January 20, 2025

SSTI Profile: BHI’s Rich Bendis on Building and Scaling Innovation Ecosystems

Richard Bendis has significant experience building biotech clusters in formerly “flyover” regions (e.g., places that lack the infrastructure to support tech-based entrepreneurs and companies). Around 2009-2010, he was giving a presentation at the National Academy of Sciences in Washington, D.C., on how to build these regions around an industry-driven private-public partnership. After the talk, someone from Johns Hopkins approached him and said they had been trying—with little success—to build a biotech cluster in Maryland. They asked him to come to Montgomery County, Maryland, the epicenter of the region’s life sciences industry.

ARPA-H Announces New Funding Opportunity for Agentic AI in Cardiovascular Care

ARPA-H has announced a new research and development funding opportunity through its Agentic AI-Enabled Cardiovascular Care Transformation, or ADVOCATE, program, focused on advancing FDA-authorized agentic AI to support continuous cardiovascular care. The program targets patients with heart failure and those recovering from heart attacks and is designed to integrate wearable data, digital health records, and AI-driven clinical agents that extend specialty care beyond traditional settings. By prioritizing regions with limited access to cardiologists, this funding effort aims to complement clinicians, improve outcomes for the nation’s leading cause of death, and accelerate safe, FDA-ready AI adoption in healthcare.

Phlow and Enveda Form AI-Driven Partnership to Strengthen U.S. Drug Manufacturing

Richmond, Virginia, Jan. 14, 2026 (GLOBE NEWSWIRE) -- RICHMOND, Va., January 14, 2026 – Phlow Corp., a leading American pharmaceutical contract development and manufacturing organization (CDMO), today announced a major advancement in AI-driven Active Pharmaceutical Ingredient (API) manufacturing process development in collaboration with Enveda, a biotechnology company that learns from life’s chemistry to create better medicines faster. Through a joint pilot program launched last year to rapidly select API routes, the companies demonstrated that high-quality, internally generated reaction data can significantly improve AI-based predictions of chemical reaction kinetics, yields, and purity profiles, compressing development timelines from years to months.

Emergent BioSolutions Wins FDA Approval for New NARCAN Nasal Spray Packaging

GAITHERSBURG, Md., Jan. 14, 2026 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for over-the-counter (OTC) NARCAN® Nasal Spray to be packaged in a new carrying case, which includes two blister packs, each enclosed with Quick Start Guide. This new packaging option is designed to be easy to carry, compact, discreet and durable, with the goal of integrating seamlessly into daily life to help encourage individuals to have life-saving NARCAN® Nasal Spray readily available during an opioid emergency.


Consumer insights reinforce the critical need for this solution. A recent survey by Emergent indicated that 74 percent of consumers prefer a discreet carrying case over standard packaging. Among college students — a population identified as one of the highest-risk groups for opioid misuse — this preference rises to 81 percent, highlighting the demand for solutions that align with their lifestyle and increase the likelihood of carrying naloxone.

Nanochon closes $4.1M Seed Prime II Funding Round

WASHINGTON, January 12, 2026 — Nanochon, a Washington, DC-based orthopedic device company developing an implant for treating articular cartilage defects in the knee, has secured commitments to close an oversubscribed funding round, bringing its total capital raised to date to $11.3 million.


The round was led by cultivate(MD), with significant contributions from The University of Virginia UVA Seed Fund, WSGR, Wealthing VC Fund, and others. While the majority of funding came from a strong group of current investors, several new individuals and funds were welcomed onto the cap table.


Nanochon intends to use the funds to sustain its first in-human clinical study in Canada, deepen research and development efforts, and begin planning for its future pivotal trial.

US biotech sector poised for 2026 rebound as IPO interest revives

By Sriparna Roy and Christy Santhosh - Jan 14 (Reuters) - Investors are eyeing a rebound in the U.S. biotech sector in 2026, as more companies are expected to go public amid a renewed deal-making appetite and a lower interest rate scenario, even as they come ​to terms with the political and regulatory environment.


Amid President Donald Trump's policy shifts, the most disruptive scenarios for healthcare now appear less ‌likely, helping restore a degree of confidence after tariff threats, funding cuts and sweeping changes to the U.S. Food and Drug Administration.


"While some uncertainty still exists, the worst case scenarios ‌have largely been taken off the table and that gives investors more comfort in taking steps into the water and making decisions based upon at least some expectation of normalcy," said Andrew Fein managing director of equity research at H.C. Wainwright.


Initial public offerings in the biotech sector plunged to their lowest level in more than a decade in 2025.

BHI EIR Insights: 7 Tactics to Optimize Launch Messaging – Part IV

by Jonathan Kay, MPP, Managing Partner, Health Market Experts & BioHealth Innovation, Inc. Entrepreneur-in-Residence


In our last three posts of this series, we discussed:


Test, Don’t Guess

Know Your Stakeholders

Listen First

The next step is to develop clear, purposeful, and actionable messages with structure.


Lesson 4: Consider Message Anatomy


A structured framework for message development ensures that your communication is consistent, credible, and compelling. The anatomy of a message consists of 3 components:


Themes

Purpose

Proof Points

Themes might include safety, effectiveness, value, convenience, trust, quality of life, etc. Each theme can have many messages used in different contexts and for different targets


Purpose is the...

MedTech Impact Partners: 2025 Retrospective: Strategic Regulatory Milestone

Dec 30  - Written By Kwame Ulmer - In the world of Large MedTech, the primary objective is managing the risk of global portfolios while ensuring clinical milestones are met. As 2025 concludes, MedTech Impact Partners (MIP) reflects on the substantive progress made by our partners.


This year, our collaborations focused on de-risking the innovation lifecycle. We worked as an extension to high-level regulatory teams, providing the research-backed advice necessary to navigate evolving FDA software guidance and complex therapeutic pathways.


Spanned 4 continents and 9 countries, supporting global market entry.


Covered 12+ clinical specialties, providing deep-dive expertise from cardiovascular diagnostics to orthopedic advancements.


Generated an estimated $1.5M+ in value creation per client through optimized pre-submissions and clinical trial cost-avoidance.

ATEC and Theradaptive Enter Strategic Partnership for Breakthrough Regenerative Technology in Spinal Fusion

CARLSBAD, Calif. and FREDERICK, Md., Jan. 12, 2026 /PRNewswire/ -- Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing spine surgery, and Theradaptive, Inc., a clinical-stage regenerative medicine company pioneering engineered protein therapeutics, today announced a definitive strategic partnership agreement. Concurrently, Theradaptive announced the initiation of a Series B investment round designed to accelerate the expansion of its proprietary protein-engineering platform across global therapeutic applications.


Under the terms of the agreement, ATEC gains exclusive U.S. commercial rights to market and distribute Theradaptive's OsteoAdapt® osteoinductive bone graft for spinal fusion.

BHI is Recruiting Entrepreneurs in Residence with AI and Quantum Commercialization Experience”

BioHealth Innovation is expanding its Entrepreneurs in Residence (EIR) network and is seeking experienced leaders at the intersection of biohealth and advanced technologies, including artificial intelligence and quantum computing.


This call is for seasoned operators with a strong commercialization background. Ideal candidates have taken innovations from concept through market entry, licensing, spinout, or acquisition, and understand the realities of regulatory pathways, customer discovery, fundraising, and scale. Experience working with startups, academic technologies, government labs, or early-stage venture-backed companies is essential. EIRs serve in a part time advisory role with BHI, working flexibly alongside other professional commitments while contributing hands on commercialization expertise.

Email BHI Founder, President, CEO Rich Bendis if you are interested.

BIOPHARMADIVE: Biotech IPOs are the industry’s lifeblood. Track how they’re performing here.

Initial public offerings make the biotechnology industry tick. Stock listings give young companies the funding they need to develop their drugs, and their venture backers an opportunity to earn a return.


For much of the past decade, biotechs found Wall Street receptive to their pitches. Public investment, drawn in by scientific advances and company successes, bolstered generations of new drugmakers.


IPO activity reached a peak in 2021, when more than 100 biotechs priced an initial offering and together raised nearly $15 billion. But that momentum came to a halt in 2022 as stock prices of newly public companies plummeted amid a sector-wide downturn. The pace of IPOs stalled and, last year, only 24 drugmakers priced initial share sales.


Emerging biotechs now face a tougher road to public markets. Which will make it? Which create value and which fail? What types of companies earn the best returns? Who are their investors?

BIOPHARMADIVE: On biotech’s biggest stage at the JPM Healthcare Conference, renewed excitement gets a stress test

SAN FRANCISCO — The irony isn’t lost on Alexis Borisy. The famed biotechnology investor has, all this week, at the industry’s biggest event, been taking meetings from a downtown hotel suite, on a glossy, powder blue couch that has an odd resemblance to a drug capsule. I guess it really does, he said with a booming laugh.


Borisy has co-founded handfuls of companies, including his current passion project, the venture capital firm Curie.Bio, and the cancer drugmaker Revolution Medicines, which is rumored to be in talks for a deal worth tens of billions of dollars. He’s also been coming to the J.P. Morgan Healthcare Conference for decades, since it was run by Hambrecht & Quist. This year, for the first time in several, he found attendees significantly more optimistic. They have reasons to be.


A historic downturn in the biotech sector that began in late 2021 is finally showing signs of subsiding. Acquisition activity spiked in the back half of last year, when at least 28 deals worth $50 million or more were announced.

AbelZeta Announces Remaining China Rights to GPC3 Armored CAR-T Therapy to be Acquired by AstraZeneca

ROCKVILLE, MD and SHANGHAI, CHINA January 18, 2026 – AbelZeta Pharma, Inc. (“AbelZeta”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, announced that AstraZeneca has agreed to acquire AbelZeta’s 50% share of the China development and commercialization rights to C-CAR031, such that AstraZeneca acquires the sole right to develop, manufacture and commercialize C-CAR031 globally. Under the terms of the agreement, AbelZeta will be entitled to receive up to $630 million from AstraZeneca including an upfront payment, and development, regulatory and sales milestone payments for the GPC3 program in China.


Under the terms of a prior agreement with AbelZeta, AstraZeneca owns the development, manufacturing and commercialization rights to C-CAR031 in rest of world, outside of China. AbelZeta is also eligible to receive additional milestone payments and royalties for rest of world development.