Company Milestones

Company Milestones

August 2000

Rocco and Amy Bruno form Lifestream Purification Systems as a Texas Limited Liability Corporation and raise funds to gain FDA market clearance for the Angel of Water CM-1 professional unit.

July 2002

FDA clears the Angel of Water as a Class II RX ONLY medical device — for use when medically indicated, such as before radiological or endoscopic examination.

August 2002

A period of re-education begins to counter the prevailing view of colon hydrotherapy units in the United States as non-prescription devices. Rocco Bruno makes training trips to Singapore, India, Hong Kong, and Bulgaria and to locations within the U.S. for training therapists to the safe operation of the Angel of Water.

May 2003

Gary Russ, an advertising photographer for 30 years as g.russ images and Marketing Director of Global Golf and Resort Marketeers, becomes a partner in Lifestream to head up efforts to enhance our products’ market position.

December 2003

FDA audits all manufactures of Class II colon irrigation equipment to enforce the regulatory status of these devices as prescription only.

May 2005

Lifestream gains certification to ISO 13485:2003 for medical devices and CE Marking for the European Union.
The Cherubum line of products, Class I [EXEMPT] devices per the USFDA, is launched.

November 2005

Rocco Bruno forms Regenesis Integrative Health Centers, LLC to act as a training facility for Angel of Water CM-1 purchasers. Other training facilities are opened in California, Washington, DC, and New York.

May 2006

CE marking is obtained for the Angel of Water. Health Canada clearance is gained in the same year. The Cherubum is self-certified by Lifestream and registered in the Netherlands.
Competitors develop a study on closed system equipment in Danbury, CT (the Danbury Hospital study) to show the efficacy of colon irrigation before colonoscopy. Closed systems deliver less patient satisfaction overall than open systems.  

June 2007

Lifestream unveils the Angel of Water CM-1 Surround unit at the I-ACT convention in Houston, TX.

December 2007

Cherubum product(s) patented.

September 2008

Australian regulatory clearance is obtained with Emergo Group Asia Pacific acting as Lifestream’s Australian Sponsor.

November 2008

Lifestream shows products at MEDICA in Dusseldorf, Germany.

May 2010

Lifestream and T&T Medical Equipment Co. Ltd. begin working toward TFDA clearance in Taiwan which is gained the following year.

October 2014

Lifestream partners with Gavriel (Gabi) Meron, founder and former CEO of Given Imaging, the company that successfully brought the PillCam to the world – to form HyGIeaCare, Inc. for the purpose of establishing Centers to bring the HyGIeaCare Prep System and procedure exclusively to the GI market.

June 2016

Article published in Journal of Gastroenterology and Digestive Diseases, Volume 1, Issue 1:003 2016, entitled Randomized Trial Comparing High Volume Rectal Water Irrigation with Standard 4 L Split-Dose PEG Preparation before Colonoscopy.