Writing a Winning Business Plan ◾ 293
1.4 e PolyMedica Mitraflex
TM
Wound Dressing
PolyMedica’s Mitraflex
TM
wound dressings represent a new generation of spyrosorbent
(bo
th breathes and absorbs), patented products affording significant advantages over the
hyd
rocolloid (water absorbing) and thin-film dressings generally available in today’s wound
ca
re market. While Mitraflex
TM
dressings are specifically designed to treat dermal ulcers,
th
ey also perform exceptionally well on abrasions, lacerations, donor sites, burns, and
der
mabrasions.
ese d ressings c ombine h igh exudate absorption a nd m oisture vapor transmission c apabilities
to
maximize wound healing through creation of an optimal moist healing environment. e
un
ique combination of these two moisture management methods in a single product results i
n
a
low profile dressing that is conformable to the complex human skin anatomy and effectively
ma
nages wound exudate. e dressings allow visual monitoring of the exudate without removal
fo
r periods up to seven days. is is a feature of particular interest to many clinicians. Finally, the
co
nformability of Mitraflex
TM
allows a placement on and consistent adhesion to body contour
s
th
at no other wound dressing can protect.
e dressings are protected under four patents (see “Patents”) in the name of PolyMedica’s
Mi
trathane
TM
medical-grade polyurethane and are manufactured at the Wheat Ridge, Color
ado
fa
cility.
PolyMedica entered into a distribution agreement dated January 1, 1990 with Calgon
Ve
stal Laboratories, a division of Calgorl Corporation, a wholly-owned subsidiary of Merck
&
Co., Inc. is agreement grants Calgon the exclusive right to sell Mitraflex
TM
wound
dr
essings in two specified sizes (4
"
× 4
"
and 8
"
× 8
"
) in the U.S. and Canada through 1995.
Ca
lgon has developed a complete marketing program with literature and promotional
ma
terial, and is currently marketing and selling Mitraflex
TM
through its 186-person sales
forc
e in North America.
As of November 1990, approximately 900,000 Mitraflex
TM
wound dressings have been
ma
nufactured and sold. Due to its exceptional clinical results, Mitraflex
TM
has been able t
o
co
mmand a premium price at retail of $4.25 for a 4
"
× 4
"
size and $8.00 for an 8
"
× 8
"
size.
Confidential PolyMedica Industries, Inc.
294 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
1.5 Other Uses of Mitraflex
TM
e microporous, absorbent nature of Mitraflex
TM
dressings can also be applied to ot
her
wo
unds, such as dermabrasions and donor sites. Dermabrasions occur during cosmetic
ab
rasion of the facial dermis of patients suffering from pock marks or severe acne. Donor sites
ar
e areas of the skin that have been “shaven” of dermis to donate skin to another area of skin
th
at has been burned.
In both cases, Mitraflex
TM
acts as a temporary artificial skin, which:
Adheres gently to intact skin
Maintains optimal fluid balance
Matches the elasticity of normal skin
Prevents mechanical abrasion
Maintains temperature homeostasis
Accelerates wound healing (compared to gauze treated wounds).
PolyMedica is well advanced in adapting the Mitraflex
TM
technology to other markets where
th
ese characteristics represent advancements in the state-of-the-art. ese include such market
se
gments as plastic surgery wound dressings, synthetic gauze dressings, veterinary woun
d
dr
essings, pigmented wound dressings, and variable adhesive dressings. ese are products
th
at PolyMedica can produce and market on its own or in conjunction with a marketing partner.
In addition, the Company is pursuing longer term possibilities of developing woun
d
dr
essings capable of delivering over-the-counter medications or ethical pharmaceuticals at the
wo
und site through external application. While no agreement has been finalized, several large
comp
anies have expressed interest in developing a partnership with PolyMedica for entry into
thi
s high sales potential market segment.
1.6 Expanding the Markets for Mitraflex
TM
PolyMedica is in the process of negotiating with other distributors for its Mitraflex
TM
pr
oducts in Europe, Japan, South America, and other international markets. e Company
in
tends to apply some of the proceeds of future financings to increase product sales efforts (see
“C
apital Requirements”).
Confidential PolyMedica Industries, Inc.
Writing a Winning Business Plan ◾ 295
2. BIOSTABLE POLYURETHANES
2.1 Definition of Biostable Polyurethanes
Polyurethanes (“PU’s”) are the best performing biomedical-grade elastomers. e only other
su
itable elastomer is the family known as silicone. Silicones are biostable, histocompatible and
hemo
compatible, but are mechanically weak. Such mechanical properties could b
e overcome by
in
creasing the thickness of the silicone-based product. However, this is not possible or desirable
i
n most applications.
Polyurethanes are block copolymers synthesized from isocyanates, macroglycols, and chain
ex
tenders. By proper selection of these three monomers, PU’s can be made flexible, semirigid,
or
rigid. ey have demonstrated high hemocompatibility, superior abrasion resistance,
ex
cellent mechanical properties, and unmatched flexure endurance. Due to these properties,
po
lyurethanes are the polymer of choice for the manufacture of the most advanced medical
de
vices.
In the past five years, research has shown that all currently available medical grade
po
lyurethanes undergo an enzymatic degradation process known as Environmental Stress
Cr
acking (“ESC”). ESC, as the name suggests, leads to surface microcracks in the corrosive
en
vironment of the living body. Once microcracking begins, it is only a matter of time before
ca
tastrophic failures of the medical device occur.
Scientists at PolyMedica have developed Chronoflex
TM
, the first biostable PU elasto-
mer
that initial tests indicate may be capable of withstanding the high corrosive biologi-
ca
l environment of the human body. Chronoflex
TM
is presently undergoing tests in three
ar
eas: (1) Vascular Grafts; (2) Pacemaker Lead Insulators; and (3) Mammary Prostheses.
2.2 Vascular Grafts
Vascular disease, such as atherosclerosis, is usually progressive. A fatty streak in the ves-
sel
can rapidly develop plaques that ultimately impede blood flow to the heart muscle. Many
pa
tients eventually need vascular grafts to bypass severely obstructed coronary arteries.
Confidential PolyMedica Industries, Inc.
296 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
Two biomaterials currently dominate the graft field: Dacron and Teflon (PTFE). Dacron
mono
filaments are woven into various intricate designs. Dacron grafts are generally used
in
large diameter (12 to 22mm) applications. Blown PTFE grafts are generally used in th
e
in
termediate diameters (6 to 12mm).
ree companies dominate the vascular graft field: C.R. Bard (Dacron), W.L. Gore (PTFE),
an
d Meadox (Dacron).
Dacron and PTFE grafts are acceptable for peripheral vascular surgery, shunts and aneurysm
repa
irs where the diameter exceeds 6mm. For diameters smaller than 6mm, which is a large
seg
ment of the market, studies indicate that miscompliance results in anastomotic hyperplasia,
th
ickened fibrin linings and kinking, with postoperative failures as high as 50% at 12 weeks.
Polyurethane grafts with improved compliance-matching to the native coronary vessels are
,
at
present, the best alternative. However, with the specter of surface microcracking inherent in
th
e commercially available polyurethanes, the industry has sought the development of a biostable
po
lyurethane. PolyMedica believes it has developed such a polyurethane in its Chronoflex
TM
pr
oduct.
To date, no organization is marketing arterial grafts suitable for the bypass of obstructed
corona
ry arteries. Each year, there are 320,000 coronary bypass surgeries in the U.S. Surgeon
s
st
ill rely on the use of saphenous veins from the patient, and are vitally interested in the
de
velopment of an off-the-shelf artificial vascular graft substitute. A major new market
op
portunity exists (in excess of $150 million per year) for the development of small bore (6mm
di
a. or less) vascular grafts. If PolyMedica’s biostable polyurethane product can be develope
d
fo
r peripheral and vascular applications, the graft market should grow to $500million
an
nually as new sizes are introduced.
2.3 Pacemaker Lead Insulators
Cardiac pacing systems are utilized by patients with some impairment in the heart’s
na
tural electrical conduction system. Normally, the rhythmic contractions of the heart
ar
e stimulated by small electrical signals emitted by the sinoatrial node. These signals are
cond
ucted downward along nerve fibers to the four chambers of the heart (first to the atria an
d
fin
ally to the ventricles) which contract to perform the principal cardiac pumping function.
Confidential PolyMedica Industries, Inc.
Writing a Winning Business Plan ◾ 297
When the natural pacing mechanism is impaired, a pacemaker is used to remedy the
problem
by stimulating the heart and restoring normal rhythm. Pacemakers are implanted
subc
utaneously and are connected to the heart muscle by means of insulated wire leads
ca
lled electrodes. The useful life of pacemakers ranges from five to ten years, but the leads are
ex
pected to survive indefinitely.
Advances in cardiac pacemakers are allowing more patients to play tennis, swim, and
ev
en jog. at is important since almost 250,000 patients received pacemakers worldwide—
a
quarter of them between the ages of 25 and 45—accounting for industry sales tha
t exceed
$
1 billion annually. Approximately 55% of implants are performed in the U.S.
Until 1981, most lead insulators were made of silicone. However, silicone insulators were
ve
ry thick so the industry began switching to polyurethane insulators. Compared to standard
si
licone rubber, PU elastomers offered several advantages, including higher tensile strength,
tea
r resistance, and abrasion resistance.
ese advantages prompted the introduction of PU leads with significantly reduced wall
th
icknesses by Medtronic, Cordis, and Intermedics. inner leads allowed easier surgical
ins
ertion, the introduction of multiple leads, and greater elasticity for the implanted lead.
e drawback once again is that these polyurethane leads are susceptible to microcrack-
in
g. Chronoflex
TM
overcomes this difficulty; samples of Chronoflex
TM
tubing are undergoing
fin
al in vivo stability tests at several laboratories.
2.4 Mammary Implants
Over 125,000 women undergo breast augmentation and reconstruction in the U.S. every
ye
ar. e total population of U.S. implants now exceeds 425,000 women. e major suppliers
ma
rketing mammary prostheses are Mentor, McGhan, Dow-Corning Wright, and Surgitek. It is
es
timated that the U.S. mammary prostheses market for these companies is about $75 million
pe
r year.
Most prostheses are composed of an outer wall of silicone rubber, filled with a silicone
ge
l core. ese prostheses are prone to leak silicone gel and frequently exhibit capsular
co
ntraction. e leakage introduces foreign material into the body and capsular contraction
Confidential PolyMedica Industries, Inc.
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