511th Edition, June 7, 2022

Rockville, MD – On June 8th, Korea SMEs and Startups Agency (KOSME), its Korean Business Development Center (KBDC) and BioHealth Innovation, Inc. (BHI) will kick-off their second virtual US Market Entry program for Korean companies expanding to the United States.

Last summer, BHI and KOSME conducted a similar pilot program, which included five medical device and diagnostics companies.

This year’s competitively selected 5-member cohort includes medical diagnostics, medical devices, health AI and software companies. Over 25 Korea-based health-tech companies applied to the program.

The program will guide the cohort to adopt cultural business differences and communication methods, outline a go-to-market strategy, connect with strategic partners & key opinion leaders, and suggest product or prototype modifications. BHI’s Entrepreneurs in Residents (EIRs) mentor the cohort to achieve a successful US biohealth market entry.

image: KOSME President Hakdo Kim and BHI President Rich Bendis

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May 31, 2022

Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19 Two-dose primary regimen of NVX-CoV2373 already demonstrated cross-reactive immune responses against Omicron and other variants

Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.

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Lung scaffolds developed in partnership with 3D Systems Corporation represent the most complex objects ever printed; reveal took place at the LIFE ITSELF Conference in San Diego

3D-printed lung scaffolds are demonstrating gas exchange in animal models

United Therapeutics expects human clinical trials of 3D-printed, cellularized lungs in the next five years

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & ROCK HILL, S.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that in partnership with 3D Systems Corporation (NYSE: DDD) it has produced the world’s most complex 3D-printed object – a human lung scaffold – and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare.

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Health and Human Services Secretary Xavier Becerra appointed Adam Russell, Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as acting deputy director of the new Advanced Research Project Agency for Health (ARPA-H).

Proposed by President Joseph R. Biden to improve the U.S. government’s ability to speed biomedical and health research, ARPA-H was established by law on March 15 and will operate as an independent entity within the National Institutes of Health.

image: National Institutes of Health in Bethesda, Md.

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GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, the companies said today, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology.

GSK is counting on Affinivax to help it compete better with Pfizer’s blockbuster pneumococcal vaccine franchise, marketed as Prevnar®, and shore up its vaccine offerings as it prepares to spin off its consumer products joint venture with Pfizer.

Image: GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology. (GlaxoSmithKline)

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Richmond medical technology company Tympanogen is a finalist in a national pitch competition from the National Capital Consortium for Pediatric Device Innovation.

The company, which develops nonsurgical treatments for ear, nose and throat issues, earned its place in the “Make Your Medical Device Pitch for Kids!” competition for its gel-patch system for eardrum repair, called Perf-Fix.

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The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards.

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

Optimizing formulation or manufacturing operations Establishing an advisory board  Layering intellectual property protection Preparing for regulatory interactions Gathering evidence to support reimbursement value Engaging with investors or strategic partners Learn more in this video about innovator consultations

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In recent days, prominent venture capital funds have come out with survival tips for their portfolio companies. While asking startup founders to tighten their belt is sound advice, it’s worth wondering when venture capital titans might be urged by their investors to scale back their own pay, too.

Their compensation has been rising fast. Last year, median cash pay for a partner at a venture capital firm, including base salaries and bonuses, rose 10% to $928,000, reported The Information, citing a survey conducted by Holt Private Equity Consultants.

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