COOLOGICS
“The Self-Health Company”
THE PAIN
Vaginitis is an inflammation of the vagina.
It normally results from an infection.
The patient typically has a discharge, itching,
burning, and possibly pain.
‣
‣
80% of females will get a vaginitis/vaginal yeast infection in their lifetime. 20% annually (Geiger 1995)
70% of young women rely on self-diagnosis and self-treatment of yeast vaginitis. (Nyirjesy 1999)
THE CURRENT SOLUTION / COMPETITION
‣
‣
‣
‣
Over-the-counter (OTC) anti-fungal drugs for VVC rank in TOP 10 of all OTC drugs sold in US with annual sales over $250M
in 2005,(Fidler 2006) over $300M currently.
Combined OTC and Office/Prescription Market $3B (U.S.)
Current OTC anti-fungal creams only 52-72% effective, take days, aggravating side effects (Soper 1995)
Current OTC remedies like Monistat treat only one out of many species of yeast, which leads to the low 52-72% cure rate
(Soper 1995). More than 60% of 1671 women give it the lowest rating of 1 out of 10 (www.drugs.com/miconazole reviews).
Symptom relief is delayed for days. Bliss treats ALL species of yeast by unique mechanism.
‣
There is NO current remedy on the market that both cures and treats
symptoms simultaneously. Bliss does this faster and more effectively,
with no side effects or drug interactions compared to the competitors.
THE CURRENT SOLUTION / COMPETITION
‣
‣
‣
Yeast infections or vulvovaginal candidiasis (VVC) account for 35% of all
forms of vaginitis.
Prestige Brands acquired Insight Pharma (Monistat TM ) for $750M in 2014.
MonistatTM is Prestige's largest and first $100M brand and has 40%
market share. Generic creams comprise the remaining market share.
Health care office visits to gynecologists for VVC expected to cost over
$3.1B by 2014 (Wilson 2005). Likewise, Prestige reports combined officebased, prescription, and OTC market is $3B.
THE CURRENT SOLUTION / COMPETITION
‣
‣
Chemicals in current anti-fungal medications act by destroying the yeast cell wall, with a low cure rate of 52-70% thus
promoting anti fungal drug resistance that kills immuno-compromised people 40% of the time as a result of
disseminated blood infections.
Topical fungal infections that are treated systemically with prescription oral DiflucanTM (fluconazole) are ineffective with a
53% cure rate at 30 days (Li et al 2015) and are a huge part of the anti-fungal resistance problem. Bliss will not
contribute to anti-fungal drug resistance since it is not a drug.
THE CURRENT SOLUTION / COMPETITION
‣
‣
‣
An Austrian Study (2004), showed a statistical significance towards a
66% reduction in spontaneous preterm births among women with
yeast infections who were treated with anti-fungal cream for 6 days
prior to 20 weeks gestation (Kiss et al 2004).
Preterm birth rate is 10% and rising, 4M births annually United States.
Worldwide, 15M babies are born prematurely and 1M die (March of
Dimes 2012). The cost to treat and care for these premature babies
that survive through adulthood is $26B (in the U.S.)
Preterm births are unpredictable, but inflammation and vaginal
infections are treatable. First non-drug remedy makes Bliss preferred
solution in pregnancy as an anti-fungal, anti-inflammatory, anti-biofilm,
& potentially anti-BV that maintains normal flora since Lactobacillus
prefers coolness.
THE COOLOGICS SOLUTION
The company’s Bliss is the first OTC medical
device to treat vaginal yeast infections----without
chemicals----outflanking current treatments—all
drug-based with a proprietary cooling remedy
that was shown in a limited independent clinical
trial to work faster and more effectively than
current OTC and prescription creams and
medicines.
Bliss is faster and more effective than current drug-based remedies and eliminates
symptoms immediately in a limited independent clinical trial. For intra-vaginal use, Bliss is
tampon-like and has a size, shape, degree of cooling, ease of use, and appearance that
was rated as acceptable by all trial participants.
THE COOLOGICS SOLUTION
Other Uses:
‣
‣
‣
‣
‣
‣
Sexual pain disorders
Anti-itch, analgesic, anti-inflammatory conditions of the vagina from any
cause.
Healing relief after childbirth and gynecologic surgeries.
Recurrent sufferers: Diabetics, Immuno-compromised, Nursing home
residents.
Can act as 'numbing agent' before bladder catheterization and vagina
rejuvenation procedures
Alternative, Integrative, Holistic, Homeopathic, Non-chemical and Allnatural remedies being sought worldwide.
THE COOLOGICS SOLUTION
Cooling
Device
Topical
Creams
Prescription
Medicines
Availability
OTC, MDs,
Internet
OTC, Internet
MDs ONLY
Independent Clinical ‘Pilot’ Study
Relief of
symptoms
Immediate
3-7 days
2-5 days
‣
Yes
No
Cure of 3
Yeasts
Drug
Interactions
Toxic Skin
Reactions
Some do, but
not always
prescribed first,
$$$$ costly!
None, All
natural
Yes, Warfarin
Yes, many*
None, All
natural
Yes, **skin
irritants,
***release
enzymes
Yes,** skin
irritants,
***release
enzymes
‣
‣
‣
‣
January -% experienced relief of the
symptoms immediately within 30 minutes.
Overall Effectiveness as an anti-fungal 100%
N=5.
100% acceptance using this device in lieu of
topical creams or oral medication.
Mouse Study (LSU)
90% reduction in fungal burden and hyphal
scores
THE COOLOGICS SOLUTION
Mechanism of Action:
‣
Coolness reverses ‘virulent’ or ‘disease causing’ yeast shapes to return to ‘non-disease’ shapes (buds) which inhabit
the body normally, without causing infections. Treats symptoms simultaneously.
Clinical studies:
‣
Candida albicans or yeast is a ubiquitous organism found in many areas of the body. It normally stays in the dormant 'bud'
shape which is the non-disease state. When triggered by external stimuli, however, heat shock proteins (HSP 90,
specifically) cause the 'buds' to turn into invasive 'filamentous' forms that cause the itching and pain associated with VVC.
Remarkably, the proprietary coolness of Bliss cures the condition because cold forces the
'filamentous' forms back into the 'bud' forms-its harmless state where it remains until subjected
to another trigger. Coolness also reduces itching, burning, pain, and inflammation caused by
PMNs (white blood cells) that are released in response to the 'filamentous' forms.
THE MARKET
There are
currently at least
8 medical
devices
approved by the
FDA for intravaginal use:
Menstrual cups, pessaries, Impressa,
diaphragms, NuvaRing. Intra-vaginal
devices such as diaphragms, menstrual
cups, pessaries and disposable Poise
ImpressaTM (for urinary incontinence),
NuvaringTM, and FemringTM are ALL
self-inserted into the vagina for much
longer periods of time and are difficult
and painful to insert and remove.
Menstrual cups must be inserted and
removed twice a day for 3-7 days in a
row. FlexTM funded with $4M.*
78% responded 'Yes' to using this device
for VVC.
42% regardless of how it is activated
(freezer versus squeezing without freezing),
even though 36% had never had a yeast
infection and 28% had never used a
tampon.
74% willing to sit or lie for 20-30 minutes to
treat their yeast infection.
80% found that other uses for the device
such as anti-itch or anti-irritation were
important features.
Recent survey
posted on
‘Ask Your Target
Market'
Bliss has method and design patents for both yeast vaginitis, bacterial vaginosis (BV) and preterm birth
prevention. BV accounts for 45% of all forms of vaginitis, combined with yeast vaginitis at 35%, Bliss covers
80% of the vaginitis market. There is no OTC product for BV on the market. Six total patents pending.
GO-TO MARKET STRATEGY
YEAR 1
YEAR 2
YEAR 3
0.25%
0.5%
1%
Revenues
$3.6
$7.2
$15.7
Expenses
$2.5
$3.5
$6.8
Net Profits
$1.1
$3.7
$8.9
Market Penetration
FUNDING
Year 1
Initial funding needed for Manufacturing
Year 2
($300K)
Branding
Regulatory
($50K)
Marketing and Advertising
Clinical trial
($150K)
Non-clinical testing
Consulting
$1.6M- 2.6M
Packaging and Distribution/
($25K)
Launch in U.K.
($75K)
Salaries
Larger clinical trial to be completed at The Ohio State University under the direction of OB/GYN Chairman, Dr. Mark Landon.
Louisiana State University's Ph.D.s, Drs. Fidel, Noverr, and Yano (leading experts in yeast vaginitis) preliminary mouse studies
show a 90% statistically significant reduction in fungal burden with cooling device (p=0.0037)
FINANCIAL
Projected Sales
Coologics will invest 20% of sales into marketing spend (marketing, advertising, and sales activities, excluding broker and
listing fees) to generate the following aggressive sales growth for its flagship anti-fungal product. One marketing study
conservatively estimated 800,000 units of Bliss sold by year 1 in the U.K.
$ 15M
$ 9.0M
$ 0.25M
$ 2.8M
Year 1 Year 2
(16 Mos)
$ 3.6M
Year 3
Year 4
Year 5
FINANCIAL
Capital Funding ($6M to $10M for aggressive marketing)
The above growth requires the following capital funding for marketing and manufacturing activities
Year 1
(16 Mos)
Year 2
Year 3
Year 4
$ 0.6M
$ 0.6M
$2.6M
(U.K. launch)
$ 1.6M
$ 1.7M
$ 1.9M
$2.7M
(U.S. launch)
$3.8M (Third Market)
Realistic revenue projections for the initial vaginal anti-fungal of $3.6M in Year 3 (U.K), $9.0M in Year 4, and $15.0M in
Year 5, with average gross margins above 60%. Cost of sales is less than $5 per package (6 disposable devices). Retailers
like CVS, Walgreens, and grocery chains currently charge $20-$25 for vaginal anti-fungal remedies with 40% margins.
FINANCIAL
FDA
‣
‣
‣
‣
‣
Class II in U.S. with 'De Novo' application pending with the FDA (October 2017)
Class I in EU making CE Mark obtainable within a few months after Declaration of Conformity via Competent Authority.
No Notified Body necessary.
Initial discussions with FDA favorable.
After proving efficacy and demonstrating safety as a non-significant risk device, pathway is straightforward with
submission of clinical and non-clinical data
Exit Strategy
‣
Coologics will be ready for round-two financing to expand into additional markets and retailers and to roll out new
products with New IP beyond the initial flagship device by Year 4. Two multinational OTC companies have preliminary
interest in this product.
‣
Hemor-rite is an OTC device to treat hemorrhoids with a cooling mechanism that reduces inflammation. OncoTech sold
it to Appia Healthcare for $80M. OncoTech spent approximately $5M to commercialize Hemor-rite which had no IP.
THE EXECUTIVE TEAM
Dale Hunt
Ph.D. Biology and J.D. UC Berkeley
John Szustaczek
CEO/CMO/MBA
Who has extensive experience in feminine
hygiene and consumer packaged goods.
He recently took Diva International
(Divacup-menstrual cup) from $2M to $35M
in sales in less than 5 years & increased
retailers from 2,000 to 46,000.
Kimberly Langdon
M.D. The Ohio State University, Inventor, Founder
Inventor whose medical knowledge and experience compelled
her to design and introduce healthier, more effective, and safer
products for feminine conditions. Ranked in the 98th percentile
as an OB/GYN resident in the U.S. Won First Place with Senior
Resident Research Project. 19 years clinical experience, retired.
Responsible for R&D, technology, medical scientific liaison.
Partner-Hahn Loeser Parks, San Diego with
extensive IP experience with patent protection,
with a technical emphasis in life sciences
(cellular biology, genetics, genomics,
immunology, microbiology, molecular biology,
pharmaceuticals, protein engineering, stem cells,
transgenics and vaccines), medical devices and
procedures (nucleic acid diagnostics, sensors and
instrumentation and surgical devices and
methods); and plants (agriculture, plant genetics,
plant patents and plant-variety protection).
CONTACTS
Thank You!