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InSitu Biologics

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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.

This Offering Has Closed
Offering Circular

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

This Offering Has Closed
Offering Circular

“ 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.

Offering Circular
  • 1 Create an account This Offering Has Closed
  • 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

 

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

February 13
Stock Sale Open Again February 13th - 18th 2019

The government shutdown in December and January has caused a tremendous backlog of quarterly and year-end filings for review at the SEC. Accordingly, our updated RegA+ Offering Price has not been reviewed.

 

We will once again open the current Offering for sales of shares at the price of $6.90 per share. This equates to a market capitalization of approximately $33.7 million dollars.

 

Shares can be purchased beginning at Noon EST on February 13 until Noon EST February 18, 2019. If we get clearance during this period, we will close to new investments at that time.

 

To start the investment process: https://www.manhattanstreetcapital.com/insitu-biologics-0

 

Feel free to reach out to me directly with any questions.

Jim Segermark
CEO
InSitu Biologics
[email protected]
(651) 338-4801

January 30
Stock Offering Reopens: Wednesday, January 30th 12PM EST

I hope this note finds you off to a great 2019.

 

We are pleased to announce that InSitu Biologics Stock Offering will again open on Wednesday, January 30th at noon eastern for one week.

 

The government shutdown resulted in the SEC being closed. That has now created a backlog of companies for the SEC to review and InSitu Biologics new proposed share price is in that backlog. We hope to announce our new price within a couple months, but hope is not a plan.

 

The good news for investors is that we will be accepting new investments at the same $6.90 per share price beginning Wednesday, January 30th 12PM EST through Tuesday, February 5th 12PM EST. To reserve your shares now or to invest after noon on the 30th, simply click this link: https://www.manhattanstreetcapital.com/insitu-biologics-0

 

The current market capitalization for InSitu Biologics is $33.7 million, with our share price and amount of shares sold since July as follows:

 

  • Tier 1: $5.75 Share Price - Sold 275,661 Shares

 

  • Tier 2: $6.85 Share Price - Sold 42,666 Shares

 

  • Tier 3: $6.90 Share Price - Sold 94,775 Shares (open Jan. 30th - Feb. 5th)

 

  • Tier 4: TBD Share Price (opens after upcoming SEC clearance)

 

We are completing numerous pre-clinical studies, and Phase 1 AnestaGel manufacturing. We expect to have our first meeting with the FDA in the near future to discuss our Phase 1 human clinical study.

 

Thank you for taking the time to view our materials and better understand this opportunity. Consider becoming a Shareholder of InSitu Biologics by making an investment here starting Wednesday, January 30th at 12PM EST.

 

As always, I am available for questions, comments, and feedback.

Jim Segermark
CEO
InSitu Biologics
[email protected]
(651) 338-4801

December 04
Over $2M in Investments Using Reg A+ Mini-IPO to Advance Non-Opioid Pain Drug Candidate into Clinical Trials

WOODBURY, Minn., Dec. 4, 2018 /Press Release/ -- InSitu Biologics, Inc., an emerging biotech company focusing on the development of AnestaGel™, has received over $2 million in investments. InSitu is believed to be in the midst of the largest Reg A+ round for a pre-revenue biotech company and anticipates investments reaching $10 million in 2019.

 

Since its Reg A+ launch, InSitu Biologics has sold-out of three SEC qualified price tiers. InSitu has since paused its Offering and will be submitting a new valuation and price qualification to the SEC to better reflect milestone achievements and business developments.

 

In pre-clinical studies, AnestaGel has proven to be a fast acting and long lasting, non-opiate painkiller, targeted for use in post-operative regional pain management and is expected to be explored for use in numerous surgical applications. Prior to the Reg A+ funding, InSitu Biologics published a peer-reviewed preclinical study in the Journal of Pain Research which found that AnestaGel:

  • Consistently lasted up to 300% longer when compared to the leading liposome-based sustained-release drug;
  • Had full nerve block beyond 72 hours (24-48 hours for liposome-based drug) and;
  • Carried 8x more painkiller than liposome-based drugs, remaining non-toxic.

"Development of non-addictive, non-opioid pain drugs lag far behind research for other diseases," said James Segermark, President and CEO. "Addiction often begins with post-operative pain management, for which there are few non-opiate solutions. Our investors understand that a change is required."

 

The Securities and Exchange Commission (SEC) Qualified InSitu on July 17, 2018, to raise up to $10 million using Reg A+. Reg A+ allows private companies to raise up to $50 million from the general public over a 12 month period. The SEC qualified Form 1-A can be found here: https://www.sec.gov/Archives/edgar/data/1723443/000147793218002887/insitu_1a.htm

 

The Company is audited by the CPA firm of Baker Tilly Virchow Krause. The Offering Circular, and ability to make an investment reservation can be found at https://www.manhattanstreetcapital.com/insitu-biologics-0

 

Forward-Looking Statements

We caution that, whether or not expressly stated, certain statements made in this news release that reflect management's expectations regarding future events and economic performance are forward-looking in nature and, accordingly, subject to risks and uncertainties. All statements other than statements of historical facts included in this release are forward-looking statements. In some cases, forward-looking statements can be identified by words such as "believe," "expect," "anticipate," "plan," "potential," "continue" or similar expressions. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Investors should not place any undue reliance on forward-looking statements since they involve known and unknown, uncertainties and other factors which, in some cases, are beyond the Company's control which could, likely materially affect actual results, levels of activity, performance or achievements.

 

 

November 25
Update #3: Share Price, Speaker Panel, and News Sightings...

Our Tier 3 of 30,000 shares is nearly full and we will pause our Stock Offering on Tuesday, November 27, 2018. At that time we plan on submitting a new price and valuation to the SEC for qualification. Upon approval of the updated Stock Offering, we anticipate our offering will again be available for purchase in January, 2019. During the pause we’ll be taking reservations for the new share price.

 

In case you’ve missed it, our pricing and investments since July 17th are as follows:

 

Tier 1: 100% Filled at $5.75 Share Price | 275,661 Shares

Tier 2: 100% Filled at $6.85 Share Price | 43,126 Shares

Tier 3: 81% Filled at $6.90 Share Price | 30,000 Shares Available; [Paused on Tuesday, Nov. 27th]

 

Dr. Daniel Sipple will be at the 2018 G20 World Brain Mapping Therapeutics Summit in Buenos Aires, presenting on November 26th. The Summit aims to contribute to President Obama’s BRAIN initiative and to expand action on the current and upcoming initiatives across the G20 nations. Dr. Sipple will be a representative on the Brain and Spine Trauma and Opioid Crisis panel.

 

More props to Dr. Sipple with his mention in the Northwestern Medicine Magazine. https://magazine.nm.org/2018/11/12/progress-notes-5/

 

Dr. Jake Hutchins was interviewed about the newly FDA cleared drug, Dsuvia. Dsuvia, an opioid-based painkiller, has been a controversial FDA clearance. We agree with Dr. Jake Hutchins that "Dsuvia fills a gap that we don't have anything else to fill with". The full story and interview: http://www.startribune.com/u-doctor-in-middle-of-opioid-conflict/500756911/

 

MedCityNews, a leading healthcare innovation news source, interviewed us for their "Founders Story": https://medcitynews.com/2018/11/founders-story-insitu-biologics/

 

We will continue to report to you on a regular basis, however, please do not hesitate to drop me a line with any questions or comments. We remain focused on getting to Phase 1 with the best possible product. We expect our non-opiate, AnestaGel to be proven safe, fast acting, long lasting, injectable and smearable.

 

Regards,

James Segermark

President & CEO

InSitu Biologics, LLC

(651) 338-4801

October 19
Update #2: Tier 2 100% Filled, On to Tier 3 at $6.90

Quick update for shareholders and prospective investors.

 

We closed our Tier 2 $6.85 level with 43,126 shares sold. The SEC approved our Tier 3 with another share price increase to $6.90 which we have allotted 30,000 shares at this level. Over 10% has already been sold this week.

 

As a reminder we will be hosting Technology Updates in Orlando on October 26 & 27 at the Marriott Marquis from 5-8 on Friday & 9am-6pm on Saturday, and in Santa Barbara on Thursday, November 15, from 4-8pm at a site to be determined. Please join us or refer a friend.

 

If you haven't seen the latest podcast you can find that here: CEO Money interviews Jim Segermark

 

As always, thank you again for interest, and financial support.

 

Jim

 

Regards,

James Segermark

President & CEO

InSitu Biologics, LLC

(651) 338-4801

www.insitubiologics.com

September 14
Update #1: Meetups, Share Price, Podcasts...

This is Jim Segermark, CEO and Co-Founder of InSitu Biologics. Quick note to share our progress and upcoming events with you. If you live, or happen to be, in the St. Paul, Orlando or Santa Barbara area, please consider joining us at one of our Happy Hour Technology Updates, please see the details below.

 

What's New:

 

As many of you know we have been qualified by the SEC to raise up to $10 million from the sale of Common A Shares over the course of 12 months. Since July 31st, we’ve raised $1.8 million. Many thanks to all of you that have made an investment and taken the time to understand the opportunity AnestaGel™ presents.

 

We opened our IPO with an initial share price of $5.75 and quickly sold out. Since then, the SEC approved a share price increase of $6.85, of which we have about $100,000 remaining. We plan on going back to the SEC after that is sold, for a new price based on milestones achieved and actions we have taken.

 

We’ve been featured in two podcasts. You can find them here: CEO Money and Future Tech Podcast

 

A few of you have had questions regarding the investment process. There is now an FAQ format that may be helpful. Here is the link.

 

InSitu Biologics shares are now sold in all 50 states and throughout the world via our FINRA Broker Dealer, SageWorks Capital, LLC.

 

 

What's Coming Up:

 

Pre-Clinical GLP Study: We will begin what we believe is our final battery of tests for AnestaGel in multiple species. These begin on October 15.

 

FDA Pre-IND Meeting: We expect to meet with the FDA in the coming months to discuss the filing for our Phase 1 Clinical Study.

 

Introductions: We want your investor friends, family, colleagues, and other medical professionals to become shareholders and spread our message and investment opportunity. If you know someone that may be interested, feel free to drop me a note; I will personally follow up.

 

Let’s Get Together: We will be hosting Technology Updates in St. Paul on October 2, at Town & Country Club from 4-7pm, Orlando on October 26 & 27 at the Marriott Marquis from 5-8 on Friday & 9am-6pm on Saturday, and in Santa Barbara on Thursday, November 15, from 4-8pm at a site to be determined. Please join us and bring a friend.

 

Your questions and favorable comments are always welcome. If you have complaints, I will find someone for you to send those to… Thank you again for interest, and financial support

 

Regards,

James Segermark

President & CEO

InSitu Biologics, LLC

(651) 338-4801

www.insitubiologics.com

Comments

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.