Introduction
The seasoned scientists at IOS focus on creating & optimizing sensing at levels of competence not normally seen in industry.
Their unique depth and breadth of scientific expertise has enabled IOS to solve challenging physical, chemical, biological, and optical challenges and convert them to extraordinary products.
The scientists are driven to succeed by their shared passion for knowledge and growth, and the desire to apply that knowledge to remedy real-world problems, from healthcare to environmental sustainability.
MISAA, LLC contains the IP for the TAC Assay and has an operating agreement with IOS to use its scientists, facilities, etc. At MISAA (Monitoring Immunosupressants Anywhere Anytime), our mission is to use our knowledge and experience to improve the health and well-being of the transplant community around the world.
FDA 510(k) presub submitted with feedback from the FDA agreeing with our predicate and clearing a 510(k) path forward. The 501(k) is a FDA regulatory process for medical devices which allows them to be approved based on a demonstration of substantial equivalence to a predicate device that is already legally marketed. In other words, we believe we’ll be able to bring this product to market more quickly than a full FDA premarket approval.
Problem
Tacrolimus (TAC) is an essential immunosuppressive drug for solid-organ and tissue transplant patients.
Frequent patient monitoring is critical to its success – TAC has a short therapeutic window that differs widely between individuals – too high a level causes drug toxicity, too low a level causes transplant rejection. Chronic rejection is a problem and a key solution is tighter control of immunosuppressant levels.
Current monitoring is by frequent blood draws measured with liquid chromatography–mass spectrometry (LC-MS/MS). Such testing is painful, complex and costly and limitations on same-day turnaround can compromise effective dose adjustments.
Solution
Over the past three years, IOS has developed and patented (pending) an ELFA for rapid, accurate, reliable and highly sensitive lab and point of care monitoring of tacrolimus levels in capillary blood from a fingerstick.
With over $4MM of non-dilutive funding, IOS has validated its fingerstick assay against the laboratory venus blood draw test.
This enables clinicians to adjust immunosuppressant drug (ISD) levels in the order of minutes rather than days.
It is less invasive and user friendly for patients, leading to improved patient outcomes.
Business Model & Market
- Test kit w/ reader and initial reagents, ~$1,300 one-time purchase
- Resupply of reagents, ~$25/Month recurring
- Cloud-based monitoring, ~$25/Month recurring
- Reimbursement per test, ~$120
Team
Use of Proceeds
If the offering's maximum amount of $1,000,000 is raised:
| Use | Value | % of Proceeds |
|---|---|---|
| Labor | $162,000 | 16.2% |
| Clinical Trials | $320,000 | 32.0% |
| Product Development | $200,000 | 20.0% |
| Materials | $60,000 | 6.0% |
| Consulting | $33,000 | 3.3% |
| Admin and Overhead | $176,000 | 17.6% |
| Intermediary fees | $49,000 | 4.9% |
Terms
This is an offering of Class B Unit, under registration exemption 4(a)(6), in MISAA, LLC, doing business as MISAA/TacAssay. This offering must raise at least $10,000 by June 21, 2024 at 11:59pm ET. If this offering doesn’t reach its target, then your money will be refunded. MISAA/TacAssay may issue additional securities to raise up to $1,000,000, the offering’s maximum.
If the offering is successful at raising the maximum amount, then the company’s implied valuation after the offering (sometimes called its post-money valuation) will be:
Financials
MISAA/TacAssay’s official name is MISAA, LLC, so that’s the name that appears in the statements below.
These financial statements have been reviewed by an independent Certified Public Accountant.
SEC Filings
The Offering Statement is a formal description of the company and this transaction. It’s filed with the SEC to comply with the requirements of exemption 4(a)(6) of the Securities Act of 1933.
We’re also required to share links to each of the SEC filings related to this offering with investors.
Understand the Risks
Be sure to understand the risks of this type of investment. No regulatory body (not the SEC, not any state regulator) has passed upon the merits of or given its approval to the securities, the terms of the offering, or the accuracy or completeness of any offering materials or information posted herein. That’s typical for Regulation CF offerings like this one.
Neither Netcapital nor any of its directors, officers, employees, representatives, affiliates, or agents shall have any liability whatsoever arising from any error or incompleteness of fact or opinion in, or lack of care in the preparation or publication of, the materials and communication herein or the terms or valuation of any securities offering.
The information contained herein includes forward-looking statements. These statements relate to future events or to future financial performance, and involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
More Info
Updates
- Apr 10, 2024MISAA, LLC Friends on Netcapital: We want you...
- Apr 5, 2024To our Netcapital MISAA-LLC funding...
- Mar 27, 2024This was posted today on the IOS LinkedIn...
- Mar 22, 2024**Great news!** IOS, MISAA, LLC's parent and...
- Mar 5, 2024Tac-Assay is our patent pending, tacrolimus in...
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