Amnion Life LLC 2019 Report

Filed on April 28, 2020

Dear investors,

This was a difficult year for us as we lost he momentum we had built on our Reg CF crowdfunding here on Wefunder, where we raised $305,000 from 186 investors.  We attempted a Reg D accredited crowdfund offering on a 3rd party but could not maintain the traction there.  We canceled the Reg D offering and planned two private fundraising events in California in March of 2020, but both had to be canceled due to Coronavirus pandemic. We've had to slow development of Amniobed Golden Hour to a minimum and have paused work on regulatory and clinical tasks.  We are in desperate need of funds to keep this project alive and get to our goal of first human trials for our device, but we are confident we will get there and we will change the field of neonatology and preterm infant care with our novel devices. 

We need your help!

Due to Coronavirus fears, we've had to cancel our fundraising events and are in great need of funds in order to keep this project alive. 

We will be re-launching a Reg CF offering on Wefunder very soon.  We will attempt to raise minimum of $125,000 in order to maintain minimum continued operation by our engineering and to pay on-going accounting, legal and patent related costs.  Our goal will be to raise $250,000 which will allow us to continue progress in development of Amniobed Golden Hour with Clinical and Regulatory teams back at work.  If we raise maximum of $535,000, it will allow us significant resources for continued research and testing of Amniobed and we will be significantly closer to our goal of initial pilot human trial.

We will relaunch on Wefunder soon and need all the help in order to raise funds and keep this project alive.


Sincerely,

Our Mission

The world is in desperate need of more sophisticated infant care. Despite ongoing technology advancements, current incubators and radiant warmers have many deficiencies that put preterm infants at risk for hypothermia. We believe our patented AmnioBed design can prevent hypothermia and save lives, reduce complications, improve short- and long-term outcomes, and decrease costs for millions of infants born preterm every year.

How did we do this year?

Report Card
B+

☺ The Good

  • A huge pivot from Amniobed in order to develop 'Amniobed Golden Hour' as a new, more simplified product for L&D wards.

  • Completed all requirements and design of Amniobed Golden Hour, sourced and procured parts and completed the prototype.

  • Won 2nd place in Cleveland Clinic Amp'd Arena Medical Innovation Summit and 3rd place in UCSF/Stanford Pediatric Device Consortium

☹ The Bad

  • Failed attempt on a Reg D accredited investor crowdfund. We failed to maintain momentum after our Reg CF raise.

  • Had to pause regulatory and clinical work to allow engineering to catch up and due to lack of funds from failed Reg D crowdfund.

  • Had to cancel two private fundraising events in CA due to Coronavirus. Failed to win an SBIR grant for the company. 

2019 At a Glance

January 1 to December 31

cash register full of money

$0

Revenue

money on fire

-$568,029

Net Loss

i owe you note

$96,220 [18%]

Short Term Debt

whiteboard of nonsense

$1,122,287

Raised in 2019

money in wallet

$56,332

Cash on Hand
As of 04/ 6/20

  • Net Margin: 0%
  • Gross Margin: 0%
  • Return on Assets: -1,303%
  • Earnings per Share: -$0.44
  • Revenue per Employee: $0
  • Cash to Assets: 39%
  • Revenue to Receivables: ~
  • Debt Ratio: 1,309%

We Our 416 Investors

Thank You For Believing In Us

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Thank You!

From the Amnion Life LLC Team

Amir Fassihi

Amir Fassihi

Founder and CEO

Medical Doctor. Radiologist/Neuroradiologist. Attended UCLA-UCSF-USC/Keck. Author of multiple patents on Amniobed. Founder and visionary behind Amnion Life.

Michael Drues, PhD

Michael Drues, PhD

Regulatory Advisor

Dr. Drues is an internationally recognized expert on cutting-edge medical technologies and regulatory affairs. He has worked for and consulted with leading medical device companies ranging in size from start-ups to Fortune 100 companies.

Molly Ferris

Molly Ferris

Consultant for Product Rollout, Marketing, Sales

20 years of expertise in device strategic planning, pre-commercial regulatory, market-entry alignment for high-growth medical device startups Experience sales pipelines across medical device verticals.

Aleksandar Siskovic

Aleksandar Siskovic

Quality Manager

Graduated Engineer of Electronics with more than 12 years of experience in QMS and practical experience in medical areas. Certified Auditor: ISO 13485, ISO 9001, ISO 14001, ISO/IEC 27001, ISO/IEC 20000-1, ISO 37001.

Details

The Board of Directors

Director Occupation Joined
Amir Fassihi CEO @ Amnion Life 2016

Officers

Officer Title Joined
Amir Fassihi CEO   2016
Voting Power
Holder Securities Held Voting Power
Amir Fassihi 1,000,000 Class A Unites, Voting 77.4%

Past Equity Fundraises

Date Amount Security Exemption
08/2018 $258,118 Common Stock Section 4(a)(2)
12/2018 $187,180 Other
04/2019 $305,892 4(a)(6)
06/2019 $766,395 Common Stock Section 4(a)(2)
11/2019 $50,000 Safe Section 4(a)(2)
02/2020 $1,000 Safe Regulation D, Rule 506(c)
03/2020 $50,000 Safe Section 4(a)(2)
03/2020 $25,000 Safe Section 4(a)(2)
07/2020 $25,000 Safe Section 4(a)(2)
10/2020 $169,091 4(a)(6)
02/2021 $12,500 Safe Section 4(a)(2)
02/2021 $5,000 Safe Section 4(a)(2)
The use of proceeds is to fund general operations.

Outstanding Debts

Lender Issued Amount Oustanding Interest Maturity Current?
Amir Fassihi
12/01/2018 $187,180 $187,180
5.0% Yes

Related Party Transactions

None.

Capital Structure

Class of Security Securities
(or Amount)
Authorized
Securities
(or Amount)
Outstanding
Voting
Rights
Class A Units 1,000,000 1,000,000 Yes
Class B Units 292,812 292,812 No
Safe Notes $76,000 $76,000 No
Profit Interest Units 11,244 11,244 No
Phantom Equity Units 1,700 1,700 No
Securities Reserved for
Issuance upon Exercise or Conversion
Warrants: 2
Options: 0

Form C Risks:

The medical device being developed may not pass the FDA requirements for safety and efficacy and may not receive the required regulatory requirements for sales and marketing of the device.

Our future success depends on the efforts of a small management team. The loss of services of the members of the management team may have an adverse effect on the company. There can be no assurance that we will be successful in attracting and retaining other personnel we require to successfully grow our business.

Clinical Trials for the device do not meet Superiority classification requirements compared to previous devices currently on the market.

The marketing approval processes of the FDA and comparable regulatory authorities in other countries are unpredictable and our product candidates may be subject to multiple rounds of review or may not receive marketing approval.

System failures may disrupt our business operations and delay our product development programs and commercialization activities.

We may acquire businesses, products or product candidates, or form strategic alliances or create joint ventures, in the future, and we may not realize the benefits of such transactions.

Our employees and our independent contractors, principal investigators, CROs, consultants or commercial collaborators, as well as their respective sub-contractors, if any, may engage in misconduct or fail to comply with certain regulatory standards and requirements, which could expose us to liability and adversely affect our reputation.

We depend on skilled labor, and our business and prospects may be adversely affected if we lose the services of our skilled personnel, including those in senior management, or are unable to attract new skilled personnel.

We may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance.

We may be unable to continually develop a pipeline of product candidates, which could affect our business and prospects.

Our preclinical studies and clinical trials may not be successful and delays to such preclinical studies or clinical trials may cause our costs to increase and significantly impair our ability to commercialize our product candidates. Results of previous clinical trials or interim results of ongoing clinical trials may not be predictive of future results.

We are planning to pursue the FDA De Novo pathway for all of our current product candidates. If we are unable to rely on the De Novo regulatory pathway to apply for marketing approval of our product candidates in the United States, seeking approval of these product candidates through the PMA pathway would require full reports of investigations of safety and effectiveness, and the process of obtaining marketing approval for our product candidates would likely be significantly longer and more costly.

We may encounter difficulties in enrolling patients in our clinical trials, which could be detrimental to business.

We have conducted, and may in the future conduct, clinical trials for our product candidates outside the United States and the FDA may not accept data from such trials.

Our facilities are subject to extensive and ongoing regulatory requirements and failure to comply with these regulations may result in significant liability.

Our current pipeline product candidate, AmnioBed, requires extensive clinical data analysis, regulatory review and additional testing. Clinical trials and data analysis can be very expensive, time-consuming and difficult to design and implement. If we are unsuccessful in obtaining regulatory approval for AmnioBed does not provide positive results, we may be required to delay or abandon development of such product, which would have a material adverse impact on our business.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.

Even if we obtain marketing approval for our product candidates in the United States, we or our collaborators may not obtain marketing approval for the same product candidates elsewhere.

The terms of approvals, ongoing regulations and post-marketing restrictions for our products may limit how we manufacture and market our products, which could materially impair our ability to generate revenue.

Our products may not achieve market acceptance, which would be essential to our company's success. Furthermore, We may not be able to respond effectively to changing consumer preferences and demand.

Competitors successfully challenging Company's patent and other intellectual properties and entering the market with similar devices.

The anticipated clinical trials do not confirm the safety and efficacy of the device. There is considerable harm and danger realized associated with the device which cannot be mitigated.

Our commercial success depends largely on our ability to protect our intellectual property.

The commercial success of our medical device products depends on the availability and sufficiency of third-party payor coverage and reimbursement.

Our failure to comply with data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.

Healthcare laws and regulations may affect the pricing of our medical device products and may affect our profitability.

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

We may be subject to claims from third parties that our products infringe their intellectual property rights.

We may be subject to claims that our employees or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients.

If we fail to comply with various procedural, document submission, fee payment or other requirements imposed by the USPTO or comparable patent agencies in other countries, our patent protection could be reduced or eliminated.

Changes in patent laws or interpretations of patent laws in the United States or elsewhere may diminish the value of our intellectual property or narrow the scope of protection of our patents.

We may become involved in litigation to protect our intellectual property or enforce our intellectual property rights, which could be expensive, time-consuming and may not be successful.

If we are unable to protect our trade secrets, the value of our AmnioBed technology and product candidate may be negatively impacted, which would have a material and adverse effect on our competitive position and prospects.

We may not be able to engage third-party CMOs to manufacture our approved medical device products on a commercial scale to meet commercial demand for our medical device products.

Our medical device products may be subject to recalls, withdrawals, seizures or other enforcement actions by the FDA or comparable regulatory authorities in other countries if we fail to comply with regulatory requirements or previously unknown problems with our medical device products are discovered after they reach the market.

If the FDA or comparable regulatory authorities in other countries approve generic versions of our product candidates, or do not grant our product candidates a sufficient period of market exclusivity before approving their generic versions, our ability to generate revenue may be adversely affected.

If our product candidates are approved for commercialization outside of the United States, we may be exposed to a number of risks associated with international business operations.

Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

The off-label use or misuse of our products may harm our image in the marketplace, result in injuries that lead to costly product liability suits, or result in costly investigations and regulatory agency sanctions under certain circumstances if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.

We may not be able to build our marketing and sales capabilities or enter into agreements with third parties to market and sell our medical device products.

Our products may be subject to reduced prices negotiated by certain group purchasing organizations that could adversely impact our product revenue.

We may not be able to enforce our intellectual property rights throughout the world, which may be problematic.

We need to protect our trademark, trade name and service mark rights to prevent competitors from taking advantage of our goodwill.

We are subject to various laws and regulations, such as healthcare fraud and abuse laws, false claim laws and health information privacy and security laws, among others, and failure to comply with these laws and regulations may have an adverse effect on our business.

Legislative or regulatory reform of the healthcare system in our target markets may affect our operations and profitability.

Our management has broad discretion in using the net proceeds from the initial public offering and may not use them effectively

We may never receive a future equity financing or elect to convert the Securities upon such future financing. In addition, we may never undergo a liquidity event such as a sale of the Company or an IPO. If neither the conversion of the Securities nor a liquidity event occurs, the Purchasers could be left holding the Securities in perpetuity. The Securities have numerous transfer restrictions and will likely be highly illiquid, with no secondary market on which to sell them. The Securities are not equity interests, have no ownership rights, have no rights to our assets or profits and have no voting rights or ability to direct the Company or its actions.

The Company may never receive a future equity financing or elect to convert the Securities upon such future financing. In addition, the Company may never undergo a liquidity event such as a sale of the Company or an IPO. If neither the conversion of the Securities nor a liquidity event occurs, the Purchasers could be left holding the Securities in perpetuity. The Securities have numerous transfer restrictions and will likely be highly illiquid, with no secondary market on which to sell them. The Securities are not equity interests, have no ownership rights, have no rights to the Company’s assets or profits and have no voting rights or ability to direct the Company or its actions.

We are an early-stage medical device company with no approved products and no historical product revenue, which may make it difficult for you to evaluate our business, financial condition and prospects.

Amir Fassihi is a part-time officer. As such, it is likely that the company will not make the same progress as it would if that were not the case.

We have not commenced commercial operations to date and our future profitability is uncertain.

We are primarily dependent on the success of our lead product candidate, AmnioBed, which is still in clinical development, and this product candidate may fail to receive marketing approval or may not be commercialized successfully.

We expect that we will need further financing for our existing business and future growth, which may not be available on acceptable terms, if at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations. The failure to obtain further financing may also prevent us from capitalizing on other potential product candidates which may be more profitable than AmnioBed or for which there may be a greater likelihood of success.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.

We depend on third parties for clinical and commercial supplies, which could affect our business. We also rely on third parties to conduct our preclinical studies and clinical trials.

Description of Securities for Prior Reg CF Raise

Additional issuances of securities. Following the Investor’s investment in the Company, the Company may sell interests to additional investors, which will dilute the percentage interest of the Investor in the Company. The Investor may have the opportunity to increase its investment in the Company in such a transaction, but such opportunity cannot be assured. The amount of additional financing needed by the Company, if any, will depend upon the maturity and objectives of the Company. The declining of an opportunity or the inability of the Investor to make a follow-on investment, or the lack of an opportunity to make such a follow-on investment, may result in substantial dilution of the Investor’s interest in the Company.

Issuer repurchases of securities. The Company may have authority to repurchase its securities from unitholders, which may serve to decrease any liquidity in the market for such securities, decrease the percentage interests held by other similarly situated investors to the Investor, and create pressure on the Investor to sell its securities to the Company concurrently.

A sale of the issuer or of assets of the issuer. As a minority owner of the Company, the Investor will have limited or no ability to influence a potential sale of the Company or a substantial portion of its assets. Thus, the Investor will rely upon the executive management of the Company to manage the Company so as to maximize value for unitholders. Accordingly, the success of the Investor’s investment in the Company will depend in large part upon the skill and expertise of the executive management of the Company. If the Management of the Company authorizes a sale of all or a part of the Company, or a disposition of a substantial portion of the Company’s assets, there can be no guarantee that the value received by the Investor, together with the fair market estimate of the value remaining in the Company, will be equal to or exceed the value of the Investor’s initial investment in the Company.

Transactions with related parties. The Investor should be aware that there will be occasions when the Company may encounter potential conflicts of interest in its operations. On any issue involving conflicts of interest, the executive management of the Company will be guided by their good faith judgement as to the Company’s best interests. The Company may engage in transactions with affiliates, subsidiaries or other related parties, which may be on terms which are not arm’s-length, but will be in all cases consistent with the duties of the management of the Company to its unitholders. By acquiring an interest in the Company, the Investor will be deemed to have acknowledged the existence of any such actual or potential conflicts of interest and to have waived any claim with respect to any liability arising from the existence of any such conflict of interest.

Minority Ownership

An Investor in the Company will likely hold a minority position in the Company, and thus be limited as to its ability to control or influence the governance and operations of the Company.

The marketability and value of the Investor’s interest in the Company will depend upon many factors outside the control of the Investor. The Company will be managed by its officers and be governed in accordance with the strategic direction and decision-making of its Management, and the Investor will have no independent right to name or remove an officer or member of the Management of the Company.

Following the Investor’s investment in the Company, the Company may sell interests to additional investors, which will dilute the percentage interest of the Investor in the Company. The Investor may have the opportunity to increase its investment in the Company in such a transaction, but such opportunity cannot be assured.

The amount of additional financing needed by the Company, if any, will depend upon the maturity and objectives of the Company. The declining of an opportunity or the inability of the Investor to make a follow-on investment, or the lack of an opportunity to make such a follow-on investment, may result in substantial dilution of the Investor’s interest in the Company.

Exercise of Rights Held by Principal Shareholders

As holders of a majority-in-interest of voting rights in the Company, the unitholders may make decisions with which the Investor disagrees, or that negatively affect the value of the Investor’s securities in the Company, and the Investor will have no recourse to change these decisions. The Investor’s interests may conflict with those of other investors, and there is no guarantee that the Company will develop in a way that is optimal for or advantageous to the Investor.

For example, the unitholders may change the terms of the operating agreement for the company, change the terms of securities issued by the Company, change the management of the Company, and even force out minority holders of securities. The unitholders may make changes that affect the tax treatment of the Company in ways that are unfavorable to you but favorable to them. They may also vote to engage in new offerings and/or to register certain of the Company’s securities in a way that negatively affects the value of the securities the Investor owns. Other holders of securities of the Company may also have access to more information than the Investor, leaving the Investor at a disadvantage with respect to any decisions regarding the securities he or she owns. The unitholders have the right to redeem their securities at any time. Unitholders could decide to force the Company to redeem their securities at a time that is not favorable to the Investor and is damaging to the Company. Investors’ exit may affect the value of the Company and/or its viability. In cases where the rights of holders of convertible debt, SAFES, or other outstanding options or warrants are exercised, or if new awards are granted under our equity compensation plans, an Investor’s interests in the Company may be diluted. This means that the pro-rata portion of the Company represented by the Investor’s securities will decrease, which could also diminish the Investor’s voting and/or economic rights. In addition, as discussed above, if a majority-in-interest of holders of securities with voting rights cause the Company to issue additional units, an Investor’s interest will typically also be diluted.

Restrictions on Transfer

The securities offered via Regulation Crowdfunding may not be transferred by any purchaser of such securities during the one year period beginning when the securities were issued, unless such securities are transferred:

  • to the issuer;
  • to an accredited investor
    ;
  • as part of an offering registered with the U.S. Securities and Exchange Commission; or
  • to a member of the family of the purchaser or the equivalent, to a trust controlled by the purchaser, to a trust created for the benefit of a member of the family of the purchaser or the equivalent, or in connection with the death or divorce of the purchaser or other similar circumstance.

Valuation Methodology for Prior Reg CF Raise

The offering price for the securities offered pursuant to this Form C has been determined arbitrarily by the Company, and does not necessarily bear any relationship to the Company’s book value, assets, earnings or other generally accepted valuation criteria. In determining the offering price, the Company did not employ investment banking firms or other outside organizations to make an independent appraisal or evaluation. Accordingly, the offering price should not be considered to be indicative of the actual value of the securities offered hereby.

The initial amount invested in a SAFE is determined by the investor, and we do not guarantee that the SAFE will be converted into any particular number of units . As discussed in Question 13, when we engage in an offering of equity interests involving Units , Investors may receive a number of Units calculated as either (i) the total value of the Investor’s investment, divided by the price of the Unit being issued to new Investors, or (ii) if the valuation for the company is more than the Valuation Cap, the amount invested divided by the quotient of (a) the Valuation Cap divided by (b) the total amount of the Company’s capitalization at that time. Because there will likely be no public market for our securities prior to an initial public offering or similar liquidity event, the price of the Units that Investors will receive, and/or the total value of the Company’s capitalization, will be determined by our management . Among the factors we may consider in determining the price of Units are prevailing market conditions, our financial information, market valuations of other companies that we believe to be comparable to us, estimates of our business potential, the present state of our development and other factors deemed relevant. In the future, we will perform valuations of our units that take into account, as applicable, factors such as the following:

  • unrelated third party valuations;
  • the price at which we sell other securities in light of the relative rights, preferences and privileges of those securities;
  • our results of operations, financial position and capital resources;
  • current business conditions and projections;
  • the marketability or lack thereof of the securities;
  • the hiring of key personnel and the experience of our management;
  • the introduction of new products;
  • the risk inherent in the development and expansion of our products;
  • our stage of development and material risks related to our business;
  • the likelihood of achieving a liquidity event, such as an initial public offering or a sale of our company given the prevailing market conditions and the nature and history of our business;
  • industry trends and competitive environment;
  • trends in consumer spending, including consumer confidence;
  • overall economic indicators, including gross domestic product, employment, inflation and interest rates; and
  • the general economic outlook.
We will analyze factors such as those described above using a combination of financial and market-based methodologies to determine our business enterprise value. For example, we may use methodologies that assume that businesses operating in the same industry will share similar characteristics and that the Company’s value will correlate to those characteristics, and/or methodologies that compare transactions in similar securities issued by us that were conducted in the market.

Company

Amnion Life LLC
  • California Limited Liability Company
  • Organized May 2016
  • 1 employees
2618 San Miguel Dr #149
Newport Beach CA 92660 http://amnion.life

Business Description

Refer to the Amnion Life LLC profile.

EDGAR Filing

The Securities and Exchange Commission hosts the official version of this annual report on their EDGAR web site. It looks like it was built in 1989.

Compliance with Prior Annual Reports

Amnion Life LLC has previously not complied with the reporting requirements under Rule 202 of Regulation Crowdfunding.

They failed to submit an annual report in the past.

All prior investor updates

You can refer to the company's updates page to view all updates to date. Updates are for investors only and will require you to log in to the Wefunder account used to make the investment.

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