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Hand Held Nitrous: Reduce Anxiety and pain in Seconds

by Mark Aldana

Nitrous Oxide Inhaler The answer to anxiety and pain during minor medical procedures. For patients ages three and up.
Lubbock, TX United States Pain Management Medical Device Equity Raise

All Team Company Patients Physicians Hospital Partners Innovation Details Investor Info Due Diligence Docs Supporters Comments Updates

About our project

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

 

 

 

About Our Team

Creator: Mark Aldana

Location: Texas

Education: University of Houston, Clear Lake

Bio: President Strata Medical Innovations

Title: President

Advanced Degree(s): B,S,, MBA

About Team Members

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

About Our Company

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

How We Help Patients

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

 

How We Help Physicians

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.

 

How We Help Hospitals

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. 

How We Help Partners

This product is avaible for distibution, licensing and other strategic partnerships around the world.  Lets talk.

Innovation Details

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.

CE Mark Certificate

ISO 13485 Certification

Canada License

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.  

 

 

 

Investor Info

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. 

Due Diligence Docs

Please note that access to the company's confidential materials is limited. Click this button to request access from the Company and its representatives.


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$ 1,701 pledged of $ 50,000 goal


Mark Aldana
President
University of Houston, Clear Lake

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Rewards All contributions are tax-deductible.