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 (menstrual pain)

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.

2003  

• Steven A. Kilgore, President of Another Way Products and Inventor of the VIPON suddenly dies.   He will be missed! 

2004 – 2005

• The new BOD decides to shift our focus to launching a clinical trial. 

• 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 (within 15 min)  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  

• Focused on steps required to conduct a formal clinical trial with a goal of obtaining FDA  marketing clearance  by 2027
• Hired consultants to aid in preparing a Pre-Submisison to FDA 

2025

• Received FDA feedback. FDA stated that our device is unique (no predicate) and therefore must follow the De Novo clearance pathway.   
• Passed  ISO 10993-1 Bio-Compatibilty Testing 
• Started 60601-1 Safety Testing  
• Developed a Sham Wave device to be used in clinical trial
• Preparing to submit a revised pre-sub that will address all FDA concerns

2026

• Formally submitted  STeP request to  FDA