INVEST IN FLOSPINE TODAY!
We’ve Got Your Back®
$162,093.06 Raised
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.
(or click)
ABOUT
HEADQUARTERS
3651 FAU Blvd, Suite 400
Boca Raton, FL 33431
WEBSITE
View Site
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
President, CEO, Director, and Corporate Treasurer
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
Director of Administration and Corporate Secretary
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
Vice President of Research and Development
Tom Fellman
Director of Sales
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
Chief Medical Officer
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
Medical Consultant
Dr. Louis Raso
Medical Consultant
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
Medical Consultant
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
Feb 1, 2023
VALUATION
$47.44M
AMOUNT RAISED
$162,093.06
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 Common Stock
MAX NUMBER OF SHARES OFFERED
368,964
Maximum Number of Shares Offered subject to adjustment for bonus shares
*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
ALL UPDATES
03.08.23
FloSpine implants inserted in patients using Augmedics xvision AI augemented reality system
OrthoVirginia, Richmond VA
Dr. Anup Gangavalli was the first surgeon in Richmond to use the Augmedics xvision Spine System, an artificial intelligence augemented reality tool that allows surgeons to "see" your spine in 3D during a minimally invasive spinal implant surgery. The tool allows the doctor better control and visualization during the surgery. Dr. Gangavalli says, "I'm excited to use the latest augmented reality technology to treat complex spinal issues in a safe and minimally invasive way."
https://www.linkedin.com/company/orthovirginia/
02.28.23
FloSpine Receives FDA Clearance for 3D Printed Titanium Cervical Implant
Medical Device Company Adds to Portfolio of 4 Existing Device Approvals
BOCA RATON, FL, UNITED STATES, February 28, 2023 /EINPresswire.com/ -- Together with FloSpine, LLC, the Research Park at Florida Atlantic University® is pleased to announce that FloSpine has achieved 510(k) clearance for its first 3D Printed Titanium Ti-Largo™ Cervical Interbody Cage System from the Food and Drug Administration (FDA).
The Ti-Largo™ Cervical Interbody Cage System is used to support the spine after a cervical collapse or damaged disc has been removed and is replaced with the Ti-Largo implant to restore the height. All Ti-Largo implants utilize titanium additive manufacturing (3D printing) and a patent-pending design to create a highly porous surface structure that allows for bone ingrowth to the implant surfaces, maximizing strength, stability and biologic fixation.
“We are very pleased with the FDA clearance of the Ti-Largo System. 3D printing our spinal implants allows us to create various shapes and sizes to match the patient’s anatomy more accurately”, says Peter Harris, president and CEO of FloSpine.
FloSpine is a spinal implant medical device company, researching and developing innovative and cost-effective solutions for spinal implants and instruments. The company's goal is to apply new technology and design concepts to solve medical problems of the human spinal column. The company provides surgeons with products resulting in enhanced surgical outcomes, shorter hospital stays, and quicker recovery times, thereby reducing the procedural and rehabilitative costs to the patient and insurer.
The Ti-Largo Cervical Interbody Cage System adds to the existing portfolio of four (4) products designed for complex spine disorders, including scoliosis and degenerative disc disease, all of which are named for locations in Florida, the company’s home.
Adding to the excitement of this new approval, Global Ventures nominated FloSpine as a 2022 GrowFL Florida Companies to Watch honoree, and it was among the select winners celebrated on February 23 at Hard Rock Live at Universal CityWalk in Orlando.
Participating in the Research Park at FAU’s Global Ventures second-stage entrepreneurial support initiative has enabled the company to access highly qualified and motivated graduate students from the FAU College of Engineering and Computer Science who have become full-time employees, access to specialized equipment at Florida Atlantic University and connections to its research faculty.
“FloSpine’s growth and success exemplifies the aims of Global Ventures, and bodes well for its future endeavors,” commented Ryan Lilly, program manager of the Research Park at FAU’s Global Ventures.
01.30.23
1 day left to invest
We are almost done with this round of investment. We are deeply grateful the response and investment from everyone! Keep it up!
01.29.23
2 days left to invest - Year In Review
- Flospine announced as top 50 GrowFL Companies to Watch
- FloSpine holds successful audit by FDA
- Physician training event brings excitement from surgeons for new expandable interlaminar fusion system
- KeyLift held successful lab showing off the latest KeyLift product in Salt Lake City
- FDA in review with KeyLift, Flospine’s new flagship product
- FloSpine at NASS – (NASS is the biggest spine society in North America, with nearly 9000 members)
- Presented new procedure to 100s of spine surgeons on MedEd Combine
- FDA in final review with 3D Printed Cervical Cage
- CEO Peter Harris speaks at BioFlorida Event
- CEO Peter Harris guest speaker at GrowFL event
- World Renowned Spine & Pain Physician Lou Raso MD Joins KeyLift Team and demonstrates technology
- 2022 Grows over 20%
- KingsCrowd Analyst Investment Report for FloSpine
- FloSpine chosen to present at Florida Venture Capital Conference
- Benzinga Analyst Report: This Medical Startup Could Disrupt The $14 Billion Spinal Fusion Market
01.28.23
3 Days Left to Invest - Treating Back Pain with a small powerful implant
01.27.23
4 Days Left - FloSpine Ready to Grow!
01.26.23
FloSpine Receives Positive Analyst Review From KingsCrowd
FloSpine’s Back Pain Technology Could Be Just What the Doctor Ordered
Author: Teddy Lyons - KingsCrowd
Category: Analyst Report, Deal to Watch
A Pain in the Back
My 32-year-old brother recently went through a grueling episode of back pain. In all honesty, it was hard to watch. He couldn’t walk for months or play with his four-year-old daughter. He ended up needing extensive back surgery to alleviate his debilitating pain. No other options were available to him given his pain level.
We all know back pain is going to hit us at some point in life. For some, like my brother, it happens far too early. For others, it may not come until old age.
But we can all agree on one thing: Back pain sucks.
Even worse is making a brutal decision between getting surgery or trying alternative forms of treatment. While getting rods and screws surgically inserted into your spine will alleviate pain, it is an expensive and daunting decision. Other options, like physical therapy, spinal cord stimulators, painkillers, or other types of therapy, can be ineffective.
Simply put, there is no intermediate option for patients who have tried alternative forms of therapy but do not want to have a full-blown surgery to insert rods and screws.
Until now.
FloSpine, the company I’m introducing to you today, has created a revolutionary new device called the KeyLift.
Picture a spine that has two compressed vertebrae that are pinching the nerves!
The KeyLift device clamps on to one of the strongest, thickest parts of the spine (called the lamina). It then expands and releases the compression, providing a chance for instant relief.
The best part? This is a minimally invasive procedure that takes about an hour to complete. And it can be done on an outpatient basis. In other words, no hospital visit or overnight stay is required.
No other company has released a device like this. The closest competitor is Boston Scientific’s Superion product, which was purchased from Vertiflex for $465 million in 2019 with annual sales of ~$50 million. The Superion implant doesn’t clamp onto any portion of the spine. It basically just sits in between the vertebrae as a spacer, and may migrate over time. In fact, the Vertiflex product received more than 300 complaints last year on the FDA Maude database. Given its advantages over Vertiflex, FloSpine is in a good position to capture market share with its innovative KeyLift device.
How It Works
Right now, the most common treatments for back pain are medication, physical therapy, cortisol injections, and, of course, surgery.
There is an enormous gap in the back pain treatment market. There is a clear need for a middle ground between minor treatments like physical therapy and serious, full-blown surgery.
The KeyLift device plugs this hole.
Here is what the ideal patient experience looks like for KeyLift customers:
- A patient goes to an outpatient surgery center.
- The practitioner makes a two-inch incision and attaches the KeyLift to the lamina. The KeyLift expands and releases the nerve and disk pressure.
- After a 20-minute procedure, the patient is out the door... usually with immediate results.
- The fusion lasts for six years or longer. After that, the patient will either be pain-free or can receive a new KeyLift if further relief is needed. And that’s it.
The KeyLift fusion technology has the potential to greatly disrupt the back pain market. In fact, it could be paradigm shifting.
No More Sleepovers
There is a seismic shift happening in the world of surgical care. Patients want to avoid overnight hospitalization at all costs. And insurance companies don’t want to pay for overnight stays either.
Some hospitals have their own outpatient surgical centers. However, ambulatory surgery centers (ASCs, which are independently owned) have become the most common choice for those seeking outpatient surgery. In fact, more than 60% of the surgeries in the U.S. since 2020 have been performed at ASC’s.
Here’s the beauty of ASCs: They are not beholden to the bureaucracy that is the American hospital system. In hospitals, new and innovative products (like KeyLift) may take six months or more to become approved. With ASCs, new products can be approved in weeks. And since they are run by surgeons (many of whom also work at hospitals), the level of care is still extremely high.
There are more than 9,000 ASCs in the U.S. It’s a $34.8 billion market. Just 183 ASCs currently offer spine surgery. But that number is growing by 200% per year and is showing no signs of slowing down. [source]
However, let’s be honest. ASCs also exist to make a profit. So how much are they going to make from the KeyLift?
FloSpine founder and CEO Peter Harris laid out the economics for us. ASCs could make around $5,000 per procedure after costs. At five procedures per day (which is conservative) at one day per week (a typical schedule for ASC spine surgeries), an ASC could make $25,000 per week. That’s big revenue to quickly add to any growing ASC.
It will be a no-brainer for ASCs to accept a product like KeyLift.
Potential Complications
Let’s not forget this is a medical device company. The KeyLift still needs to gain FDA approval. While FloSpine expects this process to be swift and plans to launch KeyLift in the second or third quarter of 2023, you simply never know with the FDA. It can always be longer and more expensive than founders plan for.
Expert Help
Fortunately, a very solid founding team is backing up FloSpine’s hugely disruptive technology. Peter is a veteran in the medical device space. He was a senior project engineer at a medtech startup called K2M that was acquired by Stryker for more than $1 billion. Peter was also director of engineering at US Spine and vice president of engineering at Amedica Corp. He is certainly well positioned to lead FloSpine through FDA clearance.
While there are risks associated with FloSpine as an investment opportunity, I believe its KeyLift technology is extremely exciting and has the potential to completely revolutionize the spine industry.
How to Invest
If you choose to invest in this Deal to Watch, FloSpine is raising capital on StartEngine. If you don't already have an account with StartEngine, you can sign up here.
Once you're logged in, visit the FloSpine raise page. Be sure to review the deal page and offering documents thoroughly before making an investment. When you're ready, click the teal “invest now” button. Enter in the amount you want to invest, starting as low as $298.70, and then move through the required steps. Make sure that your investment is confirmed, and then you're good to go.
Risk
Startup investing is inherently risky, and startup investors should expect to hold their investments without liquidity for five to 10 years. Never invest more money than you can afford to lose.
01.26.23
5 days left - Lou Raso, MD - World Renowned Surgeon Discusses Disrupting Spine Fusion Market
01.25.23
6 Days Left - Disrupt the $14B Spinal Surgery Market!
01.19.23
Final Days to Invest in a New Solution for Back Pain
With less than 14 days left to invest, this could be the last chance to invest in FloSpine's revolutionary spine technology that will provide a new solution for back pain. Be sure to see the latest reports from analysts:
Analyst Report 1: https://www.benzinga.com/news/23/01/30387096/flospine-expects-to-have-50-million-in-revenue-within-the-next-5-years
Analyst Report 2: https://www.benzinga.com/content/30309549/over-60-of-americans-will-experience-back-pain-at-some-point-flospines-solution-makes-surgery-easier
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