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InSitu Biologics

Summary

Invest in Anestagel. A new, opioid-free painkiller.

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).

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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  • 2 Choose your investing method and fund your account
  • 3 Receive your shares and monitor your investment

Investing Methods

ACH / Check / Wire

Fund your investment with an ACH, check, or wire transfer.

IRA

Fund your investment with an IRA or self-directed 401k. Click the Equity Institutional image below to learn more about funding with your IRA

 


Updates

February 01
Our Regulation A+ Offering is Now Officially Closed

Our Regulation A+ Offering is now officially closed. Please continue to follow our progress at www.insitubiologics.com, on social media, or via newsletter. Thank you.  

January 21
CEO Update: January 2020

Insitu Biologics continues to make rapid progress towards our mission of providing patients and physicians with an opioid-free solution for post-operative pain.  We have added exceptional talent to our team, are nearing manufacturability of clinical-grade product, are in communication with the FDA regarding our clinical strategy moving forward, and have engaged in fundraising on several fronts.  Thank you to everyone who has invested in this disruptive technology to curb the opioid crisis and provide a better safer solution for patients in post-operative pain.

For any final investments in our company via the open Reg A+ (click here to invest).  Please take some time to read our company update by clicking the preview image below: 

(click the preview image above to read)

December 02
Our Regulation A+ Offering has Been Extended
We have received a tremendous amount of interest in this last tier and have also received requests to hold the offering open longer to allow numerous interested parties time to execute their investments prior to year-end. So our Regulation A+ offering will remain open through December. 
We recognize that the holidays can be a busy time of year, and many of you let us know that you were wrapped up in activities with family and were unable to initiate your investment. Therefore, the extension will allow additional time to make an investment, but we ask that you initiate the process no later than December 31, 2019.

Click "INVEST NOW" on our offering page, provide your best email address and the platform will walk you through the rest of the process. 

If you've already completed your investment, we thank you very much for your contribution, belief in our mission, and trust in our Company! Keep an eye out for our future emails regarding InSitu Biologics' next steps and progress.

October 19
Offering Status Update: Our Offering is Once Again Open and Accepting Investments

As of October 19th, our Stock Offering is once again open and accepting investments. Our plan is to close our Regulation A+ Offering for the last time on Nov 30, 2019. 

The share price remains at $8.20 and prospective investors may begin the investment process via the green INVEST button on the Offering homepage

For additional information on the state of the Company and plans for the future, please read the following letter from InSitu Biologics' President and CEO, Kevin Bassett:

(Click to Read)

October 16
Offering Status Update: Our Offering is temporarily paused and in reservation mode

As of October 15, our Stock Offering is temporarily paused. During this pause, we will be taking reservations and encourage prospective investors to reserve shares via the green Make Reservation button on the offering home page.

Both prospective and current investors will be updated via The Offering page, insitubiologics.com as well as by email message for those signed up to receive our email correspondence, once The Offering is once again accepting investments. 

August 30
InSitu Biologics Announces New Leadership

InSitu Biologics Announces New Leadership

InSitu Biologics today announced that its Board of Directors has appointed Kevin Bassett as President and Chief Executive Officer and member of the Board of Directors effective September 1, 2019 as James Segermark steps down as Chief Executive Officer.

InSitu Biologics has also announces that Dr. Robert Wilson has joined the Board of Directors, effective August 28, 2019.

Kevin Bassett, M.B.A. – President and CEO

Kevin Bassett joined InSitu Biologics in September 2019 as President and CEO. Prior to joining InSitu, Mr. Bassett was General Manager of HLT Medical, a clinical-stage company developing a next-generation heart valve in the field of Transcatheter Aortic Valve Replacement (TAVR).  Kevin has also served in a variety of senior executive roles in early-stage medical technology companies over the past twenty years.

Robert Wilson, MD – Member of the Board of Directors

Dr. Wilson has dedicated his professional life to developing new methods for diagnosing and treating heart disease, and to training new physicians. He presently directs the University of Minnesota interventional-cardiology fellowship program and University of Minnesota Physicians clinical cardiovascular services.

Current Report Pursuant to Regulation A

The Company has prepared form 1-U in compliance with the U.S. Securities and Exchange Commission. This document is available to view and we encourage all shareholders to review and save immediately.

Click to View the Document

The Company is poised for tremendous growth in the coming months as we head into clinical trials with the addition of these new leaders, and we thank you for being a part of our journey.

Regards,

James Knapp
Chairman of the Board
InSitu Biologics
James.knapp@insitubiologics.com

Comments

Post comment

Tony on August 05
Does anyone know if there is anyone looking into the validity of this company? Seems like they have just disappeared. We as investors deserve an update.

KT on August 01
Any new updates or press you can update investors with?

Mike Russo on July 27
It's been almost six months since last update. Please let me know what's happening.

Maria Cristina J Cabral-Singh on May 28
I purchased a stock from last year but i did not received any updates. Please email me with the updates. Thanks

Debra on November 02
How do investors in Anestagel get paid for their investment?

Jim Segermark | CEO InSitu Biologics on March 04
Hi Tony - We are in communication with the SEC and anticipate clearance and a new price sometime during the week of May 11.

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.