MARKET OPPORTUNITY
The global microcatheter market was estimated to be roughly $800m in 2023, forecasted to grow to more than $1B by 2028 (BCC Research, M&M Research, Agile Devices estimates). The rapid growth of this market is primarily driven by the increasing global incidence of cardiovascular disease, an aging population, and the comprehensive shift to minimally invasive procedures over open surgery. The US, our beachhead geography, is estimated to represent roughly 40% of the global market.

COMPETITORS AND COMPETITIVE ADVANTAGE
The microcatheter space is consolidated, dominated by large medical device companies including Medtronic, Boston Scientific, J&J, and Stryker. Most models are largely undifferentiated, aside from materials, length, and tip shapes. Innovations have been made recently with other deflection technologies, but they are cost-prohibitive for most institutions and/or have functional deficiencies
limiting their commercial potential.

The Angler® has been shown to navigate to a wide range of anatomical targets faster than best-in-class conventional microcatheters (evidenced by bench/animal testing). This functional advantage holds the potential to reduce procedure time, cost, and risk, and increase hospital care capacity and revenue. Our core competitive edge is our coaxial deflection IP/technology that overcomes
limitations of pull-wire and other deflection technologies.

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ADDITIONAL MARKET BACKGROUND AND COMMERCIAL STRATEGY
Agile Devices is targeting procedures requiring navigation to multiple targets, OR tortuous vessels in the neuro, coronary, and peripheral vasculature, representing 70%+ of this market, according to our extensive primary research with practicing interventional radiologists, cardiologists, and neuroradiologists. Customers include hospital purchasing teams, office-based lab management
teams, and ambulatory surgical center teams. Purchase decisions are made by committees consisting of administrative leadership and senior interventional physicians at each institution. The market consists of three main segments: neuro, coronary, and peripheral vascular.

Agile Devices has developed the Angler® Steerable and Deflectable Microcatheter cleared for peripheral and coronary vascular use in the US. As we develop further indications of our device and gain positive word-of-mouth validation from early adopter clinicians (through a small set of initial independent direct sales to hospital purchasing managers, aided by our clinical advisory network), we
will primarily look to partner with an established medical device company through a direct acquisition or structured acquisition pathway with milestones/triggers in place. To-date, we have built interest in our device primarily through leveraging our clinical advisors' vast network around the US for introductions and demonstrations. We focus on the value proposition that the device is
designed to reduce procedure time, cost, and risk. Our goal has always been to de-risk the technology from a clinical perspective (with early sales and a monitored launch) as we did from technical and regulatory perspectives, but not build out a formal commercial team prior to exit.

TRACTION

• FDA clearance for peripheral and coronary vascular interventions (Q1, 2022)

• Limited Market Evaluation (LME) of 40 procedures at 9 sites around US completed with strong positive physician feedback

• Next-generation neuro-specific product (NeuroNavTM) nearing Design Select stage (est. Q2, 2024)

• NeuroNav Design Freeze completed by end of year 2024

• Significant inbound engagement with major medical device manufacturers interested in this technology

IP PORTFOLIO: NOVEL COAXIAL MICROCATHETER & MICROENDOSCOPE PATENTS
Agile Devices’ patent protected (US 9,233,225) tip deflection mechanism is based on an innovative coaxial design. Agile Devices has designed variable stiffness inner and outer shafts and an ergonomic handle to deflect the distal tip. This patented technology is scalable. Prototypes have been made with both smaller and larger inner and outer diameters. It is also a platform that can be translated for several non-vascular applications, such as GI, ENT, and others that may benefit from deflectable-tip devices.

INTENDED USE
The Agile Devices Angler® Steerable, Deflectable Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled infusion of diagnostic agents and delivery of embolic or therapeutic devices. It is meant to be used only with contrast media and therapeutic
devices that have been cleared or approved for use in the intended target area.

IP PORTFOLIO: NOVEL COAXIAL MICROCATHETER & MICROENDOSCOPE PATENTS
Agile Devices’ patent protected (US 9,233,225) tip deflection mechanism is based on an innovative coaxial design. Agile Devices has designed variable stiffness inner and outer shafts and an ergonomic handle to deflect the distal tip. This patented technology is scalable. Prototypes have been made with both smaller and larger inner and outer diameters. It is also a platform that can be translated for several non-vascular applications, such as GI, ENT, and others that may benefit from deflectable-tip devices.

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KEY COMPONENT DETAILS
Inner and Outer Shafts: Both the inner and outer shafts of our coaxial design were designed with a variable stiffness profile (stiffer proximally and softer distally) for optimal pushability and trackability. The inner shaft has a consistent 0.021” I.D. from the luer to the tip to maximize flow and embolic delivery.

Ergonomic Handle: The handle was optimized to fit in the IR physician’s hand for constant single-handed use while allowing the other hand to manipulate a wire or other devices. With this intuitive design, the physician can easily deflect the tip in both directions and does not have to look away from the fluoroscopy screen while deflecting the tip and/or manipulating the wire.

Deflectable Tip Design: The fully covered 1.5cm tip is designed to deflect consistently up to 180 degrees in both directions (on a single plane). The distal and proximal marker bands allow physicians to see the deflection of the entire tip under fluoroscopy.

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SEED-2 EXTENSION FINANCING

• ~$1.15m target extension of Seed-2 financing

• Preferred equity shares

• $7.5m pre-money valuation, ~$10m post-money valuation (including ~$1.35m Seed-2 funds raised in Dec 2022)

• All other terms remain unchanged from Seed-2 financing

LEADERSHIP TEAM
Ben Merewitz: CEO, Co-Founder, Board Director – 15+ years of strategy, management consulting, product management, corporate development, and executive leadership experience across medtech, biopharma, and industrials. MIT Sloan MBA.
Stephen Hebert: Inventor, Co-Founder – 25+ years of medical device design and founder of 5 medical device companies; Started and sold 2 neurovascular device companies to Micrus / J&J including a pull wire deflectable microcatheter called Enzo.
Leo Tsai, MD PhD MSc: Co-Founder and Medical Lead; Radiologist, Mass General Hospital; Assistant Professor of Radiology, Harvard Medical School.
Stephen Tully: V.P. of R&D – 25+ years medical device R&D experience (USCI, Bard, Covidien, Terumo, Medtronic) – Most recently developed product portfolio for Beacon Endoscopic, ultimately sold to Covidien / Medtronic.
William Gorman: Regulatory & Quality Lead (consultant) – 35+ years medical device regulatory/quality/development experience. Has shepherded dozens of devices from concept to market.

CLINICAL ADVISORY TEAM:
Muneeb Ahmed, MD: Chief, Division of Vascular and Interventional Radiology, Beth Israel Deaconess Medical Center (BIDMC). Associate Professor of Radiology, Harvard Medical School.
Ammar Sarwar, MD: Co-Director of Liver Tumor Program, Beth Israel Deaconess Medical Center (BIDMC). Assistant Professor of Radiology, Harvard Medical School.
Ajit Puri, MD: Chief, Division of Interventional Neuroradiology, UMass Memorial Medical Center (UMMMC). Professor of Radiology, Neurosurgery and Neurology, UMMMC.
Anand S. Patel, MD: Chairman of Radiology, Providence Little Company of Mary Medical Centers - Torrance & San Pedro, CA; Research Associate of Radiology, UCSF Medical Center

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BOARD OF DIRECTORS
Ben Merewitz: Board Chair; Bio above.
Christopher Rich: Board Director; Angel investor, member of Launchpad Venture Group and Sky Ventures; Corporate executive, advisor, and investor in global consumer healthcare; Led GlaxoSmithKline Consumer Healthcare’s $3 billion Wellness business; Extensive track record of marketing and new product leadership roles at Gillette / Procter & Gamble. A.B. in Economics/East Asian Studies from Harvard University and MBA from the Tuck School of Business at Dartmouth.
Patrick Rivelli: Board Director; Serial medical device entrepreneur, executive and investor for 25+ years. Currently CEO of SanaHeal, former CEO of SMART Therapeutics (acquired by Boston Scientific) & Bioabsorbable Therapeutics (acquired by Multi Cell Corporation). A.B. in Economics from Harvard University and MS in Management from the MIT Sloan School. Holds 9 issued patents.
Will Iselin: Board Observer/Advisor; Angel investor, member of Launchpad Venture Group. Experienced corporate executive, private company investor and corporate financier in the UK and the US, with decades of investment banking and transactional experience. Shareholder/director in many private companies. A.B. in History from Harvard University. 4-time US NCAA Squash Champion.
Stephen Tully: Board Observer/Advisor; Bio above.