About our project
UDPATE – From John 11/4/2013
Please see the coments section for more detail, but please note that our device is designed to work with all ostomies and Ostomates. If you are not sure if the LAD system will fit just back the project and we will provide a full money back guarantee if there is any issue. THANK YOU MY FELLOW OSTOMATES for your feedback, questions, and support.
Hi,
My name is John Accardi and I am a cancer survivor. Last year, to save my life, my surgeons removed my rectum and part of my small bowel and replaced them with a “stoma” or hole, in my abdomen. While I do appreciate the life-saving part, the open hole in my side that constantly releases excrement and flatulence is pretty damn inconvenient. You would think that in this day and age there would be some clever system to manage this fragrant effluence but let me tell you, there isn’t, or “wasn’t” I should say. Until now, the current “state of the art” consisted of large inflexible bags that leak, stink, and cost thousands of dollars a month, that is, unless you want to clean and reuse them (yuck!)
But from necessity comes invention. Unwilling to give up on socializing, swimming, and living my normal life, I turned to my good friend and fellow cancer survivor Frank Lewis to invent a better way. We are happy to announce that we have succeeded and raising funds to help my fellow ostomates everywhere, with your help. If you are an ostomate, or love someone who is, we would like to send you one of the first Ostomy Freedom™ kits. You don’t need a surgeon or a nurse to install yours and they work great. We even have a great 3-D modeling app to design custom versions if you like.
Read more about our invention here and feel free to call us at 813-644-9956 if you have questions.
Thank you for visiting and hopefully for your support.
Sincerely Yours,
John Accardi and Frank Lewis
Background of the invention
What is an ostomy?
Intestinal ostomy is a procedure that treats several conditions, including acute diverticulitis, rectal and colon cancer, trauma, or inflammatory bowel disease. This therapeutic approach can be temporary or permanent and creates many quality of life challenges. Colostomy and ileostomy surgeries interrupt normal bowel function, re-route wastes through the abdominal wall via an opening called a stoma; a urostomy is also an artificial opening in the abdomen for the release of urine when urination through the bladder and urethra is no longer possible. In all cases, wastes are collected into a pouch (worn 24/7) that must be periodically emptied. The entire collection system is an ostomy device and the person who wears it is an “Ostomate.”
As you can imagine, in many cases, wearing an ostomy device leads to intensified physical and emotional distress and a diminished quality of life. Can you imagine going on a date with one of these? In a 2007 study Ostomates using the existing technology reported a high percentage of skin irritation (76%), pouch leakage (62%), offensive odor (59%), a reduction in pleasurable activities (54%). It should come as no surprise that over half of all ostomates also report being depressed or anxious (53%). I am happy to report that I have none of these issues with our new device and look forward to helping others this way too. This is why in every kit we send we have four survey cards for before, during, and after you start using our system. We want to do our own study. (Note: study survey and analyes will be performed by MedStartr’s Clinical Trial Services team.)
The “State of the Art” Ostomy systems from the 50s until today:
Current ostomy devices are large and cumbersome, prone to leakage, not sanitary, not easily disposed of and are fragile. Numerous add-ons are necessary to minimize these inherent device problems. This technology, based on a design from 1957, creates many quality of life issues for the ostomate that prevent participation in social and outdoor activities. Marketing material from the current leaders in the field suggest otherwise, but patients know better and the statistics tell the story.
Why the LAD Ostomy Freedom System is Better
Our Ostomy Freedom™ System is new technology that addresses these quality of life issues. The Freedom System demonstrates above average wear time, comfort and ease of attachment. It displays integrity through various life activities including swimming, exercising, bathing and sexual activity. It is designed as a low cost, sanitary, disposable system thus minimizing leakage and odor while enabling public and personal activities previously “off-limits” to people living with ostomies.
How the LAD Ostomy Freedom System Works
Our patent pending system is an ultra-light, ultra-small ostomy device that uses a stabilizing sleeve along the length of the stoma, a convex barrier ring around the base of the stoma, tacky-backed wings and a waterproof/breathable belt to prevent leakage and minimize movement.
Standard Sizing or 3D Printed Custom jobs
Standard sizes fit most people but we also can custom print a device tailored specifically using our patent pending 3D scanning, modeling and printing process. Whether custom or standard, the LAD Ostomy Freedom device maximizes leak resistance and offers the ultimate in mobility and reliability.
An Easy Button for ostomates
Pivotal to the effectiveness is the disposable latex-free bag we utilize that has an Easy Button in the form of a on/off push cap, making switching bags as easy as opening a soda can.
Less to Schlep
Normally you need to bring a huge amount of ostomy Supplies wherever you go, what if this was all you needed:
Why do people need an ostomy?
Intestinal ostomy is a procedure that treats several conditions, including acute diverticulitis, rectal or colon cancer, trauma, or inflammatory bowel disease. This therapeutic approach can be temporary or permanent, and creates many quality of life challenges. Colostomy and ileostomy surgeries interrupt normal bowel function, re-routing wastes through the abdominal wall via an opening called a stoma; a urostomy is also an artificial opening in the abdomen for the release of urine when urination through the bladder and urethra is no longer possible. In all cases, waste matter is released into an appliance pouch (worn 24/7) that must be periodically emptied. As you can imagine, this is not a pleasant activity. More on this later (we know you can’t wait!)
How many people can we help?
There are about 700,000 people wearing devices like these right now in America and the number is increasing by approximately 30,000 per year. It is estimated that globally there are over 3 million such devices in use at any time. These people do not have a choice, they need to wear an ostomy device to survive. They live with these devices for over 20 years on average. Making this device better will help millions reduce the cost of their care and make them healthier and happier.
The Current Options Available for Ostomates
Like many of my fellow ostomates, I tried everything out there and found that while many current ostomy devices and ostomy prototypes are available to the ostomy patient, none substantially change the basic flawed design. There is a “If it Ain’t Broke, Don’t fix it” mentality here, but the thing is that it is broke, and the current options are making many patients broke too. Specifically, there is a noticeable lack of state-of-the-art design technology and materials application. Most manufacturers sell the same systems that they did 50 years ago with small upgrades. These devices (pouch, wafers, barriers, belts, deodorizers, seals) are simply the same technologies repackaged with a different name. In contrast, we have completely rethought the system and are bringing the next generation ostomy system that will be leaps and bounds better than what currently exists. Your help will enable us to bring this device to market and help patients have a vastly improved quality of life.
Ostomates United!
We have shown our device prototypes to several ostomates and they loved it! Here we are with @OstomyGirl after we had lunch. Thanks for your input! We look forward to getting input from hundreds of others so please spread the word! Speaking of twitter, please tweet us out or share us on Facebook or in your patient support groups. You will get an extra big Thanks on our wall of fame.
Is it Safe?
Since it is outside the body and will not affect medical outcome the Ostomy Freedom System does not need an extensive clinical trial. It DOES need an extensive ostomate trial because what our fellow ostomates think is most important to us. For this, we would like to enlist your help. As noted above, each kit will come with surveys and we will start a discussion board for everyone to talk about how it is going. We will make several videos to show all aspects of usage and include extensive instructions in your kit. All data will be analyzed by MedStartr’s Alex Fair, M.S. and Clinical Review Officer Theresa Merrill, M.S. who have published over numberous scientific papers and overseen hundreds of studies.
That stated, as an ostomate myself, I have extensively tested all our prototypes. We are in our second generation and we are ready for our first small production run. I am happy to report that I have had no irritation, no leakage, no offensive odor, and been able to live a normal life again, the most important metric. But we know this is not enough data and I, of course, could be biased. This is why every Ostomy Freedom kit we are sending also is shipping with data collection materials and links to our issue tracking website. We want to know how it is going and will survey, call, and/or email every new Ostomy Freedom kit user to find out how it is going. We have also already started a discussion board where we hope to learn from our users what they think. In fact, we would love it if you would go there right now and tell us what you think so far.
Benefits of using the LAD Ostomy Freedom System
Our ostomy device pilot prototype demonstrates an above average wear time, comfort and ease of attachment that far exceeds existing options. It displays integrity through various activities, including swimming, athletics, exercising, bathing, and general quality of life experiences. The bag itself, called the LAD Bag is designed as a low cost, sanitary, disposable system as well, thus minimizing leakage and odor and enhancing public and personal activities.
At the core of our device’s functional design is the use of lightweight durable non-allergenic polymers to construct a stabilizing sleeve around the length of the stoma and a convex barrier-ring around the base of the stoma. This prevents the leakage of bio-effluents (gases, liquids or solids. Although, we will manufacture standard circumference sizes, device features can be tailored specifically for the patient by scanning 3D images using an app on your phone. Simply load the app, point it at your stoma and it automatically uploads the images to a 3D printer for customized production.
The LAD Bag has a very small footprint and is further stabilized to the abdomen by tacky-backed “wings” on either side of the device. To ensure further stability of the barrier-ring seal and bio-effluent containment, an adjustable waterproof/breathable belt is attached to both ends of the device. A disposable latex-free bag with a push-cap for easy attachment and detachment to the device is also incorporated.
In summary the LAD distinguishes itself through the following benefits and features:
Benefits
■ small footprint – unobtrusive
■ ultra-light weight – feels like it‘s not there
■ leak-resistant – no odors or stains
■ durable – longer-lasting materials
■ waterproof & sweat-proof belt – for greater hygiene & comfort
■ non-allergenic materials – no skin problems
■ quick & easy change – sanitary disposal of pocket-carry bags
■ less cost than the competition – savings
■ custom-fit option – more comfortable and leak-resistant
Features
■ stabilizing tacky wings on polymer base device
■ stabilizing convex stoma ring on polymer base device
■ stabilizing vertical stoma sleeve on polymer base device
■ stabilizing adjustable, waterproof/breathable belt
■ latex-free collection bag with push cap
■ standard sizes or optional custom-fit base device
FDA Status
Ostomy appliances (pouch and accessories) are defined as a class I device and are exempted from the pre-market notification requirement. Thus, FDA clearance is not required before marketing the device. However, the manufacturer is required to register the location and list the devices made there and the activities performed on those devices. For further reading on the topic, please visit the FDA Site areas:
FDA Device Classifications
Our Class
FDA Marketing Rules
Can we sell these devices?
Because the device is exterior to the body and does not require a prescription, this device can be sold without FDA approval. The FDA has approved of all materials used in our ostomy device.
How We Help Patients:
The LAD Ostomy Freedom Device is an “ostomy system” designed to addresses the overall patient standard of care and quality of life issues associated with this surgical diversion. The LAD Ostomy Freedom System is designed to offer the patient the following:
■ 3D custom sizing
■ effective and disposable collection system
■ increased wear time
■ ease of management (ability for patients to maintain and use device independently)
■ peristomal skin integrity
■ lower cost per unit per monthly use
■ eliminates the need for accessories (paste, seals, sleeves, etc. )
■ eliminates complications from improper product use / preparation
■ early attainment of success/independence in care
■ reduced need for self care due to LAD Ostomy Freedom System simplicity
Overall, we help patients return to a normal life, post-ostomy, and this is the greatest benefit.
How We Help Surgeons and the Wound Care/ Ostomy Specialists
There are many benefits to the surgeon and care team for using the LAD Ostomy System
Doctor / Nursing Standard of Care:
■ Ease of teaching patient. transitioning to independence
■ Eliminate complication for incorrect flange sizing / preparation
■ Ease of teaching staff how to use product technology and care for patient
■ Create a positive effect on nursing staff due to ease of use /simplicity of application and technolog
■ No need for accessories (paste, seals, etc.)
■ Application in the presence of complications
■ Application of current technology to ostomy care
Most importantly, by using the latest and greatest technology, you can give the best possible care to your patients.
How We Help Hospitals, Institutions, and/ or Medical Facilities:
Standard of Care Hospitals , Institutions / Medical Facilities:
■ Facilitate institutional care by removing the complexity of care, allowing the patient independence, confidence and ease, sooner in post operative transitioning period
■ Minimizes concerns about peristomal / stoma concerns /complications (new patients) LAD Ostomy Freedom System evolves in conjunction with post operative sizing and function
■ Minimizes worry / post operative care and in transitioning patient home; LAD Ostomy Freedom System simplicity in use impacts the varying levels of skill offered by home support services
■ Simple to teach any patient regardless of language skills / or poor hand/strength/dexterity
■ Minimizes amount of product to be stocked and on institutional inventory
How We Help Our Partners
The impact of the LAD is revolutionary, it integrates current technology designed to positively impact quality of life issues and the standard of care that is current functioning in the Ostomy arena. This positive impact is inherent in the social, economical and life aspects of the current state of treatment and outcomes for more than 5 million patients and their families.
Whether you want your name on our product or want to distribute it in an exclusive area, we want to work with you. Please review the PARTNER rewards at the right here and let’s talk. Every deal is different, so if you don’t see what you are looking for, please call.
How We Will Spend Your Contributions:
We will:
■ Manufacture as many prototype ostomy devices as needed
■ Gather feedback from all LAD Ostomy Freedom ostomates to assess the comfort, reliability and effectiveness of the devices in real life situations
■ Ship LAD Ostomy Freedom Kits to ostomates, physicians, and nurses
■ Write up and publish the results of our trial program and use this to fine tune the device to meet established performance goals
■ Produce a final device design for mass manufacturing
■ Publish our data online for all to see and in a peer reviewed journal
Who We Are:
Frank A. Lewis – Engineering
Frank A. Lewis is a professional chemist and has been a member of the American Chemical Society for 46 years. He was a materials research scientist in the private sector (David Sarnoff Research Center – RCA Laboratories, Princeton, NJ) , an occupational health specialist with the federal government (US Public Health Service, Philadelphia, PA), a co-founder of an internet company (Acumen Technologies, Medford, NJ) and several businesses in the gourmet & natural foods industry (Cheese Village & La Fondue Restaurant, NYC; EverYoung International., Voorhees, NJ; Hill Nutritional Products and SOMA Beverages, Philadelphia, PA). Mr. Lewis is presently a visual artist and a partner in a start-up medical device company (LEWCARDIA, LLC, St. Petersburg, FL).
John Accardi, Sr. – Chief Executive Ostomate
I have spent over 30 years in senior management positions throughout the U.S. and abroad, focused largely in the transportation industry. In addition to managing hundreds of locations I also have spent more than twenty years developing businesses and coordinating projects. Please visit my linkedin profile to learn more about me or just email me.
Want to Invest?
Great, let’s talk. If this campaign is successful and we pass our “Crowd Test” with your help will go on the MedFundr Equity crowdfunding designed for crowds that care in about 7 weeks, sign up for that here
How to Find Us:
Follow us on Twitter
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Thank you for reading and considering backing our project. We would love to hear what you think, so please use the comments tab and tell us. If you prefer to discuss in private or are interested in distributing, partnering, or investing, please do not hesitate to call us or email us.
Thank You,
John Accardi and Frank Lewis
Lewcardia LLC
14-21st Street North, St #9
St. Petersburg, Fl 33713
Click here to email:
Tel 813-644-9956
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Have a question?
If the info above does not help, you can ask the project creator directly.
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