Bitterroot Bio CEO, Pavan Cheruvu, MD, on the pent-up need for innovative approaches to CVD risk reduction (like cardio-immunology).

Cardiology Pharmaceuticals

Bitterroot Bio’s Cardio-Immunology Mission

Bitterroot Bio emerged last week, announcing a massive $145M Series A round and an equally massive mission to “rewrite the practice of cardiology” through cardio-immunology therapeutics. 

Founded in 2021 and operating in stealth before now, Bitterroot Bio is taking a contrarian approach to CVD risk reduction, targeting immune response and inflammation pathways that they believe are the actual root causes of cardiovascular diseases (versus cholesterol, hypertension, etc).

Bitterroot placed more emphasis on its founders than you usually see in company launch announcements, and for good reason…

• Its Stanford-based founders were the first to discover that tumors use the CD47 protein to grow undetected by sending a misleading “don’t eat me” signal to immune cells.
• Their CD47 research led to the formation of their aptly named immuno-oncology biotech Forty Seven, which was acquired by Gilead in 2020 for nearly $5B.
• They later found that CD47 in blood vessels leads to “don’t eat me” signals that cause plaque buildup, and higher CD47 levels are associated with greater risks of stroke and heart attacks.
• While researching Forty Seven’s oncology products, they found that CD47 cancer therapy has unexpected CVD benefits.

Based on this evidence, the founders theorized that blocking CD47 might help fight cardiovascular disease, leading to their formation of Bitterroot Bio. 

The company’s lead product, BRB-002, is a protein biologic that targets the CD47/SIRPα pathway to address the underlying causes of atherosclerosis and vascular inflammation, and is currently on pace for clinical trials within the next year.

Bitterroot Bio will use its new funding – reportedly the largest-ever for a preclinical CVD biotech startup – to bring BRB-002 through its Phase 1 and Phase 2a trials, evaluate BRB-002’s potential for other cardiovascular diseases, and explore complementary acquisitions.

The Takeaway

Bitterroot emerges as one of cardiology’s most novel startups, as you’d be hard pressed to find other cardio-immunology efforts in the Cardiac Wire archives, and +$100M Series A rounds for CVD treatment startups are equally rare.

That unique starting point will create many hurdles on Bitterroot’s path towards developing the first cardio-immunology treatments, but it would also mean that the company could have a uniquely large impact on cardiovascular disease care if things go right.

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• PCI vs. CABG for LM CAD: Pooled analysis of four RCTs (4,394 patients, 1,466 w/ ACS) found that patients with left main coronary artery disease have far worse outcomes if they present with acute coronary syndrome (ACS), while showing that PCI and coronary artery bypass grafting (CABG) are both “reasonable” revascularization options. Patients presenting with ACS had far higher rates of all-cause death and cardiovascular death at 30 days than those without ACS (HRs: 3.40 & 3.21), while PCI and CABG had similar all-cause mortality rates among patients with (10.9% vs. 11.5%) and without ACS (11.3% vs. 9.6%).

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• GE’s New CMRI Recon Software: In other CMRI news, GE HealthCare announced the launch of Sonic DL, a new deep learning-based application for reconstructing MR images with a particular focus on cardiac MRI. Sonic DL acquires high-quality MRI studies up to 12X faster than conventional methods, enabling cardiac imaging within a single heartbeat, and making it well-suited for patients with arrhythmias and breath-holding challenges.

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• iRhythm’s FDA Warning: iRhythm Technologies received a downright scathing warning letter from the FDA regarding its Zio AT mobile cardiac telemetry monitor. The letter stated (among other things) that iRhythm failed to inform the FDA of two patient deaths and other issues within its required 30-day timeframe, marketed the device for indications that havent been approved by the FDA, and failed to comply with various quality procedures. iRhythm responded via an SEC filing where it committed to address the FDA’s concerns, and reiterated that the FDA warning does not directly restrict its business activities.

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