As the leaders in this industry, we are committed to clinical research in order to discover the latest medical technology. ACI Medical has clinical testing relationships with some of the best medical research facilities in the world including: Tufts Medical School - Boston, State University of New York - Stony Brook, University of Rochester - New York, Temple University School of Medicine - Philadelphia, Loyola Medical School - Chicago and Southern Illinois University - Springfield.
Corporate Background
ACI Medical, LLC. is a biomedical engineering firm engaged in the research, development, manufacture and sale of therapeutic products and technologies for individuals with varying degrees of life-impairing vascular conditions. With 25 years experience in bringing innovative healthcare products to market, ACI is committed to developing, producing and distributing the highest-quality products for patients, consumers and healthcare partners.
ACI holds exclusive rights to several U.S. patents that are the foundation of its hallmark device, the ArtAssist device.
Company History
ACI Medical was founded in 1984 in Los Angeles with the development of a novel device for IV fluid administration, which was later sold to a larger medical company. In 1986, ACI began manufacturing plastic components for other medical device companies and specialized in providing design assistance to lower costs and improve product performance.
ACI is ISO 13485:2003 certified as a medical device manufacturer and is registered with the FDA.
By request, ACI developed a special air pump for use in the blood pressure monitors of one of its plastic components customers. ACI's air pumps are now sold in various models for a variety of medical and industrial gas sampling applications. These contract OEM activities continue to this day.
In 1988, ACI began design of its APG product, a noninvasive diagnostic device for chronic venous disease. Clinical testing at major medical universities in the United States, United Kingdom and Japan led to worldwide sales in a niche market. This device, modified for space flight, has been on the Mir Space Station, and additional units are aboard the international space station for assessing the effect of long term micro gravity on the vascular system of space travelers.
While testing a prototype of a new ACI device at a local hospital, clinicians and researchers noticed that the device created a large increase in arterial blood flow. Realizing the importance to relieving arterial disease, ACI Medical sent prototypes of the ArtAssist to academic sites for further testing. After establishing that the device provided therapy that reduced ischemic leg pain, further studies identified the optimal design parameters to maximize the effect in patients with arterial disease. Several patents were issued.
Continuing studies showed both short-term and permanent benefits in properly selected patients. Immediate therapeutic benefits include reduced pain and healed ulcers. Using the device for three months leads to permanent improvements such as collateral vessel formation (called arteriogenesis) and the prolonged ability for patients to walk farther, pain free; even after cessation of use of the ArtAssist device.
Products
ACI's established products are sold worldwide and display the CE mark. They include:
The ArtAssist® device - an in-home therapeutic device designed to increase arterial blood flow to lower limbs to heal ulcers, alleviate pain and prevent amputation.
VenAssist® - a pneumatic compression device for preventing blood clots from forming in the veins of at risk hospitalized patients. Blood clots can travel to the lungs and are a major cause of postoperative death.
VenaPulse® - a noninvasive device that generates static, tourniquet pressure to limbs of patients undergoing vascular testing. It is used for vein mapping and quantification of venous flow to identify suitable distal vessel for bypass, among other uses.
APG® - a noninvasive diagnostic tool that quantifies the physiological components of chronic venous disease. APG helps identify and follow-up patients that are good candidates for deep venous reconstruction. A modified version of the APG system is used on the International Space Station to quantify the effects of prolonged microgravity on peripheral vascular tone in arms and legs.
The company also manufactures and markets:
Miniature diaphragm pumps for use in a wide variety of applications, including medical equipment, industrial gas sampling applications and toys.
Custom injection molding used with CAD/CAM capabilities and a wide range of molding equipment.
Company Mission
ACI is committed to supporting ongoing clinical research especially in treatment for preventing amputations and other complications caused by vascular disease. In addition, the company has dedicated considerable effort to requesting Medicare reimbursement for patients who are at risk of losing a limb, but who cannot afford to pay out of pocket for devices such as the ArtAssist device.
ACI is also committed to providing the highest level of customer service possible. Patients receive personal calls to ensure they are using the ArtAssist device properly and that all questions are answered.
ACI strives to provide the highest quality products and services to our customers. Devices are kept in stock for delivery within 24 hours within the lower 48 states. Should there be a problem with a rental device, in-stock replacements are immediately shipped rather than waiting for its return to the factory, repair and shipment back to the patient.
Quality Policy
It is the policy of ACI Medical, LLC., and one of its most important goals, to implement a system that is capable of consistently determining and meeting our customers’ requirements; and to include and serve as a model for current and future regulatory requirements. The safety and performance of our products are the result of each employee's commitment and responsibility, in an environment which encourages and is expressed through an effective quality system that ensures a well planned operational system with all functions of the organization working together as one.
Through our continual investment in quality, ACI Medical has achieved a global ISO 13485:2003 certification as a medical device manufacturer, providing customers with consistent results wherever they operate in the world.
Markets
The need for noninvasive medical devices that increase, monitor, or measure arterial blood flow is vital to the treatment of several patient populations, including people with diabetes and individuals suffering from what is commonly called "hardening of the arteries."
Diabetes is the most frequent cause of non-traumatic lower limb amputation, with more than 92,000 amputations performed each year. In the U.S. alone, there are 13 million diabetics, or 5.2% percent of the population. Diabetic foot ulcers, suffered by more than two million diabetics annually, are often the first symptom of reduced blood flow that can lead to amputation.
The ArtAssist device also relieves symptoms of Peripheral Arterial Disease (PAD), called "hardening of the arteries," which affects more than 4 million Americans each year.
Treating arterial disease with the ArtAssist device results in substantial cost savings to the healthcare system when compared to amputation.
Management
Company founder, Ed Arkans, has a master's degree in biomedical engineering with emphasis on electronics and human physiology. He worked at large medical device companies in product design and business development and currently holds 25 patents with others pending.
Clinical Testing Relationships and Capabilities
ACI has clinical testing relationships with some of the best medical research facilities in the world including:
Tufts Medical School, Boston
State University of New York, Stony Brook
University of Rochester, Rochester, NY
Temple University School of Medicine, Philadelphia
Loyola Medical School, Chicago, IL
Southern Illinois University, Springfield
Kaiser Permanente Hospitals
Veterans Hospitals
University of Manitoba, Canada
Imperial College School of Medicine, London
Academic Medical Center, Amsterdam
University of Utrecht, Amsterdam
Cyprus Institute of Neurology and genetics, Nicosia
