BHI News Section

Richard Hughen’s thirty years of professional medical device experience spans three Fortune 500 and four start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up developing a novel continuous predictive respiratory monitoring device for the patient bedside and home. Ric was an investor and member of the executive team that built start-up CSA Medical, from a technology license (Navy) through product development, animal trials, clinical trials, five FDA clearances, CE mark, three rounds of funding ($50M), commercial growth and a 2019 sale to Steris. Ric was Managing Director of LearnWare, a life science focused e-learning start-up, which was successfully built and sold to a private equity fund.

He is currently a reviewer for the National Science Foundation’s SBIR/STTR program, an Entrepreneur in Residence for Johns Hopkins Tech Ventures and on the advisory board for George Mason University’s Bioengineering Alliance. He is founder of Life Science Planning, a strategic consultancy for life science companies with focus on fast paced start-up, early stage and emerging growth companies. Earlier in his career, Ric led various senior management, marketing, training and sales teams for Johnson & Johnson, BD, Abbott and Cordis. Ric holds MBA and BS degrees from The Pennsylvania State University. When not working, he is typically outside training for triathlon competition.

LEIDEN, the Netherlands, November 29, 2023 / B3C newswire / — MIMETAS, a leader in human 3D disease modeling, and Yamaha Motor Co., Ltd., a developer of the CELL HANDLER™, announce a strategic joint marketing agreement aimed at advancing therapeutic development using human-relevant models throughout the early drug development pipeline. The collaboration combines MIMETAS’ comprehensive disease modeling and assay development expertise with Yamaha Motor’s state-of-the-art CELL HANDLER, an automated system for selecting, picking and imaging spheroids, tissues and organoids.

Bas Trietsch, CTO of MIMETAS, emphasized the significance of this collaboration, stating, “Introducing patient-relevant 3D disease models into the drug development pipeline is key to developing new therapeutics for unsolved diseases. However, most of these models lack a vascular system and integrated immune cells, which are critical for studying disease processes and therapy efficacy. One of the primary challenges with complex biological models lies in the variability of growth rate and morphology, making high-throughput, robust assays challenging and time consuming. To address these challenges, state-of-the-art automation, such as the Yamaha Cell Handler, is critical.”  “By combining our technologies, we will improve the quality and robustness of tissue model applications in high-throughput,” said K. Matsuno, General Manager of Medical Device Business Division of Yamaha Motor.  “Together, we can make advanced 3D human disease models suitable for all stages of early drug development.”

ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE^® trial. RGX-202 is an investigational one-time AAV Therapeutic for Duchenne muscular dystrophy (Duchenne), using the NAV^® AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle-specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.

“Progressing to dose level 2 is an important milestone in our updated strategic plans and for accelerating the development of RGX-202,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “There is a large unmet need for new therapies for boys with Duchenne, and the market is capable of supporting multiple gene therapies. We believe RGX-202 has unique, differentiating features that support its potential to be a best-in-class product.”

GAITHERSBURG, Md., Nov. 28, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

BioHealth Innovation is thrilled to announce that our esteemed Entrepreneur-in-Residence, Kwame Ulmer, has been recognized by Quroba for his outstanding contributions to the MedTech industry. This recognition is a testament to Kwame’s exceptional journey and his relentless pursuit of innovation in healthcare technology.

From Quroba’s Post:

“This month, we’re honored to shine the spotlight on a true industry luminary, our very own Kwame Ulmer.

With two decades of experience in evaluating medical technologies across both government and private sectors, Kwame’s expertise is nothing short of exceptional.

COLUMBIA, Md. (November 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Social Impact Funds investment into NasaClip.

“Nosebleeds are common, and often don’t require medical intervention. In fact, with emergency treatment many patients end up walking out of the hospital later than anticipated and in more pain than when they entered,” said Dr. Elizabeth Clayborne, CEO and founder of NasaClip. “Thanks to TEDCO’s investment we can continue our efforts to provide a more timely, efficient and cost-effective solution for patients, allowing them to get treated from the comfort of their own homes.”

As the year 2023 comes to a close, CarrTech Corp has demonstrated remarkable progress and innovation in the biotechnology and medical device sectors. The company has achieved several milestones, engaged in significant collaborations, and is poised for further advancements in the coming year. Here are some of the key highlights from CarrTech Corp’s journey over the past year:

GRAND RAPIDS, Mich., Nov. 27, 2023 /PRNewswire/ — cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that they have made a significant investment into Nanochon, a Washington, D.C.—based regenerative cartilage innovator.  

Nanochon develops solutions utilized by sports medicine physicians to treat active patients requiring cartilage restoration.  Nanochon’s Chondrograft™ replaces lost or damaged cartilage and encourages new growth using an innovative material and 3D printed designs that are cost-effective and easy to deploy treatment options.

BETHESDA, Md., Nov. 24, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (“Gain” or the “Company”) (Nasdaq: GANX) today announced the closing of an underwritten public offering of 2,545,000 shares of its common stock and warrants to purchase up to an aggregate of 1,272,500 shares of its common stock at a combined public offering price of $2.005 per share and accompanying warrant, including 331,956 shares of common stock and warrants to purchase 165,978 shares of common stock issued pursuant to the full exercise by the underwriter of its over-allotment option. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $4.01 per set of securities, yielding an effective price of $2.00 per share and $0.01 per warrant. The warrants were sold at the rate of one warrant for every two shares of common stock. The warrants have an exercise price of $2.75 per share, are exercisable immediately, and will expire five years following the date of issuance.