News Hub | News Direct

Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
Article thumbnail News Release

4 Stocks to Watch in the Booming Regenerative Medicine Market

BSEM, ZBH, SNN, MDXG

Regenerative medicine is revolutionizing healthcare. It encompasses a range of cutting-edge therapies aimed at repairing or replacing damaged tissues and organs, offering tangible solutions rather than mere symptom management. With a global market projected to surge from USD 29.42 billion in 2023 to an estimated USD 154.05 billion by 2033, regenerative medicine presents significant investment opportunities. This burgeoning field focuses on utilizing tissue engineering, cellular therapies, and medical devices to harness the body's natural healing processes, paving the way for unprecedented medical advancements. By addressing the root causes of ailments and enabling the regeneration of tissues and organs, regenerative medicine holds immense promise for transforming patient outcomes and reshaping the healthcare landscape. Investors should pay close attention to the developments in regenerative medicine, as they represent not only a paradigm shift in medical treatment but also a lucrative avenue for growth. Here are four companies in the market segment for your watchlist. SNN Smith+Nephew (NYSE: SNN) is a prominent medical technology company specializing in the repair, regeneration, and replacement of soft and hard tissue. With a focus on innovative solutions, Smith+Nephew is positioned as a key player in the regenerative therapy segment. In its recent trading update for the first quarter ended March 30, 2024, Smith+Nephew reported a 2.9% increase in revenue, reaching $1,386 million. This growth highlights the company's resilience and market presence. It is driven by strong performance in orthopaedics, sports medicine, and ENT. Orthopaedics revenue saw a 4.4% increase on an underlying basis, with notable growth in key segments such as hip and knee implants outside the US. Similarly, strong performance in sports medicine joint repair and the growth of the REGENETEN product line drove an underlying 5.5% increase in revenue for sports medicine and ENT. Despite some softness in Advanced Wound Management, Smith+Nephew maintains its full-year 2024 guidance, expecting underlying revenue growth in the range of 5.0% to 6.0%. This guidance reflects the company's confidence in its ability to capitalize on market opportunities and drive sustainable growth. Furthermore, a recent randomized controlled trial (RCT) validated Smith+Nephew's REGENETEN Bioinductive Implant by showing a noteworthy 68% decrease in full-thickness rotator cuff re-tear rates. With over 100,000 procedures completed globally since its introduction, the REGENETEN Bioinductive Implant is poised to contribute significantly to Smith+Nephew's growth in the regenerative therapy segment. As investors seek potential opportunities in the regenerative therapy sector, Smith+Nephew (NYSE: SNN) stands out as a company with innovative solutions and strong growth prospects, making it a stock worth considering. Major global medical technology provider Zimmer Biomet Holdings, Inc. (NYSE: ZBH) continues to demonstrate robust financial performance, reporting impressive first-quarter results. The company, headquartered in Warsaw, Indiana, posted a net income of $172.4 million for the quarter, translating to earnings of 84 cents per share. After adjusting for amortization costs and restructuring expenses, earnings stood at $1.94 per share, surpassing expectations set by Wall Street analysts. In terms of revenue, Zimmer Biomet exceeded forecasts, generating $1.89 billion in revenue for the period. This figure outpaced the expectations of analysts surveyed by Zacks Investment Research, who had projected revenue of $1.87 billion. These results underscore the company's strong market position and its ability to deliver value to shareholders. Last year, in 2023, Zimmer Biomet Holdings Inc. agreed to acquire Embody Inc. for $155 million at closing, with an additional $120 million in contingent milestone payments over the next three years. The deal includes Embody’s entire portfolio of collagen-based regenerative solutions for soft tissue injuries. This strategic move further solidifies Zimmer Biomet's presence in the regenerative medicine sector. Autologous cellular therapies are at the forefront of regenerative medicine. Such treatment options include blood and bone marrow aspirates and concentrations. Zimmer Biomet offers Platelet-Rich Plasma (PRP) products to produce PRP, which can be mixed with autograft or allograft materials. Their BioCUE Blood and Bone Marrow Aspirate (bBMA) Concentration System and Plasmax Plasma Concentration System are notable contributions to this field. Moreover, Zimmer Biomet's cartilage repair solutions can address osteochondral deficiencies in multiple anatomic locations. These solutions provide early interventions that can limit the need for further surgical intervention and potentially divert the progression of these lesions. The philosophy defining Zimmer Biomet's hard tissue products is based on the complex processes involved in tissue repair. Their extensive portfolio includes matrix/scaffold, signaling proteins, and tissue-forming cells that work together to form new tissue, particularly bone. This approach acknowledges the limitations of traditional autograft procedures and offers innovative synthetic bone graft substitutes to overcome these challenges. In addition to their involvement in hard tissue products, Zimmer Biomet offers soft tissue management products suitable for various practices, including orthopedics, plastic surgery, and general surgery. This comprehensive portfolio underscores Zimmer Biomet's commitment to advancing regenerative medicine and highlights the company's recognition of the potential future in this area. Moving forward, Zimmer Biomet's continued focus on innovation and strategic acquisitions positions it as a key player in the evolving landscape of regenerative medicine. With a strong foundation in orthopedic devices and an expanding portfolio in regenerative solutions, Zimmer Biomet is well-positioned to drive growth and deliver value to investors in the years to come. MDXG MiMedx Group, Inc. (NASDAQ: MDXG ) stands as a pioneer and leader in the regenerative medicine sector, dedicated to helping humans heal. With over a decade of experience in managing chronic and hard-to-heal wounds, MiMedx offers a leading portfolio of products tailored for applications in wound care, burns, and surgical sectors of healthcare. The company's vision is to emerge as the foremost global provider of healing solutions through relentless innovation aimed at restoring quality of life. MiMedx specializes in developing and distributing placental tissue allografts across various healthcare sectors. Leveraging its patented and proprietary PURION process, MiMedx processes human placental tissues to produce allografts that retain the tissue's natural biological properties and regulatory proteins. This processing method, which combines aseptic techniques with terminal sterilization, ensures the preservation of the tissue's integrity and efficacy. In the first quarter of 2024, MiMedx achieved significant milestones, demonstrating its continued growth and success. With net sales reaching $85 million, reflecting an impressive 18% growth over the prior year period, the company showcased its strong market presence and growing demand for its products. Additionally, MiMedx reported a GAAP net income from continuing operations of $9 million with an adjusted EBITDA margin of 22%, highlighting its solid financial performance and operational efficiency. Furthermore, MiMedx expanded its product portfolio through a distribution agreement with Regenity Biosciences, introducing a 510(k)-cleared collagen particulate xenograft product set to launch later in the year. This move aligns with MiMedx's commitment to enhancing its offerings and meeting the evolving needs of its customers in the wound and surgical markets. Under the leadership of Joseph H. Capper, MiMedx's Chief Executive Officer, the company continues to demonstrate clinical strength, commercial effectiveness, and disciplined expense management, positioning itself for sustained growth and long-term success. With a focus on relentless innovation and diversification of its portfolio, MiMedx remains poised to deliver innovative healing solutions and drive shareholder value in the dynamic healthcare landscape. For investors with a greater appetite for risk, BioStem Technologies Inc. (OTC: BSEM) represents a compelling opportunity. BSEM is focused on developing, manufacturing, and commercializing placental-derived biologics for regenerative therapies. Its proprietary BioRetain processing method is central to its innovation, preserving crucial growth factors and tissue structure, which differentiates its products in the advanced wound care market. In the first quarter of 2024, BSEM reported revenue of $41.9 million, a significant increase from $0.6 million in the same period the previous year. This growth is primarily driven by the market acceptance of AmnioWrap2, a placental-derived allograft for various wound applications, according to CEO Jason Matuszewski. The company's gross margin was 95%, up from 82% in the first quarter of 2023, reflecting the impact of increased sales and an agreement with Venture Medical. Additionally, BioStem achieved net income for the first time in its history, marking a notable milestone. BSEM has also enhanced its operational capabilities. The company has engaged McCoy Clinical Consulting to lead pivotal clinical trials for Diabetic Foot Ulcer (DFU) and Venous Leg Ulcer (VLU) treatments. Moreover, BioStem completed a comprehensive two-year audit, a step towards listing on a national stock exchange, which enhances financial transparency and governance. A significant development for BioStem is the United States Patent and Trademark Office’s (USPTO) prioritized examination of its patent for the BioRetain processing technology. This patent is essential for protecting BioStem’s method of processing human amniotic tissue, a key differentiator in the regenerative medicine market. The company's intellectual property portfolio supports its commitment to innovation and its potential to impact the wound care market, which is projected to grow steadily. BioStem has expanded its product offerings and market reach with products like AmnioWrap2, VENDAJE, and VENDAJE AC, processed at its FDA-registered and AATB-accredited facility in Pompano Beach, Florida. These products have gained market traction, supported by BioStem’s quality management system and adherence to current Good Tissue Practices (cGTP) and current Good Manufacturing Practices (cGMP). Operational highlights include acquiring assets from Auxocell Laboratories, launching AmnioWrap2 nationwide with Venture Medical LLC, and securing commercialization agreements for Avenova Allograft with NovaBay. The company’s products have also been listed with the U.S. Department of Defense and Veterans Administration, broadening its market presence. On May 15, Zachs Small Cap Research published a comprehensive research report on BioStem Technologies Inc. (OTC: BSEM) highlighting their recent financial results and issuing a valuation of 23.25 per share. 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 by BioStem Technologies to assist in the production and distribution of this content. 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 Mark McKelvie +1 585-301-7700 Mark@RazorPitch.com Company Website http://razorpitch.com

May 20, 2024 06:00 AM Eastern Daylight Time

Article thumbnail News Release

The HERizon Disposable Hysteroscope aims to redefine industry standards

Minerva Surgical, Inc.

Minerva Surgical announces the immediate and exclusive distribution of a new disposable hysteroscope that will be displayed at the Annual Clinical & Scientific Meeting of American College of Obstetricians and Gynecologists in San Francisco, CA. The company plans to soon rebrand the new disposable hysteroscope as HER izon, and their goal is to redefine the standards of efficiency and accessibility in gynecological care. “This marks a significant milestone in the company’s mission to address the needs of gynecologists and further advance Women’s Health,” states Minerva Surgical Chief Medical Officer Eugene Skalnyi, M.D. “ HER izon embodies versatility as a hysteroscope, facilitating an array of procedures both in the operating room and office settings. It is one of a few technologies that our team plans to launch to better serve the evolving patterns in Gynecology.” The HER izon Disposable Hysteroscope is a cutting-edge system that is introduced in alignment with ACOG and AAGL's advocacy for the elimination of blind assessment practices in the uterine cavity. Several key features of the HER izon Disposable Hysteroscope include. 1. Disposable Design: Single-use hysteroscope eliminates the need for traditional hysteroscope reprocessing, reduces the risk of cross-contamination, and ensures compliance with sterility standards. 2. Angled Cannula Tip: Provides rigidity to help enter the cervical canal and articulation to navigate an array of uterine cavity positions. 3. Compact Footprint: 4.8mm outer diameter sheath requires minimal or no dilation and 6Fr working channel allows for a broad spectrum of procedures such as direct visualization polypectomy, endometrial biopsy, D&C, and IUD removal. 4. User-Friendly Interface: High-Definition image technology, two LED lights provide bright and clear visualization, and the intuitive interface enables seamless system navigation. Dr. David Glassman, DO FACOG EMIGS, a prominent gynecologist in Phoenix, Arizona, shared his excitement about the new HER izon Disposable Hysteroscope, stating, “ HER izon is a revolutionary advancement in hysteroscopy technology. Designed with precision and patient comfort in mind, HER izon offers unparalleled clarity and control, providing healthcare professionals with a clearer view and easier access to the uterine cavity. Its innovative features enhance procedural efficiency, reducing both patient discomfort and procedure times. With HER izon, healthcare providers can elevate their practice, delivering superior care and empowering women to take control of their health with confidence.” The introduction of the HER izon Disposable Hysteroscope underscores Minerva Surgical’s commitment to providing gynecologists with solutions that improve patient outcomes. About Minerva Surgical, Inc. Minerva Surgical is a commercial-stage medical technology company focused on developing, manufacturing, distributing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. The Company has established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of Abnormal Uterine Bleeding (AUB) in most uterine anatomies. The Minerva Surgical solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the uterus by avoiding unnecessary hysterectomies. For more information about the HER izon Disposable Hysteroscope and other innovative medical devices from Minerva Surgical, please visit www.MinervaSurgical.com. The disposable hysteroscope is manufactured by Jiyuan Medical. Contact Details Minerva Surgical Kevin Tracey +1 855-646-7874 media@minervasurgical.com Company Website https://minervasurgical.com/

May 16, 2024 09:00 AM Eastern Daylight Time

Article thumbnail News Release

FOR IMMEDIATE RELEASE

Apple Rush Company, Inc.

Apple Rush Company, Inc. (Otcpink:APRU), a leading player in the functional beverage industry, proudly announces it has cleared up final details of brand ownership with Bob Corr and Corr Brands, Inc. Tony Torgerud, CEO of Apple Rush, has negotiated a historical closing on the rights and trademarks of Corr Brands, Inc. In the transaction, Bob Corr has agreed to transfer the rights of the Corr Brands, Inc. trademarks and to forgo any royalties from previous agreements to give Tony and Apple Rush the best opportunity to succeed moving forward. Tony Torgerud said, “I have been negotiating for a year with Bob and he finally felt it was time to work out an agreement that would benefit everyone. Over the next couple months, all the required paperwork will be filed for transference and updates on all intellectual property held by Corr Brands, Inc. Not having to pay royalties will add thousands to the bottom line.” This agreement solidifies the future of the “Rush” family of brands that have been in the market since 1972. Bob Corr stated, “I want to see Apple Rush succeed and I feel the timing is right to get this deal done. I retired a long time ago and it is now time to write the next chapters of this story and with Apple Rush having its own production capabilities and its own tunnel pasteurizer, it is an opportunity that shouldn’t be wasted. I have given up hundreds of thousands of dollars in royalties, licensing fees and shares to enhance shareholder value.” With our pilot production abilities, we hope to do some reformulations to introduce a 2024 version of Ginseng Rush and the relaunch of the original Apple Rush flavor line. Apple Rush has held a license for 13 states and International distribution for the last 8 years and now owns the IP without paying the $5,000 per state license, another bottom line gain for all of our stockholders. About The Apple Rush Company, Inc. The Apple Rush Company, Inc., through its subsidiary APRU, LLC, is a distributor of CPG products under the trademarked Apple Rush brand, Element brand and other labels. The Apple Rush brand has more than 50 years of existence in the natural beverage industry. As a historical leader in the organic and natural beverage sector our goal is to now become a leader in the distribution of anhydrous hemp oil products nationwide. For more information, please go to www.aprubrands.com, www.element-brands.com, elementk.kratomwave.store www.alkhemicalroots.com with our expanded product portfolio. Safe Harbor Act: Forward-Looking Statements are included within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategy, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations including words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. We are under no obligation to (and expressly disclaim any such obligation to) update or alter forward-looking statements, whether as a result of new information, future events or otherwise. Contact Details Apple Rush Company, Inc. Tony Torgerud +1 888-741-3777 dtorgerud@aprullc.com Company Website http://www.aprubrands.com

May 14, 2024 10:00 AM Eastern Daylight Time

Article thumbnail News Release

Lisata Therapeutics gets 2024 off to a strong start as it prepares for crucial ASCEND trial results

Lisata Therapeutics Inc

Lisata Therapeutics Inc (NASDAQ:LSTA) CEO David Mazzo tells Proactive's Stephen Gunnion that 2024 is a pivotal year for the oncology company, with Phase 2b ASCEND trial top-line data expected in the fourth quarter. Discussing the company's first-quarter milestones, Mazzo said the results are anticipated to be foundational for the company's future, potentially leading to provisional approval applications in Australia and subsequent discussions with the FDA and EMA. Mazzo highlighted Lisata's effective cash management, with over $43 million in funds ensuring operations into 2026. The company has achieved several regulatory milestones, including orphan designations for pancreatic cancer and glioma in the EU and US, and a rare pediatric disease designation for osteosarcoma in the US. Additionally, Mazzo discussed the rapid progress of the BOLSTER trial in cholangiocarcinoma, expected to provide early data points in 2025. The company plans to expand its trials and anticipates potential partnership announcements by year-end, driven by these developments. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 13, 2024 10:45 AM Eastern Daylight Time

Video
Article thumbnail News Release

Cloud DX secures 4th Provincial Health contract for remote patient monitoring

Cloud DX

Robert Kaul, CEO of Cloud DX, discussed with Steve Darling from Proactive the new Remote Patient Monitoring Agreement for Cloud DX RPM Services, which has been secured with a Canadian Provincial Health Authority. This agreement expands Cloud DX's provision of Connected Health remote patient monitoring products and services across Canada, now including contracts with Alberta, Yukon, Prince Edward Island, and a Master Services Agreement with Mohawk Medbuy—the country's largest hospital procurement agency. Kaul shared with Proactive that the contract spans 36 months and includes options for two 12-month extensions. Each subscription under these contracts is projected to average $1,520 CAD annually, covering the costs associated with the Connected Health Kit, which includes patient-prescribed hardware, software, and connectivity solutions. Over the four months leading up to April 30, 2024, Cloud DX has announced a significant growth milestone, securing 26 new contracts. These agreements span across hospitals, paramedic services, U.S. clinics, and include two Canadian provinces, marking a significant inflection point in the company’s expansion and presence in the healthcare industry. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

May 08, 2024 02:48 PM Eastern Daylight Time

Video
Article thumbnail News Release

Poolbeg Pharma's POLB 001 immuno-modulator II receives fully-granted patent from US Patent Office

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) chief legal officer John McEvoy joins Proactive's Stephen Gunnion with news that POLB 001's Immuno-modulator II has received the fully granted patent from the US Patent Office. McEvoy explained the patent encompasses a class of drugs for treating and preventing hypercytokinemia (cytokine storms) in patients triggered by an immune response, applicable across multiple disease indications. The granted patent further solidifies Poolbeg Pharma's robust intellectual property portfolio for POLB 001, potentially increasing the asset's value and making it more attractive to potential partners. McEvoy highlighted the company's ongoing efforts to strengthen and expand their IP portfolio, noting existing patents covering p38 MAP kinase inhibitors for influenza treatment and hypercytokinemia. Additional patents have been filed, particularly focusing on cancer immunotherapy applications of POLB 001. The company has also applied for patents concerning dosage regimens based on results from their recent LPs trial, aiming to protect innovations and maintain a competitive edge in the pharmaceutical market. This strategic IP protection is crucial for safeguarding the company's products and ensuring shareholder value, particularly as they seek partnerships to further develop POLB 001. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 08, 2024 08:32 AM Eastern Daylight Time

Video
Article thumbnail News Release

Creo Medical honoured with King's Award for Enterprise in Innovation

Creo Medical Group PLC

Creo Medical Group PLC (AIM: CREO) CEO Craig Gulliford joins Proactive's Stephen Gunnion with the news that the company has been recognised with the King's Award for Enterprise in Innovation, an accolade honouring innovative UK companies for their impact in their respective sectors. The award highlights Creo's influence on patient outcomes through their advanced medical technologies. Gulliford emphasised the rare honour, noting that among over five million companies in the UK, only 59 received this award this year. The company leverages a unique combination of bipolar radiofrequency energy with microwave energy, focusing on miniaturising surgical procedures. This innovation has led to significant advancements in treatment effectiveness and cost-efficiency, particularly noted in a recent NHS case study that showcased substantial economic benefits, including a reduction in theatre costs and patient hospital stays. This recognition allows Creo Medical Group to join a select group of internationally recognised brands, enhancing their credibility and market presence. Gulliford expressed pride in the team's achievement and optimism about future innovations, particularly in addressing complex medical conditions like lung cancer. The award not only validates past efforts but also sets a high standard for the company's ongoing commitment to healthcare innovation. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

May 08, 2024 07:50 AM Eastern Daylight Time

Video
Article thumbnail News Release

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

Video
Article thumbnail News Release

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

Video
12345 ... 83