Pipeline

Overview

Endomedix has developed a platform technology that can be used to develop at least 4 separate product categories or intended uses, each with multiple indications for use. These categories include surgical hemostats, tissue sealants, drug delivery and tissue engineering vehicles. All these intended uses utilize the same basic technology and starting materials, and are protected by the issued patents assigned to Endomedix. Due to the attractiveness of the market, the competitiveness of the Company’s technology in this market, and the acquisition activity in this space by strategic market participants, the Company has chosen to focus its energies on the surgical hemostat market opportunity.

Surgical Hemostats

IMS data estimate that 2.6 to 3 million surgical procedures performed annually in the U.S. use a topical hemostat product. The U.S. market is estimated to be $2 billion for hemostatic products and growing 11.2% annually. The worldwide hemostat and sealant market is projected to grow from $4.5 billion in 2013 to 6.7 billion in 2017, a 10% annual growth.
The Company has selected to focus on surgical hemostasis due to the opportunity to use its technology to develop devices that produce faster hemostasis, easier to use, and less costly to produce. Speed of action is one of the fundamental targets for product development in this space. Reducing the time for hemostasis can translate into the shortening of the surgical procedure and the reduction of general anesthesia requirements, both of which are costly. Reduction of procedure time also reduces the opportunity for infection and may reduce post-operative morbidity, both of which are costly. Thus the Endomedix technology can produce hemostats which can significantly reduce surgical OR and anesthesia costs to the hospital and improve patient care outcomes.

The Company has selected intracranial or brain surgery as its targeted first indication for use because the need for improved products for this indication is so pronounced and because the Company’s technology has unique characteristics that are particularly relevant in this indication. The speed of action of the Company’s prototypes suggest that it can reduce the time of a surgery by 30+ minutes, saving the hospital $3,000 – $4,000 per case. In addition, the Company’s hydrogel devices shrink in wet environments and do not swell. Current products swell when used, potentially causing a spike in intracranial pressure, which is a common cause for revision brain surgery and which can cost $70,000 per case.

After the device for intracranial surgery is cleared for use, premarket clearance for additional indications will be pursued. We believe that spinal surgery and ENT surgery would be the next applications and would use the same product formulation as will the device for intracranial surgery.

Tissue Sealants

According to Life Science Intelligence, as reported in Medtech Strategist, the worldwide surgical sealants market is currently valued at about $1.3 billion and growing at a rate of 5.4%, compounded annually. The growth rate is greatest in Asia, while the U.S. and Europe will experience growth of 3%. The market growth will be driven by new, next-generation products designed to offer greater sealing strength and improved biocompatibility. The current market penetration of sealants and glues is the U.S. stands at about 25% of eligible surgeries.
The Company’s technology utilizes natural biopolymers that are believed to break down via enzymatic degradation and are excreted via the kidneys. Our devices would be 4x–5x stronger than the commonly used fibrin glue. The Company may choose to seek a strategic partner for this application in order to accelerate commercialization.
Drug Delivery

Researchers have evaluated functional prototype drug delivery systems in vitro and in vivo for the sustained of various drugs, antibiotics and PPAR-gamma inhibitors. The results were successful, though we are not pursuing this indication at this time.

Drug Delivery

Researchers have evaluated functional prototype drug delivery systems in vitro and in vivo for the sustained of various drugs, antibiotics and PPAR-gamma inhibitors. The results were successful, though we are not pursuing this indication at this time.

Tissue Engineering

Independent researchers at a major medical university are engaged in a tissue engineering project, utilizing the Company’s materials in a project to regenerate spinal disks. At this point, our role is to provide materials for the funded research. This project may become a point of focus for the Company in the near future.