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American Heart Association Honors Centre for Neuro Skills with Group Stroke Hero Award

Centre for Neuro Skills

American Heart Association (AHA) awarded Centre for Neuro Skills, a leading brain injury and rehabilitation provider, with the Group Stroke Heroes award. The group hero award recognizes a group committed to educating, inspiring, and bringing awareness to stroke. CNS was selected among other stroke support groups, stroke teams, families, private associations, medical facilities and more. CNS’ mission is to provide quality post-acute neurorehabilitation to stroke and traumatic brain injury survivors, helping them to regain their independence. Its group of physicians, researchers, clinicians, and therapists deliver innovative therapy treatment to stroke patients to reduce disability and maximize independence. CNS regularly partners with organizations like AHA and the Brain Injury Association of America to raise funds, awareness, and education for stroke prevention and rehabilitation. In 2023, CNS raised more than $26,000 for innovative research and education to fight against heart disease and stroke through the participation of four American Heart Association Heart Walks in Dallas, Tarrant County, Kern County, and Austin. CNS President and Chief Executive Officer David Harrington chaired the Kern County Heart Walk, while Dr. Matthew Ashley, Chief Medical Officer, joined the Executive Leadership Team in Austin County. Clinicians and staff across all seven CNS locations hosted fundraisers, silent auctions, and events - all geared toward raising money for the Heart Walks. “We at Centre for Neuro Skills are all so proud and honored to be recognized with the Group Stroke Hero Award by the American Heart Association,” said David Harrington, president and chief executive officer of Centre for Neuro Skills. “I want to thank our entire CNS team for their tireless dedication to helping our stroke patients receive the best possible rehabilitation therapy.” In addition to community involvement, CNS’ experts educate the public about stroke through CNS’ media platforms, website, continuing education webinars, contributed content and media interviews. CNS regularly invites stroke survivors to share their stories through their online blog and YouTube channel, showcasing the different types of strokes, the causes of strokes, and their journeys to recovery. AHA also selected one of CNS’ patients, Craig Northcutt, who received the Stroke Survivor Hero award, recognizing an individual who has survived a stroke and used their experience to educate, inspire and bring awareness about stroke. To learn more about Centre for Neuro Skills (CNS) and its brain injury rehabilitation programming, visit www.neuroskills.com. *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, Twitter, LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

May 01, 2024 10:10 AM Pacific Daylight Time

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Cloud DX Reports Significant Revenue and Profit Growth in 2023

Cloud DX

Cloud DX CEO Robert Kaul joined Steve Darling from Proactive to discuss the company's impressive performance in its 2023 full-year results. Notably, Cloud DX reported a substantial 55.4% increase in revenue, reaching $1.8 million. A key driver of this growth was the remarkable surge in subscription revenue, which soared by nearly 70%, surpassing the overall revenue increase. This shift towards subscription revenue, characterized by high margins exceeding 90%, has significantly bolstered profitability, with gross profit doubling to $1.2 million, reflecting a remarkable 112% increase. The company's stellar performance is further underscored by its operational efficiency, as evidenced by a noteworthy $1.3 million reduction in operating expenses. This reduction was achieved through strategic staff cost management, executed without compromising on customer service quality. As a result, Cloud DX achieved a more than 20% decrease in operating loss, setting a positive trajectory towards profitability and positive cash flow in the coming quarters. Looking ahead, Cloud DX is well positioned to solidify its presence in the remote patient monitoring market in Canada. The company boasts the largest share of provincial contracts and maintains robust partnerships with major industry players such as Medtronic and Teladoc Health. Moreover, Cloud DX's successful early conversion of convertible debt at a premium underscores its strong financial management and commitment to enhancing shareholder value. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 30, 2024 12:04 PM Eastern Daylight Time

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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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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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Made in the USA: Ultrahuman plants flag in US with manufacturing facility UltraFactory to make first wearable rings in the country

Ultrahuman

With smart ring market leadership within its sights, Ultrahuman has today announced plans to open a manufacturing facility poised to accelerate its production capacity. The UltraFactory will be located in Indiana. It opens within the next six months and will be the launchpad for Ultrahuman’s next phase of growth. The UltraFactory will offer an end-to-end production capability and is based on the company’s first operational model of such a facility in India. This development comes hot on the heels of a $35 million fresh investment in the company (series B funding round) and reaffirms Ultrahuman’s ambition to become the market leader in the smart ring space in the next 12 to 15 months. The company has already seen phenomenal growth over the past year, becoming the second-largest player in the smart ring market while maintaining profitability. The opening of the new UltraFactory, will add a production capacity of 200,000 smart rings and present an additional $100m revenue opportunity annually. This is a push towards establishing smart ring market leadership in the US. Ultrahuman’s ability to make significant long-term manufacturing investments, supported by its profitability, is unique in the smart rings market. As a result, UltraFactory’s cutting-edge end-to-end production capabilities will enable the company to fully capitalize on what the company sees as its biggest competitive advantage: fast product development and iteration, and speed of execution in rolling out to global markets. With the US market growing in importance for Ultrahuman in recent months, the move will help the company lower costs in shipping and logistics, while aiding the US government in its push to strengthen domestic manufacturing rather than manufacturing in offshore locations, like China. This brings an expected hiring boom of 150 new Ultrahuman employees in the US over the next 12 months split between engineering and research (30%) and commercial operations (70%). Mohit Kumar, Founder and CEO of Ultrahuman commented: “US is an interesting market for us given it has always been huge in terms of demand for the product but we’re also seeing tremendous value from a manufacturing and research perspective. UltraFactory US would enable manufacturing for health tracking smart ring devices and give us the ability to do necessary research to evolve the form factor further.” Ultrahuman has seen phenomenal growth over the past 12 months, becoming the second-largest player in the smart ring market while maintaining profitability. "Our vision of being the top player in terms of both active devices and geographic presence is within reach, thanks to our rapid expansion and the love we've received from our users," added Mohit Kumar. UltraFactory will help Ultrahuman support its recent retail expansion into over 150 outlets worldwide, spanning iconic locations like London’s Selfridges on Oxford Street, Changi Airport in Singapore, and the Virgin megastore in Dubai. In addition to their smart ring called Ring AIR, the Ultrahuman product suite includes a continuous glucose monitoring wearable called M1 Live, a home health device called Ultrahuman Home and a preventive blood testing product called Blood Vision. Their platform integrates glucose, sleep, movement, blood markers, and HRV, offering a comprehensive approach to health monitoring. "Our growth is a testament to the user love for our products, highlighted by industry-leading NPS and engagement metrics since the launch of our latest model, the Ring AIR. Our relentless focus on improving user experience through continuous firmware and software updates is what sets us apart," Mohit Kumar emphasized. "Shipping a new firmware version every 2 weeks and weekly app improvements reflect our commitment to excellence and our speed of execution, our biggest competitive advantage. We’ve also iterated on hardware at the speed of software by designing novel devices like Ultrahuman Home, a home health monitor.” Looking ahead, Ultrahuman is on track to surpass $100 million in annualized revenue run rate (ARR) by the end of 2024, a milestone that will be achieved profitably. "Our ability to make long-term manufacturing investments, supported by our profitability, is unique in the smart ring market," Mohit Kumar noted. Ultrahuman's dedication to scientific validation and innovation is further evidenced by the completion of a clinical trial involving 105 participants, aimed at validating the ‘Metabolic Score’ generated on the Ultrahuman platform. "Our long-term investment in R&D and intellectual property is a cornerstone of our strategy, ensuring that our products not only meet but exceed the highest standards of efficacy and reliability," Mohit Kumar concluded. About Ultrahuman Ultrahuman is the world's most advanced metabolic fitness platform. Ultrahuman’s products include the Ultrahuman M1(continuous glucose monitoring sensor), the Ultrahuman Ring and Blood Vision, a preventive blood testing platform with the pioneering UltraTrace™ technology. By collating different biomarkers, Ultrahuman is helping people improve their energy levels and lifestyle, track their workout, sleep and recovery, and avoid metabolic disorders. For more information and updates on Ultrahuman, please visit ultrahuman.com or follow us on Facebook, Instagram, Twitter, LinkedIn, and YouTube. Contact Details Ultrahuman Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Ultrahuman Hisham Syed hisham@ultrahuman.com Company Website https://www.ultrahuman.com/

April 23, 2024 10:15 AM Eastern Daylight Time

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ANGLE achieves breakthrough with EU patent for CellKeep technology, with the US to follow

ANGLE PLC

ANGLE PLC chief executive Andrew Newland discussed significant advancements in the company's technology, including a European patent for the CellKeep slide, with US intellectual property protection from the US set to follow soon. Newland told Proactive's Stephen Gunnion that CellKeep significantly improves the deposition of cancer cells on microscope slides, a common issue in medical laboratories. This method notably reduces cell loss during the transfer process by over 70%, addressing a longstanding problem in the industry. The innovation involves a special funnel attached to the slide, allowing gentle centrifugation and liquid removal while maintaining cell integrity, thereby increasing the effectiveness of subsequent analyses. Additionally, Newland highlighted the development of optimized antibodies for cell phenotyping, which are integrated into ANGLE's Parsortix system. This integration is packaged as the Portrait Plus CTC Staining Kit, simplifying the process for less experienced labs and extending market reach. The kit includes a mix of dehydrated antibodies, designed for ease of use and long shelf life, enhancing the diagnostic process's reliability and efficiency. Commercially, ANGLE has introduced these innovations in a comprehensive kit format, priced at £3,000 for ten samples, significantly enhancing the company’s value offering. Newland also touched on ANGLE’s positive business trajectory, mentioning a breakthrough in DNA profiling and a substantial contract with a major pharmaceutical company, which could potentially yield significant revenues through the development of companion diagnostics. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 23, 2024 09:17 AM Eastern Daylight Time

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