Omnicell to Release Third Quarter 2024 Financial Results on October 30, 2024




Omnicell to Release Third Quarter 2024 Financial Results on October 30, 2024

FORT WORTH, Texas–(BUSINESS WIRE)–Omnicell, Inc. (Nasdaq:OMCL), a leader in transforming the pharmacy care delivery model, will release its financial results for the third quarter 2024, before market open on Wednesday, October 30, 2024. The Company will host a conference call and webcast to discuss its financial results at 8:30 a.m. ET that same day.

All interested parties are invited to listen to the live call and presentation by dialing (800) 715-9871 in the U.S. or (646) 307-1963 in international locations. The Conference ID is 6944646. A link to the live and archived webcast will also be available on the Investor Relations section of Omnicell’s website at https://ir.omnicell.com/events-and-presentations/.

About Omnicell

Since 1992, Omnicell has been committed to transforming pharmacy care through outcomes-centric innovation designed to optimize clinical and business outcomes across all settings of care. Through a comprehensive portfolio of robotics, smart devices, software, and expert services, Omnicell solutions are helping healthcare facilities worldwide to uncover cost savings, improve labor efficiency, establish new revenue streams, enhance supply chain control, support compliance, and move closer to the industry-defined vision of the Autonomous Pharmacy. To learn more, visit omnicell.com.

OMNICELL and the Omnicell logo are registered trademarks of Omnicell, Inc. or one of its subsidiaries.

OMCL-E

Contacts

Kathleen Nemeth

Senior Vice President, Investor Relations

ir@omnicell.com

Recent NFL Concussion and Parkinson’s News Brings Attention to the Long-Term Consequences of Head Impacts in Football




Recent NFL Concussion and Parkinson’s News Brings Attention to the Long-Term Consequences of Head Impacts in Football

BrainScope Research Suggests Exposure to Repetitive Head Impacts is Reflected in Brain Electrical Activity Features Associated with Neurodegenerative Diseases

ROCKVILLE, Md.–(BUSINESS WIRE)–#NFL–In the aftermath of Miami Dolphins quarterback Tua Tagovailoa suffering another alarming concussion, debate has focused on whether he should retire or risk irreversible brain damage from subsequent concussions. This was closely followed by the announcement of NFL Hall of Famer Brett Favre’s diagnosis of Parkinson’s disease, causing growing concern about the long-term impact of repetitive head impacts in contact sports like football. Favre’s diagnosis sheds light on the increasing evidence linking repeated concussions to neurodegenerative diseases.

A study published in the Journal of Neurotrauma in February 2023 highlights how exposure to repetitive head impacts (RHI) is associated with long-term disturbances in brain function, and that earlier age of first exposure may be associated with more prominent changes. The study included a cohort of 90 former NFL players with self-reported cognitive, behavioral, and/or mood symptoms plus 25 healthy matched controls who were participants in the National Institutes of Health (NIH)-funded Diagnosing and Evaluating Traumatic Encephalopathy using Clinical Tests (DETECT) study, and an additional 44 healthy controls obtained from a concussion assessment study under a Department of Defense research contract to BrainScope (#W81XWH-14-C-1405). As part of the DETECT study researchers from the Boston University CTE Center completed multiple assessments, including collecting quantitative electroencephalogram (qEEG) data using BrainScope devices. The publication reported that using machine learning based on qEEG features, the NFL players were accurately differentiated from those without RHI, and included features which are known markers for neurodegenerative conditions such as Alzheimer’s Disease, Chronic Traumatic Encephalopathy (CTE) and Parkinson’s disease.

Research shows that returning to play before returning to normal brain function after a concussion, or suffering from multiple head impacts over a lifetime, can exacerbate the potentially debilitating long-term consequences of repeat concussive trauma to the brain. Early exposure to the physical demands of football contributed to many legendary NFL careers including Brett Favre’s, but it also subjected him to the risks associated with repeated head impacts from a young age. BrainScope’s research also indicated that players who began playing football at a younger age (before 12 years old) exhibited more severe changes in brain function than those who started at age 12 or older. The findings emphasize the need for more stringent concussion protocols in youth sports, including more objective concussion assessments, as early exposure and ineffective diagnostic tools may increase the risk of later developing neurological disorders.

Leslie S. Prichep, Ph.D., Chief Scientific Officer at BrainScope noted, “This study, in collaboration with researchers at Boston University, provided a unique population to investigate the impact of repeated head impacts. The results highlight the importance of understanding the long-term consequences of RHI on brain function and emphasize the need for objective markers of brain changes associated with RHI and for the ability to monitor such changes over time.”

Brett Favre’s recent disclosure of his Parkinson’s diagnosis comes at a time when sports leagues, including the NFL, are under increasing scrutiny over their handling of concussions. While rules have been introduced to reduce helmet-to-helmet collisions and improve concussion protocols, these measures may not be enough to prevent serious health consequences. Concussion protocols have proven to be highly subjective because they rely on clinical observation and self-reported symptoms. The good news is that objective assessment tools for concussion do exist.

Laurie Silver, CEO of BrainScope, added, “Brett Favre’s diagnosis with Parkinson’s disease puts a human face on a growing public health issue. We can no longer ignore the role of concussions in neurodegenerative diseases. It is essential that more objective assessment tools are incorporated into concussion protocols to protect current and future generations of athletes.”

About BrainScope

BrainScope is a pioneering medical neurotechnology company dedicated to improving brain health through objective, diagnostic insights that enhance patient care. BrainScope applies state-of-the-art machine learning and deep learning to brain electrical activity (EEG) to create radiation-free, rapid, inexpensive and more accessible new biomarkers that greatly expands the utility of traditional EEG data. Known for its advancements in the assessment of mild traumatic brain injury, BrainScope’s commercial point of care device is the only FDA-cleared technology to objectively assess head-injured patients for both brain bleeds and concussions. BrainScope helps clinicians quickly rule out the need for head CT scans, while offering a rapid, objective assessment of concussion in about 10-15 minutes. The company is currently exploring new biomarkers including for Alzheimer’s, stroke assessment, concussion subtyping, military blast exposure and Covid brain fog. BrainScope is committed to revolutionizing brain health management across acute care, drug development, and consumer health. For more information, visit www.brainscope.com.

Contacts

Laurie Silver, CEO

info@brainscope.com

GE HealthCare Announces Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent




GE HealthCare Announces Phase I Results for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent

• Results of the Phase I clinical trial, presented at the bi-annual Contrast Media Research symposium in Oslo, Norway, conclude that this novel macrocyclic manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported.
• If approved, this agent could provide an alternative to gadolinium-based contrast agents and address the potential impact of post-patient excreted gadolinium in the environment.
• The clinical trial program demonstrates GE HealthCare’s commitment to innovation in contrast media and to building a portfolio of MRI imaging agents to address radiologists’ needs for their patients.

CHALFONT ST GILES, England–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) has today announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. The results, which will be used to support ongoing clinical development, concluded that in a first-in-human study, this manganese-based contrast agent was well tolerated with no serious adverse events, dose-limiting toxicities or clinically relevant findings reported, according to an abstract presented at the 2024 bi-annual Contrast Media Research symposium in Oslo, Norway.

MRI contrast agents, which are typically gadolinium-based, are used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue. This macrocyclic, extra-cellular, general-purpose, manganese-based contrast agent has comparable relaxivity (the ability to enhance signal intensity) to gadolinium-based agents and is expected to be diagnostically similar to current gadolinium-based products. Unlike gadolinium, manganese is naturally occurring in – and efficiently eliminated – from the body. Along with its suitable image-enhancing properties, this manganese-based agent could be a viable alternative to gadolinium, particularly in light of perceived concerns relating to gadolinium retention and the potential impact of post-patient excreted gadolinium in the environment.

Dr Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics business segment, said, “These are encouraging Phase I results for this manganese-based contrast agent and we look forward to completing the next steps in the clinical development process. This is part of our pipeline of products aiming to improve patient outcomes across care pathways.”

Dr Robert J. McDonald, Radiologist at Mayo Clinic and Contrast Media Safety Committee Board member for the American College of Radiology, whose group has collaborated with GE HealthCare during the research phase, commented, “GE HealthCare’s manganese-based contrast agent could offer benefits such as reduced risk of tissue deposition and improved safety for certain vulnerable patient populations compared to gadolinium-based agents, while also providing comparable imaging capabilities and potentially lower environmental impact.”

The Phase I trial was undertaken at the clinical research unit at Oslo University Hospital, Rikshospitalet, Norway, and benefited from partial funding provided by the Norwegian Research Council. GE HealthCare has two contrast media facilities in Norway. One site in Oslo, where this manganese-based contrast agent was developed, is celebrating its 150-year anniversary this year. In addition, GE HealthCare’s active pharmaceutical ingredients (API) manufacturing site in Lindesnes, southern Norway, is celebrating its 50^th year of production.

Kevin O’Neill, President and CEO of GE HealthCare’s Pharmaceutical Diagnostics segment, added, “As we celebrate milestone anniversaries for these two facilities, the Phase I results are a reminder of Norway’s heritage of innovation that has shaped the field of diagnostic imaging, improving patient outcomes worldwide. We aim to offer more choice to radiologists, delivering a broad portfolio that can enable personalized care and address unmet patient needs.”

GE HealthCare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support 120 million procedures per year globally, equivalent to four patient procedures every second. For more than 40 years, GE HealthCare contrast media has been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X , Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

Contacts

GE HealthCare Media Contact:
Mathilde Bouscaillou

M +33 6 47 00 82 71

mathilde.bouscaillou@gehealthcare.com

Thermo Fisher Scientific Showcases Expanded Biopharma Services, Capabilities and Innovations at CPHI Milan 2024




Thermo Fisher Scientific Showcases Expanded Biopharma Services, Capabilities and Innovations at CPHI Milan 2024

Company Launches Accelerator™ Drug Development, 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) Services that highlight advanced capabilities to help pharmaceutical and biotech customers solve global health challenges with new medicines and vaccines

MILAN–(BUSINESS WIRE)–Thermo Fisher Scientific Inc., the world leader in serving science, will showcase its latest innovations enabling the molecule-to-medicine journey and host a series of sessions that feature industry developments during CPHI Milan 2024, Oct. 8-10, in Milan, Italy. Leaders and experts from the company will be present at conference booth #7B18 to discuss how Thermo Fisher is supporting biotechnology and pharmaceutical companies across indications, modalities, sizes and stages of the drug development journey, demonstrating the company’s global momentum.

“Thermo Fisher is transforming drug development and manufacturing processes to support customers as they move critical programs forward to tackle global health challenges with speed, quality and efficiency,” said Michael Shafer, executive vice president and president, biopharma services, Thermo Fisher Scientific. “We connect the steps between discovery and delivery – from early testing and analytical support to clinical research design to trial conduct, clinical supply chain management, manufacturing and commercial scale-up – and we strive to ensure a seamless transition, mitigate risks and accelerate innovation at every stage.”

Bringing together research and manufacturing processes

To help speed and simplify the complex journey of drug discovery and development, the company is launching Accelerator™ Drug Development, Thermo Fisher’s 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) drug development solutions. Accelerator™ Drug Development is transforming the pharmaceutical value chain for emerging biotechs and large pharmaceutical companies by providing a customizable suite of manufacturing, clinical research and clinical supply chain services, including small molecule, biologics and cell and gene therapies, supporting customers at every stage from pre-clinical to commercialization.

Expanding pharma services capabilities

To help accelerate pre-clinical oral drug development, Thermo Fisher expanded sites in Cincinnati, Ohio, and Bend, Ore., to enable research and development, manufacturing and testing of oral solid dose drug formulations.

This year, the company also has invested in expanding its global clinical trial network, including a new GMP-certified ultra-cold facility in Bleiswijk, Netherlands, innovative label printing solutions and seamless packaging integration in Basel, Switzerland, and expanded clinical trial logistics solutions in Buenos Aires, Argentina. The company opened an Innovation Lab in Center Valley, Pa., to serve as a coworking lab space to create, test and validate forward-thinking services and innovative solutions that address common pain points across clinical trials.

Thermo Fisher continues to support the ongoing shift to patient-centric drug delivery methods and is collaborating with Stevanato Group to help streamline the production of the on-body delivery system Vertiva^®. This partnership can help enable a better patient experience and expanded treatment options as an off-the-shelf product for pre-filled sterile injectables. In Monza, Italy, Thermo Fisher is using next-generation technologies, such as augmented reality and virtual reality, in its new Training Center and Aseptic Academy to provide employees with hands-on experience to drive innovation in steriles manufacturing.

Broadening global laboratory services for clinical research

To serve pharma and biotech customers with advanced laboratory services and leading-edge instrumentation across all phases of pharmaceutical development, Thermo Fisher’s PPD^™ clinical research business is expanding its global laboratory services with a new bioanalytical lab in GoCo Health Innovation City in Gothenburg, Sweden, to help accelerate health innovation.

Driving more sustainable clinical research services

DHL Express and the PPD™ clinical research business of Thermo Fisher have joined forces to drive more sustainable clinical research services. The business will use DHL Express’ GoGreen Plus service and invest in sustainable aviation fuel to reduce emissions from air transportation. The collaboration enables the business, and by extension, its customers, to reduce greenhouse gas emissions associated with global clinical research air shipping logistics by up to 80%.

CPHI Milan expert live sessions

On Oct. 8 and 9, Thermo Fisher’s experts will participate in several sessions, including:

• Navigating Shifts in CDMO-Pharma Relations: Trends and Implications, Faye Boeckman, senior director, market development, pharma services, Tuesday, Oct. 8, 11:35-12:30 CET, Hall 5 – 5B49
• Fireside Chat: Navigating Outsourcing Partnerships for Start-Ups, Kelly Howard, vice president, commercial operations, viral vector services global and advanced therapies, pharma services, Tuesday, Oct. 8, 13:15-13:40 CET, Hall 5 – 5B49
• Optimizing ADC Processes: Advanced Strategies with High-Quality Bioreagents, Dom Price, senior manager, technical sales, production chemicals and services – EMEA, bioproduction, Tuesday, Oct. 8, 13:45-14:10 CET, Hall 3 – 3F97
• Development and Validation of Automated Rapid Protocols to Ensure Mycoplasma-Free Biologics, Benjamin Ziehr, manager, cell lab, clinical research, Tuesday, Oct. 14:45-15:10 CET, Hall 5 – 5B49
• Maximizing Outsourcing and Manufacturing Success Through Strategic CDMO and CRO Partnerships, Jennifer Cannon, president, commercial operations, pharma services, Wednesday, Oct. 9, 13:45-14:10 CET, Hall 5 – 5B49

To learn more about the company’s capabilities, please visit thermofisher.com.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Contacts

Media Contact Information:

Erin Morton

Phone: (352) 519-8351

Email: erin.morton@thermofisher.com

Emily Landers

Phone: (617) 275-6527

Email: elanders@greenoughagency.com

ViroCell Biologics to Host Panel Event at 2024 Cell & Gene Meeting on the Mesa




ViroCell Biologics to Host Panel Event at 2024 Cell & Gene Meeting on the Mesa

The annual conference will be attended by Team ViroCell, including its newly appointed VP of Corporate Development and Strategy, Nicholas Ostrout, PhD

LONDON & NEW YORK–(BUSINESS WIRE)–ViroCell Biologics (“ViroCell” or the “Company”), a cell and gene therapy (“CGT”) Contract Development and Manufacturing Organization (“CDMO”) specializing in GMP viral vector manufacturing for clinical trials, announces that Farzin Farzaneh, PhD, Co-Founder and Chief Scientific Officer of ViroCell Biologics, will be hosting a panel event on Synthetic Biology at the annual Cell & Gene Therapy Meeting on the Mesa, to be held on 7-9 October 2024 in Phoenix, Arizona, US (full details below).

ViroCell also announces the appointment of Nicholas Ostrout, PhD, as Vice President of Corporate Development and Strategy, who will be attending the conference alongside the broader ViroCell team. Nicholas brings a wealth of CGT commercial development and corporate strategy experience to ViroCell’s growing team, as the Company moves to expand its network of strategic partners. He was most recently Senior Director of Strategic Development and Partnerships at Charles River Laboratories, where he was responsible for developing and executing business engagement and development strategies for the company’s CGT assets, across the entire Charles River portfolio. Prior to this, Nicholas worked at Lonza as Senior Director (Global Head) of Commercial Development, within Lonza’s Personalized Medicine Business Unit. There, he served as head of the transactions team, securing access to promising technologies in the area of cell therapy manufacturing and development. Nicholas holds a PhD in Immunology from the Case Western Reserve University, Cleveland, Ohio, and a Bachelor of Sciences degree from Denison University, Granville, Ohio.

John W. Hadden II, CEO at ViroCell, commented: “We are looking forward to joining CGT’s brightest minds at the Meeting on the Mesa this week. We are excited to host a thought-provoking panel event on synthetic biology in the CGT sector. Team ViroCell will be there in full force and will be joined by our newest member, Nicholas Ostrout. We extend a warm welcome to Nick, who will apply his significant experience and track record in CGT corporate development to accelerate ViroCell’s growth.”

Nicholas Ostrout, PhD, VP Corporate Development & Strategy, ViroCell Biologics, added: “I look forward to working with such an exceptional team. The Company’s approach to de-risking next-generation vectors and accelerating therapies into clinical trials is truly differentiated and I’m excited to apply my experience to further unlock ViroCell’s potential as a business and its ability to support innovators.”

Panel event details:

Virtual attendance is available, which includes a livestream of ViroCell’s panel event and the ability to view all conference sessions on-demand. Please visit https://meetingonthemesa.com/ for full information, including registration.

Notes to editor:

ViroCell

ViroCell Biologics is an innovation-driven Contract Development and Manufacturing Organization (“CDMO”) focused exclusively on the design, derisking, and GMP manufacture of viral vectors for clinical trials. Built around one of the most prolific academic viral vector manufacturing teams, ViroCell was created to address the global demand for precisely engineered viral vectors. The team leverages its deep track record to help clients to de-risk and accelerate novel cell and gene therapies into and through clinical development, with a mission of being the partner of choice for corporate and academic innovators. Focused initially on manufacturing lentivirus and gamma-retrovirus vectors, ViroCell enables clients to start clinical trials on a scalable platform, delivering value by reducing costs, time and regulatory risk.

www.virocell.com

Contacts

For more ViroCell information, please contact:

ViroCell
John W. Hadden II, CEO

info@virocell.com

For ViroCell media enquiries, please contact:

FTI Consulting
Simon Conway / Victoria Foster Mitchell / Tim Stamper

ViroCell@fticonsulting.com
+44 (0)20 3727 1000

Hudson Therapeutics and Shaperon to Actively Pursue Global Licensing Partnerships at Key Industry Conferences in Q4 2024




Hudson Therapeutics and Shaperon to Actively Pursue Global Licensing Partnerships at Key Industry Conferences in Q4 2024

CAMBRIDGE, Mass. & RESEARCH TRIANGLE PARK, N.C. & SEOUL, Korea–(BUSINESS WIRE)–Hudson Therapeutics, a leading innovator in therapeutic solutions and a US subsidiary of Shaperon, announced that Shaperon and Hudson Therapeutics will participate in five major international conferences this fall. With a strategic focus on securing global licensing partnerships, Shaperon and Hudson Therapeutics will actively promote its innovative clinical programs addressing significant unmet needs in atopic dermatitis, alopecia areata, and idiopathic pulmonary fibrosis, an orphan indication for human and animal health.

Hudson Therapeutics and Shaperon will engage in the following events:

– Animal Health, Nutrition and Technology Innovation Asia 2024 – October 7 – 8, 2024 / Tokyo, Japan

– Bio Japan | Regenerative Medicine Japan | HealthTech Japan – October 9 – 11, 2024 / Tokyo, Japan

– Pharm Partnering Summit – October 16 – 17, 2024 / Boston, MA USA

– Bio Europe – November 4 – 6, 2024 / Stockholm Sweden

– 8^th Dermatology Drug Development Summit – Number 12, 14, 2024

“At these key conferences, we aim to take a leading role in advancing our innovative therapeutic solutions, not just for humans but for veterinary medicine as well,” said Dr. Seung-Yong Seong, CEO of Shaperon. “By actively engaging with potential global partners, we intend to accelerate the commercialization and global distribution of our programs targeting idiopathic pulmonary fibrosis, alopecia areata, and atopic dermatitis, addressing clinical unmet needs in these areas.”

Ms. Janice Marie McCourt, CEO of Hudson Therapeutics, reinforced this initiative: “These conferences offer invaluable opportunities to drive strategic collaborations. We are actively seeking partnerships to help us bring our NanoMab-based therapies to market globally, enhancing treatment options for inflammatory and fibrotic diseases in humans and companion animals.”

Hudson Therapeutics and Shaperon are committed to positioning themselves at the forefront of innovation by actively pursuing global licensing strategies and building strong early-stage collaborations. This initiative-taking approach ensures their leadership in the rapidly growing autoimmune and inflammatory disease sectors

According to The DATA Bridge Market Research, the global market for Alopecia Areata Treatment is projected to grow from $9.58 billion in 2024 to $17.93 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 17.93%.

Hudson Therapeutics invites interested parties to discuss partnership opportunities during the upcoming events.

ABOUT SHAPERON

Shaperon is a clinical stage biotech company developing novel inflammasome inhibitors. Its unique mechanism of action of GPCR19-P2X7 modulation suppresses a broad spectrum of inflammatory cytokines including IL-1β, IL-18, IL-6, and TNF-α by controlling both priming and activation phase of inflammasome, whereas conventional approaches are designed to suppress only the activation phase. With this unique and novel modality which is best suited to address complex immune-mediated inflammatory disorders, Shaperon is currently developing multiple clinical programs in atopic dermatitis, alopecia areata, alzheimer’s disease, and COVID 19 pneumonia in addition to pre-clinical pipeline assets, focused in MASH and obesity therapeutic areas.

ABOUT Hudson Therapeutics

Hudson Therapeutics, a US subsidiary of Shaperon was founded and incorporated in the US in 2023 to lead global clinical trials, investor relations, commercial strategy, and business development of assets from Shaperon. Hudson also plans to develop Shaperon’s early-stage assets in the future.

Contacts

For more information or to schedule a meeting, please contact:

Ellie Jung, Chief Communications and Administrative Officer

Email: ellie@hudsontherapeutics.com

CONMED Corporation Announces Preliminary Third Quarter Financial Information




CONMED Corporation Announces Preliminary Third Quarter Financial Information

LARGO, Fla.–(BUSINESS WIRE)–As a follow up to the Current Report on Form 8-K issued by the Company on September 30, 2024, CONMED Corporation (NYSE: CNMD) announced preliminary financial information for the third quarter of 2024. The Company expects revenue in the range of $315 million to $318 million and adjusted diluted net earnings per share growth in excess of its previously provided guidance of 9% to 11%.

CONMED will report full financial results for the third quarter of 2024 after the market close on Wednesday, October 30, 2024. The Company’s management will host a conference call at 4:30 p.m. ET that same day to discuss the results.

To participate in the conference call via telephone, please click here to pre-register and obtain the dial-in number and passcode.

This conference call will also be webcast and can be accessed from the “Investors” section of CONMED’s website at www.conmed.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

The information in this press release is preliminary and subject to completion. This preliminary financial information is the responsibility of management and has been prepared in good faith on a consistent basis with prior periods. However, the Company has not completed its financial closing procedures for the period ended September 30, 2024, and its actual results could be materially different from this preliminary financial information. As a result, prospective investors should exercise caution in relying on this information and should not draw any inferences from this information regarding the Company’s financial information that is not provided. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles.

About CONMED Corporation

CONMED is a medical technology company that provides devices and equipment for surgical procedures. The Company’s products are used by surgeons and other healthcare professionals in a variety of specialties including orthopedics, general surgery, gynecology, thoracic surgery, and gastroenterology. For more information, visit www.conmed.com.

Forward-Looking Statements

This press release and associated conference call may contain forward-looking statements based on certain assumptions and contingencies that involve risks and uncertainties, which could cause actual results, performance, or trends to differ materially from those expressed in the forward-looking statements herein or in previous disclosures. For example, in addition to general industry and economic conditions, factors that could cause actual results to differ materially from those in the forward-looking statements may include, but are not limited to the risk factors discussed in the Company’s Annual Report on Form 10-K for the full year ended December 31, 2023, listed under the heading Forward-Looking Statements in the Company’s most recently filed Form 10-Q and other risks and uncertainties, which may be detailed from time to time in reports filed by CONMED with the SEC. Any and all forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company’s performance on a going-forward basis. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management’s expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct.

Contacts

CONMED Corporation
Todd W. Garner
Chief Financial Officer
727-214-2975
ToddGarner@conmed.com

Avistone Announces Updates on ANS014004




Avistone Announces Updates on ANS014004

BEIJING–(BUSINESS WIRE)–Beijing Avistone Biotechnology Co., Ltd (also referred to as “Avistone Biotechnology” or “Avistone”), an innovative biotechnology company focused on precision oncology therapeutics, today announced that the Phase I dose escalation study evaluating ANS014004 (“ANS01”), a novel small-molecule type II c-Met tyrosine kinase inhibitor (TKI) was recently cleared to proceed with enrollment of patients in Canada by Health Canada. The U.S. Food and Drug Administration (FDA) cleared ANS01’s Investigational New Drug (IND) Application last year and the trial is currently enrolling US patients in the dose escalation portion of the phase 1 study. Detailed information on the trial can be found at https://clinicaltrials.gov/study/NCT06307795.

There is also a concurrent, ongoing Phase I study operating in China and detailed information on this study can be found at: https://clinicaltrials.gov/study/NCT06328439.

Both Phase I studies are enrolling patients diagnosed with locally advanced or metastatic solid tumors harboring a pathogenetic MET alteration (including MET mutation, MET amplification, MET overexpression, or MET fusion) and the primary objectives are (1) to evaluate the tolerability and safety of ANS014004 and (2) to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ANS014004.

Mesenchymal epithelial transition (MET) proto-oncogene receptor tyrosine kinase (RTK) is a cell surface receptor selective for hepatocyte growth factor (HGF), and is involved in embryogenesis regulation, wound healing, organ regeneration, angiogenesis, and immunomodulation. Aberrant MET oncogenic alterations include MET exon 14 skipping (MET∆ex14) mutations; activating mutations in the kinase domain; MET gene amplification; MET fusions; and MET protein overexpression. These oncogenic alterations occur in a wide range of human solid cancers.

Presently, type I c-Met inhibitors are used as monotherapies in patients with locally advanced or metastatic NSCLC with MET∆ex14 mutations. However, development of post-treatment resistance to type I c-Met inhibitors occurs clinically, including through acquired mutations in codons D1228 and Y1230. No drugs have been approved globally for MET alteration indications other than MET∆ex14 mutations. Next generation MET inhibitors are thus needed to treat patients harboring various MET oncogenic alterations beyond MET∆ex14, including post-treatment acquired mutations.

About Avistone Biotechnology
Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone) is an innovative biotechnology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies in Non-Small Cell Lung Cancer (NSCLC) and in other solid tumors.

Contacts

David Chung

Chief Business Officer

david.chung@avistonebio.com

FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening




FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening

Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity

Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test

Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025

MADISON, Wis.–(BUSINESS WIRE)–Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).¹

FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.¹* Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT**) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.²

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer,” said Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study. “The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said Kevin Conroy, Chairman and CEO of Exact Sciences. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”

CRC is often considered the most preventable, yet least prevented form of cancer.³ It remains the second deadliest cancer in the United States.⁴ The Cologuard Plus test will build on the success of the Cologuard^® test, which has been used more than 17 million times and helped meaningfully improve national CRC screening rates in the United States.^5,6 Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences’ commercial organization and industry-leading ExactNexus™ technology platform, making ordering and resulting seamless for more than 350 health systems. The innovative, non-invasive test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce (USPSTF) guidelines, and included within quality measures.

*The Cologuard Plus test demonstrates 91% specificity including non-advanced findings, 93% specificity including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.

**Refers to the commercially available Polymedco OC-Auto® Micro 80iFOB Test

About the BLUE-C Study

BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of the Cologuard Plus test (multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based colorectal cancer screening test. Using colonoscopy as a reference method, the robust study design directly compared the Cologuard Plus test and an independent fecal immunochemical test (FIT*). The BLUE-C study cohort is diverse and reflective of the U.S. population. About 40% of all participants identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. This enrollment diversity helps ensure that the BLUE-C findings and the Cologuard Plus™ test are relevant for all screen-eligible individuals, regardless of race or ethnicity. ²

About the Cologuard Plus test

Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences’ lab and increase the valid result rate. Exact Sciences is preparing for the commercialization of the Cologuard Plus test.

About the Cologuard test

The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).

The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal DeeP-C study. The Cologuard test is easy to use, can be completed at home, and does not require any time off or special preparation.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Exact Sciences, Cologuard and Cologuard Plus are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. The Cologuard and Cologuard Plus tests are not available outside of the U.S.

Forward-Looking Statements

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding our expectations for the commercialization of Cologuard Plus, the performance of Cologuard Plus in a commercial setting, and Cologuard Plus’ receipt of Medicare coverage and inclusion in guidelines. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

References

1. Cologuard Plus Instructions for Use. Exact Sciences Corporation. Madison, WI.
2. Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. New Engl J Med. 2024;390(11):984-993.
3. Itzkowitz SH. Incremental advances in excremental cancer detection tests. JNCI. 2009;101(18)1225-1227.
4. ACS. Cancer facts & figures 2024. Atlanta: American Cancer Society; 2024.
5. National Institutes of Health. The Cancer Trends Progress Report. https://progressreport.cancer.gov/detection/colorectal_cancer. Accessed July 29, 2024.
6. Ebner DW, Finney Rutten LJ, Miller-Wilson LA, et al. Trends in Colorectal Cancer Screening from the National Health Interview Survey: Analysis of the Impact of Different Modalities on Overall Screening Rates. Cancer Prev Res (Phila). 2024;17(6):275-280.

Contacts

Media (U.S.):

Lindsey Dickinson        

+1 608-690-0383        

lidickinson@exactsciences.com 

Investor:

Erik Holznecht

+1 608-800-6605

investorrelations@exactsciences.com

Alpha Cognition Announces Change of Officer




Alpha Cognition Announces Change of Officer

VANCOUVER, British Columbia–(BUSINESS WIRE)–Alpha Cognition Inc. (CSE: ACOG) (OTCQB: ACOGF) (“Alpha Cognition” or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, announces that Don Kalkofen has resigned as the Chief Financial Officer of the Company to pursue other opportunities.

“On behalf of Alpha Cognition, I want to thank Don for his contributions to the Company over the past two years,” said Michael McFadden, Chief Executive Officer of the Company. “During his service, Alpha Cognition has made significant strides in its transformation including approval of ZUNVEYL for the treatment of mild-to-moderate Alzheimer’s Disease and has positioned the Company to launch this innovative treatment in early 2025. The Company’s outsourced model for the finance function will assure that consistency and continuity of day-to-day accounting and regulatory filings continues with minimal disruption.”

The Company is pleased to announce that Jay Yoo will assume interim accounting leadership responsibilities for the Company. Jay has sixteen years of experience as a CPA, CFA, and has led accounting and finance positions, including responsibilities for SEC filings, at multiple companies during the last seven years. The Company is completing its search for a new Accounting and Finance leader and expects to announce the new leader later in the quarter.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.

ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.

This news release includes forward-looking statements within the meaning of applicable United States and Canadian securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the Company’s clinical development activities, the timing and results of clinical trials, and timing for appointing a permanent CFO. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital, including bridge funding, to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedarplus.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1 registration statement as filed with the SEC on June 14, 2024 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

Contacts

For further information:

Michael McFadden, CEO

Tel: 1-858-344-4375

info@alphacognition.com