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

 

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

 

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