Overview

Bleeding and leakage remain compelling problems to solve. Patients matter.

The AC5 Surgical Hemostatic Device™ value proposition is based on the premise of faster and safer surgery. The product is designed to be simple (user-friendly), effective (works promptly), versatile (useful in challenging situations such as laparoscopic surgery**), and safe. These claims alongside the multipurpose nature of AC5™ distinguish it from first-generation solutions currently in use.

Large markets filled with problem products

In 2012, annual worldwide sales were over $2.8B for hemostatic agents and nearly $1.3B for fibrin and other sealants, which seal other leaks (cerebrospinal fluid, pleural, etc.). These products are anticipated to surpass global combined sales of over $7B in 2017.

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Available hemostatic* products possess a combination of troubling limitations: slow onset of action, unreliability, user-unfriendliness, and risk for adverse effects, including healing problems, adhesion formation, infection and other safety concerns. This ongoing and unacceptable situation has opened the door for new products.

Customers seek better products

Arch spoke with surgeons, operating room managers, sales reps for competitive products, and hospital administrative decision-makers regarding their thoughts on what they wanted in an ideal product. While better efficacy and reliability are important, additional desired product features were identified which have been incorporated into our products design. Many of these additional features in and of themselves could prove sufficient to support tremendous product uptake and use. We learned that users seek some combination of the following characteristics, all of which are strategically relevant to the Arch Therapeutics program:

Laparoscopic friendly Indifferent to status of coagulation cascade or “blood thinning” drugs
Simple to prepare, store Non-immunogenic
Easily applied/handled Does not promote infection and may prevent infection
Transparent Promotes a clear field of vision; does not obstruct view
Flowable Non-sticky (to tissue or equipment)
Enables normal healing Does not contain human blood product or animal components
Non-toxic Does not cause surgical adhesions

*Hemostasis or haemostasis (from the Ancient Greek: αἱμόστασις haimóstasis "styptic (drug)") is the process of stopping bleeding, or preventing blood from leaking from damaged blood vessels and tissues. (The opposite of hemostasis is hemorrhage.)

**Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a modern surgical technique in which operations are performed through small incisions (usually 0.5–1.5 cm) as opposed to the larger incisions needed in open surgery. Keyhole surgery makes use of images displayed on TV monitors to magnify the surgical elements.

1Source: MedMarket Diligence, LLC; Report #S180, “Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2008-2015.”