About our project

The problem we solve: Nobody likes needles. Patients stay away from procedures due to fear and anxiety. Injection complications are frequent and costly. Needlestick injuries cost the medical system hundreds of millions. There's no need for any of it, anymore.

About our solution: We have an FDA approved, easy to use self-administration tool for any liquid subcutaneous medication. Completely pain free, causes no scarring, generates no dangerous waste, and anybody can learn to use it on themselves without fear. Economically competitive with safe needle technologies but reduces anxiety, increases patient compliance, and carries benefits for practitioners and hospitals.

We are manufacturing the new products already. The devices were previously in the market and we have restored them. All animal testing, clinical data, white papers and FDA documentation is up to date. We are the only solution that is over-the-counter approved for diabetic insulin, and approved for any subcutaneous liquid that a physician or dentist wants to prescribe. We have some European distribution channels opening and we wish to bring it to the American diabetes market for the 300,000 patients newly diagnosed every year. So many other drugs can use this technology, including hormone therapies, painkillers, vaccines and cancer drugs. We are ready to go now!

About Our Company

How We Help Patients

• No pain, no anxiety - no fear. Just a snapping noise in under one second and it's done.
• Usable by a youth or adult with no training; can be administered by a technician or supervisor instead of a nurse or nurse practitioner, saving millions per year
• No pain on injection (relieving the 20% of averse or phobic patients who avoid basic treatment)
• No risk of deep bleeding, large bruises or other accidental damage of the surrounding tissue
• Less expensive than others on the market, but codes also work for Medicare and Medicaid reimbursement
• Drastic reduction in site contamination and infection (occurs in 6%-8% of injections)
• Less lost drug product due to spillage or poor syringe technique
• Can be administered virtually anywhere on the body (no “vein-hunting”)

How We Help Physicians

• Can have professionals with minimal training administer the drugs (no nurse practitioner required)
• No extensive sterilization or needle waste disposal costs
• Drastically reduce returns due to injection site infections (currently 6%-8% of all injections)
• Reduce patient anxiety and times for patient visit, especially in pediatrics
• Can be administered virtually anywhere on the body (no “vein-hunting”)
• Eliminates needle stick injuries that affect 2 million health care workers per year

How We Help Hospitals

• No dangerous medical waste disposal, eliminating a cost of $30-$50 / liter / day for more than 6000 institutions in Canada/USA alone
• Drastic reduction in site contamination and infection (occurs in 6%-8% of injections)
• Creates great appeal for pain-free clinics (pediatric, dental…)
• Similar costs and coverage as syringe-based regimen
• Elimination of needlestick injuries and resulting staff downtime - 3000 occur in hospitals every day, with costs and damage ranging from $5000 per incident and absenteeism to massive claims
• Device designed to be reused without sterilization
• Compliance with sharps incidents requirements (federal and state law) are also greatly reduced

How We Help Partners

If you are a health insurance company, these are the benefits in working with us; 

• Enables inexpensive home-based self-care
• Improves adherence to drug regimens, better outcomes and reduced complications
• Reduced incidence of site infection and return visits
• Eliminates needlestick injuries and resulting staff insurance claims

If  you are a drug developer, whether you are an innovator, biosimilar or generic provider; 

• Better adherence yields better outcome statistics
• Less adjuvants and excipients results in lower costs per dose
• Better tolerance than oral doses – reduced stomach ulcers, oral complications
• Drastically lower dose costs in powder formulation (for our next generation product)
• Co-packing opportunities can reduce medical errors in dosing, and risk of spoilage in handling
• Possibility of extending patent life of key drugs – longer profit life - ask us about it!

Challenge Mission

Innovation Details

Intellectual Property Summary

We have licensed patent-protected material from our academic partners, but the bulk of the intellectual property lies in the devices used to manufacture the equipment. Since we have been granted equivalency status for other approved devices by the FDA, the barrier to entry is the extensive animal testing, clinical trials, quality assurance effort and comprehensive FDA filing process that we have completed already. 

Clinical Information

We have a library of clinical data that shows efficacy of drug delivery for this technology compared to syringe delivery, much of which has been published already. We will only need to perform equivalency trials for new drugs that we want to recommend, to establish that particular dosing and formulations have the same pharmacodynamics with this delivery mechanism. 

Regulatory Status

We have two FDA approvals; one to use the product for U-100 and equivalent insulin doses for type 2 diabetes, sold over the counter, and the second is for general purpose subcutaneous administration with a prescription. 

How we will use the funds raised

The funds will be used to get the product into the hands of diabetes care clinics, support groups, medical device writers and bloggers, patient associations, and veteran's care institutions so that the public opinion of the product can begin to take shape. There are a handful of needle-free technologies on the market today, but they are so tightly controlled and bound up with specific drug products that very few people know about them. There's no reason, in our opinion, for this technology to be kept out of the hands of every self-injecting diabetes patient and small clinic.

Thank You

If you know someone who hates needles - and most people do, even if they won't admit it - this is a gift. No anxiety, no pain, and no scarring. This has got to make the lives of your friends considerably easier. If you have friends who inject themselves daily (or multiple times), there might not be much you can do about their illness, but isn't this something you can do about their treatment? 

Supporters

• 
  Ephraim Zagelbaum, Master’s Degree in Business Administration from Seton Hall University
  10/06/2017 - Liked the project.
• 
  RICHARD ERVOLINO
  01/27/2017 - Liked the project.
• 
  Dr. Jonathan Landry, MD, MS, MBA
  01/19/2017 - Liked the project.
• 
  Chase Garrett
  01/18/2017 - Followed the project.
• 
  Suraj Vid
  12/12/2016 - Followed the project.
• 
  Suraj Vid
  12/12/2016 - Interested in helping your project as a mentor or team member.
• 
  Mr. Dan Cohen
  12/08/2016 - Liked the project.
• 
  Francie Grace
  11/18/2016 - Liked the project.
• 
  Mary Benek
  11/17/2016 - Liked the project.

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