Introduction of SagaPro and SagaMedica

1. Icelandic. Pure. Effective.
SagaPro
Icelandic herbal supplement
TM
for urinary frequency
Perla Bjork Egilsdottir, biochemist
Deputy Director / Marketing Director
SagaMedica ehf.

2. Summary
• Overview
SagaPro
Angelica archangelica
SagaMedica
harvesting
• Urinary frequency
• SagaPro - Clinical study results
• Competition – product comparison
• Market experience
• SagaMedica’s line of products

3. SagaPro - For Urinary Frequency
Reduces the number of bathroom visits at night
Main users
• Men and women suffering from overactive bladder
• Men suffering from prostate enlargement (BPH)
Fast acting and measurable
• Results after one packet
• Easy to know if it’s working
o Just count the number of visits at night
Clinically studied

4. Some background info
Where is Iceland?
• Between North America and
Europe
• About the size of Kentucky
• Population: 320.000

5. Angelica
The Angel’s Herb
...has developed for 8-10 thousand years in Iceland
...is one of or even the only medicinal herb with Nordic origin
...was the first grown vegetable in Scandinavia

6. Angelica
The Angel’s Herb
• Used in Iceland for 1100 years
o Vikings sold it in south Europe because of
its healing powers
o So valuable that Iceland’s first lawbook
specifically banned angelica theft
• Named after an archangel
o Known as “The Angel’s Herb”
o Angelica was thought to cure Plague
• 20 years’ scientific research
o by SagaMedica and collaborators from the
University of Iceland
• Grows all over Iceland
o Not endangered
• Often considered to be a weed
o Our “Green Gold”
SagaPro is produced from angelica leaf

7. SagaMedica
Dr. Sigmundur Gudbjarnason
o Co-founder of SagaMedica
o Former president of the University of Iceland
o Respected lecturer
o Professor at Wayne State University School of
Medicine in Detroit in 1961-1970
o Was one of the first scientist to study the health
benefits of Omega-3 fatty acids in 1970s and their
role in cardiac health
o Worked as a “Distinguished Visiting Scientist” at the
FDA in 1983
o Began his studies on Icelandic medicinal herbs in
1992
o Steinthor Sigurdsson joined Dr. Gudbjarnason in
1995. Steinthor earned his Phd in 2009 for
biochemical research on Icelandic medicinal herbs
o As a team SagaMedica’s scientists have published 6
peer-reviewed studies

8. SagaMedica
Icelandic natural products manufacturer, founded in 2000
o Growth: in 2008, 4 employees in 3 full-time positions
in 2012, 10 employees in 7,6 positions
o Production and harvesting is subcontracted
o SagaMedica’s products are very popular in Iceland and SagaPro is leading the
natural market.
o Voxis launched in Norway 2005
o New shareholders January 2010
o U.S. and Canada launch in October 2010
o Clinical study results on SagaPro
published in July 2012

9. Eco-friendly harvesting
• Angelica grows abundantly in Iceland
• Its proliferation is even considered too intense
in some areas
• SagaMedica’s harvesting can benefit local
authorities that would otherwise have to
eradicate the herb in a costly way
Angelica distribution
SagaMedica works with local people in several
places in Iceland
Harvesting
• Is performed by local people in a
responsible way
• Is done in several places in
Iceland allowing SagaMedica to Source: The Icelandic Institute of Natural History
rest areas if needed
• Offers jobs to farmers and young
people in the summer

10. Hrísey Island
North Iceland
• this island is one of SagaMedica’s main source for Angelica
• the island has a population of 180 people
• it gets almost 24 hours of sunlight per day during Angelica’s main growth period
• local people, great stories
– inhabitants use Angelica seeds for breakfast cereal
– inhabitants drink Angelica tea
– It is said that they couldn’t start a retirement home (islanders too healthy)

11. Pure and eco friendly
Harvesting performed by locals in July and August

12. Nocturia
Frequent nighttime urination
Definition: A common problem
Nocturia is defined as the Age Prevalence
interruption of sleep by the
60 – 70 11% – 50%
need to urinate.
Weiss and Blavias, 2000
80 80% - 90%
Weiss and Blavias, 2000
• Increases with age in both men and women
• Nocturia is the most common symptom of prostate enlargement
• The causes of nocturia are many and can be divided into conditions
affecting the storage of urine in the bladder (bladder capacity) and
those involving excessive production of urine (polyuria)
• Sleep loss is a major cause of stress and can affect brain cell
regeneration
• Nocturia is not often talked about
• Spouses are affected too – Getting in and out of bed can be disruptive

13. Icelandic. Pure. Effective.
Clinical study on SagaPro
Results

14. Clinical study
Peer reviewed paper on the study has been published in a medical journal:
Scandinavian Journal of Urology and Nephrology
Pharmaceutical study. Approved by IMA (Lyfjastofnun) and NBC (Vísindasiðanefnd).
(EudraCT, 2010-019668-35)
The first clinical study to be conducted on an Icelandic natural product.
The study was managed and monitored by Encode Clinic under the supervision of
clincial staff members from Landspitali Háskólasjúkrahúsi (University Hospital Iceland)
Hrefna Guðmundsdóttir, MD, specialist in internal medicine and renal diseases
Guðmundur Geirsson, MD, specialist in urology
The study was twice awarded grants from the Icelandic Technology Development
Fund

15. Clinical study
Objective, materials and methods
•Investigates the effects SagaPro has on nocturia in men
•Parallel, randomized, double-blind and placebo controlled
•69 were randomized to receive SagaPro or Placebo (3 LTFO)
•Average of ≥2 nocturnal voids
•Duration 8 weeks
Clinical characteristics
Patients with
Average age Average number of sleep
N and range nocturnal voids disorders
Placebo 35 67.44 (47 - 85) 2.74 5
SagaPro 31 66.31 (49 - 86) 2.81 3

16. Clinical study
Safety and tolerability
Vital signs were monitored and
urinalysis performed throughout the study.
No severe adverse events were reported
and overall there were no difference between
the treatment groups (i.e. SagaPro and Placebo)
SagaPro is safe and well tolerated treatment

17. Clinical study on SagaPro
Results
Test population
The actual number of Nocturnal voids, Nocturnal polyuria
index and Nocturnal bladder capacity index decreased but the
difference between the treatment groups was not significant
Heterogenous group
• Underlying factors related to nocturia
Overactive bladder
Benign prostate enlargement
Nocturnal urine production
Sleep disorders, sleeping time
Subgroup analysis

18. Clinical study on SagaPro
Results
Reduction in nocturnal voids
for a subgroup with reduced nocturnal bladder capacity (NBC-index>1.3) and excluding those with sleep disorders
Low nocturnal bladder capacity is directly related to urinary
frequency. NBC index indicates reduced bladder volume at
night – a higher index indicates less nocturnal bladder
volume.
The SagaPro group experinced a
sgnificant reduction in voiding frequency
and NBC index.
N=29

19. Clinical study on SagaPro
Results
Increase in average nocturnal bladder volume
per nocturnal void for subgroup with less than 260 ml volume initially
N=49

20. Clinical study on SagaPro
Results
Increase in smallest nocturnal bladder volume
per void for a subgroup with less than 260 ml average nocturnal bladder volume initially
The SagaPro group had a significant increase in
smallest nocturnal void volume of 66 milliliters.
N=49

21. Clinical study on SagaPro
Results
N=17
* A “standard night” of 520 minutes was defined to harmonize different sleeping patterns.

22. Clinical study on SagaPro
Results
N=24

23. Summary
1. SagaPro is safe and well tolerated
2. SagaPro increases average nocturnal voided
volume, smallest nocturnal void volume and
increases nocturnal bladder capacity
3. SagaPro reduces nocturnal voids
4. SagaPro increases the duration of the first
sleep period (HUS) in the oldest group

24. Conclusion
SagaPro
• has beneficial effect on bladder capacity
• can benefit men and women
• safe and well tolerated
• according to the study SagaPro has most beneficial
effects for those who have more severe symptoms

25. SagaPro - How does it work?
• Research suggests leukotriene inhibition is the most likely
explanation
• Leukotrienes have been shown to contract smooth muscle cells,
which are found in the bladder and urethra
- Which causes an increased and urgent need to urinate
• Overactice detrusor (bladder muscle) can lead to a reduced
bladder capacity and cause nocturia
• SagaPro contains isoquercitrin which is thought to calm
leukotriene induced contraction
• SagaPro may relax smooth muscle cells in the bladder by
inhibiting leukotriene activity
• SagaPro does not reduce libido

26. SagaPro contains isoquercitrin
Isoquercitrin is thought to calm contraction in the bladder
and is believed to be helpful for urinary frequency

28. SagaPro - For Urinary Frequency
Market experience
• Sold domestically since 2005
• Most popular Icelandic herbal
supplement
• Has replaced Saw Palmetto as
#1 product for urinary frequency
in Iceland

29. Line of products
Continuous research and product development
SagaVita
(tincture 2002 / tablets 2007)
Cold and flu prevention - Antiviral
SagaMemo
Voxis (2003) SagaPro (2005) (tincture 2009 / tablets 2012)
For a sore throat For urinary frequency For a healthy memory

30. US and Canada launch in 2010
vs.
For Urinary Frequency Urinary function support*
*This statement has not been evaluated by the Food and Drug
Pour la fréquence urinaire Administration. This product is not intended to diagnose, treat, cure
or prevent any disease.

31. Voxis - throat lozenges
• For a sore throat
– Made from angelica leaf
– Most popular lozenges in Iceland
– “Voice of Iceland”
• Sugar free version being
developed. With isomalt (from
beets)

32. Voxis - North America
Voxis premium and
Voxis sugarfree

33. SagaMemo
• For healthy memory
– Made from angelica seeds and Wood cranesbill
– Synergy occurs between the two herbs
– Mixture of the herbs increases amount of
neurotransmitter important for a healthy memory
• Peer-reviewed study published
– Clinically studied in Korea on Alzheimer patients*
Ref: 1. INM176 Clinical Trial at Korea’s Samsung Seoul Medical Center Lifts Hope for Prevention and Treatment of Alzheimer disease. 2001/11/272. Adopted
from www.scigenic.com dated 26.01.2009.

34. SagaVita
• Cold and flu prevention
– made from angelica seeds
– has antiviral properties and is used
for cold and flu prevention
– may alleviate stress since it reduces
cortisol production

35. Great publicity – release of clinical study results
Newspapers
National TV
Radio stations
Web media
Response from US
regarding further studies