Company Overview
| Company Name |
KIPS BAY MEDICAL, INC. |
| Company Address |
3405 ANNAPOLIS LANE MINNEAPOLIS, MN 55447 |
| Company Phone |
763-235-3540 |
| Company Website |
www.kipsbaymedical.com |
| CEO |
Manny Villafaña |
| Employees (as of 9/1/2012) |
14 |
| State of Inc |
DE |
| Fiscal Year End |
12/31 |
| Status |
Withdrawn (6/26/2012) |
| Symbol |
KIPS |
| Exchange |
Nasdaq SmallCap Market |
| Share Price |
$1.48 |
| Shares Offered |
10,135,135 |
| Offer Amount |
$17,249,999.40 |
| Total Expenses |
$495,615.00 |
| Shares Over Alloted |
1,520,270 |
| Shareholder Shares Offered |
-- |
| Shares Outstanding |
26,480,714 |
| Lockup Period (days) |
180 |
| Lockup Expiration |
-- |
| Quiet Period Expiration |
-- |
| CIK |
0001460198 |
We estimate that our net proceeds from the sale of the common stock offered
pursuant to this prospectus will be approximately $13.3 million, or
approximately $15.3 million if the underwriters exercise in full their option
to purchase additional shares, assuming a public offering price of $1.48 per
share, the closing price of the Company's common stock on October 15, 2012,
and after deducting the underwriting discount and the estimated offering
expenses that are payable by us.
We intend to use the net proceeds from this offering primarily for the
following purposes:
• approximately $2.0 to 3.0 million to fund the process of seeking regulatory
approval to market our eSVS Mesh in the United States and abroad, including
human clinical trials;
• approximately $1.0 to 2.0 million to fund the development and testing of
additional applications of our eSVS Mesh; and
• the remainder for working capital and general corporate purposes, including
commercialization activities for our eSVS Mesh in select European and other
international markets and for the purchase of capital equipment and expansion
of facilities.
The expected use of net proceeds from this offering represents our current
intentions based upon our present plans and business conditions; however,
there may be circumstances where a reallocation of funds is necessary. The
amount and timing of our actual expenditures depend on numerous factors,
including the costs of seeking regulatory approval in the United States
and abroad and the costs of developing and testing additional applications
of our eSVS Mesh. The costs and timing of the development, particularly
conducting clinical studies and trials, regulatory approval and
commercialization of medical devices are highly uncertain, are subject to
substantial risks and can often change. Accordingly, we may change the
allocation of use of these proceeds as a result of contingencies such as
the progress and results of our clinical studies and trials and other
development and commercialization activities, manufacturing requirements
and regulatory or competitive developments. A portion of the net proceeds
may be used to acquire or invest in complementary businesses,
technologies, services or products in the event we identify opportunities
for such acquisitions or investments that we believe are in the best
interests of our stockholders.
We have no current plans, agreements or commitments with respect to any of
the foregoing acquisitions or investments, and we are not currently engaged
in any negotiations with respect to any such transaction. Management will
retain broad discretion in the allocation of the net proceeds of this
offering. You will not have the opportunity to evaluate the economic,
financial or other information on which we base our decisions on how to
use the proceeds.
The development and commercialization of medical devices to treat
cardiovascular disease is a highly competitive industry. Physicians and
patients may select among a variety of treatments to address coronary
artery disease, including pharmaceutical therapy, balloon angioplasty,
stenting with bare metal or drug-eluting stents, and CABG procedures,
with the selection often depending upon the health of the patient and the
stage of the disease. If physicians or their patients choose alternative
treatments to CABG surgery due to the disadvantages of CABG surgery, such
as the failure rate of CABG surgery, or if additional alternative treatments
for cardiovascular disease are developed, there may be a decrease in the
number of CABG surgery procedures. The American College of Cardiology/American
Heart Association treatment guidelines state that CABG is the only
recommended revascularization procedure for those patients with CAD in their
left main coronary artery or CAD in three or more coronary arteries.
Our eSVS Mesh is designed to improve the structural characteristics and
long-term performance of vein grafts in CABG surgery. If our eSVS Mesh is
proven to do so successfully, we believe physicians may more frequently
choose to perform CABG surgery over alternative treatments. We expect the
primary competition for our eSVS Mesh to be other products or techniques to
improve the effectiveness of vein grafts in CABG surgery.
We are aware of three companies that have developed mesh devices to be used
on the outside of blood vessels. Vascular Graft Solutions, ("VGS"), an
Israeli company, is developing a product called the Fluent expandable
external support system which is designed to reduce vein graft failures in
CABG surgery. VGS is currently conducting its first in-human trial in the
United Kingdom. According to information filed on ClinicalTrials.gov, VGS
expects to enroll approximately 30 patients and complete data collection
for their primary outcome measure in June 2012. Alpha Research, a Swiss
company, has developed a product known as the Biocompound Graft for use in
coronary and peripheral bypass operations. The product is a stainless steel
braided mesh, indicated for use in coronary or peripheral bypass with
patients who have irregularly shaped veins. B. Braun, a German company,
has developed a product known as ProVena for use in peripheral bypass
operations. The product is a woven polymer mesh, indicated for use in
peripheral artery bypass operations using vein grafts.
We believe that the VGS product will be a direct competitor to our eSVS
Mesh if and when the results of their on-going clinical trial in Great
Britain allow VGS to secure a CE Mark approval for their product.
We believe that the Alpha Research and B. Braun products are not currently
direct competitors to our eSVS Mesh, and are not likely to become direct
competitors in the near future, because the Biocompound Graft is intended
for use only with irregularly shaped veins and the ProVena is intended for
use with non-coronary procedures. However, it is possible that one or both
of these companies, or other potential competitors, will seek approval to
use these or similar devices for procedures with similar or identical
indications for use as our eSVS Mesh.
The key competitive factors affecting the success of our eSVS Mesh are
likely to be the effectiveness, safety profile and price of our eSVS Mesh,
as compared to existing methods for CABG surgery. We believe a potential
disadvantage associated with our eSVS Mesh is the possibility of allergic
reaction to the implant materials. According to a July 2009 article in the
Journal of Invasive Cardiology, nickel allergy after implantation of a
nitinol-containing device is rare. This article described the rate of
nickel allergy in cardiovascular implants to be between 0.002% and 0.02%.
The article also stated that the patients with nickel allergy symptoms
responded to medical management at the time of the reaction, did not require
device explant, and no longer require medications for the reaction. In order
to further safeguard against this rare occurrence, the eSVS Mesh instructions
for use state that it is contraindicated for patients with a known allergy
to nitinol. We believe another potential disadvantage associated with our
eSVS Mesh is the possibility of damage to the saphenous vein during
placement of our eSVS Mesh. If the physician does not select the proper
size eSVS Mesh relative to the size of the vein, the saphenous vein may be
damaged while placing our eSVS Mesh over the vein. For example, if too
small an eSVS Mesh is chosen, there could be damage to the saphenous vein
caused by stretching the vein while trying to place it inside our eSVS Mesh.
We have provided specific directions in the eSVS Mesh instructions for use
on how to properly size veins and place our eSVS Mesh. In addition, we
provide a sizing tool with our eSVS Mesh to ensure proper vein sizing. The
commercial success of our eSVS Mesh will depend upon the results of clinical
trials of the technology and experience with the technology in the commercial
marketplace.
If the commercialization of our eSVS Mesh technology is successful, we
expect that other medical device companies, many of which are larger and
have greater financial resources than we do, will seek to enter into this
market by introducing competing technologies.
Company Description
We are a medical device company focused on developing, manufacturing and
commercializing our external saphenous vein support technology, or eSVS R
MESH, for use in coronary artery bypass grafting, or CABG, surgery. Our
eSVS Mesh is a nitinol mesh sleeve that, when placed over a saphenous vein
graft, or SVG, during CABG surgery, is designed to improve the structural
characteristics and long-term performance of the vein graft. CABG is one of
the most commonly performed cardiac surgeries in the world; according to the
Cleveland Clinic, each year, over 800,000 CABG surgeries are performed
worldwide.
In CABG procedures, surgeons harvest blood vessels, including the internal
mammary artery from the chest and the saphenous vein from the leg, and
attach the harvested vessels to bypass, or provide blood flow around,
blocked coronary arteries. The effectiveness of the procedure, however,
is often limited by the failure rate of SVGs, which has been shown in
various studies to range from 7% to 26% one year after surgery and 39%
ten years after surgery. Failure of these grafts, typically evidenced by
partial or complete blockage and reduced or stopped blood flow, can lead
to the need for further coronary interventions up to and including additional
CABG procedures. We believe the use of our eSVS Mesh with SVGs in CABG
surgery can improve the long-term outcomes of CABG procedures by preventing
the expansion, or dilation, of the SVG and preventing the resulting injury
in order to maintain the openness, or patency, of and improving blood flow
through the SVG. The result would be a reduced need for costly, potentially
complicated reoperations or revascularization procedures and an improved
patient quality of life.
We continue to achieve modest levels of sales in select international markets
while we pursue additional clinical studies to demonstrate the clinical
effectiveness of our eSVS Mesh. We believe these studies will support
increased clinical utilization and reimbursement decisions internationally.
Accordingly, we have incurred net losses of $2.7 million, $4.3 million and
$10.9 million in the six months ended June 30, 2012 and the years ended
December 31, 2011 and December 31, 2010, respectively. Our net loss for the
year ended December 31, 2010 included a non-cash charge of $2.3 million,
resulting from a modification to an investor stock purchase option exercised
in February 2010, and a $5.0 million charge for the first milestone payment
due and paid to Medtronic, Inc. in June 2011, one year after the first
commercial sale of our eSVS Mesh.
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We were incorporated in Delaware in May 2007. Our principal executive offices
are located at 3405 Annapolis Lane North, Suite 200, Minneapolis, MN 55447.
Our telephone number is (763) 235-3540, and our website is
www.kipsbaymedical.com.