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Vessix Vascular (Formerly Minnow Medical)
Medical Devices & Tech
26052 Merit Circle, Suite 106
Laguna Hills, CA 92653 USA
phone:949 716-2205
fax:
Symbol Private
Founded 2003
Employees 11
www.vessixvascular.com/
Research Sector Medical Devices & Tech
Summary Description
Catheter-based Energy Treatment for Peripheral Artery Disease, including in-stent restenosis and DVT.
Management
Raymond W. Cohen, Chief Executive Officer Prabodh Mathur, Chief Product Development Officer Sharon Riddle, Vice President of Market Development; Mike Handley, VP, Clinical and Regulatory Affairs Dan Dearen, Chief Financial Officer; Olav Bergheim, Chairman
Keywords
cardiovascular disease, artery disease, catheter technology, peripheral artery disease, in-stent restenosis, DVT

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Updated: Nov. 21, 2011

Description
Vessix Vascular, Inc. continues to expand the endovascular clinical applications for its patented low-pressure percutaneous transluminal angioplasty catheter mounted with RF electrodes. The Company is working with leading scientists and physicians in the U.S. and Europe and with the financial support of world-class investors including Edmond de Rothschild Investment Partners, OrbiMed Advisors and NeoMed Management.
Products / Services
Through collaboration with leading physicians, researchers and scientists, Minnow Medical has developed its initial product, the ZCath® Peripheral Vascular System. The ZCath® combines a patented low-pressure percutaneous transluminal angioplasty catheter mounted with RF electrodes that provides controlled energy to modify lesion compliance and reduce plaque volume while minimizing vessel trauma typically seen with traditional angioplasty or stenting.
Technology / Differentiation
Established peripheral artery procedures utilize a wide range of technologies from surgical by-pass to endovascular treatments such as angioplasty, stenting, laser, and atherectomy therapy. These therapies acutely provide restored blood flow in the legs but have shown limited durability in vessel patency. There remains a clinical need for alternative or adjunctive therapies to improve long-term outcomes in patients with Peripheral Arterial Disease (PAD) and In-Stent Restenosis (ISR).
Market / Customers
In-Stent Restenosis (ISR) in the peripheral arteries is Minnow?s primary target market. Historically, arterial disease in the superficial femoral artery (SFA) has been treated with bypass surgery or percutaneous transluminal angioplasty (balloon angioplasty) and stents were placed only when angioplasty failed to open the artery. As recently as five years ago, stents were used only as a bailout procedure when angioplasty failed. The primary reasons that angioplasty fails at the time of treatment are elastic recoil, residual stenosis and flow-limiting dissections caused by the procedure. Stent use in treating peripheral artery disease is now commonplace and the number of stent procedures in the SFA and renal arteries is projected to grow at a compound annual growth rate of 8.5% through 2015. The increased use of stents in the legs is because stenting avoids or solves the problems caused by angioplasty including elastic recoil, residual stenosis and flow-limiting dissections. iData Research, Inc. estimates growth in SFA stent procedures at 11.8% CAGR from 2011 through 2015 while the renal artery market is sizable but with minimal growth. There are approx 500,000 stents being placed each year in peripheral arteries in the US and Europe and currently approx. 160,000 in-stent restenosis cases. One of the risks or problems of deploying stents in the legs, which is the same issue in the coronary arteries, is late stage clinical failure or In-Stent Restenosis. It is estimated that in the best case scenario approximately 37% of stents are occluded within of one year of treatment. In conversations with our medical advisory board and other publications it can be assumed that more than 50% of stents fail due to ISR within one to two years. The following graph shows the forecasted number of potential ISR cases in the United States and Europe in the SFA and renal arteries assuming a conservative 37% ISR rate: The above graph does not reflect any potential from the greater than 500,000 potential SFA-Popliteal and renal ISR cases from 2005 through 2010 in the U.S. and Europe, other peripheral applications such as tibial, carotid or iliac or ISR in the coronary arteries which is currently estimated at 230,000 cases in the U.S.
Competitors / Substitutes / Alternatives
Current catheter-based treatments for artery disease include; plain old balloon angioplasty, laser, cryoplasty and atherectomy.
Strategy
Establish clinical efficacy for various clinical indications and partner with large established players to license and distribute our products.
Funding
We are seeking $7 to $10 million in new capital to complete our European study for ISR which is scheduled to begin in late Q1 2011 and to conduct a clinical study in the U.S. Proceeds from the financing will also be used to improve our disposable catheter design and to optimize for manufacturing and gross margin improvement. In addition, we are working with our physician advisors on identifying additional applications such as treating hemodialysis vascular access dysfunction, hypertension and deep vein thrombosis.
Status
Minnow has already treated over 80 patients in Europe, has a CE Mark for its ZCath System and a 510(k) pending with the FDA for its initial indication. The Company is planning a new study to treat patients with in-stent restenosis in peripheral arteries. Study to begin in early 2011.


2012-02-09-3618