At the core of Lifestream Purification Systems’ mission is our commitment to providing the highest quality colon hydrotherapy equipment for the healthcare practitioner and for the client. Our mission of “inspiring ideas for quality of life” directs our efforts and our quality policy.
Lifestream Purification Systems, LLC sets the standard for providing products and services that enhance the practitioner’s ability to empower people to live more healthful lives.
We fulfill our mission, vision and quality policy by focusing on the needs of our customers and their clients. We emphasize the ongoing innovation of our products and services and the continuous improvement of the methods and processes that successfully bring those products to the customer.
Rocco Bruno forms Lifestream Purification Systems as a Limited Liability Corporation in the state of Texas with ten small private investment units to gain FDA market clearance for the Angel of Water CM-1 professional unit. Rocco Bruno continues with R & D and implements a professional crating and packing system, CNC cut cabinetry, an illustrated User’s Guide, and other improvements that make the Angel of Water increasingly mass marketable. Amy Heilman Bruno, a Haverford College graduate with two masters degrees (Linguistics and Chinese Medicine) and Rocco’s wife, is installed as General Manager to create and develop the quality system and standard operating procedures for medical devices with the aid of two consultants recently retired from the heart valve industry in Austin, TX.
FDA clears the Angel of Water as a Class II medical device with a prescription requirement or order for sale from an MD or a DO or other licensed practitioner with scope of practice over colon hydrotherapy. The device is cleared for use when medically indicated, such as before radiological or endoscopic examination.
Rocco Bruno is awarded protection of the Angel of Water trademark through the U.S. Patent and Trademark Office on August 20th.
2002 – 2005
A long period of re-education begins to counter the prevailing view of colon hydrotherapy units in the United States as non-prescription and non-medical against FDA’s clearance guidelines. Lifestream competitors sell units that in many cases do not meet the definition of colon irrigation units set out in 21 CFR (Code of Federal Regulations) 801.109. Lifestream sells units mainly to I-ACT (international association of colon therapists) practitioners who have become accustomed to treating units as consumer goods with no medical device reporting requirements or training requirements. Lifestream continues to attend yearly I-ACT conventions and other events such as Academy for Anti-Aging Research trade show in Las Vegas and Body, Mind, Spirit Expo in Los Angeles.
Rocco Bruno makes training trips to Singapore, India, Hong Kong and Bulgaria and to locations within the U.S. for training therapists to operations 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 launch a marketing department and brings a second small round of investment capital. Investment monies are used to develop a mold for the Cherubum Personal Hygiene System.
FDA audits all manufactures of Class II colon irrigation equipment and performs a market correction as to the legal and regulatory status of these devices. “Sale by prescription only” is enforced, causing the market to mature and professionalize itself. Correction is precipitated by a large grass roots movement that embraces colonics for various medical conditions. Colonics have not reached mainstream consciousness yet in the United States but are gaining recognition worldwide in alternative/anti-aging markets such as Asia and UK.
Gary Russ garners a second round of investment capital to develop a regulatory portfolio by adding certification to ISO 13485:2003 for medical devices and the CE Mark for legal marketing in EU.
Lifestream retains the services of Alquest in Minneapolis, MN to perform a GAP analysis and begin guidance on CE paperwork, most of which is written in-house at Lifestream.
The Cherubum Personal Hygiene System for the home (a Class I Exempt medical device) is introduced after two years of prototyping and development. Patent and Trademark applications are filed with the U.S. Patent and Trademark Office.
Rocco Bruno forms Regenesis Integrative Health Centers, LLC to have a larger training facility for Operations Training to the Angel of Water in an active integrative clinic that offers skin care, massage, chiropractic, nutritional counseling and colon hydrotherapy. Trainings to become a certified colon hydrotherapist are also given approximately six times a year and attract attendees from the world over, many of whom are associated with I-ACT.
The Regenisis clinic model is packaged and licensed to practitioners seeking a ”turnkey” concept.
CE marking is obtained for the Angel of Water. The Cherubum is self-certified by Lifestream and registered in the Netherlands.
Sales have increased over the course of 2005 and 2006 to include large clinics in Singapore, Hong Kong, Bulgaria, UK, Mumbai, Malaysia, and doctors and other licensed practitioners have increasingly embraced the modality of colon hydrotherapy as celebrities such as Oprah, Kevin Trudeau (Natural Cures), Anthony Robbins (motivational speaker) and Dr. Mehmet Oz (Columbia University and one of Bill Clinton’s cardiac physicians) have elevated the discussion, importance, and acceptance of alternative health measures in the United States of America.
Competitors develop studies on closed system equipment in Danbury, CT (the Danbury Hospital study) to show the efficacy of colon hydrotherapy before colonoscopy.
Lifestream unveiled the new Angel of Water CM-1 Surround unit at the I-ACT convention in Houston, TX. New system proves to be huge success and outsells competitor 10 to 1 at convention.
(Began shipping Surround units in October 2007 after some mold adjustments.
Rocco Bruno and Gary Russ attend MEDICA in Dusseldorf to hold meetings with potential distributors arranged by Emergo Group, Lifestream’s authorized representative for the European market.
Lifestream has significant distributor interest in the Angel of Water CM-1 by medical device companies. Lifestream signs Inside Out Health Services for Canadian distribution and engages in negotiations for sub-Saharan Africa.
Rocco Bruno is awarded a Design Patent by the United States Patent and Trademark Office for his Cherubum “Lavage Chair” home cleansing product on December 25.
Rocco Bruno makes a training trip to Nairobi, Kenya to work with distributor clinic.
Australian regulatory clearance is filed for with the ARTG with Emergo Group Asia Pacific acting as Lifestream’s sponsor.
Lifestream partners attend MEDICA Tradeshow in Dusseldorf.
Lifestream partners with Taiwanese group to begin working on clearance for Taiwan.