Velico - Military Brochure

CAUTION: Investigational device. Limited by Federal (or US) law to investigational use.

The FrontlineODP™ System is currently under investigation and has not received FDA approval for any indication.

Program Funded by BARDA. Contract number #75A50121C00059

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FrontlineODP Spray Dried Plasma System

We combine our passion, expertise, and transformative technology to stop preventable death by bleeding and save lives across the world.

Velico is a private, clinical stage medical technology company headquartered in Beverly, Massachusetts. We are committed to the mission of reducing preventable death from bleeding.

We are developing a novel, spray dried plasma manufacturing system that will equip blood centers around the world to produce spray dried plasma products for transfusion.

FrontlineODP™ (On Demand Plasma) rehydrates in minutes at the point of medical care making it ideal for early, pre-hospital use on ground and air ambulances, in military settings, and for mass casualty events.

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For over 20 years, Velico has been focused on developing innovative blood and plasma products for transfusion. We have focused our efforts on improving the usability, accessibility, and shelf life of specialized blood products.

We have developed a broad portfolio of patents to protect our inventions. Our investment in talented people, intentional collaborations, innovative engineering and novel technology developments will yield products which will improve access to blood and save countless lives around the world upon release of our first product, FrontlineODP™. This, and the products that follow, will be vital to the future of blood.

Richard Meehan President, CEO and Chairman

A message from Richard

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Introducing FrontlineODP™ Preventable death from hemorrhage following trauma is a global concern which has been targeted by trauma surgeons, emergency medical providers, mass casualty planners, the military and national governments as a top priority.

Velico is proud to be developing the FrontlineODP™ Spray Dried Plasma System in support of this call to action.

FrontlineODP™ is a spray dried plasma unit designed for rapid rehydration, intended to support the management of traumatic hemorrhage in situations where conventional plasma is unavailable or impractical.

This includes pre-hospital transfusions, rural and austere healthcare settings, and military applications.

Spray Dried Plasma

This is our innovative solution…

FrontlineODPTM Spray Dried Plasma Manufacturing System

FrontlineODPTM (On Demand Plasma)

Efficient. Scalable. Reliable.

In just over 30 minutes, the FrontlineODP™ Spray Dried Plasma System transforms one unit of plasma into a stable, ready-touse spray dried plasma product. With the FrontlineODP™ System, you can produce up to 9,000 units annually.

4 Plasma

VeliDryer

VeliSealer

Transfusion ready in 2.5 minutes

#PlasmaEverywhere

Watch how the FrontlineODP™ Spray Dried Plasma System works

The FrontlineODP™ Spray Dried Plasma System is being designed for easy integration in blood center component laboratories. Decentralized production by blood centers will aim to take advantage of blood component manufacturing expertise and product supply chains, from established volunteer blood donor bases to end user distribution including emergency logistics channels.

Decentralized production sets the stage for local spray dried plasma self-sufficiency and national emergency preparedness including civilian, government and military collaboration for strategic stockpiles and readiness for major mass casualty events.

Stability Targets

FrontlineODP™ (On Demand Plasma) Room Temperature 1 Year Rehydrates in 2.5 minutes

Comparable Factor Activity

Ultra Lightweight PVC Bag

24 months Shelf Life

FrontlineODP™ System

Refrigerated 2 Years

Decentralized manufacturing

Integrates into blood bank labs

Designed for ease of use and operation

Scalable Production Capacity

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Why is it needed?

30-40 percent of deaths from bleeding are considered preventable. In the United States preventable death from bleeding takes over 30,000 lives per year with over 100,000 more estimated throughout the rest of the world †.

During World War II, over 10 million Units of dried plasma were produced to satisfy demand. Current global production capacity is less than 30,000 units, falling far short of today’s military and civilian demand.

A spray dried plasma solution will potentially allow for new methods of blood product distribution throughout the EMT community.

The potential longevity of Spray Dried Plasma

means that emergency vehicles may be able to carry this product for longer than whole blood or other alternatives without replenishing as often.

In addition, as spray dried plasma is being designed to be stored in ambient conditions, it has the potential to save more lives, especially where emergency vehicles do not have appropriate refrigerated facilities but could provide ambient controlled temperature storage conditions. †

Cannon JW. Hemorrhagic shock. N Engl J Med. 2018 Jan

25;378(4):370-9

Our Production Models Velico aims to deliver the highest-output dried plasma production solution on the planet - unmatched in scalability and built to secure sovereign blood supply chain independence.

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Scan to read more about our veliPod solutions

Velico has engineered two flexible production models for its groundbreaking FrontlineODP™ Spray Dried Plasma System, each designed to meet the evolving needs of modern blood operations.

The first model is the veliPod - a modular, self-contained laboratory built within the compact footprint of a standard shipping container.

Transportable and customizable to specific requirements, the veliPod offers a rapid, scalable solution for establishing spray dried plasma production anywhere it’s needed.

Our second model offers a fixed installation that integrates seamlessly into existing blood component laboratories with no specialized processing environments or clean rooms required. Designed to streamline workflows, it boosts both efficiency and responsiveness in plasma processing operations.

FrontlineODP™ Model Military Usage

Velico Medical Inc.

Military Bases/ Local Blood Centers

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Manufactures Systems / Consumables Sells Systems / Consumables to military Bases

Produces FrontlineODPTM Provides to Military Medical / Service Members

FrontlineODP™ (On Demand Plasma) Intended Use FrontlineODPTM has the potential to revolutionize emergency and prehospital care by: Expanding plasma accessibility for ground and air EMS teams Enhancing availability in rural and underserved areas

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Providing battlefield-ready plasma solutions for military use Strengthening mass casualty preparedness with regional stockpiles

Rehydration The FrontlineODP™ unit is easily rehydrated in two and a half minutes with 200ml of sterile water (SWFI), making it practical in prehospital and hospital settings (i.e. rural) where fresh plasma is unavailable.

Watch how easily The FrontlineODPTM spray dried plasma rehydrates

Transfusion Uncontrolled hemorrhage is recognized as the leading cause of preventable death among victims of trauma. The early administration of plasma has been demonstrated to be lifesaving for many of these patients †.

Sperry JL, et al. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock.

N Engl J Med. 2018 Jul 26;379(4):315-326

†

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Together, we can save lives For more information please contact: Richard Meehan, President & CEO

Andre Cap, Chief Scientific Officer

US 100 Cummings Center # 436H, Beverly, MA 01915, United States +1 978 232 8370

US: +1 (978) 338 4590 EU: +353 (86) 020 9272

US: +1 (210) 410 6882

Europe

rmeehan@veli.co

acap@veli.co

5 Clarendon Mews, Lad Lane, Dublin 2, Ireland, D02 EE61 +353 1 2500 055

www .veli.co