Applied BioLogics

Introducting COMPUFLO®

From MILESTONE SCIENTIFIC, INC.

Executive Summary

Milestone Scientific is the world leader in advanced injection technology. Its first generation product, CompuDent^®, a precision metered, computer controlled, local anesthetic delivery system, was developed to meet the needs of the dental market and enables a dentist to consistently administer safe, effective and painless injections.  A similar device for use in medicine, the CompuMed^®, was never actively marketed by Milestone, though favorably reviewed in medical journals for uses in colorectal surgery, rhinoplasty, podiatry, hair implantation and other procedures.

In order to develop a second generation product specifically designed to meet the needs of the medical market place, in 2000 Milestone Scientific began development of a pressure/force computer controlled delivery system.  The system, subsequently named the CompuFlo^®, was patented in March 2001.  While continuing to provide the painless delivery of local anesthetics and the other benefits of CompuMed^®[1], CompuFlo^®  also provides significant additional benefits.  Those benefits include the use of a wide range of drugs and medicaments rather than just anesthetics as well as the precise determination, through pressure read-outs, of the tissue or space into which the drug or other medicament is being injected.  The pressure/force feedback information provided by CompuFlo^® makes the system suitable for infusion, profusion and suffusion of a wide range of fluid drugs and medicaments and the aspiration of bodily fluids or previously injected substances.  CompuFlo^® technology is believed to serve as an excellent platform for more than 700 medical procedures[2], including epidurals, injections into the intra-articular joint space for treatment of arthritis and for patient administered drug and medicament delivery.  Milestone Scientific intends to develop products for medical uses through partnerships with other well known medical/healthcare companies.

The Technology

The CompuFlo^® pressure/force computer controlled injection delivery system technology is an advanced, patented and FDA approved medical technology for the painless and accurate delivery of drugs, anesthetics and other medicaments into all tissue types, as well as for the aspiration of bodily fluids or previously injected substances.  Its regulation and control of flow rate continues to provide the CompuDent^®’s and CompuMed^®’s benefit of painless injections while its Dynamic Pressure Sensing^™ provides visual and audible in-tissue pressure feedback, identifying tissue types to the healthcare provider.  This pressure feedback information extends the benefit of painlessness from anesthetics with known viscosities to a wide range of liquid drugs and other medicaments with varying viscosities and flow rates.  Dynamic Pressure Sensing^™ also allows the healthcare provider to know when certain types of tissue have been penetrated and permits the healthcare provider to inject medicaments precisely at the desired location.  Thus, pressure feedback can prevent the suffusion of tissue outside the intended target area, a vitally important characteristic in the injection of chemotherapeutics and other toxic substances.  Additionally, precisely controlling in-tissue pressure increases patient safety by reducing the risk of tissue damage and post-treatment pain related to excessive pressure that may occur during certain injections. Identification of the tissue in which the needle tip is imbedded is believed to be highly important in Epidural injections, intra-articular injections and numerous organ, subcutaneous and intramuscular injections.  CompuFlo^® should permit many procedures now done using general anesthesia to be performed using local anesthesia,[3] and can sharply reduce the amount of local anesthetic required to perform many procedures.[4]  The system replaces the conventional syringe,[5] currently used for administering liquids into the body, and various aspirating devices.

Opportunities for the Technology

In a study conducted by the Biotech Marketing Alliance, the number of potential applications for the CompuFlo^® technology stands at more than 700.  Areas of particular initial interest include epidural injections, arthritic joint pain management, injectable drugs or medicaments that are currently administered by the patients themselves and  personal insulin pumps.

Epidurals:  Epidurals are commonly administered to women during childbirth and are also used, with increasing frequency, by anesthesiologists, pain management specialists, and other medical professionals for the treatment of acute pain in the back and lower extremities.  An estimated 3.2 million women in the U.S. annually receive epidural injections during childbirth and the number of epidurals for pain management significantly exceeds that figure.  This accounts for a $200 million United States epidural injection market just for childbirth.  Further, epidurals are contra-indicated for children and other patients whose epidural space is smaller than generally found in full-sized adults.  Milestone Scientific believes that with the CompuFlo^®  these patients could often be treated with epidurals.

CompuFlo^®’s pressure sensing technology provides an objective tool that consistently and accurately identifies the epidural space by correctly detecting the difference in pressure between the ligamentum flavum and the extraligamentary tissue. Its hand piece design prevents needle deflection and enables the practitioner to more quickly and more consistently find that space.  Knowing the precise location of a needle during an epidural injection procedure provides a measure of safety not presently available to doctors using conventional syringes who identify the epidural space by relying on the subjective perception of loss of resistance to air or saline.  Medical literature indicates that 30% of the epidural injections miss the epidural space and require that the needle be removed and the injection process be repeated.  Complications from a misplaced needle include extended periods of pain, and sometimes paralysis and seizures.  CompuFlo^® significantly reduces these risks.

 Arthritic Joint Pain Management: Osteoarthritis currently affects nearly 21 million people in the U.S. and accounts for nearly 25% of visits to primary care physicians.  It is estimated that 80% of the U.S. population will have evidence of osteoarthritis by age 65.  The rapidly aging U.S. population should significantly increase the number of osteoarthritis sufferers.

The market for osteoarthritis pain relieving injections in just the small joints of the body is estimated at $2 billion annually.  In the absence of curative procedures,  patients are obliged to endure painful multiple annual injections for a lifetime.  Often these injections are not efficacious because the syringe failed to locate the intra-articular space or did not inject the appropriate volume of hyaluronic acid or other medicament into that space.  The CompuFlo^® technology has been successful in painlessly administering viscous hyaluronic acid and other medicaments into the intra-articular space in both small and large joints using its computer-controlled pressure sensing capabilities.

Self Administered Drug Delivery:  In 2006, the implantable/injectable drug delivery market generated $9.8 billion in revenue worldwide.  It is anticipated that the market will reach $12.6 billion by 2010.  Numerous large pharmaceutical/healthcare companies have developed drugs to treat chronic conditions that sometimes require injections daily (Multiple Sclerosis for example) or often as frequently as twice weekly.

The drugs that have been developed for these chronic conditions are often viscous and acidic which results in significant pain during injection.  These injectable drugs are routinely self-administered in a home or office setting using spring loaded automatic injection devices.  The CompuFlo^® technology, using the pressure sensing capabilities, will serve as a painless subcutaneous injection method for these self-administered drugs.  A significant reduction in pain during delivery will have a positive impact on compliance, which is a major consideration when physicians are considering which drugs to prescribe.

Personal Insulin Pumps:  There are currently 14 million people with diabetes in the United States.  It is estimated that roughly 1.4 million people with diabetes are insulin users.  The Personal Insulin Mini-Pump (PMP) market is dynamic and growing.  The innovations over the past five years have focused primarily on miniaturization and physical design.  The current PMP designs are slow to detect drug “occlusion” due to over-pressure, are not capable of detecting micro-tubing or component connections leakage and they can not detect trapped air-bubble formation within the micro-tubing leading to insufficient dosing of insulin.  Additionally the PMP’s lack the ability to control and manage “exit-pressure” during infusion in real time.

The CompuFlo^® technology is capable of providing solutions to these design limitations.  The use of Dynamic Pressure Sensing™ will enable the PMP to  anticipate and detect instantly occlusions, air bubbles and other situations resulting from an “over-pressure” condition and to detect “open-flow” conditions resulting from breach of the disposable tubing set and/or connectors.  The technology also allows “exit-pressure” to be a controlled parameter of insulin infusion reducing risks of tissue damage during infusion and eliminating pain.  Integration of the CompuFlo technology into a PMP has the potential of creating significant product differentiation in the market place.

The Other Advantage

The CompuFlo^® technology is patented and embedded in an FDA approved prototype.  The technology is currently being used in the Single Tooth Anesthetic  (STA^™) Injection System, and, in part, in its CompuDent^® predecessor, which are both, sold worldwide in the dental market.  Over 35 million patient injections have been given with these two products.   The CompuFlo^® technology has been tried and proven by healthcare providers with over 70 publications validating the efficacy and safety of the technology in a variety of medical injection applications.  Any device that is developed utilizing the CompuFlo^® technology will only require a simple 510(k) approval from the FDA, thus minimizing development cost and time to market.

About Milestone Scientific

Headquartered in Livingston, New Jersey, Milestone Scientific is engaged in pioneering proprietary, highly innovative technological solutions for the medical and dental markets.  Central to Milestone’s IP platform and product development strategy is its patented CompuFlo^® technology for the improved and painless delivery of local anesthetic and a wide range of other liquid medicaments. Specifically, CompuFlo^® is a computer-controlled, pressure sensitive infusion, perfusion, suffusion and aspiration technology, which provides real-time readouts of pressures, fluid densities and flow rates, enabling the advanced delivery and removal through aspiration of a wide array of fluids.  The Single Tooth Anesthetic (STA^™) Injection System, a computer-controlled local anesthesia delivery system that uses this technology, provides dentists with audible and visual signals as to in-tissue pressure.  Milestone’s existing painless injection systems are currently sold in 25 countries. For more information on these and other innovative Milestone products, please visit the Milestone’s web site found at www.milesci.com.

Contact:         Joe W. Martin

jmartin@milestonescientific.com

973.535.2717

[1] The Wand^® handpiece used in both the CompuMed^® and CompuDent^® systems, utilizes the pencil grip which provides an unprecedented tactile sense and accurate control; the bi-directional rotation permitted by the handpiece eliminates needle deflection and resultant tissue tearing and damage and fosters accurate delivery; and the handpiece’s ergonomic design makes injections easier and less stressful to administer.

[2] Based on a study by Biotech Marketing Alliance.

[3]  Demonstrated by the CompuMed® in rhinoplasty.

[4]  Demonstrated by the CompuMed® in colorectal surgery.

[5]  The syringe injection system was invented in 1853 and has not significantly changed in over 150 years.