HAYWARD, Calif., April 21 /PRNewswire-FirstCall/ -- Cholestech Corporation announced today that it has entered into a market development and product distribution agreement with Itamar Medical Limited ("Itamar") involving private label distribution of Itamar's Endo-Pat 2000, a novel and proprietary system for assessing vascular endothelial dysfunction. Itamar, based in Caesarea, Israel, is a medical innovation company engaged in the development of devices to measure peripheral arterial tone ("PAT"). PAT is a neurovascular signal discovered by Itamar that provides a non-invasive window to the autonomic nervous system and arterial health. Itamar's PAT(TM) based products can provide an early stage detection of heart disease, facilitate patient follow-up and improve patient care while reducing the overall cost of medicine. The Endo-Pat 2000 System has received 510(k) clearance from the FDA for use as an aid in the detection of coronary artery endothelial dysfunction and is the only device ever to obtain such clearance. As a non-invasive product, the Endo-Pat 2000 does not require a waiver under the Clinical Laboratory Improvement Amendment (CLIA) in order to be marketed to the physician office market.
The Endo-Pat 2000 System consists of three components. PAT signals are obtained using two disposable probes placed on fingers of the individual being tested. A portable unit connects to and operates the probes, and signal analysis and the endothelial dysfunction report are generated via a laptop computer. Endothelial dysfunction assessments can be completed in a 20 minute office visit. Marketing clearance was obtained by demonstrating equivalence of the Endo-Pat 2000 System with an invasive procedure that assessed endothelial dysfunction in coronary arteries. The clinical research was conducted at the Mayo Clinic.
Warren E. Pinckert II, President and Chief Executive Officer of Cholestech, said, "The addition of the Endo-Pat 2000 System broadens our portfolio of products that enable physicians to assess and monitor heart disease and diabetes. The ongoing revenue stream from sale of the one time use probes fits with our existing razor/razor blade business model. We will continue to actively pursue additional opportunities to leverage our established installed base in the physician office market by adding technology platforms and related products focused on chronic diseases."
"We are very pleased to announce our relationship with Cholestech," said Israel Schreiber, President and CEO of Itamar. "The Endo-PAT system will make it possible for the first time for cardiologists to non-invasively uncover a wealth of information about endothelial dysfunction and will provide valuable insights into other important aspects of cardiovascular health. The Endo-PAT is the third PAT Signal device to receive FDA clearance, as we will continue to develop and commercialize with leading researchers and corporations worldwide, comprehensive products and programs to bring this important new physiological signal to medical practice, worldwide."
The Endo-Pat 2000 is under continuing clinical investigation at major medical centers such as the Mayo Clinic, Harvard and Yale. In addition, pharmaceutical companies developing new agents to treat endothelial dysfunction are now including it in trials, and it was recently incorporated into the Framingham Heart Study. As part of its agreement with Itamar, Cholestech will invest resources to support pre-launch market research and market development activities. Cholestech will be responsible for the sale and installation of the Endo-Pat 2000 in early adopter sites to further promote recognition of the product and technology while assessing United States market development needs. Cholestech has also retained the right to enter into a multi-year distribution agreement with Itamar for the Endo-Pat 2000.
About Endothelial Dysfunction and Atherosclerosis
The vascular endothelium consists of a single layer of cells that line the inside walls of all blood vessels. It acts as an organ, sending and receiving molecular signals involved in complex interactions within these vascular walls. The endothelium regulates tone of the vessels, controls the flow of blood, and directs the process of inflammation. The functioning of these endothelial cells -- endothelial function -- is normally kept in balance. Atherosclerosis risk factors such as high cholesterol, high blood sugar, high blood pressure, smoking, aging, obesity, chronic infection, and inflammation can all disrupt this balance and lead to endothelial dysfunction.
Vascular disease experts recognize endothelial dysfunction as an early stage in the development of atherosclerosis. Atherosclerosis is at the core of cardiovascular and cerebrovascular diseases and complications of diabetes that lead to potentially fatal outcomes such as heart attack, aneurysms, and stroke. Many existing therapies may improve endothelial function. These include statins used to lower high cholesterol and angiotensin converting enzyme (ACE) inhibitors used to treat high blood pressure. Prior to the approval of the Endo-PAT, there was no non-invasive device available to researchers and physicians to reliably assess endothelial function.
Cholestech is committed to enabling people to lead longer, healthier and more active lives. Cholestech provides easy to use, accessible diagnostic tools and information to health care practitioners in over 35 countries around the world. Cholestech offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose and glycemic control, and liver function at the point of care. Health care providers can use the CLIA-waived Cholestech LDX(R) and Cholestech GDX(TM) Systems to initiate and monitor the progress of patient therapy. By providing effective disease management solutions, Cholestech's goal is to be a leading provider of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
Cholestech LDX(R) is a registered trademark and Cholestech GDX(TM) is a trademark of Cholestech Corporation. All other trademarks mentioned in this document are the property of their respective owners. For more information about Cholestech and its products visit us on the web at http://www.cholestech.com/.
Itamar Medical Ltd. is pioneering the introduction to medicine of a non-invasive window to the autonomic nervous system and arterial health -- the PAT(TM) (Peripheral Arterial Tone) neurovascular signal. The company's researchers are developing proprietary technologies, including non-invasive finger probes and advanced digital signal processing algorithms, to apply peripheral arterial tonometry in a number of important clinical applications including various aspects of cardiology and sleep medicine. The initial PAT screening, diagnostic, and follow-up products are now undergoing evaluations in leading clinical centers. Itamar Medical was established in 1997, is headquartered in Caesarea, Israel and has an office in Boston, MA.
Safe Harbor Statement of Cholestech Corporation Under the Private Securities Litigation Reform Act of 1995
This release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 concerning our pursuit of opportunities to leverage our installed base and our beliefs regarding the benefits of the Endo-Pat 2000. Actual results may differ materially from those in the forward-looking statements due to risks and uncertainties, including risks inherent to business development activities, demand for the Endo-Pat 2000 and other factors. Additional considerations and important risk factors are described in Cholestech's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.