Tokyo July 28, 2009: Hair Clinic REVE 21, "Reve21" (President Katsumasa Okamura, Chuo-ku, Osaka-shi, Osaka) and DIGNITANA AB, "Dignitana" (CEO Martin Waleij, Swedish company) signed a distribution agreement for DigniCap? back in April 2009 and now have agreed to enter into a wider collaboration to further strengthen their partnership here in Japan.
Reve21 have now made a direct investment and formed a tie-up with Sweden-based Dignitana, thus an agreement was concluded between Reve21 and Dignitana on May 2009 stating that Reve21 will deal with Dignitana's DigniCap? system using exclusive marketing rights in Japan.
Furthermore Dignitana have granted Reve21 an option to make market assessments in Asia and Oceania for launching DigniCap? to further create synergies of the two company's partnership in Japan.
In the fall of 2009, Reve21 and Dignitana will initiate a due diligence process as DigniCap? potential production partners in Japan aiming to make further cost reductions of the DigniCap? product and also to make the best use of future large volumes for not only Asian but also world-wide markets.
Both companies will also start to evaluate the medical device market for DigniCap? not only in Japan but also in other areas in Asia.
In the fall of 2009, Reve21 will start regulatory clinical trials of the DigniCap? system, and the CRO that will support in this process has already been selected.
Reve21 corporate philosophy is to change the lives of people from all over the world who are suffering from hair loss into lives of self confidence and delight. Also pursue both, physical and spiritual happiness of all its employees. Additionally, Reve21 supports both, hair loss and heart-care by becoming a major contributor in the establishment of scalp cooling for chemotherapy patients as a world wide standard for significantly reducing or even eliminating chemotherapy induced alopecia.
Journalists with inquiries, please contact:
kouhou@reve21.co.jp
martin.waleij@dignitana.com
+46 - 733 - 93 70 76
DIGNITANA AB
CEO Martin Waleij
Head Office Visiting address: Ruben Rausings gata 9, Lund, Sweden
Established 1999
Share Capital 3,516, 334 SEK
Dignitana is a Swedish public company based in the innovation cluster of Lund in the Öresund region. The company focuses on a patented invention DigniCap?, a medical device for preventing hair loss in chemotherapy patients through controlled and reliable cooling of the scalp. DigniCap? has been developed in close cooperation with the oncology clinics at leading university hospitals in Sweden. For more information please check their website at http://www.dignitana.com/
Hair Clinic REVE21: Hair growth specialist Reve21 helps solve "hair trouble," like hair loss and scalp conditions together based on its unique hair growth techniques. For more information please check their website at http://www.reve21.co.jp/eng/company/
Contact for more information
Misa Umehara, Public Relations, Hair Clinic REVE21
Shin-maki-chou bldg. 4, 1-8-17, Yaesu, Chuo-ku, Tokyo
kouhou@reve21.co.jp T&F 03-3510-1321
Q&A
1. Post Market Surveillance Report in Northern Europe
Data of 2249 patients treated with DigniCap? system were collected from 20 clinics in Scandinavia between 2001 and 2007. The results are reported in a Post -market surveillance report (2007). Of the 2249 treated patients (mainly breast and ovarian cancer), 1922 of them did not need wigs which indicate an average success rate of over 85% in terms of non-wig usage.
2. Who can not use the DigniCap system?
Based on the data reviewed, the following recommendations identify the right candidate to receive scalp cooling with the DigniCap? system:
a) Scalp cooling can be routinely used for both palliative and adjuvant settings in a wide variety of solid tumors rarely metastasizing to the scalp such as (breast, ovarian/endometrial, prostate, lung, stomach, colon).
b) Scalp cooling can be used on a wide selection of chemotherapy regimens particularly when anthracyclines (doxorubicin, epirubicin) or taxanes (paclitaxel, docetaxel) are used. The results are higher in single-drug therapy than in combination therapy, e.g. when etoposide and clyclophosphamide are added).(Please see the list of recommended drug regimens and cooling time for the DigniCap? system)
c) Scalp cooling should be avoided in patients with hematological malignancies with hematogenic metastases (e.g. myeloma, leukemia, and lymphoma) should due to possible risk of scalp metastases. However, in certain cases it may feel appropriate to offer scalp cooling on the basis of quality of life.
d) Scalp cooling can be controversial in patients with non-haematological malignancies who undergo chemotherapy with a curative intention.
e) Scalp cooling is not recommended in cases of cold sensitivity, migraines, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia.
3. DigniCap? system consist of the following advantages
* An inner cap that is used under the silicon cap, single use which improves hygiene for the patients and contributes for further improved results.
* An outer cap that ensures even better fitting of the silicon cap to the head to further improve results
* A cooling robotics the DigniCap? with the following advantages.
- Smaller and Lighter.
- Hard disk has been replaced, new internal design of electronics, microprocessor and use of flash memory.
- Developed under both ISO 13 485 and the US FDA.
o It will be possible to sell it to 1 user (and later update to 2 users).
o The instrument will exist in a 120 VAC and a 230 VAC version.
5. Investment in Dignitana
Reve21 invested 1 million SEK into Dignitana, at a share price of 0.10 SEK, and Reve21 will be offered a seat in the Board of Directors.
6. Option of making a market assessment of other markets in Asia and Oceania
In order to obtain synergistic effects to strengthen the partnership, Reve21 has acquired the right to evaluate marketing options in Taiwan, Australia and New Zealand. We really want to offer our "hair loss" solution around the globe.
7. About the clinical trial
After reporting to health authorities, we intend to start clinical trials within this year with support from CRO, i.e., Clio Science Inc, Tokyo.
8. The aim and advantage of the collaboration:
1) To eliminate anxiety caused from losing hair during chemotherapy for breast cancer patients.
2) Expansion of new hair-growth business
3) Penetration to healthcare business
4) First step onto international business
9. Clinical Evidence
A number of clinical studies have been carried out to evaluate the safety and efficacy of the system:
1. Lundgren-Eriksson et al. Total prevention of taxoid-induced alopecia by a new model of cold cap, Eur J Cancer, 1999; 35 (suppl 4): 376.
2. Henriksen et al. Advanced computerised cold cap for preventing chemotherapy induced alopecia. Eur J Cancer, 2003; 1(5):369.
3. Ridderheim et al. Scalp hypothermia to prevent chemotherapy-induced alopecia is effective and safe: a pilot study of a new digitized scalp-cooling system used in 74 patients. Support Care Cancer, 2003; 11:371-7.
4. Byahov. Alopecia prevention in chemotherapy patients. Methods of controlled scalp cooling. Meditsinskaya Cartoteka, 2006.
5. Kato et al. Evaluation of DigniCap? system for the prevention of chemotherapy induced hair loss in breast cancer patients. Poster: 16th Japanese Breast Cancer Society in Osaka, Sept 26-27, 2008. Post Market Surveillance Report, 2001-2007. Over 2200 patients are reported to have used the DigniCap? in Scandinavia between 2001 and 2007.
6. Most recent in Japan; out of 65 adjuvant patients, 94 % had success rate (Kobayashi et al, 2008.)
July 28, 2009
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