Viveve Peroleh CE Mark untuk Pengobatan Ginekologis Kelemahan Vagina

AsiaNet 42795

Perusahaan akan memulai pembahasan mengenai distribusi pada Konferensi J.P.
Morgan

PALO ALTO, Calif., 6 Januari 2011 /PRNewswire-AsiaNet/ — Viveve, Inc.,
perusahaan bidang kesehatan wanita dalam tahap pengembangan, hari ini
mengumumkan telah memperoleh tanda CE (Conformite Europeene) Eropa atas
penggunaan Sistem Viveve-nya untuk pengobatan tanpa operasi kelemahan vaginal
introitus (pembukaan), setelah persalinan, untuk memperbaiki fungsi seksual
wanita.

(Logo: http://photos.prnewswire.com/prnh/20110106/SF25673LOGO)

“Tanda CE ini merupakan peristiwa penting dalam strategi komersialisasi
kami,” kata Kerry Pope, Presiden dan CEO Viveve. “Kami telah mendengar dari
para pemimpin penting yang memberikan opini di Eropa dan Kanada tentang
prosedur Viveve dan pentingnya ketersediaannya untuk pasien mereka.”

“Saya dapat mengatakan bahwa di seluruh dunia, penelitian dan pengembangan
yang bermanfaat bagi fungsi seksual wanita belum berada di garis depan inovasi
medis,” tegas Dr. Michael Krychman, Ginekolog dan Direktur Eksekutif, The
Southern California Center for Sexual Health and Survivorship, Newport Beach,
CA. “Dengan tanda CE ini, Viveve dapat membawa prosedur mereka kepada sejawat
saya di Eropa yang saya yakin pasiennya akan diuntungkan dari prosedur ini.”

“Kami akan segera membangun jaringan distribusi kami di negara-negara
anggota Uni Eropa serta negara lain yang mengandalkan proses tanda CE, seperti
Kanada dan Australia,” lanjut Pope. “Para penasihat klinis kami bersama dengan
penelitian kami sendiri memberitahu bahwa peluang pasar bagi prosedur Viveve di
negara-negara maju besar dan kami berharap dapat mengukuhkan kehadiran kami di
Eropa.”

Ada tiga komponen pada Sistem Viveve: generator RF yang telah dioptimalkan
untuk digunakan di kantor; bagian tangan yang didesain khusus untuk aplikasi
itu; dan ujung sekali pakai. Prosedur ini dilakukan di ruang praktek dokter
oleh ahli kandungan/kebidanan yang terlatih, tanpa memerlukan pembiusan, dalam
waktu kira-kira 30 menit. Pada tahun 2009, penelitian menggunakan Sistem
Viveve, yang disetujui IRB Risiko Non-Signifikan “Pertama pada Wanita”,
dilakukan di Amerika Serikat. Semua wanita dalam penelitian ini melaporkan
peningkatan rasa rapat vagina selama berhubungan seksual pada 1, 3 dan 6 bulan
pasca pengobatan. Selain itu, dari wanita yang telah mengalami penurunan
kepuasan seksual minimal 1 tahun pasca melahirkan, semua melaporkan peningkatan
kepuasan seksual pada interval 1, 3 dan 6 bulan. Penelitian ini diumumkan pada
September 2010 oleh Journal of Sexual Medicine dan dapat ditemukan di situs web
perusahaan di http://www.viveve.com.

Tentang Viveve(TM)
Viveve adalah perusahaan bidang kesehatan seksual wanita yang berbasis di
Palo Alto, California. Sistem Viveve adalah perangkat medis yang digunakan
untuk prosedur tanpa operasi kelemahan pasca persalinan vaginal introitus,
kondisi kualitas hidup yang diakui secara medis. Ia saat ini tidak dijual di AS.

Pembiayaan Seri A perusahaan ini dipimpin oleh GBS Venture Partners dan
5AM Ventures. Untuk informasi tambahan, kunjungi http://www.viveve.com atau
hubungi Sherree Lucas di +1-650-321-3332 ext 213.

SUMBER: Viveve, Inc.

KONTAK: Sherree Lucas dari Viveve, Inc.
+1-650-321-3332, ext. 213

Viveve Obtains CE Mark for Gynecologic Treatment of Vaginal Laxity

PALO ALTO, Calif., Jan. 6, 2011 /PRNewswire-AsiaNet/ —

Company to begin distribution discussions at J.P. Morgan Conference

    Viveve, Inc., a development stage women’s health company, announced today that it has received the European CE (Conformite Europeenne) mark for the use of its Viveve System for the non-surgical treatment of laxity of the vaginal introitus (opening), after childbirth, to improve female sexual function.

    (Logo: http://photos.prnewswire.com/prnh/20110106/SF25673LOGO)

    “The CE mark is a key milestone in our commercialization strategy,” said Kerry Pope, President and CEO of Viveve. “We have heard from key opinion leaders in Europe and Canada about the Viveve procedure and the importance of its availability to their patients.”

    “I can say that worldwide, research and development to benefit women’s sexual function have not been at the forefront of medical innovation,” stated Dr. Michael Krychman, Gynecologist and Executive Director, The Southern California Center for Sexual Health and Survivorship, Newport Beach CA. “With the CE mark, Viveve can bring their procedure to my European colleagues whose patients I believe will benefit from this procedure.”

    “We’ll immediately begin building our distribution network within the European Union as well as other countries that rely on the CE mark process, such as Canada and Australia,” Pope continued. “Our clinical advisors along with our own research tell us that the market opportunity for the Viveve procedure in developed countries is substantial and we’re looking forward to establishing our presence in Europe.”

    There are three components to the Viveve System: the RF generator that has been optimized for use in an office setting; the hand piece that is specifically designed for the application; and the single-use disposable tip. The procedure is performed in the doctor’s office by a trained OB/GYN, without the need for anesthesia, in approximately 30 minutes. In 2009, a “First in Women” Non-Significant Risk IRB approved study using the Viveve System was conducted in the United States. All women in the study reported an improved feeling of vaginal tightness during intercourse at 1, 3 and 6 months post treatment. In addition, of the women who had experienced a decrease in sexual satisfaction at least 1-year post vaginal delivery, all reported an improvement in sexual satisfaction at 1, 3 and 6 month intervals. This study was published in September 2010 by the Journal of Sexual Medicine and can be found on the company website at http://www.viveve.com.

    About Viveve(TM)
    Viveve is a privately held women’s sexual health company based in Palo Alto, California. The Viveve System is a medical device used for the non-surgical procedure of post-birth laxity of the vaginal introitus, a medically recognized quality of life condition. It is currently not available for sale in the U.S.

    The company’s Series A financing was led by GBS Venture Partners and 5AM Ventures. For more information, visit http://www.viveve.com or contact Sherree Lucas at +1-650-321-3332 ext 213.

    SOURCE: Viveve, Inc.

    CONTACT: Sherree Lucas of Viveve, Inc.
             +1-650-321-3332, ext. 213