At RESI Boston 2024, held on September 25th at the Westin Copley Place, Montgomery County-based biotechnology company miRecule, a client of BioHealth Innovation Inc. (BHI), showcased its groundbreaking RNA therapeutic programs. As part of Biotech Week Boston, RESI Boston provided a premier opportunity for miRecule to engage in in-person networking with potential investors and partners, followed by virtual partnering sessions on September 26-27. miRecule presented the innovative work stemming from its DREAmiR™ platform, which leverages genomic and patient outcome data to create highly personalized RNA therapies for cancer and muscular dystrophy.

EchoGuide is Sonavex’s pipeline product designed to improve cannulation for dialysis patients.

Baltimore, MD (September 25th, 2024) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it was awarded a $2 million Small Business Innovation Research (SBIR) Phase IIB Grant from the National Institutes of Health (NIH) to advance EchoGuide^TM, Sonavex’s pipeline product designed to reduce cannulation injury for dialysis patients. The grant will support activities necessary to pursue regulatory clearance from the Food and Drug Administration and fund a clinical trial.

GAITHERSBURG, Md., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first participant has been dosed with GIM-407 in a first-in-human, phase 1 clinical trial in healthy volunteers, which is the stepping stone of the clinical development plans to develop it for patients with autoimmune diseases. Based on novel biology, GIM-407 is the only selective T-regulatory cell activator of its kind in development. It is a small molecule that is administered orally marking the first autoimmune disease program for the company.

The 10th Annual BioHealth Capital Region Forum has once again brought together some of the most influential leaders and innovators in the biohealth industry. This year’s Forum features a stellar lineup of returning presenters and keynotes, each contributing unique insights into the state of the biohealth sector, both locally and nationally. Here’s a look at some of the standout sessions from this year’s event.

"The caliber of speakers at this year’s BioHealth Capital Region Forum was truly exceptional. From industry veterans to emerging leaders, the insights shared reflected the depth of expertise and innovation driving the growth of our biohealth ecosystem. We were honored to host such influential voices who are shaping the future of healthcare and biotechnology, and their contributions made this year’s event one of the most impactful yet," said Rich Bendis, President and CEO of BioHealth Innovation, Inc.

The BioHealth Capital Region Forum had the honor of hosting Maryland Governor Wes Moore, who addressed attendees at the 10th Annual event held at the US Pharmacopeia (USP) in Rockville. Prior to his speech, Governor Moore met with a select group of local leaders and industry experts, including Montgomery County Executive Marc Elrich, Rich Bendis, President and CEO of BioHealth Innovation, Inc., Ronald T. Piervincenzi, Ph.D., CEO of USP, Peter S. Briskman, Executive Managing Director of Brokerage at JLL and others.

Governor Moore’s attendance underscored the strategic importance of the biohealth industry to Maryland’s economy. His participation signified the state’s commitment to remaining at the forefront of biotech innovation, supporting the growth of life sciences companies, and fostering partnerships between government, industry, and academia. By engaging directly with industry leaders, Moore highlighted Maryland’s pivotal role in shaping the future of healthcare and biotech.

ROCKVILLE, MARYLAND, September 23, 2024 – BioHealth Innovation, Inc. (BHI) and Georgetown University’s Office of Technology Commercialization (OTC) have entered into a strategic collaboration to accelerate the commercialization of innovative research and technologies developed by Georgetown University faculty, staff, and student entrepreneurs.

BHI and its experienced Entrepreneurs-in-Residence (EIRs) and network of analysts will provide support, mentorship, and commercialization expertise to the recently launched Georgetown Tech Ventures (GTV). GTV is supported by the Build to Scale (B2S) program, which is led by the Economic Development Administration’s Office of Innovation and Entrepreneurship. As part of this initiative, BHI will assist GTV in strengthening its entrepreneurial ecosystem by interacting with Georgetown’s faculty, staff, and student entrepreneurs and will leverage BHI's extensive experience in commercialization and entrepreneurship to help GTV effectively manage the development and launch of innovative ventures. This effort will include conducting seminars, offering one-on-one mentorship, and leveraging BHI’s network to increase visibility for GTV’s programs. The collaboration will also help raise the profile of Georgetown’s innovation initiatives by tapping into significant events like the BioHealth Capital Region Forum and BHI’s various communication platforms such as weekly newsletters, blogs, and the BioTalk podcast.

The commercialization and technology transfer arm of the storied Baltimore university is helping to foster the region’s burgeoning tech scene.

BY Steven Melendez

During the opening day of the BioHealth Capital Region Forum at US Pharmacopeia in Rockville on September 17^th, 2024, Virginia Governor Glenn Youngkin was awarded the 2024 Governor of the Year by the Biotechnology Innovation Organization (BIO). This prestigious award recognizes governors who have demonstrated strong leadership and commitment to advancing biotechnology in their states.

Governor Youngkin, who has been instrumental in driving economic development across Virginia, spoke about the Commonwealth’s expanding role in the life sciences sector. “Investing in biotechnology is investing in Virginia’s future,” he remarked, highlighting the importance of Virginia’s research triangle and ongoing efforts to foster innovation. Under his leadership, Virginia has secured nearly $71 billion in capital investments, transforming the state into a significant hub for biotechnology and other industries.

Montgomery County Executive Marc Elrich helped kick off the 10th Annual BioHealth Capital Region Forum once again this year, reinforcing the county’s pivotal role as the epicenter of the BioHealth Capital Region. In his opening remarks, Elrich highlighted the county’s vast biohealth assets, including NIH, NIST, FDA, USP, and a thriving network of innovative companies. He also emphasized that this significant event has been proudly hosted in Montgomery County for the past decade.

Throughout his speech, Elrich reiterated Montgomery County’s commitment to fostering growth and innovation in the biohealth sector. He spoke on the importance of collaboration between government, industry, and academia to drive advancements that will benefit the region and have a global impact on healthcare and biotechnology.

The 2024 Women’s Health Innovation Summit USA taking place from September 23-25, 2024, in Boston, MA. This event will serve as a leading platform for accelerating innovation, investment, and partnerships within the women's health sector. The summit will bring together key industry players, including professionals from pharma, biotech, medical devices, femtech, and startups, as well as investors, healthcare providers, and researchers, to discuss cutting-edge advancements in women's health care.

BETHESDA, Md. and SINGAPORE, Sept. 23, 2024 /PRNewswire/ -- VerImmune Inc., ("VerImmune"), a venture-backed biotechnology company developing a groundbreaking Virus-inspired Particle (ViP™) platform technology, today announced the successful first closing of $4.5 million in its Pre-Series A financing round.

The financing was led by Beiley Biofund, an early-stage venture capital firm focused on cutting-edge technologies that address high unmet medical needs. New investors, including Dr. John Ballantyne, PhD, co-founder and former CSO at Aldevron, participated in the round, alongside returning investors Proxima Ventures, Mana Ventures, Gaingels, and others.

Network will analyze and improve how genomic information is integrated into patient care.

The National Institutes of Health (NIH) is awarding $5.4 million in first-year funding to establish a new program that supports the integration of genomics into learning health systems.

Present in many hospitals across the United States, learning health systems are a type of clinical practice that bridges research and patient care. These systems use a variety of methods to continually analyze patient data. Clinicians then use the results of those analyses to refine practices and improve future care.

The new Genomics-enabled Learning Health System (gLHS) Network aims to identify and advance approaches for integrating genomic information into existing learning health systems. As genomic testing becomes increasingly common, more and more genomic data are available in clinical settings, and learning health systems present an opportunity to translate this evidence quickly and directly into improvements in medical care.

Day 1 Recap: A Dynamic Start to the 10^th Annual BioHealth Capital Region Forum

The 10^th Annual BioHealth Capital Region Forum kicked off with a strong showing of leadership from both Maryland and Virginia, setting the tone for the rest of the week. BHI President and CEO Rich Bendis opened the day by thanking Ronald T. Piervincenzi, Ph.D., CEO of USP, for hosting the conference for the third year in a row. Ronald T. Piervincenzi, Ph.D., introduced Montgomery County Executive Marc Elrich, who welcomed attendees to Montgomery County, where this event has been held all ten years. Elrich highlighted the importance of Montgomery County, which is the epicenter of the BioHealth Capital Region.

BioHealth Capital Region Week 2024 welcomed Immobazyme, a biotech company from Stellenbosch, South Africa, to compete in the 9th Annual Crab Trap Competition. Specializing in precision fermentation products, Immobazyme focuses on developing treatments for diabetic foot ulcers (DFUs), with the goal of reducing amputation rates and improving the quality of life for diabetic patients worldwide. Ethan Hunter, Chief Operations Officer of Immobazyme, represented the company and delivered a compelling pitch to the panel of judges.

Linshom Medical, a TEDCO-backed company, located in Baltimore, MD, was named the winner of the 9th Annual Crab Trap Competition during the BioHealth Capital Region Forum. Linshom impressed the judges with their groundbreaking wearable respiratory monitoring device, the first FDA-cleared technology to deliver an operating room-quality respiratory profile to the patient bedside.

By continuously providing critical metrics such as Respiratory Rate (RR), Tidal Volume (TV), and Minute Ventilation (MV), Linshom’s device predicts respiratory decline up to 70 minutes before an emergency, reducing costly ICU transfers, rapid response activations, and potentially saving lives. Unlike bulky, expensive equipment limited to the ICU or operating rooms, Linshom’s device brings precise, predictive respiratory monitoring to the bedside, addressing a fundamental gap in patient care. Judges praised Linshom for its technological innovation, clear path to market, and the critical need it addresses in modern healthcare, particularly in post-operative and emergency settings.

U.S. Pharmacopeia (USP) is currently seeking Expert Volunteers from diverse professional backgrounds to contribute to its vital mission of safeguarding the quality of medicines, dietary supplements, and food ingredients. For over 200 years, USP has maintained trust in healthcare products through rigorous standards, and now they are calling on scientists, healthcare professionals, regulatory experts, and academicians to join them for the 2025–2030 cycle.

Volunteering with USP offers a unique opportunity to work alongside global experts from academia, industry, and regulatory bodies to help review and revise USP standards. These standards are essential for public health, legally recognized in the U.S., and used in over 150 countries. Volunteers will lend their expertise to address emerging health concerns, build awareness, and reduce the risk of substandard healthcare products. As a part of an Expert Committee, you’ll help shape global healthcare and contribute to ensuring that consumers worldwide have access to safe and reliable products.

This biotechnology company aims to save lives through their transformative medical device.

COLUMBIA, Md., (September 23, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Builder Fund investment in CarrTech, a life sciences company working to support patients and healthcare providers. The Builder Fund is part of TEDCO’s Social Impact Funds, an umbrella of funds designed to support underserved founders and communities.

“The purpose of CarrTech and our medical device FROG®, is saving lives by mitigating the risk of preparing ampoule-based medication,” said CarrTech’s founder and CEO Sue Carr. “My team and I are incredibly optimistic about the huge impact TEDCO’s investment could bring to the healthcare community.”

WILMINGTON, Del., September 20, 2024 – FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1

The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FLUMIST to eligible individuals 2-49 years of age.1

What’s happening? ARPA-H is launching the Emerging Health Innovators (EHI) Initiative to increase access to government research funding for early career researchers and community health innovators to address health care gaps in the U.S.

Why it matters? Early career researchers and community health innovators, including those from minority-serving institutions and community-based organizations, will now have more opportunities to pursue bold and technically risky R&D projects, but who have been unable to take these leaps using traditional funding opportunities.

Clinicians caring for children are often left to rely on off-label devices and medications approved for adults, especially during national disasters and other emergencies. Children’s National Hospital is launching a new partnership with the federal Biomedical Advanced Research and Development Authority (BARDA) to develop much-needed solutions for this vulnerable population.

This new pediatric-focused hub will be known as the SPARK Hub—or the Hub for Special Populations Acceleration, Research and Knowledge for Innovations in Pediatrics. It will join a network of four existing BARDA hubs to develop various tools for national health emergencies, including infectious disease outbreaks or chemical, biological, radiological and nuclear attacks. The new opportunity for Children’s National positions the organization as a leader among those working to ensure clinicians and their patients have the resources they need in crises, approved for kids and ready for clinical use.

With COVID-19 still spreading and mpox emerging as a public health emergency of international concern, the National Institutes of Health (NIH) is upping preparations for future pandemics.

The Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness network (ReVAMPP) will research pathogens that currently lack effective treatments and vaccines, with the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) committing up to $100 million per year to the effort so long as funds are available, the agency announced Sept. 13.

“In the wake of the COVID-19 pandemic and ongoing outbreaks of emerging infectious diseases, the need for robust pandemic preparedness is evident,” NIAID Director Jeanne M. Marrazzo, M.D., said in the release. “The ReVAMPP network will enable researchers to fill key knowledge gaps and identify strategies to develop safe and effective medical countermeasures for targeted virus families before the need becomes critical.”

TOKYO, September 18, 2024 — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that DIGITIVA™, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA). DIGITIVA is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*. DIGITIVA is the first digital health offering from Astellas in the U.S.

DIGITIVA is designed to place patients impacted by heart failure at the center of their care, allowing them to take a more active role in managing their health while working in partnership with their care team. DIGITIVA is comprised of three components: the CORE 500™ Digital Stethoscope developed by Eko Health Inc., a smartphone app designed for heart failure patients and built on the Welldoc, Inc. platform, bolstered by educational content from the American Heart Association, and a dedicated clinical review team. The DIGITIVA clinical review team triages patient data, including previously elusive biomarkers specific to heart failure, and notifies the patient’s treating physician when certain signals are present that may indicate the patient would benefit from intervention, with the goal of impacting clinical outcomes such as acute decompensation events and re-hospitalizations.

RICHMOND, Va., Sept. 17, 2024 /PRNewswire/ -- Activation Capital proudly announces the launch of Start-the-Journey, a new BioHealth Pre-Accelerator designed to equip early-stage biotech and life science entrepreneurs with the knowledge and tools to build successful startups. Powered by Fat Robin Consulting, this innovative program supports founders in the initial phases of their entrepreneurial journey, preparing them for more advanced initiatives like Activation Capital's Frontier BioHealth, launched earlier this year to support scaling advanced-stage startups.

WASHINGTON, DC (September 17, 2024) – Today, the Biotechnology Innovation Organization (BIO) awarded Virginia Governor Glenn Youngkin with its 2024 Governor of the Year Award. 

BIO’s annual award honors governors for their leadership and commitment to strengthening biotechnology in their state. For over a decade, the award has recognized governors from across the country and both sides of the aisle.

“Investing in biotechnology is investing in Virginia’s future,” said Governor Glenn Youngkin. “As the Commonwealth’s cutting-edge research triangle and network continues to expand, my administration is determined to remain at the forefront of fostering innovation. I am incredibly humbled to receive this award, and I look forward to further solidifying Virginia’s role as a leader in the life sciences industry.”

COLUMBIA, Md., Sept. 17, 2024 /PRNewswire/ -- The Maryland Stem Cell Research Commission (MSCRC) announces the allocation of approximately $4.5 million in new grant awards to advance stem cell research and technology. These grants will drive innovative research with the potential to deliver life-saving treatments and transformative cures for patients with a variety of medical conditions.

This award has been awarded to 11 accomplished scientists from Maryland-based institutions and companies. The awardees include researchers from renowned academic institutions such as Johns Hopkins University and the University System of Maryland, as well as pioneering companies such as Therapative Inc. and Caleo Biotechnologies, Inc. Non-profit organizations, including Regenerative Orthopedics and Sports Medicine, LLC are also among the recipients. The grants will support critical research into treatments for brain diseases such as Alzheimer's and dementia, blindness, autoimmune diseases, inflammatory bowel disease and orthopedic conditions, among others.

The much-anticipated BioHealth Capital Region Week is finally upon us, promising three days packed with keynotes, competitions, and invaluable networking opportunities. Here's what attendees can look forward to each day:

Day 1 Highlights: The 10^th Annual BioHealth Capital Forum will open with two special guests—one in the morning and another in the afternoon—setting the tone for a day of high-level discussions and networking opportunities. Keynotes for the day include:

• AMGEN’s Entrance to the BioHealth Capital Region: Robert Stoffel, VP of Rare Disease, Complex Biologics, and Strategic Technology Alliances at Amgen, will discuss the company's strategic initiatives and their impact on the region.
• State of the Bio Industry: John Crowley, President and CEO of BIO, will provide an insightful look into the current landscape and future directions of the Bio industry.

Day 2 Highlights: Day two features the highly competitive Crab Trap competition with finalists Cerillo, Immobazyme, Linshom Medical, Liquet, Optosurgical, and Plakous Therapeutics. These innovative companies will pitch their groundbreaking advances to a panel of esteemed judges.

Rockville, MD—September 17^th, 2024 —The BioHealth Capital Region Forum is honored to announce that Maryland Governor Wes Moore will attend the event this morning to deliver welcoming remarks between 9:00 am – 10:00 am. As the premier gathering for the biohealth industry in Maryland and the surrounding region, the Forum celebrates the significant contributions of this sector’s vitality and innovation landscape.

Governor Moore’s presence underscores the importance of the biohealth industry to Maryland and highlights his administration’s commitment to supporting this vital sector. “We are thrilled to welcome Governor Moore to the BioHealth Capital Region Forum. His continued support plays a crucial role in our mission to advance Maryland as a top biohealth hub in the country,” said Rich Bendis, President and CEO of BioHealth Innovation, Inc.

COLUMBIA, Md. (September 16, 2024) — TEDCO, the Maryland Technology Development Corporation, is thrilled to announce the 10th Entrepreneur Expo, set to take place on Wednesday, December 4, 2024, at the Renaissance Harborplace Baltimore Hotel. This premier, award winning event caters to a diverse audience, previously comprised of entrepreneurs (65%), individuals in the economic development industry (11%), speakers and thought leaders (6%) and others (18%), making it a key gathering for Maryland's entrepreneurial community, showcasing resources and providing invaluable networking opportunities.

ROCKVILLE, Md. and SOUTH SAN FRANCISCO, Calif., Sept. 15, 2024 (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 and innovative bioprocessing applications, and Kamau Therapeutics, a clinical-stage stem cell therapy gene correction company, today announced they are entering into a strategic platform license (SPL) agreement.

Under the terms of the agreement, Kamau 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.

Frederick, MD, September 13, 2024 — VaLogic Bio, a platform company of 424 Capital and a leading provider of compliance and SaaS services to the life sciences industry, proudly announces the acquisition of Facility Logix (FLGX), a renowned firm specializing in planning, developing, and project management for life sciences facilities. This acquisition aligns with VaLogic Bio’s strategic vision to enhance its capabilities and broaden its footprint in the life sciences sector.

COLLEGE PARK, Md., September 11, 2024--(BUSINESS WIRE)--IonQ (NYSE: IONQ), a leader in the quantum computing industry, and the University of Maryland (UMD), an international powerhouse in quantum research and applications, today announced an agreement to expand their partnership to provide state-of-the-art quantum computing access at the National Quantum Lab at Maryland (QLab). QLab provides UMD-affiliated students, faculty, researchers, staff and partners with an unprecedented opportunity to work closely with IonQ’s scientists and engineers as they gain experience with industry-leading trapped ion quantum computers.

QLab, a first-of-its-kind lab for quantum research and development, has supported multiple cohorts of undergraduate interns, multiple academic research projects, and multiple companies within UMD’s Quantum Startup Foundry and Mid-Atlantic Quantum Alliance. Workshops have also been held for government partners such as NASA Goddard Space Flight Center, as well as other events and tours for government and international visitors.

PASADENA, Calif., Sept. 10, 2024 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. (NYSE: ARE), the first, preeminent, longest-tenured and pioneering owner, operator and developer of collaborative mega campuses in AAA life science innovation cluster locations, today announced that Joel S. Marcus, the company's executive chairman and founder, is being honored with the inaugural Bisnow Life Sciences Icon & Influencer Award tomorrow afternoon, Wednesday, September 11, 2024. This prestigious award highlights Mr. Marcus and Alexandria's significant long-term contributions to and lasting impact on the life science real estate sector and broader life science industry. He will accept the award on his own behalf and that of Alexandria at Bisnow's International Life Sciences & Biotech Conference in Rockville, Maryland.

In a recent MedCity News article, Renée Arnold, entrepreneur-in-residence at BioHealth Innovation and the National Institutes of Health, emphasizes the critical importance of early planning for reimbursement strategies in digital health startups. She discusses the common misconception that securing a reimbursement code is the final hurdle, when in reality, startups must ensure insurers will cover their product and that the payment aligns with their pricing model. Learn more about why startups need to integrate reimbursement planning early in their journey and avoid potential setbacks post-FDA approval.

Why Digital Health Startups Should Start Thinking About Their Reimbursement Pathway Earlier

By Katie Adams on September 10, 2024 - Some of the most challenging yet most important processes for digital health startups to navigate are those related to reimbursement and coding.