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.
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.
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.
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.
FDA audits all manufactures of Class II colon irrigation equipment to enforce the regulatory status of these devices as prescription only.
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.
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.
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.
Lifestream unveils the Angel of Water CM-1 Surround unit at the I-ACT convention in Houston, TX.
Cherubum product(s) patented.
Australian regulatory clearance is obtained with Emergo Group Asia Pacific acting as Lifestream’s Australian Sponsor.
Lifestream shows products at MEDICA in Dusseldorf, Germany.
Lifestream and T&T Medical Equipment Co. Ltd. begin working toward TFDA clearance in Taiwan which is gained the following year.
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.
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.