Healthcare Industry News: SDF-1
News Release - January 5, 2010
Bioheart Inks Deals with Distributors to Introduce Home Heart Failure Monitoring Systems Throughout the U.S.
SUNRISE, Fla.--(HSMN NewsFeed)--Bioheart, Inc. (OTCBB:BHRT ) announced today that the company has signed distribution agreements with Restoration Medical, McRay Medical, Alamo Scientific and Morey Medical. These distributors will assist Bioheart with introducing its Home Heart Failure Monitoring Systems to physicians and hospitals throughout the United States. McRay Medical will distribute the systems in Northern California; Alamo Scientific will distribute in Texas, Louisiana and Arkansas; Morey Medical will distribute in Oklahoma and parts of Kansas; Restoration Medical will distribute the monitoring systems in the rest of the country."Restoration Medical is thrilled with the opportunity to partner with Bioheart, Inc. for the nationwide launch of the BH 3370 Home Monitoring Service. Given the growing epidemic of heart failure, the timing could not be better to offer this unique cost saving solution to our hospital customers," reports Jeff Donofrio, President of Restoration Medical Inc.
“We’ve built our business model specifically for rapid deployments of high quality products and services into the marketplace for situations just like this. Because our nationwide sales organizations average 20 plus years of experience, Restoration Medical can instantly put the Bioheart product line in front of key physicians, hospital administrators and other important decision makers,” says Managing Partner, Tom Newman.
Donofrio adds, "We believe this is the first of many potential products from a rich pipeline of Bioheart technologies for our clients."
Bioheart elected to have a distributor network rather than hiring a sales force for its heart monitoring system. The company believes that distributors are capable of discerning the precise needs of their customers and which of their customers would best use an innovative product. Furthermore, they are constantly in touch with their customer base and are well able to convey the desire for product enhancements to Bioheart. Bioheart and its staff have a history of responding to customer needs with product improvements that have been cutting edge and have addressed those needs.
Todd Endersby, President of Alamo Scientific, Inc. said, “Alamo Scientific is a specialty medical distributor out of San Antonio Texas. We seek out, and promote, the very best new medical device innovations for improving care. Alamo Scientific’s staff works with hospitals and their clinicians, providing training on how to properly use forefront healthcare technologies to improve patient care and outcomes. Alamo has a staff of eleven that will be Bioheart’s field team in Texas, Louisiana, and Arkansas. We became extremely excited to work with Bioheart after having a Chief of Cardiology literally track us down in a heart center after he heard that ‘the Bioheart people’ were in his facility.”
The compact 3370 Home Heart Failure Monitoring System engages patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. The data are regularly monitored by remotely located medical professionals, who watch for any abnormal readings that may signal a change in the patient’s health status. These changes are reported back to the treating physician or nurse and are also available for them to review on the internet on a secure care provider site as a fully functional database. The monitoring system collects patient data every day from a range of devices such as weight scales and blood pressure cuffs. Patients also use the system daily to answer a set of questions related to their ability to function and their general well being. The questions were developed by cardiologists and are geared to detect abnormalities. Regular data input and monitoring of heart failure patients enables the health care team to detect signs and symptoms of change in patient status as they occur, leading to reduced hospitalizations, reduced costs and better patient outcomes.
Karl Groth, Chief Executive Officer of Bioheart, said: “We are very excited to have established our relationships with these distributors, all of which have excellent reputations and are well established in their respective territories. We feel that we have built an exceptional and well respected sales network. Our distributors are key to helping us penetrate the vast heart failure market with our at home monitoring systems.”
Heart failure is a debilitating condition. When heart failure is in an advanced state, the heart is unable to pump enough blood to the body to allow a person to enjoy a normal, productive life. This disease affects over 5 million people in the United States. Over 500,000 new cases are diagnosed annually in the U.S., making heart failure the most rapidly growing of all cardiovascular disorders.
According to statistics provided by the American Heart Association, in the US, approximately $22.5 billion are the direct and indirect annual costs of heart failure treatment. Persons over the age of 65 experience heart failure as the number one cause of hospitalization and the number one cause of death.
In the United States, worsening of chronic heart failure leads to more than 1 million hospital admissions per year and a 50 percent risk of subsequent hospitalization within six months of discharge.
Studies of in-home monitoring of heart failure patients have demonstrated a 73% reduction in hospitalizations. Similarly, ER visits are seen to have dropped 88%. Reducing the number and, therefore, cost of heart failure events, as well as these hospitalization recurrences that are so devastating to patients, is a goal of the Bioheart Heart Monitoring System.
“Morey Medical Resources is pleased to add the Bioheart 3370 Heart Monitoring System to our growing line of products,” stated Michael Morey, President of MMR. “Physicians and hospitals across Oklahoma are recognizing this state-of-the-art device as a technologically advanced method for managing their home bound chronically ill patients while helping to reduce costs to hospitals.”
Bioheart has included its heart monitoring system in its product portfolio for several reasons: 1) to monitor patients treated with its MyoCell® therapy for congestive heart failure; 2) to monitor patients treated with its TGI 1200 adipose derived stem cell treatment for the period immediately following treatment for cardiac issues, and, 3) to carry forward its objective of preventing cardiovascular disease from depriving patients of a normal life.
W. Dennis McIntosh, President of McRay Medical, LLC, added. "One of the challenges in managing heart failure is that there are numerous palliative therapies available and numerous clinicians involved with prescribing and/or monitoring these therapy plans. Bioheart's Home Monitoring System provides comprehensive solutions to these clinicians in managing their patients on a continual basis and minimizes the revolving door of heart failure hospitalization. We are excited about representing Bioheart, as we are able to supply real and predictive solutions to help to manage outcomes and costs of CHF."
The heart failure monitors are reimbursed by Medicare to the home health companies. In 2009, reimbursement was added to the National Episode Rate for cardiac patients. The monitors, in conjunction with the nurse’s visit are essential to the well being of chronic heart failure patients. Care Plan Oversight (CPO) reimbursement also allows physicians to bill Medicare for their time overseeing the care of home care or hospice patients.
About Bioheart, Inc.
Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and other cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell®, is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including the TGI 1200, an autologous, adipose tissue-derived stem cell treatment for acute heart damage and ischemia, and MyoCell® SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins.
For more information on Bioheart, visit www.bioheartinc.com.
Forward-Looking Statements:
Except for historical matters contained herein, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would", "estimate", or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Investors and others are cautioned that a variety of factors, including certain risks, may affect our business and cause actual results to differ materially from those set forth in the forward-looking statements. These risk factors include, without limitation, (i) our ability to obtain additional financing; (ii) our ability to control and reduce our expenses; (iii) our ability to establish a distribution network for and commence distribution of certain products for which we have acquired distribution rights; (iv) our ability to timely and successfully complete our clinical trials; (v) the occurrence of any unacceptable side effects during or after preclinical and clinical testing of our product candidates; (vi) the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; (vii) our dependence on the success of our lead product candidate; (viii) our inability to predict the extent of our future losses or if or when we will become profitable; (ix) our ability to protect our intellectual property rights; and (x) intense competition. The Company is also subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2008, as amended by its Annual Report on Form 10-K/A, and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2009 and March 31, 2009.
Source: Bioheart
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