BHI Weekly Newsletter Archives

PLANO, Texas & BALTIMORE–(BUSINESS WIRE)–Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced dosing of the first patient in its Phase 1 clinical trial evaluating STM-01 as a treatment for heart failure with preserved ejection fraction (HFpEF).

This is the first-ever clinical study of an allogeneic, off-the-shelf stem cell therapy in HFpEF, a leading cause of hospitalization, morbidity, and mortality worldwide. An estimated 6.7 million adults in the U.S. are affected by heart failure, with HFpEF comprising at least half of these cases.

March 25, 2025 – John Knowles, Studio B Writer – The BioCapital Region, which includes Washington, D.C., Maryland and Virginia, is one of the top life sciences clusters in the United States.

Prince William County has rapidly emerged as a key player in Northern Virginia’s life sciences sector. The Prince William County Department of Economic Development and Tourism, or PWCDEDT, has been focused on diversifying the economy and leveraging assets like George Mason University’s Science and Technology Campus to attract innovative companies to the region.

PWCDEDT Deputy Director Trevor Johnson said that the county’s life sciences growth can be traced back to its abundant rural land, offering a rare opportunity for expansion in the Greater Washington area.

By Dan Beyers, Katelyn Keiser – CoStar News – March 26, 2025 – If there is a field of dreams in Baltimore these days, it might be 4MLK, the gleaming new eight-story, 250,000-square-foot lab and office building that stands at the gateway of the University of Maryland’s life science and technology center, BioPark.

When it is fully leased, 4MLK hopes to house the largest cluster of bioscience companies in the greater Baltimore region, bringing 1,000 jobs to the city and doubling the size of the workforce now employed by nearly three dozen companies at the center. It’s an ambition that earned the project a 2025 CoStar Impact Award as judged by real estate professionals in the market.

COLLEGE PARK, Md., March 26, 2025 /PRNewswire/ — Registration is open for “Business of Life Sciences and Healthcare for Leaders” (B-LSHC) — an immersive five-day program focused on leadership development and honing critical-thinking and problem-solving skills in medical product development presented by Smith Executive Education at the University of Maryland’s Robert H. Smith School of Business.

The in-person program takes place June 23-27, 2025, at Van Munching Hall on UMD’s College Park campus and is designed for mid-to-advanced career professionals in the LSHC ecosystem including pharmaceutical, biotech and medical device industries; health policy; patient advocacy; regulators; investors; and leaders across medical and regulatory fields.

Program sessions will begin at 8:30 a.m. each day “and end with a luminary keynote speaker who will inspire and challenge participants to think outside the box toward the goals of creating innovative solutions for some of our most challenging problems in the LSHC ecosystem,” says Wendy Sanhai, PhD, professor of the practice in management and organization for the Smith School and one of the workshop’s organizers. 

BETHESDA, Md., March 31, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced a poster presentation showcasing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction. The poster titled ‘Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals’ was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago on March 30, 2025.

Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate how machine learning signal analysis of a symptomatic population may provide a robust, non-invasive alternative to measuring PCWP elevation, potentially making early detection of HFpEF and PH subtypes more accessible.

SILVER SPRING, Md., March 27, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced that it has entered into an agreement with Advantus Health Partners (“Advantus”), to provide access of Elutia’s EluPro™ Antibiotic Eluting BioEnvelope to Advantus’ core group purchasing organizations (GPO) solutions portfolio.

“Teaming up with Advantus is another major step forward in meeting the strong customer demand for EluPro,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “Our pilot launch of EluPro has exceeded our expectations as physicians recognize the unique value that this antibiotic envelope brings in preventing infection for patients that use a cardiac implantable electronic device. Broadening our GPO coverage with Advantus allows us to benefit from their sustainable contracting solutions, making EluPro more widely available to physicians nationwide.”

Digital Health Leader’s Innovation in Real-Time Sensor-Based AI Sets New Standards for Personalized Cardiometabolic Care

COLUMBIA, Md.–(BUSINESS WIRE)–Welldoc®, a digital health leader revolutionizing cardiometabolic care, today announced the issuance of four new patents, marking its 54th patent grant. This milestone underscores Welldoc’s relentless commitment to innovation and leadership in leveraging artificial intelligence (AI) and advanced predictive capabilities based on real-time sensor data. The company’s digital health platform empowers individuals with personalized AI-driven digital coaching to enable self-management of cardiometabolic conditions, positive lifestyle changes and improved overall health and outcomes.

The new patents focus on Welldoc’s unique approach to combining dense, sensor-based data specifically collected from Continuous Glucose Monitors (CGM), with AI to predict future engagement levels, health metrics and improved outcomes. This includes the development of a “CGM-GPT” model using generative AI techniques to predict future glucose values.

GeneDx recognized for its innovative approach to accelerating genetic diagnosis and transforming the future of healthcare by ending the diagnostic odyssey

GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced today they have been named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025, and recognized as the No. 2 in the Biotech category. This year’s list shines a spotlight on businesses that are shaping industry and culture through their innovations to set new standards and achieve remarkable milestones in all sectors of the economy.

NanoQT, a Tokyo-based quantum computing company, recently announced its expansion into Maryland, with the intent to strengthen the company’s research and development capabilities and commercialization in the U.S.

The move follows the company’s participation in Maryland’s Global Gateway program, which incentivizes foreign companies to “soft land” in the U.S., offering affordable office spaces at Maryland incubators as well as access to advisors and other resources. As a Global Gateway participant, NanoQT took up residency at the Quantum Startup Foundry incubator on the University of Maryland campus, where the company will maintain its presence.

BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

“Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,” said Gene Mack, President and CEO of Gain Therapeutics.

GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced Multiscore, an advanced AI-powered decision support tool designed to revolutionize genetic analysis by improving diagnostic efficiency, streamlining workflows, and enhancing clinical insights. Multiscore is embedded into GeneDx’s interpretation platform as a decision support tool to help clinical geneticists focus on the most relevant genes during their clinical analysis. GeneDx will present the AI-powered decision support tool at ACMG, in a session: Multiscore, a Gene Ranker Powered by Artificial Intelligence and Real-World Clinical Data, Shows High Sensitivity in 10,000 Exomes and Genomes which received one of the limited spots in an industry-specific platform session.

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 12, 2025 – Gaithersburg’s Shuttle Pharmaceuticals Holdings Inc. (NASDAQ: SHPH) has brought in a new executive to spearhead the biotech’s business activity, freeing up its longtime leader, a cancer doctor and physician administrator, to focus on research and development.

The company’s co-founder and chief executive, Dr. Anatoly Dritschilo, is now one of two co-CEOs, and will oversee the clinical trials and scientific work required to get its lead candidate for an aggressive brain cancer to patients. And Christopher Cooper, a former oil and gas industry exec who also leads a telecommunications company, has joined Shuttle as the other co-CEO on an interim basis. He will focus on the business activity and raising money through the capital markets, the firm said Wednesday.

Rockville, Md. (March 11, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply.  

BANGALORE, India, March 10, 2025 /PRNewswire/ — Syngene International Limited ('Syngene'), a global contract research, development, and manufacturing organization (CRDMO), today announced the acquisition of its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines.

The state-of-the-art biologics facility, acquired by Syngene USA Inc., a wholly owned subsidiary of Syngene, from Emergent Manufacturing Operations Baltimore, LLC (a subsidiary of Emergent BioSolutions Inc.), will expand Syngene's growing global biologics footprint to better serve its customers across both human and animal health market segments. The new site will increase Syngene's total single-use bioreactor capacity to 50,000L for large molecule discovery, development, and manufacturing services. Additionally, it will provide Syngene's customers with continuity of supply from its four development and manufacturing facilities located in India and North America, offering services ranging from cell line development, process optimization and both clinical and commercial supply.

COLUMBIA, Md., (February 25, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Pathotrak. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage technology and life sciences businesses in Maryland. Through this fund, companies are offered an experienced team that is focused on supporting the entrepreneurial journey.

“Ensuring food safety is a growing challenge, and current testing methods are often slow and costly for producers,” said Javier Atencia, CEO of Pathotrak. “With TEDCO’s continued support, we are advancing our technology in an effort to shorten the time required for pathogen detection, empowering manufacturers with what we hope are faster, more reliable solutions.”

POTOMAC, MD / ACCESS Newswire / March 4, 2025 / IGC Pharma, Inc. (“IGC” or the “Company”) (NYSE American:IGC) today announced an advancement in its Artificial Intelligence (“AI”) platform with the development of a new AI-driven model designed to improve the diagnosis of Alzheimer’s disease (AD) and other causes of dementia. With Alzheimer’s accounting for approximately 60-80% of all dementia cases, alongside other conditions such as vascular disease, Lewy body disease, and frontotemporal degeneration, accurate diagnosis is critical to ensuring the right treatment strategy.

Dementia affects over 55 million people worldwide, causing progressive cognitive decline, memory loss, and behavioral changes. Despite its widespread impact, current diagnostic methods often rely on invasive procedures, expensive imaging, and subjective clinical assessments, leading to high rates of misdiagnosis and delayed treatment.

GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, announced today an indication expansion for its industry leading genetic testing to now include cerebral palsy (CP). In conjunction with Cerebral Palsy Awareness Month, the company is expanding its strategy of focusing on pediatric rare disease patients to now include offering testing for pediatric patients with CP. This strategic indication expansion underscores the importance of improving access to exome and genome testing for patients with CP to shorten the diagnostic odyssey and accelerate the path to treatment.

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 5, 2025 – A New York health care technology company that recently adopted a new name has also found a new home — in Greater Washington.

Claritev Corp. (NYSE: CTEV), a 45-year-old firm previously known as MultiPlan Corp. (NYSE: MPLN), has moved its corporate headquarters to McLean, according to filings with the Securities and Exchange Commission.

The building at 7900 Tysons One Place, known as Tysons Tower, also counts Intelsat Corp. and Deloitte LLP as tenants.

Claritev’s move to McLean represents somewhat of a fresh start for the business, which last year lost $1.6 billion and was hit with several lawsuits from the American Medical Association and several health systems alleging it colluded with insurers to underpay doctors.

GAITHERSBURG, M.D., March 06, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company, today announced that it will host a virtual R&D Day on Thursday, March 13, 2025 beginning at 12:00 pm Eastern Time.

The event will include presentations from renowned Key Opinion Leaders (KOLs) in obesity, MASH and each of the two additional indications, covering the scientific rationale for pemvidutide in each indication, clinical data generated to-date and plans for the continued development of pemvidutide, including the upcoming topline data readout from IMPACT, the Company’s Phase 2b trial in MASH, which is expected in the second quarter of 2025.

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today announced it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI’s previously completed randomized controlled Phase 3 trial.

Collaboration Aims to Develop First Intranasal Therapy for Mild Traumatic Brain Injury Aka Concussion, Establishing a Comprehensive Test-to-Treat Platform

ANNAPOLIS, Md., Feb. 19, 2025 /PRNewswire/ — Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD’s pruritus (itch), and directly treating the immuno-inflammatory cause of the disease.

TG Therapeutics to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support the development and commercialization of azer-cel, its allogeneic CD19 CAR T cell therapy program, for the treatment of autoimmune diseases

ROCKVILLE, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics, today announced they are entering into a strategic platform license (SPL) with TG Therapeutics, a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.

Under the terms of the agreement, TG Therapeutics obtains non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.

Collaboration Aims to Develop First Intranasal Therapy for Mild Traumatic Brain Injury Aka Concussion, Establishing a Comprehensive Test-to-Treat Platform

SARASOTA, Fla. and RICHMOND, Va., Feb. 11, 2025 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN), a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, today announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for traumatic brain injury (TBI). This collaboration seeks to develop the first intranasal therapy for mild traumatic brain injury (mTBI) aka concussion, creating a comprehensive trigger-to-treat platform by combining BRAINBox’s advanced multimarker/ multimodality diagnostic capabilities with Oragenics’ novel therapeutic development.

Newswise — Children’s National Hospital and Virginia Tech are expanding their research partnership, building on a successful collaboration established in 2019. This partnership will advance pediatric health through innovative discoveries and therapies with an initial focus on pediatric cancers, including brain tumors.

The partnership brings together Children’s National, ranked among the nation’s top pediatric hospitals by U.S. News & World Report, and Virginia Tech, a leading academic research institution. Together, they aim to deliver transformative advancements to enhance outcomes for children facing devastating diagnoses.

“Over the years, our partnership with Virginia Tech has demonstrated the power of combining top-tier research expertise with a shared commitment to improving pediatric health,” said Catherine Bollard, senior vice president and chief research officer and director of the Center for Cancer and Immunology Research. “This expansion underscores our belief that by working together, we can accelerate discoveries and develop life-changing therapies for children with cancer and other rare diseases.”

GERMANTOWN, Md., Feb. 06, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it has filed for CE Mark registration for the Eversense^® 365 CGM system.

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.