and has been compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website https://razorpitch.com/

January 31, 2025 07:30 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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IntusCare Celebrates Milestone Year Building Momentum for 2025

IntusCare

IntusCare, a technology leader in the PACE market, celebrated a transformative year in its offerings for PACE (Programs of All-Inclusive Care for the Elderly), underscoring its commitment to supporting value-based care (VBC) models that serve complex senior populations. The company looks to build on the significant momentum in 2025. IntusCare starts the year with additional funding, having recently announced the company raised $11.5 million in a strategic follow-on financing round, bringing total funding to over $27 million. This infusion of capital will fuel the launch of CareHub, a comprehensive care management platform, and support the expansion of IntusCare’s existing suite of Revenue Integrity, Population Health, and Utilization Management solutions. Additionally, the company plans to accelerate its artificial intelligence research, aiming to enhance user experiences for healthcare providers and staff. Notably in 2024, the company announced the launch of two new products and one new service, all specifically designed for PACE. CareHub: The first PACE-specific EMR and practice management system for workflows to manage the VBC model, revolutionizing how interdisciplinary care teams, quality, and compliance managers care for older adults with complex healthcare needs. Intus Revenue Integrity System (IRIS): The first real-time, data-driven risk adjustment system designed specifically for PACE and VBC organizations. IRIS is designed to support PACE and VBC clinical, financial, compliance, and leadership teams to optimize workflows for consistent risk adjustment results. Delegated Utilization Management (UM) Service for PACE: The availability of fractionally-staffed Integrated Care Services (ICS) clinicians and nurses who optimize utilization management for organizations. “This year has been exciting in terms of building a foundation and the momentum to better serve our customers through technology and the expertise we bring to the industry,” said Robbie Felton, CEO and co-founder of IntusCare. “Initially when we started this company during college, we began as a data provider for PACE programs for better care decisions empowered by population health analytics. Now, we’ve grown in scope with delegated services, risk adjustment, and an EMR and practice management system, providing more value to our clients who are empowered to provide even better care for their complex, senior patients.” Much of IntusCare’s growth in scope took place within the last year, propelled by deep partnerships with their customers who shared their needs with the company. The vision for CareHub emerged when customers shared pain points such as reducing staff documentation and administrative burden, integrating disparate data systems, and enabling actionable workflows for interdisciplinary care teams. “Ultimately, we want to be the place where all value-based care organizations that manage risk for complex care come to do their work. CareHub is a key foundation of the ultimate operating system that we're looking to build for the space and community,” said Evan Jackson, co-founder and Chief Operating Officer for IntusCare. Strategic Partnerships Over the last year, IntusCare grew its strategic partnerships, including the addition of new PACE programs as clients along with alliances with other technology companies to improve offerings to customers. IntusCare now serves 70+ PACE organizations across the country, adding 33 new partners in 2024, an increase of ~90% over 2023. This growth is driven by our commitment to both grow alongside our existing partners and expand throughout PACE with the aligned goal of empowering high quality participant care. In addition, IntusCare is breaking down industry silos by prioritizing data access and interoperability through strategic partnerships with leading technology companies. This approach ensures the delivery of impactful, integrated solutions that better serve its customers. An example of how IntusCare is prioritizing interoperability with PACE organizations is through its collaboration with MedVision for seamless data integration, improved care coordination, regulatory and compliance support, and operational and financial efficiencies. Another partnership with Grane Rx will allow their pharmacy solutions to integrate with CareHub supporting medication safety, streamlined workflows, and advanced ePrescribing within the platform for PACE. Thought Leadership Education Providing software solutions is not enough within the complex healthcare environment, including some of the intricacies of PACE. IntusCare used its expertise and connections to support thought leadership educational opportunities to benefit the PACE ecosystem. Chief Population Health Officer Laura Ferrara, an experienced PACE leader, presented at several PACE organization conferences and meetings throughout the year, including a PACE Basics workshop at the National PACE Association’s annual conference in October. In November, IntusCare hosted a virtual conversation on “PACE and the Future of Healthcare Data Interoperability” with leading guests within healthcare and the PACE community. IntusCare CEO Robbie Felton moderated the discussion with Shawn Bloom, CEO and president of the National PACE Association (NPA); Dr. David Feinberg, Chairman of Oracle Health; and Stephanie Rock, Vice President of Product & Client Delivery at IntusCare. Team Growth In order to expand its software and services options, IntusCare strategically grew its team, including the addition of key leadership positions. Bharath Kakarla joined as the Senior Vice President of Engineering to lead the technology team, collaborating closely with product and design counterparts to ensure that IntusCare's products and services align seamlessly with customer needs. Stephanie Rock joined as Senior Vice President of Product and Client Delivery, leading the product and design teams to ensure the company meets the needs of IntusCare’s current and future partners. For more information and to schedule a demo or consultation, reach out through IntusCare’s website. About IntusCare ‍ IntusCare develops innovative predictive analytics platforms aimed at improving geriatric care outcomes. Founded in 2019 by Brown University undergraduate students, IntusCare empowers geriatric care providers to deliver more effective patient management and treatment for dual-eligible seniors – some of the most socially vulnerable and clinically complex individuals in the U.S. healthcare system. Visit our website to learn more intuscare.com. Contact Details Alison Matthiessen +1 401-490-9700 intuscare@svmpr.com Company Website https://intuscare.com/

January 29, 2025 10:00 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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