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Research Industries receives FDA authorization to market Biofilter hemoconcentrator, Plans second quarter launch.


Industries Corporation (NASDAQ/NMS:REIC REIC Real Estate Institute of Canada
REIC Real Estate Industrial Complex
REIC Real Estate Investment Corporation
) Monday announced that it has been authorized by the U.S. Food & Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to market its new cardiovascular hemoconcentrator, Biofilter(TM).

The Company expects to market the Biofilter(TM) in the second half of next quarter. Research Industries anticipates a significant contribution to sales and earnings in the second half of this fiscal year, as much of its distribution network has, until recently, sold competitive hemoconcentrators in the cardiovascular marketplace.

Hemoconcentrators are an increasingly common element of the open-heart surgery open-heart surgery

Any surgical procedure opening the heart and exposing one or more of its chambers, most often to repair valve disease or correct congenital heart malformations (see congenital heart disease).
 bypass circuit, which provides life support for bypass patients. The purpose of the device, a hollow-fiber filter, is to separate excess fluids from the patient's blood during the procedure which have accumulated due to the introduction of cardioplegia solutions as well as bypass circuit priming and intravenous solutions.

If the build-up of such solutions is not reversed, it can cause fluid overload fluid overload Hypervolemia, plethora Medtalk A systemic excess of fluids. Cf Volume depletion.  in the cardiovascular system cardiovascular system: see circulatory system.
cardiovascular system

System of vessels that convey blood to and from tissues throughout the body, bringing nutrients and oxygen and removing wastes and carbon dioxide.
, resulting in post-operative heart muscle stress. "As Research Industries is a world leader in specialized cardioplegia catheters and nutrient solutions that protect the heart muscle during surgery, the Biofilter(TM) is a logical extension of the company's proprietary cardiovascular product line," said Gary L. Crocker, president and chief executive officer.

The device will be initially introduced into the U.S. market, and during the second half of the fiscal year will be rolled out internationally on a country-by-country basis as market approvals are received. The Biofilter(TM), which will sell for about $95, addresses a potential worldwide market of approximately 700,000 bypass and valve replacement surgeries. Currently, hemoconcentrators are used in about 50 percent of bypass and valve replacement surgeries in the U.S., with international market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market
penetration - the act of entering into or through something; "the penetration of upper management by women"
 varying by country.

"The Biofilter(TM) product complements our long-term strategy of targeting highly specialized surgical niches with few focused competitors," added Crocker, "and the primary decision makers for the hemoconcentrator purchase are the same cardiovascular surgeons who currently utilize our broad lines of cardioplegia devices, solutions and specialty bypass blood transport cannulae. Thus, we are in an excellent position to penetrate a significant share of this important cardiac niche opportunity."

The new Biofilter(TM) is fabricated fab·ri·cate  
tr.v. fab·ri·cat·ed, fab·ri·cat·ing, fab·ri·cates
1. To make; create.

2. To construct by combining or assembling diverse, typically standardized parts:
 using a proprietary manufacturing process which leaves no residual chemicals that could be flushed into the body with blood, thereby offering a significant competitive advantage to existing hemoconcentrators. The company also noted that its plans include incorporating the hemoconcentrator capability with its heparin heparin (hĕp`ərĭn), anticoagulant produced by cells in many animals. A polysaccharide, heparin is found in the human body and occurs in greatest concentration in the tissues surrounding the capillaries of the lungs and the liver.  removal technology, resulting in a new product that would simultaneously remove both excess fluids and heparin post-operatively. REIC recently initiated human testing in Europe utilizing its heparin removal device.

"This new hemoconcentrator line not only represents an immediate revenue growth opportunity but also strategically complements our emerging line of heparin removal devices," said Crocker.

Research Industries recently reported its fiscal 1995 revenues and earnings. Health care revenues grew by 28 percent to $28.637 million, or $.81 per share, led by sales of the company's disposable surgical devices, which grew by 31 percent.

Research Industries is a diversified biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 firm specializing in the development, manufacture and sale of hospital disposable products primarily for cardiovascular and vascular surgery Vascular surgery is a subspecialty of general surgery in which diseases of the vascular system, or arteries and veins, are managed, largely via surgical intervention. The vascular surgeon is trained in the diagnosis and management of diseases affecting all parts of the vascular , as well as specialty pharmaceuticals.

CONTACT: Research Industries Corporation, Salt Lake City

Nancy E. Schultz, 801/562-0200
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 11, 1995
Words:536
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