by Mark Aldana
The problem we solve: We solve the very large problem of anxiety and pain during minor medical procedures. Indicated for patients ages 3 and up. Product can be used in the waiting room for anxiety or immediately before and during minor medical procedure for pain. Vasectomy, cystoscopy, biopsy, facial aesthetic injections, mole removal, venous access procedures, minor emergency, hospice care for agitated patients, etc. Hand Held Nitrous 1) solves a world-wide problem, 2) addresses a billion dollar market and 3) has no direct competition.
About our solution: Hand-Held Nitrous® is a re-usable pocket-sized nitrous oxide inhaler. Each dose refill delivers 180 seconds of gas. Anxiety and pain reduction occurs immediately. The device is small, easy to use, requires no special training, uses no electricity and is inexpensive. The device uses medical grade nitrous oxide and folds to fit in the nurse's pocket. The gas cylinder and mouth piece are disposable.
Progress to date:CE Marked - June 2017 (CE650446)
ISO Certified (FM 650454)
Canada Approved - May 2017 (Lic. No. 99099)
Patented: (US 2014/0090644 A1)
Sales to Date: $ 50,000.00
Current Number of Investors: 11
Raised First Round: $ 480,000.00
Europe and Canada:
This products is currently approved in Europe and Canada for human use.
USA:
Approved for Animal Use Only: (NDA 141446).
Human Use: This product may NOT be sold in the USA for human use, pending FDA approval of the inhaler. The gas is approved in the USA under NDA 208069. The inhaler has been submitted to the FDA under the "De Novo" process
Creator: Mark Aldana
Location: Texas
Education: University of Houston, Clear Lake
Bio: President Strata Medical Innovations
Title: President
Advanced Degree(s): B,S,, MBA
Robert Schmid
Plastic Surgeon, MD
Biography: Lubbock Plastic Surgery Institute
Strata Medical Clinical Advisory Board and Investor
Title: Plastic Surgeon
Advanced Degree(s): MD
Howard Beck
Urologist, MD
Biography: Lubbock Urology Clinic
Strata Medical Clinical Advisory Board and Investor
Title: Urologist
Advanced Degree(s): MD
Sajad Zalzala
Family Practice, MD
Biography: Coral Medical Health Spa
Strata Medical Clinical Advisory Board and Investor
Title: Family Practice
Advanced Degree(s): MD
Steve Aldana
Vice President, PhD
Biography: Strata Medical Innovations, Inc.
Strata Medical Investor
Title: Vice President
Advanced Degree(s): PhD
Strata Medical Innovations Inc.
Location: 3706 76th Street
Lubbock, TX 79423
Founded: 2013
Website: https://handheldnitrous.com/
Blog: http://www.handheldnitrous.com/blog/
Product Stage: In the Market
YTD Sales: Less than $250,000
Employees: 3-5
If you have been to the urologist or gynecologist, or have had to take your child to the pediatrician or emergency room, then you know how stressful it can be to sit in the wating room while in pain or having a little anxiety waiting for that procedure.
Wouldn't it be nice to hear the words, "Let's give you a little nitrous oxide right now to take the edge off?"... and for just a few dollars you can have a little pain and anxiety relief without having a needle pointed at you or being hurt more than you already are!
Hand Held Nitrous is the answer.
Join me in helping bring this wonderful, new inovative device to you and your love ones.
Strata Medical Innovations
HEALTH CARE LIMITATIONS: YOU MUST BE FROM CANADA OR CE MARK RECOGNIZING COUNTRIES TO ORDER FOR HUMAN USE
VETERINARIANS: THIS PRODUCT IS AVAILABLE FOR SMALL ANIMAL USE IN THE USA NOW
This device helps urologists, gynecologists, plastic surgeons, dermatologists, family medicine, minor emergency, facial aesthetic injectors, pediatricians, interventional radiologists, dentists, geriaticians, podiatrists, hospitals and clinics create a less stressful and less painful expereince in their care.
Any patient undergoing a stressful medical office procedure is a candidate for Hand Held Nitrous.
Hand Held Nitrous can be administered while waiting for a procedure, just before the procedure or during the procedure.
Hospitals:
Do you a desire to better patient's overall expereince in your facility? How many patients receiving IV lines and foley catheters, are performed in your facility a day that would benefit from Hand Held Nitrous. Lets talk how we can make your patients stay at your facility better. Avaiable outside the USA only.
This product is avaible for distibution, licensing and other strategic partnerships around the world. Lets talk.
Intellectual Property Summary
Patent completed and granted under Patent Number: US 2014/0090644 A1
Hand Held Nitrous is a registered trademark of Strata Medical Innovatios, Inc.
Clinical Information
Clincal study performed, click this link.
Clinical evaluation required for CE Mark, on file at Strata Medical Innovations..
Regulatory Status
Follow this link to see Certifiation.
Approved for animal use in the USA under New Drug Application 141446
Nitrous Oxide Gas approved under New Drug Appliocation 208069
Inhaler NOT approved. De Novo route of approval. Second clinical study required.
How we will use the funds raised
Build International Sales Fource and Increase Sales
Obtain US FDA Approval for the Inhaler.
Obtain additional informative clinical data for educational and awareness marketing tools.
Thank You
Thank you for consdiering Hand Held Nitrous
I am very excited about the future of Strata Medical Innovations and Hand Held Nitrous.
Market Size
There are over 30 million painful medical office procedures performed in the US every year.
The US is estimated to be a 1 billion dollar market. The rest of the world is estimated to be a 1 billion dollar market.
Projected 3 Year Growth
Since approveal obtained in May 2017 in Canada and June in Europe, sales iare approximately $ 50,000.00.
We intend to achieve 17 million in revene in three years with a profit marhing of 30%.
Numbers are based on Strata Medical rasing money.
Revenue Model
Build international sales fource.
Seek out strategic partners for licensing contracts that make products that are uncomforable to use under local anesthetics such as arterial and venous lines and stents, urological products, lip fillers, etc.
Sell company outright to other companies that make products synergistic to Hand Held Nitrous.
Obtain US FDA Approval
Competitors
The Status Quo: Why change what I have been doing for years.
Larger N2O gas delivery Systems - Entonox (Capitol Equipment - Evacuation Plumbing Required)
Traction
Current sales as of June 2017 $ 50,000
One distributor in Canada, delivers medical grade gases.
One dirstributor in the UK, sells facial aestehetic injections
Many other distributors being sought around the world. Licensing agreements beng sought.
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