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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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CEO Roby Zomer discusses Argent BioPharma's future in pharmaceuticals

Argent BioPharma Ltd

Argent BioPharma managing director and CEO Roby Zomer speaks to Proactive's Stephen Gunnion following the company's rebranding from MGC Pharmaceuticals, alongside a comprehensive restructuring. Zomer explained the shift marks a refined focus on the pharmaceutical sector, discarding previous activities not aligned with pure pharmaceutical processes. Zomer highlighted the company’s advancement in drug discovery, particularly through a multidisciplinary approach and modern technologies such as nanotechnology and mRNA modulation. These innovations are targeted at addressing unmet medical needs. The company has developed notable products including CannEpil and CimetrA. CannEpil targets refractory epilepsy and has shown efficacy in controlling seizures without reported adverse events. CimetrA, developed during the COVID-19 pandemic, is designed to alleviate COVID-19 symptoms and prevent cytokine storms, with potential applications in treating other autoimmune diseases. Both drugs are now being prescribed in key markets including the United States and Europe. Zomer expressed optimism about the future, emphasizing ongoing research and progress in obtaining regulatory approvals. The focus will remain on enhancing early patient access schemes, which are expected to significantly impact revenue. Over the next 24 months, Argent BioPharma plans to introduce more innovative treatments to the market. Contact Details Proactive UK Proactive UK +44 20 7989 0813 UKEditorial@proactiveinvestors.com

May 01, 2024 10:07 AM Eastern Daylight Time

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Immunic Phase 2 EMPhASIS trial data highlighted in peer-reviewed neurology journal

Immunic Inc

Immunic Inc (NASDAQ:IMUX) CEO Dr Daniel Vitt joined Proactive's Stephen Gunnion with news of the publication of extended data from the Phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting multiple sclerosis (RRMS) in the peer-reviewed journal, Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology. Vitt noted that the EMPhASIS trial demonstrated a notable reduction in gadolinium-enhancing lesions by 78% and 74% in two high-dose groups compared with the placebo. These results also correlate with improvements in serum neurofilament light chain levels, consistent with recent interim phase 2 clinical data from the ongoing CALLIPER trial in progressive MS, indicating ongoing progress in the field. Vitt highlighted the study's contribution to understanding the neuroprotective and anti-inflammatory effects of the treatment under investigation. The drug's potential impact on the treatment landscape of MS, particularly its role in addressing disease progression independent of relapse activity, was emphasized. Immunic is also conducting the CALLIPER trial in progressive MS, with key results expected by April 2025. Additionally, the phase 3 ENSURE trials are actively enrolling, with projected readouts in 2026. Dr Vitt expressed optimism about the drug's unique profile, combining safety and effectiveness in potentially altering the management of all forms of MS. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 01, 2024 10:02 AM Eastern Daylight Time

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Poolbeg Pharma and Silk Road Therapeutics announce strategic collaboration on novel orphan drug

Poolbeg Pharma PLC

Poolbeg Pharma PLC CEO Jeremy Skillington and Tim Coté CEO of Silk Road Therapeutics join Proactive's Stephen Gunnion with details of an exclusive 12-month option agreement with Silk Road Therapeutics for Poolbeg to acquire a novel topical drug aimed at treating oral ulcers in patients with Behçet's disease, a rare and debilitating condition. Skillington said the move is aligned with Poolbeg's strategic focus on rare and orphan diseases. Coté, with an extensive background in orphan drug approvals from his time at the FDA, highlighted the potential of the drug given its unique formulation and unmet need in the market. He explained the severe impact of Behçet's disease, underscoring the innovative potential of their topical treatment in improving the quality of life for those affected. Both CEO expressed optimism about their collaboration's potential to fast-track this novel treatment to market, leveraging Poolbeg’s and Silk Road's combined expertise. Furthermore, Skillington provided insights into Poolbeg’s financial health and strategic developments over the past year, mentioning a robust cash position of £12.2 million at the end of 2023. He emphasised the company's disciplined capital allocation and the expansion of its intellectual property portfolio. Looking ahead, Skillington outlined Poolbeg's focus on progressing its pipeline, particularly ongoing projects like POLB001 in the oncology sector, addressing cytokine release syndrome—a critical side effect in cancer immunotherapies. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 01, 2024 09:51 AM Eastern Daylight Time

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Nevis Brands Expands Major Distribution with Exclusive Licensing Agreement in Mississippi

Nevis Brands

Nevis Brands CEO John Kueber joined Steve Darling from Proactive to announce the company has announced a significant expansion in Major's distribution through an exclusive licensing agreement with Stash House for production and distribution in Mississippi. Under this agreement, Stash House will have exclusive rights to produce and distribute the full lineup of Major products in the state. The Major lineup includes dose-able 100mg THC beverages available in flavors such as Blueberry, Fruit Punch, and Blackberry Lemonade. Known for delivering the effects of cannabis within a short timeframe of 10-20 minutes after consumption, Major has gained popularity since its initial launch in Washington State in 2019, with over 5 million bottles sold to date. Kueber highlighted Mississippi's recent legalization of cannabis for medical use in January 2023, which has led to the licensing of over 400 dispensaries in the state. This agreement marks Major's entry into its 10th state for production, further expanding its reach across the United States. Currently available in Washington, Oregon, Arizona, Ohio, Colorado, Nevada, California, and Missouri, Major is also preparing for production in Michigan, signaling the brand's continued growth and market penetration. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 30, 2024 12:12 PM Eastern 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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Immunic CEO Dr Daniel Vitt marks International Day of Immunology with discussion on its crucial role

Immunic Inc

Immunic Inc CEO Dr Daniel Vitt joins Proactive's Stephen Gunnion on the International Day of Immunology to discuss the broad and crucial role of immunology in human health. Vitt said immunology encompasses immune responses against pathogens like viruses, including the coronavirus, and also plays a significant role in combating cancer. He highlighted the importance of the immune system in managing and preventing autoimmune diseases, where the body mistakenly attacks its own cells, leading to various conditions. Focusing on Immunic's efforts, Vitt detailed their drug development pipeline, particularly in addressing chronic inflammatory and autoimmune diseases such as multiple sclerosis, ulcerative colitis, Crohn's disease, and celiac disease. He spotlighted multiple sclerosis, with ongoing phase three studies in its relapsing form and a phase two study, named the CALLIPER trial, for its progressive form. The latter holds particular promise as it targets an area with currently no available treatments. For celiac disease, Vitt reported promising results from a phase one B proof-of-concept study that showed positive data across various metrics, including histology and biomarker levels. Plans are underway for further phase two studies in celiac disease and potentially other indications. Vitt also shared his personal journey from chemistry to immunology, driven by the potential to develop drugs that address significant medical needs. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 29, 2024 11:11 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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