We’ve Got Your Back®

INVEST IN FLOSPINE TODAY!

At FloSpine, we have developed a new solution to treat back pain, the KeyLift™. The KeyLift™ is implanted and expands to release nerves that are under pressure due to aging or injury. This condition is known as lumbar spinal stenosis and we believe that we have a new solution to treat it. We consider ourselves to be a leading medical device company applying new technology and design concepts to solve medical problems for the human spinal column. We believe our new, innovative, high-margin and cost-effective medical device spinal implants have the potential to disrupt the pain and spinal market. With 6 US patents, and 4 Patent Applications (2 International), we are in review with the FDAand in prototyping stages for the development of the latest solution for back pain: KeyLift™. FloSpine® is registered as a Medical Device Manufacturer with the Food and Drug Administration (FDA).
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This Reg CF offering is made available through StartEngine Capital, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
FloSpine

Reasons to Invest

  • FloSpine currently offers and is developing new spinal fusion implants and instrumentation that, in our view, will allow surgeons to address 90% of patient needs. The orthopedic implant industry is characterized by very high gross profit margins with. FloSpine's Gross Margins on its products at 70-90%.
  • The US is the biggest market for spinal implants, estimated $7.0 billion in 2016 and is expected to reach $12.2 billion by 2024, with 5% CAGR (source)

  • FloSpine’s leadership has over 40 years of spine and orthopedic experience. Peter Harris, President and CEO has worked for very successful start-up companies, including K2M which sold to Stryker for $1.4 B in 2018.  





Overview


We’ve Got Your Back®


We are FloSpine - and we have a new solution for back pain. We believe we’re a leading medical device company whose goal is to apply new technology and design concepts to solve medical problems of the human spinal column. 


A Unique Expandable Interlaminar Implant

FloSpine’s new minimally invasive KeyLift™ implant will potentially offer a unique solution to the problem of back pain, which may eliminate the traditional placement of screws and rods in a patient's spine to correct spinal stenosis and relieve pain.


In addition, due to the smaller incision required for the KeyLift™ device, the procedure may be performed on an outpatient basis in an Ambulatory Surgery Center (ASC). Patients may be discharged after a couple of hours following the procedure and may immediately feel some pain relief.


Here are some of KeyLift’s™ specs:


  • The KeyLift™ Device may be inserted through a small incision (about 2 inches). This leads to faster patient recovery and less blood loss
  • Fits in-between the two laminae of the spine and is expanded to release the nerve root pressure once in the patient. (Each vertebra has a lamina that is the bridge of bone that covers the spinal cord). This is advantageous as the bone is thicker in this region, less chance of bone cracking


*The above is a rendering of a future product. Images are computer generated demo versions. Product is still currently under development with the FDA and is not yet available on the market.



Spinal Stenosis occurs when a patient's disc starts to collapse causing the existing nerve roots and spinal cord to get pinched. The KeyLift™ is designed to restore the height between the 2 affected vertebrae, thereby releasing the pinched nerves and bringing relief to the patient.


  • We feel it is the only expandable interlaminar implant on the market that can expand in-situ. 4mm of expansion is available.
  • The KeyLift™ implants are available in a variety of sizes allowing the surgeon to choose the best anatomical fit for the patient. 


*The above is a rendering of a future product. Images are computer generated demo versions. Product is still currently under development with the FDA  and is not yet available on the market.


  • Anti-migration ridges on the implants that can prevent dislodgement
  • Proposed in 2 different lengths and 4 different heights. This can give the surgeon a choice of implants to fit the patient's anatomy 
  • We believe that each KeyLift device will sell between $6,500 to $9,000 giving FloSpine a Gross Margin of over 95%


FloSpine Background


FloSpine is focusing on minimally invasive surgical techniques which we believe will  result in shorter hospital stays and faster recovery for patients, and we’ve already accomplished this with our Largo®, Canaveral®, and Panama® products


FloSpine has assembled a team of leading surgeons across the US who advise FloSpine Engineers with design and development of groundbreaking new products. 


We also have a large number of surgeons who consistently use current FloSpine products in their patients to treat a variety of spine conditions. World famous Dr. Richard Guyer has endorsed FloSpine’s Minimally Invasive Pedicle Screw System (source) and has used the system on some of his patients. Dr. Guyer is well known for performing successful back surgery on legendary golfer Tiger Woods in 2017 (source).


*The above product images are computer-generated renderings of products currently available on the market.


The Problem


It is estimated that 70% to 80% of American adults will experience back pain at some point in their lives

(source


We believe back pain is the leading symptom prompting visits to orthopedic surgeons and neurosurgeons, and the second leading symptom prompting visits to primary care physicians. On top of that, Approximately 250-500 K US residents have symptoms of spinal stenosis (source).


And when it comes to the traditional fusion to treat these patients,  surgeons typically place screws and rods into the patient’s spine and perform a fusion between the affected vertebras. This usually entails a large incision and a longer recovery, typically with an overnight hospital stay (source).


Interbody fusions (fusing of the spinal vertebra) is the most commonly performed spinal procedure in the United States, with over 352,000 performed annually (source). 


There has also been a growing shift in patient care that has been exacerbated since the Covid-19 pandemic, as patients have become more reluctant to spend overnight in hospitals and prefer to have their procedures performed in a surgery center (source).



The Market


Global spinal implants and surgical devices market is expected to generate $17.5 Billion in revenue by 2024, growing at 5.80% CAGR


In our view, pain management procedures in ASC’s are becoming more popular as pain management physicians are reducing the use of opioids and are increasingly using mechanical spinal implant devices.


Our KeyLift™ device is placed in-between the lamina of the spine - which consists of thicker bone and has large teeth that will prevent migration of the implant. With that, we believe the KeyLift™ has the potential to capture a large market share, as we feel it will be the only expandable interlaminar device on the market.


Recently, a minimally invasive spinous process spacer implant was acquired in a deal for $465M (source).


Our Traction


We believe the KeyLift™ will be the first expandable interlaminar device on the market 


FloSpine already has 3 FDA cleared products and has generated over $8.7 million in revenue since our initial product launch in 2015, with 20,000+ implants in patients. But the launch of the KeyLift will usher in a new product with an even more exciting customer pathway through interventional spine. 


Not to mention, FloSpine has added additional surgeons and four new hospital system accounts. This gives FloSpine access to hundreds of hospitals nationwide.



Here’s a look at our existing innovations:


Cervical Spine: The Panama® Anterior Cervical Plate System is used to stabilize a fusion in the cervical spine. It is commercially available to treat up to a 5 level cervical fusion.



Lumbar and Thoracic Spine: The Canaveral® Pedicle Screw System consists of 3 separate products that are commercially available to treat conditions like degenerative disc disease, scoliosis, and minimally invasive spine surgery.


FloSpine’s Canaveral™ Deformity (Scoliosis) System

 

FloSpine aims to eventually incorporate a B2C model, but for now our target markets are…

  • Hospitals & Surgery Centers - 4,500 US hospitals and over 9,000 active ambulatory surgery centers. FloSpine is currently approved and has contracts with some of the largest hospital systems in the country, including Hospital Corporation of America (HCA), Tenet Health and Bon-Secours/Mercy Health Systems.
  • Sales Representatives - Recruit, contract, train and deploy over 200 in-direct spine sales representatives (1099’s).
  • Surgeons - Majority of the sales with the KeyLift System will be generated by Interventional Pain Management Surgeons in Surgery Centers.


Why Invest


We have a new solution for back pain 


And with that, we believe FloSpine is poised with its current and new products to take advantage of this growing trend. 







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ABOUT

HEADQUARTERS
3651 FAU Blvd, Suite 400
Boca Raton, FL 33431
VALUATION
$47.44M

At FloSpine, we have developed a new solution to treat back pain, the KeyLift™. The KeyLift™ is implanted and expands to release nerves that are under pressure due to aging or injury. This condition is known as lumbar spinal stenosis and we believe that we have a new solution to treat it. We consider ourselves to be a leading medical device company applying new technology and design concepts to solve medical problems for the human spinal column. We believe our new, innovative, high-margin and cost-effective medical device spinal implants have the potential to disrupt the pain and spinal market. With 6 US patents, and 4 Patent Applications (2 International), we are in review with the FDAand in prototyping stages for the development of the latest solution for back pain: KeyLift™. FloSpine® is registered as a Medical Device Manufacturer with the Food and Drug Administration (FDA).

TEAM

Peter Harris
Peter Harris
President, CEO, Director, and Corporate Treasurer

Mr. Harris has more than 22 years of spine experience and has been responsible for the development of many successful medical spine products. Before founding FloSpine, Mr. Harris was the Vice President of Engineering for Amedica Spine Division. Prior to this in 2004, Mr. Harris joined startup K2M, Inc. as their Senior Project Engineer, which was successfully sold to Stryker Medical for $1.4 Billion. Mr. Harris graduated with a Diploma in Mechanical Engineering from the Cape Peninsula University of Technology.

Peter's primary function is leading FloSpine LLC, which is the operational side and is 100% owned by FloSpine Holdings Inc. Peter dedicates a few hours managing FloSpine Holdings Inc and approximately 60 hours/week working for FloSpine LLC.

Waldi Harris

Waldi Harris

Director of Administration and Corporate Secretary

As Co-Founder, Waldi contributes 30+ years of experience in Nursing, Education, HR & Payroll functions (50-250 weekly contractors); leading Administrative, QA & Inspection teams. 

Recently as a RN at Boca Raton Regional Hospital, she assisted with customizing & teaching medical staff the Cerner HER system for the Labor & Delivery, Postpartum, Newborn Nursery, and Neonatal ICU departments.

As top AE supporting AEG, Merck, J&J, & Qualcomm she was a talent scout of Executives, Finance and IT professionals. Waldi opened multiple employment branches & onsite offices; and over 100 franchises for owners of health equipment/salons.

Waldi’s primary function is managing FloSpine LLC, which is the operational side and is 100% owned by FloSpine Holdings Inc. Waldi contributes a couple of hours managing FloSpine Holdings Inc and approximately 50 hours/week working for FloSpine LLC.

James Spitler

James Spitler

Vice President of Research and Development

Mr. Spitler has more than 20 years of orthopedic experience in spine, total knee, shoulder and hip specializations. He has worked for Sulzer Medical, Arthrex, Medtronic, C.R. Bard, IMDS and brings start-up experience from IST with Texas Back Institute. Mr. Spitler owns more than 14 patents in spinal technology and has launched many successful products. He has a BS in Mechanical Engineering from Texas A&M University.

Tom Fellman

Tom Fellman

Director of Sales

Mr. Fellman is a veteran of the United States Navy. After receiving an honorable discharge he attended and graduated from the University of South Florida in Tampa, FL. After graduation Tom worked with several pharmaceutical companies. This exposure led him to opening up his own distributorship. 

Tom joined the Amendia team and within a few years he and his team worked their way up to be one of the largest distributors of spinal products in the US. Tom enjoys working with surgeons, listening to their obstacles and prides himself on providing solutions. 

Dr John Afshar

Dr John Afshar

Chief Medical Officer

Dr. John Afshar is a board certified fellowship trained neurosurgeon specializing in minimally invasive surgery of the spine and the brain. He received both his undergraduate and medical degree from Georgetown University in Washington, DC. He completed his residency in neurologic surgery at the Georgetown University Medical Center in Washington, DC. During his residency he further received specialized training at the Armed Forces Institute of Pathology and Children’s National Medical Center in Washington, DC as well. He then underwent a research fellowship in brain tumors and cerebrovascular disease at the world renown National Institutes of Heath in Bethesda, Maryland where he published several scientific articles. He obtained national recognition for his research by receiving the Galbraith award from the Congress of Neurologic Surgeons. He further performed a spinal fellowship at Tampa General Hospital/University of South Florida in Tampa, Florida. He is a Diplomate of the prestigious American Board of Neurologic Surgery. He is also a member of the Congress of Neurologic Surgeons and the North American Spine Society. 

From his extensive experience at the Georgetown University Medical Center Dr. Afshar’s approach to his patients is based on the concept of “cura personalis” which translates as “ the care of the whole person “. With this compassionate guiding principle and evidence based medicine he will optimize both the conservative and surgical treatment outcomes of all his patients.

Dr Chen-Lun Soo

Dr Chen-Lun Soo

Medical Consultant

Dr. Cheng-Lun Soo, MD is a orthopedic spine specialist in Oklahoma City, OK. Dr. Cheng Lun Soo graduated from University of Kentucky College of Medicine in 1993 and completed his residency at Baylor College Of Medicine. He currently practices at One Core Health and is affiliated with Great Plains Regional Medical Center. Dr. Soo is board certified in Orthopedic Surgery.

Dr. Louis Raso

Dr. Louis Raso

Medical Consultant

Board-certified in both pain management and anesthesiology, Louis J. Raso, MD, PA, is extensively trained in a wide range of services to relieve chronic pain and improve the quality of his patients’ lives. At his practice in Jupiter, Florida, Dr. Raso specializes in treating persistent pain that isn’t treatable with other therapies and focuses on identifying the root cause of his patients’ pain.

Dr. Raso is certified by the American Board of Anesthesiology and stays active in pain management research and technology. In addition to his clinic work, Dr. Raso authors articles on pain management techniques for medical journals and book chapters, and he lectures on the subject around the country and throughout Europe. 

After earning his medical degree from Rutgers New Jersey Medical School in Newark, New Jersey, Dr. Raso went on to complete both his training in anesthesiology and a fellowship in pain management at Thomas Jefferson University in Philadelphia. He remains actively involved in educating other physicians about spinal cord stimulation technology and research.

Dr Anup Gangavalli

Dr Anup Gangavalli

Medical Consultant

Dr. Anup Gangavalli is an orthopedic surgeon specializing in minimally invasive and reconstructive spine surgery practicing at St Mary's Hospital in Richmond, VA

Dr. Gangavalli received his Medical Degree at Stony Brook University in New York where he obtained a BS in Neuroscience with Dual Honors in Research and a Minor in Chemistry. 

Dr. Gangavalli attended the Orthopedic Surgery Residency program at St. Luke’s University Hospital & Health Network in Bethlehem, PA and he completed his fellowship training in Spine Surgery at the Cleveland Clinic in Cleveland, OH. 

Dr. Gangavalli has gained ample exposure to a wide range of spinal pathologies and an extensive training in the diagnosis and management of adult spinal disorders including degenerative cervical, thoracic and lumbar disease, spinal deformity, intradural and extradural spinal tumors, spinal trauma, spinal infections, congenital spinal abnormalities, and complex reconstruction/revision cervical and lumbar pathology.

TERMS

FloSpine
Overview
PRICE PER SHARE
$2.90
DEADLINE
Jan 2, 2023
VALUATION
$47.44M
AMOUNT RAISED
$73,017.52
Breakdown
MIN INVESTMENT
$298.70
MAX INVESTMENT
$1,069,995.60
MIN NUMBER OF SHARES OFFERED
3,448
OFFERING TYPE
Equity
ASSET TYPE
COMMON
SHARES OFFERED
Class B Non-Voting Shares
MAX NUMBER OF SHARES OFFERED
368,964

Maximum Number of Shares Offered subject to adjustment for bonus shares


Company

:

FloSpine Holdings, Inc.

Corporate Address

:

3651 FAU Blvd, Suite 400, Boca Raton, FL 33431

Offering Minimum

:

$9,999.20

Offering Maximum

:

$1,069,995.60

Minimum Investment Amount

(per investor)

:

$298.70











Terms


Offering Type

:

Equity

Security Name

:

Class B Non-Voting Shares

Minimum Number of Shares Offered

:

3,448

Maximum Number of Shares Offered

:

368,964

Price per Share

:

$2.90

Pre-Money Valuation

:

$47,440,957.90











*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.

Investment Incentives and Bonuses*

Time-Based:

Super Early Bird Bonus – Friends and Family

Invest within the first 5 days and receive 10% bonus shares.

Early Bird Bonus

Invest within the first 10 days and receive 5% bonus shares. 

Amount-Based:

$10,000+ | Tier 1

Invest $10,000 and receive 4% bonus shares

$25,000+ | Tier 2

Invest $25,000 and receive 7% bonus shares

$50,000+ | Tier 3

Invest $50,000 and receive 10% bonus shares + a 30-minute zoom with our CEO.

*In order to receive perks from an investment, one must submit a single investment in the same offering that meets the minimum perk requirement. Bonus shares from perks will not be granted if an investor submits multiple investments that, when combined, meet the perk requirement. All perks occur when the offering is completed.

*Investors will receive the highest single bonus they are eligible for among all bonuses based on the amount invested or time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus in addition to the aforementioned bonus.

The 10% StartEngine Owners' Bonus

FloSpine Holdings, Inc. will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.

This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Class B Common Stock at $2.90 / share, you will receive 110 shares of Class B Common Stock, meaning you'll own 110 shares for $290. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.

This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.

Investors will receive the highest single bonus they are eligible for among the bonuses based on the amount invested and time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus and the 10% Loyalty Bonus Perk for all previous Crowdfunding offering 1 investors on StartEngine in addition to the aforementioned bonus. 

PRESS

Article Image
Becker's Spine Review

3 things to know about FloSpine

Article Image
Greater Fort Lauderdale Alliance

Research Park at Florida Atlantic University® Based FloSpine Receives FDA Clearance for PANAMA™ Medical Device

Article Image
News Desk Florida Atlantic University

Distinguished Entrepreneur: Peter Harris, chief executive officer of FloSpine

Article Image
Global Ventures Companies

FloSpine is the industry leader in spinal implants. We've Got Your Back®

Article Image
OrthoSpineNews

FloSpine announces the commercial launch of its CANAVERAL®Minimally Invasive Pedicle Screw System










ALL UPDATES

11.29.22

FloSpine Successfully Passes Annual FDA Audit

Boca Raton, Florida, November 18, 2022

FloSpine, LLC is pleased to announce that it passed a recent inspection conducted by the Food and Drug Administration (FDA). The inspection was carried out during the week of November 14th, 2022, at FloSpine’s headquarters in Boca Raton, Florida. At the end of the audit, two observations were issued and have been addressed. "We are very pleased with the outcome of the FDA inspection and continue to improve quality to ensure patient safety." Peter Harris, President and CEO.

http://www.fda.gov/MedicalDevices/

Stay tuned for more exciting announcements from FloSpine as we grow!



11.28.22

KeyLift Appears on National Physician Education TV Segment

The new solution to back pain, KeyLift, had the opportunity to join a premier national Medical Education TV segment. Watch below as the KeyLift is demonstrated by CEO Peter Harris at MedEd Combine



11.04.22

Thank You to our Amazing Team of Investors

We are so grateful to everyone here who have invested and who are interested! We are almost at 1 month in and are so pleased with everyone's contributions. Thank you for taking a risk and jumping in.

We are growing & changing the industry, and we are excited to use our funds for the latest product we hope will be in the market soon, KeyLift.

It's not too late, join us and get in on the ground floor!

10.21.22

Meet Panama: Latest in Cervical Spine Technology

Join CEO Peter Harris introduces the FDA cleared Panama Anterior Cervical Plate

Panama, another FloSpine Innovation 

+Cervical fusions up to 5 levels! 

+Best in Class Angulation 

+ScrewBlock Tech for preventing backout



10.17.22

FloSpine to exibit at MedEd Combine this Saturday, October 22, 2022. Please register to see the LIVE webinar.

See FloSpine, LLC’s new #KeyLift trial in action at MedEd Combine. Register now & tune in; as it's this week on Saturday, Oct 22; 2022.
https://www.linkedin.com/posts/meded-combine_theres-still-time-to-register-for-meded-activity-6986156981174632448-9ek8?utm_source=share&utm_medium=member_desktop


10.10.22

Hands-On with KeyLift Expandable Interlaminar Spine Fusion System

Get to know FloSpine's innovations with our Innovations Highlight Videos


KeyLift Expandable Interlaminar Spine Fusion System

A Unique Expandable Interlaminar Implant FloSpine’s new minimally invasive KeyLift™ implant will potentially offer a unique solution to spine problems, which may eliminate the traditional placement of screws and rods in a patient's spine to correct spinal stenosis and relieve pain. In addition, due to the smaller incision required for the KeyLift™ device, the procedure may be performed on an out-patient basis in an Ambulatory Surgery Center (ASC). Patients may be discharged after a couple of hours following the procedure and may immediately feel some pain relief. 

+The KeyLift™ Device may be inserted through a small incision (about 2 inches). This leads to faster patient recovery and less blood loss.
+Fits in-between the laminar of the spine. This is advantageous as the bone is thicker in this region, less chance of bone cracking.

*Keylift device is pending FDA 510(k) clearance and is not available for purchase in the United States.


10.07.22

Early Bird Investors' Bonus Ends Soon

We are grateful for your interest and investment into FloSpine! To encourage early investors, we are pleased to offer early bird bonuses. The final Early Bird Bonus of 5% additional shares ends on Sunday, Oct 9... about 48 hours left!


We are leading an investment and spine technology revolution! Learn more about our existing FDA Cleared Products currently being used by Spine Surgeons and Neurosurgeons around the USA: https://flospine.com/products-flospine/ 


Sincerely,

Peter Harris CEO

10.06.22

Meet FloSpine Founder & CEO Peter Harris

We are pleased to have you join us on our journey to grow our Medical Device company and treat people in pain!

We want to get to know you, and to start that off, here is a message from our CEO & Founder, Peter Harris:


Here are some highlights about FloSpine:

  • 3 Product lines cleared by the FDA
  • 2 new Product lines in review with the FDA
  • 2021 Revenue: $1.5M 
  • Over 20,000 products have been implanted in patients to date
  • Growing rapidly!

10.03.22

Less than 48 hours left for early bird bonus!

Hi everyone, this is Peter Harris CEO of FloSpine.

Thank you to everyone who has invested in these first few days... We won't be stopping until we hit our target!

The early bird gets the worm and you have less than 48 hours to receive the Super Early Bird Bonus.


For anyone who is new to FloSpine, let me tell you: FloSpine is a spinal implant company that researches and develops innovative and high-end medical devices for spinal implants and instruments. FloSpine currently has three product lines cleared by the FDA and has a revolutionary new fusion product that is currently under review with the FDA. Since its first product launch in 2015, over 20,000 FloSpine products have been implanted in patients around the USA.

We are excited that you are interested and joining us on our journey to grow and develop the highest quality medical devices in the world... as always, We've Got Your Back® 

*KeyLift images and renderings are in the prototype phase. KeyLift device is pending FDA 510(k) clearance and is not available for purchase in the United States.










Owners bonus
Stack Owner's Bonus & Rewards!

Members get an extra 10% shares in addition to rewards below!

REWARDS

Multiple investments in an offering cannot be combined to qualify for a larger campaign perk. Get rewarded for investing more into FloSpine.

$298.00

StartEngine Owner’s Bonus

This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.

$10,000.00

Tier 1

Invest $10,000 and receive 4% bonus shares.

$25,000.00

Tier 2

Invest $25,000 and receive 7% bonus shares.

$50,000.00

Tier 3

Invest $50,000 and receive 10% bonus shares + a 30-minute zoom with our CEO.

JOIN THE DISCUSSION













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Canadian Investors Investment opportunities posted and accessible through the site will not be offered to Canadian resident investors. Potential investors are strongly advised to consult their legal, tax and financial advisors before investing. The securities offered on this site are not offered in jurisdictions where public solicitation for offerings is not permitted; it is solely your responsibility to comply with the laws and regulations of your country of residence.


California Investors Only – Do Not Sell My Personal Information (800-317-2200). StartEngine does not sell personal information. For all customer inquiries, please write to contact@startengine.com.


StartEngine’s Reg A+ offering is made available through StartEngine Crowdfunding, Inc. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. For more information about this offering, please view StartEngine’s offering circular and risk associated with this offering.