Join InSitu Biologics CEO Jim Segermark, CSO Bill Taylor and Medical Advisor Jake Hutchins MD to learn about its long-lasting and long-acting non-opiate painkiller, AnestaGel.
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InSitu Biologics
InSitu Biologics is an emerging biotech company focusing on development of AnestaGel™, a long-lasting and long-acting non-opiate painkiller. The sustained release drug AnestaGel is expected to be used in post-operative surgical procedures. AnestaGel may be a solution in relieving pain for broken bones, cosmetic surgery, hip/knee replacements, hernia, and more. For an in-depth look at our plans, audited financials, and other company information please read our Regulation A+ offering circular qualified by the U.S. Securities and Exchange Commission (SEC).
View the Offering Circular
On average, 115 Americans die every day from an opioid overdose. -drugabuse.gov
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Insitu Biologics
Why AnestaGel
Why We Created AnestaGel
We identified the opportunity to make a better sustained release pain drug after we eluted colored water for over seven days from our Matrix™ BioHydrogel. After we did that, we knew we could pursue the perfect site specific, sustained release product for regional pain relief. AnestaGel could stay in place, elute for days, and hold a larger, non-toxic dose of the non-opiate drug, bupivacaine. We surveyed numerous physicians, and the overwhelming response to what we were doing confirmed our own beliefs: AnestaGel is what surgeons and anesthesiologists want for a post-operative analgesic.
Pain Management
Overview
According to The New Guidelines Released for Postoperative Pain Management, by Dr. Laurie Barclay and Pauline Anderson, acute postoperative pain is common, occurring in more than 80% of patients, with approximately 75% of these having moderate, severe, or extreme pain. Postoperative pain relief is inadequate in more than half of patients, which can negatively affect quality of life, function, and functional recovery, as well as increasing the risks for postsurgical complications and persistent postsurgical pain. Complications due to catheter placement for pain pumps, and patients self-medicating with opiates is not the answer. A site specific sustained release non-opiate drug, that lasts for at least 72 hours, with quick onset to get ahead of the pain curve and keep the nerve receptors disengaged is the answer.
Chronic Pain:
100
million Americans
suffer from chronic pain each year
Economic Impact:
$635 billion
The annual economic impact of pain in the U.S. is estimated to exceed $635 billion affecting more lives
than heart disease, diabetes and cancer combined.
Opioid Epidemic
Overview
Although opioids prove to be an effective treatment for pain management, the issues associated with opioid addiction continue to garner major focus. The need for a more effective, longer-lasting product for post-operative pain management is critical, and represents a significant positive behind the early commercial acceptance and success of Exparel®, despite its shortcomings, and in the development of, AnestaGel, which could be an effective non-opioid alternative in controlling surgical pain. Getting ahead of the pain curve and staying ahead of the pain curve for 72 hours is the key to reducing opioid use, especially in children, effectively eliminating the triggering of the opioid receptor.
Opioid Facts / Stats
-
1
Opiates were declared an epidemic by the Centers for Disease Control
-
2
Over 64,000 deaths were reported in 2016 due to drug overdoses.
-
3
On average, 115 Americans die every day from an opioid overdose.
-
4
40% of all opioid overdose deaths involve a prescription opioid.
-
5
Each year more than 70 million postsurgical patients receive opioids, and research shows 1 in 15 will go on to long-term use
-
6
In the U. S. there is a 55% increase in length of hospital stay due to opioid related AEs
-
7
A CDC study shows that even one-day prescriptions can lead to long-term abuse, and a full 30% of those given a month-long prescription developed opioid dependence.
What is AnestaGel
AnestaGel is a biocompatible drug, the consistency of gelatin, that is being explored for the use as injectable or spread by a surgeons hand and instruments into the target area of the body that would create post-surgical pain. AnestaGel then targets and binds to pain receptors so that patients could have near immediate pain-relief while lasting up to three days, or more. Unlike almost all other painkillers, AnestaGel is targeted for a specific region within the body, is designed to stay in that area, does not migrate to other regions of the body, and is easily metabolized* (*findings based on pre-clincial trials).
AnestaGel vs Opioids
AnestaGel
- Non-addictive
- Site-specific
- Fast-acting
- Analgesic effect for 72+ hours
Opioids
- Used in 80% of all procedures
- Highly Addictive
- Short-acting (hours)
- Central Nervous System & Cardiovascular toxicity
- Cognitive disorientation, slow breathing, sedation, and other side effects
- Non site-specific
- Outcome unsure
AnestaGel Medical Specialties
Pediatrics
Orthopedics
Physiatry
Oral Surgery
Plastic Surgery
Current Treatments
Overview
The current post-operative pain treatment options is dominated by opiates at 95% use and then other non-opioids make up 5%. Only one sustained release drug for post-operative has been cleared by the FDA. That drug is Exparel. While it does work, many clincal shortcomings have been reported in peer-reviewed, published journal articles. Based on our pre-clinical reports and surveying, we believe AnestaGel represents the product everyone wants, with the potential outcomes they expect from a sustained release drug.
AnestaGel vs. Industry
AnestaGel™ offers a new and transformational approach to perioperative pain management
that is opioid-sparing, tunable, biocompatible, target site-specific, and flexible
Swipe left to view table
| Design Set | Pumps | Exparel | AnestaGel |
|---|---|---|---|
| Harmless |
 No |
 Yes |
Yes |
| Removable / Reversible (if necessary |
Yes |
no |
Yes |
| Biocompatible |
No |
Yes |
Yes |
| pH Neutral |
No |
No |
Yes |
| Predictable Elution |
Yes |
No |
Yes |
| Non-Migratory |
No |
No |
Yes |
| Visualized |
Yes |
No |
Yes |
| Absorbed / Metabolized |
No |
Yes |
Yes |
| Single Step Use |
No |
No |
Yes |
Pre-Clinical GLP Study
Under the direction of Dr. Jake Hutchins, we compared AnestaGel™ to EXPAREL (Pacira, Inc.) in a GLP controlled pre-clinical study. Jake is the Director of the Regional Anesthesia Acute Pain and Ambulatory Surgery Division, and the Medical Director for the M Health Ambulatory Surgery Center, at the University of Minnesota. We found that:
300% Longer
Initial animal study revealed AnestaGel lasted up to 300% longer
8x More Capacity
AnestaGel carried 8 times more capacity
72+Hours
AnestaGel had full nerve block beyond 72 hours
Information about the pre-clinical results can be found in the Offering Circular
Or see our study at the Journal of Pain Research
Market Size
Insitu Biologics believes that AnestaGel can be in three distinct markets for perioperative
pain management
Surgical Site / Perioperative
Estimated 90 million surgical procedures in the US, resulting in $10B of drugs / devices being sold in the US
Peripheral Nerve Block
This occurs in the majority of surgical procedures, and is a product market that is estimated to grow to $20B by the Year 2025
Epidural
Estimated 2.5M procedures in the US and a product market estimated at $1B
Animal Market
InSitu Biologics intends to pursue a strategic licensing transaction with a worldwide Animal Care Company that it believes could be of significant financial benefit to the Company. The global pet care market is expected to reach USD 202.6 billion by 2025, according to a new report by Grand View Research, Inc. Rise in the adoption of pets and growing demand for premium care products, and veterinarian care are a few factors expected to drive market growth.
For 2018 reports, find M&A Activity, Capital Market Conditions, and Current Trends for the Pet Industry over at The Deal Hound
Watch our recorded veterinarian webcast
Animal Market Opportunity - AniGel SR
We believe that AniGel SR, composed of our Matrix Technology and our proprietary mix of bupivacaine, could be brought to the rapidly expanding $200B+ annual Worldwide Animal Health market in the very near future by the right commercial partner. A few examples of those surgical procedures include:
The combined surgical market for the three segments above represents over 50,000,000 surgeries annually, at a projected ASAP of $75- $100 for Canine and Feline, and $275 for Equine.
In just two years, an estimated 14,000 of the 98,000 veterinarians in the US have been trained on the use of Nocita, an analgesic extending liposome injection. AniGel has soundly outperformed Nocita in head to head tests measuring pain relief and the level of non-toxic pain relief medicine in the bloodstream.
The Opportunity
$48,000,000
Current Valuation
$8.20
Current Share Price
$10,000,000
Max Capital Raise
$2,460.00
Min Investment
“ As a high volume surgeon I use EXPAREL all of the time; but as a user, we know its performance varies from patient to patient. When I saw the work that was being done on Matrix BioHydrogel, I had to get involved. AnestaGel™ is the product I wanted from the start. That’s why I am a shareholder. ”
-Dr. Stefano Sinicropi Spine Surgeon, President, Midwest Spine and Brain Institute
Market Cap
Market cap compared to leading competitors
As of Oct 19, 2019 at 12 PM CST
What's Next?
It is very rare that an early stage financial opportunity in an easy to understand product is presented for investment to the general public. While complex in its design, and intricate to make, we believe AnestaGel represents that rare case for a potentially large return on investment, due to our low market capitalization in a large cap market. Our patent position and refinement of product components represent years of research and development being captured to bring AnestaGel to the market. Clinicians and surgeons across the country are preparing to change how they treat pain; AnestaGel is aiming to be in their repertoire of opioid alternatives as this change, which will take decades, begins.
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Managing post-surgical pain in children is difficult, and I think acute pain in a fracture is even harder to treat. Based on the pre-clinical work that InSitu has done on AnestaGel, I think AnestaGel may the solution I have been seeking.
Dr. Dan Sipple
D.O., Physiatrist
Updates
April 30
Informational Webinar - Tues. May 14th | Wed. May 15th
April 25
MedCity's Pitch Perfect Contest (Video)
Earlier this week Jim and co. traveled to Chicago for MedCity's Pitch Perfect Contest. Here is his 4 minute pitch.
April 23
InSitu Biologics Overview Deck
April 16
[event] 4.18.19 Biotech & The Opioid Crisis - NY, NY
We're hosting a get together to network and have Dr. Jake Hutchins MD, Executive Medical Director at M Health Ambulatory Surgery Center, discuss the advancements made within the emerging field of non-opiate, peri-operative pain management. Let us know if you'd like to attend or signup here: https://www.eventbrite.com/e/biotech-the-opioid-crisis-tickets-59748194458
Network, Drinks, & Appetizers | Free
Thursday, April 18th | 5-8 PM
Staybridge Suites, Parlour Room - New York, NY
Jim Segermark, CEO of InSitu Biologics
1-651-338-4801 or [email protected]
March 27
InSitu Biologics Update #8: Stock Reopen, Animal Market, Upcoming Events
I hope this letter finds you off to a great 2019. To receive timely information on your Company, please continue to check this Update Section as we post our news here as it happens. We post information on social media as well. I use LinkedIn; please send me an invite, message me that you are a Shareholder, and you will see the information I put out as soon as it becomes available. The Company also reports news on our InSitu Biologics, Twitter, Instagram and Facebook channels; please follow us there.
Animal Care Market Opportunity
We have begun discussions for exclusive worldwide licensing of AniGel for the Animal Care market. AniGel is our post-operative, sustained release formulation that can be used for pets of all sizes, from the smallest of cats and dogs to the Budweiser Clydesdale’s. The annual pet care market is estimated at over $130 billion and forecasted to steadily grow through 2025. Our website has more information on the opportunity and a peer-reviewed study of AniGel (AnestaGel) compared head to head with the only product for animals on the market today, Nocita, (Exparel from Pacira).
Offering Update
We are pleased to announce a 2:1 Share Split, and that we have Qualification from the SEC to sell our shares at the price of $8.00 per share. If you are not familiar with a 2:1 Share Split, that means you have two shares for each share you previously had, now at a price of $8, as opposed to the same number of shares at $16. The Market Capitalization of InSitu Biologics is now approximately 74.5 million. This is calculated by multiplying the Total Shares in the Company (9,311,51) by the Share Price of $8.00. We are currently offering 50,000 shares at $8 per share.
Company Progress
We are building a pilot scale manufacturing line. Without a human hand touching our Product, we will mix all the ingredients, pump them through a pipe, and fill syringes. While everything in that process remains sterile. When this is completed and fully validated for Human Use, which has its challenges, we will be ready to begin our Phase I Clinical Study. We will provide an update on that timing at the end of Q2 2019.
Our 2018 audit by Baker Tilly Virchow Krause nears completion and will be filed in an update with the SEC. In the meantime, you can find our offering in the link below:
https://www.manhattanstreetcapital.com/insitu-biologics-0
Upcoming Events
We will be hosting Prospective Investor Events in NJ on 3/28, Naples, FL on 4/8 and 4/9, NYC on 4/18, and NYC again on 5/9. Please go to our website to learn more, or contact me and I will send you or your interested contact an invitation.
Our events can also be found at: EventBrite.com / insitubiologics.eventbrite.com
Thank you for your investment and continued interest. Please share our story.
Jim Segermark
CEO
InSitu Biologics
[email protected]
(651) 338-4801
March 20
Announced: March & April Events in New Jersey and Florida
Announcing two upcoming events:
Investing in Biotech: Investors for Non-Opiate Pain Solutions
Casual conversation, drinks, appetizers & NCAA Sweet 16 Hoops
Thursday, March 28th | 5-?? PM EST
D'Arcy's Tavern - Bradley Beach, NJ
Biotech Investment Presentation & Lunch
Monday, April 8 or Tuesday, April 9 | 11:30AM – 2:00PM EST
Naples Beach Hotel & Golf Club
RSVP: https://www.eventbrite.com/e/biotech-investment-presentation-lunch-tickets-57477709376
Feel free to reach out to me directly with any questions.
Jim Segermark
CEO
InSitu Biologics
[email protected]
(651) 338-4801
Offering Circular
Please read the Offering Circular here: Get Offering Circular
An offering statement regarding this offering has been filed with the SEC. The SEC has qualified that offering statement, which only means that the company may make sales of the securities described by the offering statement. It does not mean that the SEC has approved, passed upon the merits or passed upon the accuracy or completeness of the information in the offering statement. You may obtain a copy of the offering circular that is part of that offering statement from here.
https://www.manhattanstreetcapital.com/sites/default/files/Insitu_Offering_Circular_10-19-19.pdf
You should read the offering circular before making any investment.
The offering materials may contain forward-looking statements and information relating to, among other things, Insitu Biologics, its business plan and strategy, and its industry. These forward-looking statements are based on the beliefs of, assumptions made by, and information currently available to the company’s management. When used in the offering materials, the words “estimate,” “project,” “believe,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify and constitute forward-looking statements. These statements reflect management’s current views with respect to future events and are subject to risks and uncertainties that could cause the company’s actual results to differ materially from those contained in the forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. The company does not undertake any obligation to revise or update these forward-looking statements to reflect events or circumstances after such date or to reflect the occurrence of unanticipated events.
Securities are offered through Sageworks Capital, LLC., a registered broker-dealer and member FINRA/SIPC. Neither InSitu Biologics, Inc. nor Sageworks Capital, LLC provides any investment advice or make any investment recommendations to any persons, ever, and no communication through this website or in any other medium should be construed as such.
InSitu Biologics, Inc. securities are not publicly traded and are intended for investors who do not need a liquid investment. This investment is NOT a bank deposit (and thus NOT insured by the FDIC or by any other federal governmental agency), are NOT guaranteed by Sageworks Capital, LLC or InSitu Biologics, Inc., and MAY lose value. Investors must be able to afford the loss of their entire investment.
Any financial projections or returns shown on the website are illustrative examples only, and there can be no assurance that any valuations provided are accurate or in agreement with market or industry valuations. Investors should conduct their own due diligence, not rely on the financial assumptions or estimates displayed on this website, and are encouraged to consult with a financial advisor, attorney, accountant, and any other professional that can help you to understand and assess the risks associated with any investment opportunity. Please refer to the offering circular for full details and disclosures, including a subscription agreement should you choose to invest.
Insitu Biologics, Inc. is required to pay an advisory retainer fee of $6,000, plus the same value of warrants at the respective issue price. In addition, they will pay a technology admin and service fee of $25 per investor, plus the same value of warrants at the respective issue price. As of 11/30/2018 Insitu Biologics has paid $24,000 in fees.
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