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Hemogenyx Pharmaceuticals outlines significant progress with HEMO-CAR-T in 2023

HemoGenyx Pharmaceuticals

Hemogenyx Pharmaceuticals PLC CEO Dr Vladislav Sandler tells Proactive's Stephen Gunnion that 2023 was a significant year for the company, marked by notable progress with its HEMO-CAR-T product candidate. The key achievement for the year was the submission of a new Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to commence a phase one clinical trial for the treatment of relapsed refractory acute myeloid leukemia. However, the process faced a setback due to issues with lentivirus purity, resulting in a clinical hold. After re-manufacturing the lentivirus, Hemogenyx successfully addressed the FDA's concerns and received approval to proceed with the clinical trials. Furthermore, Sandler reported a successful fundraising which will support the upcoming clinical studies. The company also entered a service agreement with Prevail Infoworks for the clinical trials. In addition to its advancements in HEMO-CAR-T, Hemogenyx continued developing other programs, such as its proprietary Chimeric Bait Receptor (CBR) platform, showing promise in treating non-Hodgkin lymphoma and exploring applications in solid rare tumors. For 2024, the primary focus remains on advancing these clinical trials, particularly the phase one studies, with an immediate goal to initiate patient treatment. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 29, 2024 11:52 AM Eastern Daylight Time

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New Standard of Care? IceCure Submits Final ICE3 Data To FDA, Minimally Invasive Cryoablation Shows Similar 5-year Recurrence Outcomes To Surgery With Hormone Therapy

Benzinga

By Meg Flippin, Benzinga IceCure Medical Ltd. (NASDAQ: ICCM), the Israeli medical device developer of ProSense®, an advanced liquid-nitrogen-based cryoablation therapy that destroys tumors (benign and cancerous) by freezing them, is one step closer to getting U.S. Food and Drug Administration approval to market ProSense® to treat patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. IceCure just reported final clinical trial results of 100% patient and physician satisfaction with the minimally invasive procedure. At the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense® cryoablation, followed by hormone therapy, were estimated to be free from local recurrence Earlier in April, the company submitted its final data to the FDA which included five-year follow-up data from its ICE3 study, a sub-analysis of the ICE3 results compared to studies that evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery and received hormone therapy and real-world data from the use of ProSense® globally, including post-market commercial use as well as data from independent third-party studies. ProSense®, which received the FDA's Breakthrough Device Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast and tumors in the kidney and liver. Positive Topline Results IceCure’s ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The five-year recurrence-free rates from the study, which evaluated IceCure's minimally invasive 20-to-40-minute outpatient cryoablation procedure, were in line with expectations and showed similar outcomes to lumpectomy, the current standard of care for early-stage breast cancer patients, which is breast surgery that requires an operating room and hospital stay. In the ICE3 study, 96.39% of patients (187 out of 194 patients) were local recurrence-free with no significant device-related adverse events or complications reported. A comparison of this result from the ICE3 study shows similar outcomes in five-year recurrence rates compared to patients in other studies who were treated with lumpectomy followed by hormone therapy. The LUMINA study reported a 97.7% recurrence-free rate at five-year follow-up and the PRISMA meta-study, which included Lumina, reported a 97.19% recurrence-free rate at five-year follow-up. ICE3 results are also in line with data from real-world use of ProSense® by third parties in territories where IceCure's cryoablation system is used to treat early-stage breast cancer. In the final ICE3 analysis, no significant device-related adverse events or complications were reported, and all patients and physicians reported satisfaction with the ProSense® procedure, the company said. That means 100% of physicians and patients were happy with the treatments they received. Dr. Richard Fine, ICE3’s lead investigator, presented final data from the ICE3 study at the American Society of Breast Surgeons 25th Annual Meeting, where he commented, "Cryoablation is a safe, minimally invasive ablative procedure with acceptably low five-year same breast recurrence similar to that of lumpectomy for similar patient populations, with the benefit of being an office-based, nonsurgical treatment. Further study within a clinical trial or registry is needed to confirm cryoablation as a viable alternative to surgical excision in the appropriately selected patients.” Dr. Fine’s presentation, which received the conference’s Scientific Impact Award, was well received by breast surgeons who are constantly looking for treatments that are minimally invasive and effective. A New Way To Treat An Old Problem What makes cryoablation so attractive to freeze and destroy tumors is that it is minimally invasive, has little pain associated with it and thanks to an ultrasound or computerized tomography can accurately destroy diseased tissue within the tumor zone. Cryoablation also costs less than a lumpectomy and reduces the risk of follow-up surgery. With a lumpectomy, the re-excision rate is between 14-21%. IceCure’s ProSense® has the potential to become a new standard of care treatment for women with early-stage T1 invasive breast cancer, marking a major improvement to the care available today. Some researchers have even called cryoablation the “ ultimate esthetic solution for breast cancer ” because it reduces the need for pre-emptive or corrective surgical procedures to maintain or restore breast volume, contour and symmetry. "Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA's response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval," stated IceCure CEO Eyal Shamir. With Reimbursement In Place, IceCure Is Ready To Go With the final data submitted, IceCure is ready to go once the FDA gives it the green light. The company received what it said was the first Medicare coverage approval of a cryoablation procedure for breast cancer. The Centers for Medicare & Medicaid Services (CMS) set the reimbursement payment at about $3,400 for the facility alone. Additional coverage, including payment for the physician, is expected upon establishment of the permanent CPT Category I code, which is conditioned on factors including the company's receipt of FDA marketing authorization of ProSense® for breast cancer. Having that reimbursement should enhance the usage of the ProSense® system. Nearly 300,000 women are diagnosed with invasive breast cancer yearly, and the majority have to undergo invasive treatments and deal with follow-up surgeries in the quest to live cancer-free. IceCure is changing that by freezing tumors to destroy them. IceCure seems poised to do exactly what it set out to do: provide women with an alternative minimally invasive treatment option. Featured photo by Angiola Harry 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

April 29, 2024 08:20 AM Eastern Daylight Time

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AI Frontiers in Healthcare: Revolutionizing Medicine at the 2024 1ArtificialIntelligence Global Conference

1BusinessWorld

As the healthcare sector undergoes a technological transformation, artificial intelligence (AI) is at the forefront, driving significant advancements. The 1ArtificialIntelligence | 2024 Global AI Conference will delve into these developments during its standout session, " Breaking New Ground: How AI and Tech Startups Are Revolutionizing the Digital Health Landscape. " Scheduled for May 9, this pivotal discussion promises to highlight the innovative role of AI in reshaping healthcare delivery and management. Moderated by Sally Ann Frank, Worldwide Lead for Health & Life Sciences, Microsoft for Startups, this panel brings together industry luminaries who are pioneering the integration of AI into healthcare. The session features: - Sally Ann Frank, WW Lead, Health & Life Sciences, Microsoft for Startups - Stead Burwell, Founder & CEO, Outbound AI - Lana Feng, Co-founder and CEO, Huma.Al - Andrew Gostine, CEO, Artisight - Ankur Teredesai, CEO, CueZen These experts are set to discuss the transformative impact of AI across various aspects of healthcare: - AI-Driven Diagnostics and Personalized Treatment: The panel will explore how AI is enhancing diagnostic accuracy and enabling personalized treatment plans that are tailored to individual patient needs. - Operational Efficiency: Insights will be shared on how AI is streamlining operations within healthcare facilities, from administrative processes to patient care, reducing costs and improving service delivery. - Ethical and Regulatory Frameworks: As AI becomes more entrenched in healthcare, the panelists will tackle the ethical considerations and regulatory challenges that need to be navigated to ensure responsible deployment of AI technologies. The discussion is not just about what AI is currently achieving but also about its future potential. The panelists will provide forecasts on emerging technologies, anticipated regulatory developments, and the long-term implications of AI in healthcare. This session will serve as a comprehensive guide for healthcare professionals, technology innovators, and policymakers interested in the intersection of AI and healthcare. For those looking to stay at the cutting edge of healthcare innovation, the "Breaking New Ground" session at the 1ArtificialIntelligence | 2024 Global AI Conference is an unmissable event. It offers a unique opportunity to hear from the trailblazers who are not only navigating the challenges of AI integration but are also setting the stage for the next generation of healthcare solutions. Contact Details Media Enquiries +1 212-220-6677 info@1businessworld.com Company Website https://1businessworld.com

April 28, 2024 03:17 PM Eastern Daylight Time

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Over 200 passionate programmers participated in The Bucharest Hackathon 2024, and the total prizes exceeded 50,000 dollars

STORM Partners

https://we.tl/t-lk7ZTXr33k Bucharest, 25th of April 2024: On April 14th, the Odeon Theater hosted the second edition of The Bucharest Hackathon, the first hackathon in Romania dedicated to enthusiasts of new technologies. The competition brought together over 200 amateur and senior programmers, both Romanian and foreign, who came from Bucharest as well as from other cities in the country, such as Cluj, Brasov, or Craiova. For 24 hours, they coded and competed in developing software projects that tested the limits of modern technologies. The top three teams won the grand prize of a total value of $30,000, but 25 teams were also selected to receive special prizes from the partners. For the final competition, 35 teams were selected. “ The Bucharest Hackathon is attracting more and more participants. I was impressed by the level of competence of the teams and projects and their achievements in only 24 hours. The jury members, most of whom have international experience, appreciated the location and organization, stating that they felt like they were at a hackathon in Silicon Valley. Genezio was chosen by more than half of the teams to implement their solution. ” Andrei Pitis, CEO & Co-founder of Genezio. “ From the moment we saw the first registrations for the event, we realized that we were going to have a completely different edition: an iconic location, much bolder ideas, much more creative solutions, but also a considerable effort - and so it was. The Bucharest Hackathon was truly an emotional roller-coaster: from the trust in the colleagues on our team to the transformation of an idea into a product, and to the decisive moment when you find out if you are among the winners,” said Flavian Manea, CEO and co-founder of Bware Labs. “At MultiversX, we are proud to support innovation and entrepreneurship in our tech community. The partnership with The Bucharest Hackathon underlines our commitment to the future of technology and innovation in Romania. We are excited to see such creative ideas turned into reality and provide the necessary support for these projects to become successful startups”, Daniel Serb, VP of Business Development of MultiversX. Each of the three winning teams received prizes worth over $10,000, as well as Amazon vouchers worth $15,000, while the teams that won special prizes from the partners received $20,000 in vouchers on the Blast platform, developed by Bware Labs, $10,000 in Genezio vouchers, two startup support prizes from MultiversX, a special prize from Google: Google Nest Hub (2nd Gen) smart speakers, an innovation prize from PiSquared worth $2,500 in vouchers and $2,000 in consulting vouchers from Astrarizon. Fork_Exec, Salty, and Awesome Hackers are this year's winning teams at The Bucharest Hackathon This year’s grand prize of $5,000 was won by the Fork_Exec team, made up of Dejanu Alexandru, Opri Cezar, and Dumitru Iulia. Fork_Exec developed a software solution based on speech recognition and artificial intelligence technologies that allows programmers to automate parts of coding based on voice commands. Second place, worth $3,000, went to the Salty team, composed of Kerimberdi Agayev Kaibov Merdan and Cihan Ilhan. They proposed an application for high school students to receive guidance on complex math problems. The application takes the user’s handwriting and, combining OpenAI and AWS Cloud technologies provides the answer to the problem almost instantly. The third prize, of $2,000, was won by the programmers from the Awesome Hackers team, namely Puiu Răzvan, Ene Cosmina, and Manea Lucas. Awesome Hackers created a neural data collection platform designed to help improve cognitive function and focus. In addition, two of the participating teams will receive support from MultiversX so that their ideas can reach the startup stage (Awesome Hackers and Mental Regression). Among the special prize winners is also the Wildcard team, who received a Nest Hub 2nd Generation from Google. The jury was made up of tech experts, IT entrepreneurs, and top executives from the companies: Genezio, Bware Labs, MultiversX, Google, Stripe, PiSquared, XOXNO, and Amazon Web Services. For this edition, the main partners Genezio and Bware Labs, the co-founding companies of The Bucharest Hackathon project, were joined by the Romanian blockchain company MultiversX. Among the partners of the second edition of The Bucharest Hackathon are the companies Stripe, PiSquared, XOXNO, Google, Amazon Web Services, Astrarizon, and xExchange. The event was sponsored by Orange Romania, AQUA Carpatica, Blue Romania, Domeniile Averești, Komoder Romania, Nespresso Professional, and Good Routine by SECOM, with media and communication partners Republica, Innovation Labs, ETH Bucharest, Caracteristic PR, KCD Romania, and the Student League Electronics. About The Bucharest Hackathon The Bucharest Hackathon is a 24-hour competition dedicated to programmers and enthusiasts of modern technologies, such as AI, Dev Tools, blockchain, and others. Although initially dedicated to those in Bucharest, the event welcomed programmers from other cities or countries in both editions. The event was founded by Bware Labs and Genezio in 2023 to provide enthusiasts of modern technologies with the space, resources, and challenges they need to develop themselves and test both their limits and those of new technologies. About MultiversX MultiversX is a highly scalable, secure, and decentralized blockchain network built from first principles, to solve the two fundamental problems critical for widespread, global adoption: a transition from dialup to broadband, and a significant UX paradigm shift. Media Contact: Dan Voicu, Head of Communications dan.voicu@multiversx.com Distributed by STORM Partners. Contact Adrian Bono for interviews and quotes - adrian.bono@storm.partners or telegram @STORMPartners Contact Details MultiversX Dan Voicu, Head of Communications dan.voicu@multiversx.com Company Website https://multiversx.com/

April 25, 2024 11:07 AM Eastern Daylight Time

MariMed closes acquisition of a dispensary in Illinois marking the company’s 5th in that state

MariMed Inc

MariMed CEO Jon Levine joined Steve Darling from Proactive to to share the Company’s significant developments, including its recent of Allgreens Dispensary, LLC, which closed on April 9, 2024. The acquisition enabled the Company to operate its 5th Thrive-branded dispensary in Illinois. It followed the recent opening of the Company’s processing facility in Mt. Vernon, Illinois, which enabled the Company to distribute its portfolio of top-selling brands throughout the high-growth state. Illinois surpassed $1.6 billion in adult-use cannabis sales last year, and MariMed looks to continue expanding there as current regulations in Illinois permit operators to own up to 10 dispensaries. In addition to its expansion efforts in Illinois, MariMed has acquired the assets of Our Community Wellness & Compassionate Care Center in Prince George's County, Maryland. This acquisition marks MariMed's second adult-use Thrive Wellness dispensary in Maryland, complementing its existing location in Annapolis. The Company is vertically integrated in Maryland, with a cultivation and processing facility in Hagerstown that distributes MariMed products state-wide. As a company dedicated to developing and distributing great brands and delivering an exceptional customer experience at its retail stores, these recent acquisitions underscore MariMed's commitment to strategic expansion and enhancing its footprint in key cannabis markets. Contact Details Proactive North America Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

April 24, 2024 02:01 PM Eastern Daylight Time

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Nevis Brands announces major shots are now for sale in dozens if dispensaries in Missouri

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the successful completion of the initial production run of Major shots in Missouri through its licensee, Stash House Distro. This milestone marks the expansion of Nevis Brands' product offerings into the Missouri market, with three flavors of its 2-ounce Major shots—Fruit Punch, Blackberry Lemonade, and Blueberry—now available for sale. Nevis Brands has previously introduced these products in Washington and Ohio, achieving successful distribution. The Major shots are infused with 100mg of THC and leverage a proprietary formula of flavor and emulsion technology, enabling rapid onset effects in under 20 minutes with minimal cannabis taste. The products are now accessible to consumers in numerous dispensaries across Missouri, further solidifying Nevis Brands' presence in the cannabis beverage market. Additionally, Kueber shared news regarding the restructuring of the company's Promissory Note due to SoRSE Technology Corp., which was initially part of Nevis Brands' purchase of the SoRSE Technology business units "THC Essentials," including the Major brand. Under the revised terms of the agreement, Nevis Brands will pay USD $100,000 by April 30th, 2024, and proceed with periodic payments to retire the note principal by December 31, 2024. This strategic move reflects Nevis Brands' commitment to managing its financial obligations while continuing to expand its product portfolio and market presence. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 24, 2024 01:57 PM Eastern Daylight Time

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Creo Medical says NHS case study reveals significant efficiencies from Speedboat technology

Creo Medical Group PLC

Creo Medical Group PLC (AIM:CREO) CEO Craig Gulliford discusses an NHS case study that showcases the efficacy of Creo's Speedboat technology. In an interview with Proactive's Stephen Gunnion, Gulliford discussed the case study, which was conducted by the NHS Supply Chain responsible for the procurement of devices and consumables worth approximately £4 billion. This study, which analysed 130 cases, demonstrated significant cost savings and clinical outcomes, with almost £700,000 saved and reductions in hospital stay times for patients, which potentially impacts surgical and endoscopy waiting lists significantly. Gulliford also outlined future plans involving routine guidance by NICE and ongoing partnerships with the NHS Supply Chain to further implement and leverage the technology across UK trusts. He emphasized the dual benefits of clinical excellence and cost savings. Additional updates from Gulliford included progress in other areas of the company, like advancements with robotics and polymeric technology, and significant regulatory developments. Overall, these initiatives are part of Creo’s strategy to expand its product range and increase utilisation of its technology not just in the UK but globally, he added. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 24, 2024 10:56 AM Eastern Daylight Time

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ANGLE partners with AstraZeneca in groundbreaking oncology contract

ANGLE PLC

ANGLE PLC chief executive Andrew Newland joins Proactive's Stephen Gunnion with news the company has entered a significant contract with AstraZeneca, marking its second major collaboration with a large pharmaceutical company. Newland, expressed enthusiasm about this development, noting the contract's potential to expand ANGLE's services in oncology trials. The initial phase of the contract is valued at £150,000, but it holds substantial potential due to the possibility of implementing a new assay in numerous cancer trials involving AstraZeneca. The scope of the collaboration includes the development of assays for examining proteins on cancer cells across multiple trials, with potential earnings of £2,000 per time point in over 460 trials. The contract also enables ANGLE to further validate and possibly expand its FDA approvals, positioning it uniquely as a provider of comprehensive diagnostic solutions internationally. Looking ahead, the successful execution of the contract could lead to extensive financial gains for ANGLE PLC, ranging into the tens or even hundreds of millions of pounds, particularly as AstraZeneca's trials progress and its drugs approach commercial launch. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 24, 2024 10:52 AM Eastern Daylight Time

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Cloud DX seeing customer loyalty with 2 Ontario Community Paramedic Service contract renewals

Cloud DX

Cloud DX CEO Robert Kaul joined Steve Darling from Proactive to share exciting updates with Proactive regarding the renewal of Master Deployment Agreements with paramedic services in Ontario. These agreements, spanning 12 months with an Ontario County Paramedic Service and 24 months with the Guelph Wellington - City of Guelph Paramedic Service, signify the continued partnership between Cloud DX and these healthcare providers. In Ontario, Community Paramedic Services leverage Cloud DX's Connected Health Remote Patient Monitoring (RPM) services to offer daily monitoring of vital signs, physical symptoms, and chronic conditions to seniors. Through the Cloud DX mobile app, patients can interact with paramedics, facilitating close oversight and empowering patients to manage their own care effectively. Of particular note is the Community Paramedicine for Long-Term Care (CPLTC) program, fully funded by the Ontario provincial government to provide additional care for seniors before admission into long-term care facilities. The recent announcement of an additional $174 million CAD in funding to expand the CPLTC program from 2024 onwards underscores the importance and growth potential of this initiative. Kaul emphasized that contract renewals are a significant sales metric for Cloud DX, demonstrating the company's ability to continue serving satisfied clients effectively. Cloud DX has successfully renewed and extended Master Service Agreements with Community Paramedic Services in 10 Ontario counties, further solidifying its position as a trusted partner in the healthcare industry. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 23, 2024 01:43 PM Eastern Daylight Time

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