Development History
WAVE is the latest version of the VIPON device that was patented
over 25 years ago but never successfully commercialized until now.
1998
- Steven A. Kilgore is granted Patent US5782779A for the VIPON, described as a “vibrating tampon apparatus for easing a woman’s menstrual cramps”.
- Patent assigned to Another Way Products, LLC.
1999
- Clinical Practice Report on the VIPON by Dr. Kermit E. Krantz, Chairman of Ob-Gyn Dept – University of Kansas School of Medicine (KU).
- All 8 subjects reported pain relief from Dysmenorrhea.
2000
- FDA grants 510(k) marketing clearance to the VIPON (510(k) K992493
- Indication of Use: Absorption of menstrual fluid (tampon). Clinical Trial required to support an Indication for relief from Dysmenorrhea.
2002 to 2005
- Clinical Trial Protocol Development for VIPON, Contract Negotiations with CRO (Alquest/NAMSA) & Study Sites, Fund Raising.
2006
- Clinical Trial Begins: “A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen”, NCT00951561.
2009
- Clinical Trial Completed: Data showed VIPON to be non-inferior to Ibuprofen for relief of Dysmenorrhea. Statistical analysis showed VIPON to be significantly faster acting than Ibuprofen. See Clinical Trial Study Report for details.
2008 to 2011
- Opened negotiations with Ruggli, AG (a Swiss Company) to mass produce VIPON
- After testing VIPON and reviewing our clinial trial data, DAX Holdings, AG (a Swiss company and owner of Ruggli) proposes we form a joint venture.
- Formed VIPON AG; a joint venture formed between Another Way Products and DAX Holdings, AG (a Swiss company).
- VIPON was redesigned for mass production & renamed: TAMIA. Tamia received marketing clearance from SWISSMEDIC for relief of Dysmenorrhea
- VIPON AG ceased operations when test marketing showed that TAMIA’s price was too high for a disposable / single-use product.
2012
- Medical Journal Publication: Tamia Clinical Practice Report (Gynecology, April 2012)
2013
- Medical Journal Publication: Vipon Clinical Trial Report (Journal of Women’s Health: June 2013).
2021
- Leveraging the knowledge gained from developing VIPON and Tamia, our earlier devices, David Conroy turned to the voices of women. Their insights guided the design of WAVE, prioritizing a reusable product that eliminated the need for a tampon and lowered the effective cost to the user.
2022
- Prototype WAVE was built that successfully met all design goals.
2023
- Bench testing of the finished product showed that the performance characteristics of WAVE’s vibratory stimulus were comparable to that of VIPON.
- Hush Tech LLC is formed to commercialize WAVE.
- Utililty Patent filed for “FlexStem” delivery system
- Design Patent filed for WAVE design
2024
- WAVE becomes an FDA Listed, OTC, Class 2, 510(k) exempt, Medical Device listed under FDA product code: KXQ
- Preparing to file FDA 510(k) to obtain marketing clearance for Wave with Indication of Use for the Relief of Dysmenorrhea.
- Launched retail website: WaveByHush.com
- ACOG Medical Conference approves WAVE device to be Exhibited in “Innovation Lane” ; Booth 746, Minneapolis, MN May 16 to 18