Corporate Profile

Headquartered in Doylestown, Pennsylvania, Prescient Medical, Inc. (PMI) was founded in 2004 to commercialize pioneering products that help prevent heart attacks. To this end, the privately-held medical device company has licensed and developed new diagnostic techniques and treatments designed to provide interventional cardiologists with a greater array of technologies for diagnosing and treating the full spectrum of coronary plaques.

Currently, the company’s robust product development portfolio includes both diagnostic and therapeutic catheter-based devices that will allow cardiologists to more precisely tailor focal treatments according to the unique needs of each patient. Among these products are the stent-like vProtect™ Luminal Shield, for treatment of soft, lipid-rich plaques; and the vPredict™ Optical Catheter System, designed to analyze and quantify the chemical composition of arterial plaque and assess its vulnerability to rupture or erosion.

Each year, 1.4 million Americans will have a heart attack. More than half have no previous symptoms, and 650,000 will not survive, making it the leading cause of death in the United States. PMI’s target market is the 80 percent of patients whose heart attacks are caused by soft plaques that suddenly rupture, resulting in a clot that blocks blood flow. For these patients, no diagnostic or treatment methods currently exist.

Prescient Medical’s goal is to reduce deaths from heart attacks through the use of its revolutionary diagnostic and treatment approaches, which will better enable cardiologists to identify a wider range of at-risk plaques. These technologies are expected to be available commercially by January 2009.

The Cardiology Challenge

Each year, one out of every 100 Americans over the age of 35 will suffer a coronary event.

Over one million of these individuals will have a heart attack. More than half of these people have no previous symptoms, and almost half of them will not survive. Existing technologies are capable of treating only two of every ten heart attack patients – those with gradual narrowing of the arteries caused by hardened or calcified plaques.

Currently available stents have not impacted the death rate from heart attacks, and the following concerns have been raised about their use:

• Restenosis – tissue proliferates inside the artery causing it to re-narrow. This problem is more common with bare metal stents (BMS)
• Late Stent Thrombosis – clots form inside the stent itself, months or years after implantation. This problem is more common with drug-eluting stents (DES.)

For the remaining eight heart attack patients, it is believed that their heart attacks were caused by soft plaque hidden within the arterial wall that suddenly ruptured, resulting in a clot that blocks blood flow to the heart. For these patients, no clinically validated diagnostic or treatment methods currently exist.

As a result, Prescient Medical has assembled a management and advisory team to address the market opportunity in the existing stent market, and become a leader in the emerging vulnerable plaque market, which industry experts believe could exceed $30 billion worldwide.

The Future of Interventional Cardiology

In 2008, an estimated 4.6 million cardiac catheterizations will be performed in the United States, with nearly 3 million more in Europe and Japan. Existing diagnostic technologies do not provide interventionalists with critical information about the chemical composition of coronary plaques.

Since no clinically validated diagnostic technology presently exists, these plaques can not be reliably located and therefore can not be treated. Prescient Medical is currently the only company focusing on the detection and treatment of soft plaque that can suddenly rupture and result in a heart attack.

By linking the detection of soft plaque to treatment, PMI will be able to successfully grow the diagnostic catheter market and open up a new therapeutic market, which can potentially eclipse the current $6.5 billion stent market.

Within the next few years, Prescient Medical is expected to launch the first of these new revolutionary plaque detection and treatment technologies.

The vPredict™ Optical Catheter System, slated for clinical trials in 2008, is designed to provide interventional cardiologists with extensive knowledge of plaque composition, enabling them to make more informed decisions to meet patients’ medical needs. The catheter consists of an array of 8 optical fibers. These fibers remain in close proximity to the vessel wall, emitting monochromatic light. Compounds in the vessel wall and atheroma scatter the light, changing the wavelength of a portion of it. The scattered light is collected by the optical catheter and shifts in the light wavelength, called the Raman spectrum, are analyzed.

Components of the arterial wall and plaques are identified by their unique spectra, a technique called Raman spectroscopy. Because of its remarkable accuracy and versatility, Raman spectroscopy is a mainstay in analytical chemistry labs, and Prescient is the first company to adapt it for intravascular use.

As clinical studies establish correlations among spectroscopic profiles, histologic features, and clinical events, the applications of the vPredict™ Optical Catheter System are expected to grow to include the evaluation of pharmacologic treatment efficacy and detection of residual drug in drug-eluting implants. It may soon also play a central role in determining the optimal treatment for stenotic plaques and assessing rupture or erosion risk of non–flow limiting intermediate (vulnerable) plaques.

In addition, The vProtect™ Luminal Shield from Prescient is expected to offer a significant departure from existing stent designs – rather than simply preserving the lumen, it is designed to securely conform to the arterial wall, shielding the coronary circulation from plaque rupture while preserving vessel compliance.

The self-expanding design of the vProtect™ Luminal Shield will also help minimize vessel injury, which may limit neointimal hyperplasia and restenosis and allow the vessel to heal. Unlike earlier self-expanding designs, the vProtect™ Luminal Shield produces ample radial forces to cover soft lesions and achieve excellent strut apposition.

Clinical trials of the vProtect Luminal Shield are also expected to begin in early 2008.

The Prescient Management Team

The Prescient management team has more than 180 years of combined experience in the interventional cardiology marketplace.

While at Johnson & Johnson Interventional Systems Company (now Cordis Corporation, a Johnson & Johnson company) (JJIS), Prescient’s founding members and advisory team developed and commercialized the leading focal treatment for coronary artery disease – coronary stents – which now comprises an annual $6.5 billion global market.

In addition, the company’s CEO commercialized the hsCRP diagnostic test, the first biomarker added to the cardiac panel by the CDC/AHA in over 30 years. PMI’s EVP of R&D, is recognized worldwide as an expert in Raman spectroscopy, which is considered the gold-standard for detecting and quantifying chemical composition.

Together, the Prescient Medical team is now focused on the potentially much larger vulnerable plaque marketplace. By creating a comprehensive product portfolio based upon more than 50 issued patents and patent applications for diagnosis and treatment technologies, Prescient Medical is focused on becoming a market leader in pioneering new technologies that reduce deaths from heart attacks.
Near term, the team has also positioned itself to address other large market opportunities within the current stent and peripheral vascular markets.