Leading the Way in Digital Auscultation of the Heart
The American Heart Association estimates that about 12 million Americans are afflicted with coronary heart disease. When health care expenditures and lost productivity are taken into account, a study conducted by the University of Florida shows that the total cost of this epidemic to Americans is approximately $99.8 billion annually. This condition kills nearly 2,600 people in the U.S. daily, leading to direct and indirect costs that exceed $368.0 billion each year.
The Biosignetics Corporation, founded in January 2004, is a small business start-up located in Exeter, New Hampshire, 45 minutes north of Boston. It was founded with the singular focus and mission of developing an inexpensive and widely available early detection heart diagnosis system - digital stethoscope. We are focused on the cardiovascular market segment, specializing in cardiac rhythm management, monitoring, and diagnostics. Our short-term product strategy is to focus solely on the developing software applications that will utilize electronic stethoscope for sound data collection.
"As auscultatory skills are known to be lacking in many or most practicing physicians, the availability of an inexpensive diagnostic tool for cardiac auscultation would be a distinct benefit in health care delivery."
Douglas L. Roy, M.D.,FRCPC, FAHA
"If we wait for susceptible individuals to develop symptoms before deciding to treat, the earliest symptom is often death. The challenge is to develop non-invasive screening methods."
Michael S. Brown & Joseph Goldstein,
Winners of the Nobel Prize for Medicine, 1985
Biosignetics Corporation had developed patent-pending (USPTO 60/546,742) heart energy signature phonocardiograph (PCG) software. This software allows converting complex multi-component non-gaussian heart sounds into simple and self-referencing X-ray like images. Company developed patent-pending signal processing methodology, which can lay the foundation for the new generation of software based non-invasive early detection heart diagnostic instruments. They will comprise of the electronic stethoscope and advanced signal processing software for the personal digital assistants (PDA’s), notebooks and personal computers. This system will be utilized by the health care service sector: hospitals and individual physicians. Ultimately, it will become available for the home-care market segment and patients themselves. Our digital stethoscope technology will allow inexpensive and comprehensive screening. Earlier detection will enable early intervention and allow considerably less expensive and less invasive treatment.
Right now Company offers two software products that are focused on the educational and non-clinical research markets and work with heart sound databases, while at the same time working on the regulatory approvals with the US Food and Drug Administration.
According to Frost & Sullivan, in 2003, worldwide revenues in the medical device and equipment market were $176.2 billion and were expected to grow 6.5% over the next three years. The most important growth drivers are the continued aging of the global population and the associated increase in age-related diseases. Cardiovascular market segment is estimated at $15.4 billion and cardiac rhythm management at $5.9 billion. According to Dall'Asta, Chief Financial Officer at Siemens Corporate Research, there is a market niche of $2 billion USD for non-invasive sound based diagnosis devices just in the United States. Worldwide sales will considerably exceed that figure.
Company was formed and incorporated in the State of New Hampshire on January 14th, 2004. Biosignetics is U.S. owned private corporation. On Feb. 2nd 2004 the first internal test version of the BSignal Heart Energy Signature software was released and tested on a variety of heart sound data. Several detailed reports were released. On Feb. 23rd, 2004 provisional patent application for the "Heart Energy Signature Description, Method and Format” was filed with the United States Patent and Trademark Office. On April 2nd, 2004 Biosignetics released the second test version of the software including BSignal Phonocardiograph and Heart Energy Signature packages. First Educational and Non-Clinical Releases of these Software packages took place on May 28th, 2004. During February-March 2004 Biosignetics had developed the theoretical foundations of early detection algorithms and in May 2004 we filed corresponding invention disclosures. Approximately at the same time we had initiated several informal collaborations with clinical research facilities in the United States and Worldwide aiming to develop additional controllable sources of heart sound data. We registered with the FDA on April 28th, 2004, obtained market clearance in Oct. 2004 and aim our first commercial clinical release of BSignal Phonocardiograph Software for the fall 2006. We are presently going through the process of additional software validation and establishing Good Manufacturing and Software Design Practices (GMP) required for the clinical release. Our intention is to file 510K FDA pre-market approval notice for the Heart Energy Signature System in 2006. Our last major software release was in September 2006, with Phonocardiograph Monitor Version 3.5 and BSignal
Heart Energy Signature Visualization System Version 3.5. Both products are available for purchase.