|1||Amniobed is designed to prevent hypothermia in preterm infants.|
|2||Hypothermia is associated with increased rate of mortality and morbidity.|
|3||Infant incubator with synthetic amniotic fluid replicating the environment of the womb.|
|4||Patents issued in the US and China. Pending in Europe, Japan, India and Australia.|
|5||25% - 78% of very preterm infants in the US and 53% of very preterm infants in a large European study had hypothermia in 1st hour of life.|
|6||Raised $1.44M in previous rounds.|
|7||3 Years of R&D. Designed, sourced, procured and assembled Amniobed Golden Hour plus software.|
Every year, 15 million babies are born before their due date. With very thin skin, little subcutaneous fat, and underdeveloped organs, preterm infants are highly vulnerable to heat loss, which can lead to hypothermia, a drop in their core body temperature of more than one degree Celsius. Hypothermia in preterm infants is a serious concern which can lead to significant stress reaction and is directly associated with subsequent increased incidence of respiratory distress, apnea, convulsions, anemia, sepsis, periventricular leukomalacia, necrotizing enterocolitis, meningitis, brain hemorrhage and death.
In the U.S., complications from premature birth is the leading cause of death for infants.
The first hour of care in the field of neonatology and trauma is called the 'golden hour'. Proper medical care in first sixty minutes after trauma or birth is highly consequential in determining the short term and longer term outcomes. Infant hypothermia in the golden hour of care is called 'transitional hypothermia' and is a great medical concern. In large European and American studies, the incidence of 'transitional hypothermia' in very preterm infants has been reported as much as %53 and as high as 78% in extreme preterm infants. (Wilson et al. 2016) (Bhatt et al. 2007)
Transitional Hypothermia in the golden hour is linked to increased chance of negative outcomes and increased chance of subsequent infant death. It can be and it must be prevented. Prevention of transitional hypothermia in infants is what Amniobed Golden Hour is being designed to prevent.
Amniobed Golden Hour is the first incubator utilizing synthetic amniotic fluid designed to prevent transitional hypothermia in preterm infants.
We believe we can build a better incubator. Our patented solution, the AmnioBed, recreates the natural in-womb environment to nurture critical ongoing development, decreasing the short and long-term complications common in premature births.
AmnioBed is a new approach to incubation. We submerge the infant partially in specially crafted fluid that mimics a mother's amniotic fluid in temperature, electrolyte balance, pH and minerals. This way, the infant can stay warm upon birth in a fluid environment just like they would in the womb, instead of use of humidified incubators or radiant warmers.
Over the three years, we've done tremendous amount of research and development to design and develop our first product, Amniobed Golden Hour. Below is time-lapse video of our engineers in Serbia building the device.
Over the next six to 12 months, we plan to do the necessary safety testing of the device. All plastic that come into contact with fluid that comes into contact with infant needs to be tested for safety. All electrical components needs to meet international ISOstandards and FDA requirements for testing. Software needs to be tested and validated and finally, doctors and nurses need to perform usability testing to ensure the device is safe prior to our first clinical trials.
Founded Amnion Life
1st Round Seed Funding Secured
With funds raised, began R&D and feasibility study.
Cleanroom R&D facility built in Pozega, Serbia - Amnion Life Pozega LLC Established
US AmnioBed Patent Application Granted by USPTO
International Patent Application Through PCT Approved
Proof of Concept Design Completed
Parts and Material for Prototype Sourced and Procured
2nd Round of Seed Funding Secured
Prototype Built and Prepared for Initial Testing
Quality Management System in Place
Initial Risk Analysis Completed
Comprehensive clinical review of device User Needs completed by Clinical Team
Initial Clinical Evaluation Report prepared
Artificial Placenta R&D Completed –Patent application drafted and submitted
Second Patent on Amniobed obtained - Expanded claims to include adult size patients
Awarded 2nd place out of 100 competing companies at Stanford-UCSF Pediatric Device Consortium
Completed Reg CF Crowdfund Round [raised $305K from 186 investors]
Amniobed’s Patent Application granted and issued in China.
Our patent portfolio now includes multiple patents on Amniobed. Our patent claims on Amniobed were broadened on subsequent application to include adult size patients. In addition, we were awarded a US patent on Artificial Placenta. Below is the roadmap for our future product development:
Nothing in the world is as precious as life. When a new infant is born, as a society, we take collective responsibility to protect their lives and ensure that the necessary resources for a nourishing and comfortable environment are in place. Our infants and children are vulnerable – they require and deserve tremendous care. Specifically, preterm infants are the most vulnerable, and therefore require the greatest care.
Preterm infants have bodies accustomed to and in need of the warm and nourishing world of mother's womb. Outside the womb, they cannot survive without great effort to keep them warm, oxygenated and nourished. Virtually any environmental issue during this early stage has the potential to lead to life-long difficulties and disabilities. To date, our health care system has done a tremendous job caring for and nourishing preterm infants until they are safe enough to be discharged home. But the healthcare we currently provide is not enough. There are still too many preterm infants leaving hospitals with life-long disabilities. Others endure lengthy stays in the NICU that can last 110 - 140 days, or more, causing tremendous psychological, social and economic hardship for families. Our goal is to get preterm infants discharged and home – healthier, quicker and with fewer complications.
We as a company feel honored and blessed to shoulder the responsibility to help improve the lives of our preterm infants. I am also honored and excited to be working with a team of individuals from across the world who share the same passion and dedication to this project. As a team, we are determined to build a safe and effective incubator, significantly superior to the 20th-century technology still in use today. We believe the environment found “in the womb” is the gold standard of care at this stage of human development, and progress towards a fluid environment for these infants is natural and expected. We are proud to be at the forefront of that progress.
We realize that our path is long and difficult. Yet we have already come a long way and will remain focused because our goal is too critical for humanity to allow it to go unrealized. We believe that our investors will be financially well rewarded for their support - but the greatest reward for us will be to witness the countless lives improved and saved, and the countless number of families that get to spend a lifetime together because of this new technology.
Amnion Life has financial statements ending December 31 2019. Our cash in hand is $45,830, as of April 2020. Over the three months prior, revenues averaged $0/month, cost of goods sold has averaged $0/month, and operational expenses have averaged $12,000/month.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this offering. Some of the information contained in this discussion and analysis, including information regarding the strategy and plans for our business, includes forward-looking statements that involve risks and uncertainties. You should review the "Risk Factors" section for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Nearly 15M infants worldwide are born premature. Due to underdeveloped organs, the dramatic shift from amniotic fluid to air puts them at risk for hypothermia, dehydration, and infections which can lead to sepsis, organ injuries, and even death. To substantially improve preterm infants' chances of survival and reduce the time needed in intensive care, we designed AmnioBed, a patented, cost-efficient, fluid-filled solution that can mimics a mother's amniotic fluid environment.
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.
Given the Company’s limited operating history, the Company cannot reliably estimate how much revenue it will receive in the future, if any.
Amnion Life LLC was incorporated in the State of California in May 2016.
Since then, we have:
Historical Results of Operations
Our company was organized in May 2016 and has limited operations upon which prospective investors may base an evaluation of its performance.
Related Party Transaction
Refer to Question 26 of this Form C for disclosure of all related party transactions.
Liquidity & Capital Resources
To-date, the company has been financed with $194,653 in debt, $1,011,000 in convertibles, and $125,000 in SAFEs.
After the conclusion of this Offering, should we hit our minimum funding target, our projected runway is 12 months before we need to raise further capital.
We plan to use the proceeds as set forth in this Form C under "Use of Funds". We don’t have any other sources of capital in the immediate future.
We will likely require additional financing in excess of the proceeds from the Offering in order to perform operations over the lifetime of the Company. We plan to raise capital in 6 months. Except as otherwise described in this Form C, we do not have additional sources of capital other than the proceeds from the offering. Because of the complexities and uncertainties in establishing a new business strategy, it is not possible to adequately project whether the proceeds of this offering will be sufficient to enable us to implement our strategy. This complexity and uncertainty will be increased if less than the maximum amount of securities offered in this offering is sold. The Company intends to raise additional capital in the future from investors. Although capital may be available for early-stage companies, there is no guarantee that the Company will receive any investments from investors.
Runway & Short/Mid Term Expenses
Amnion Life LLC cash in hand is $45,830, as of April 2020. Over the last three months, revenues have averaged $0/month, cost of goods sold has averaged $0/month, and operational expenses have averaged $12,000/month, for an average burn rate of $12,000 per month. Our intent is to be profitable in 36 months.
Since December 31, 2019 the spread of COVID-19 has severely impacted many local economies around the globe. In many countries, businesses are being forced to cease or limit operations for long or indefinite periods of time. Measures taken to contain the spread of the virus, including travel bans, quarantines, social distancing, and closures of non-essential services have triggered significant disruptions to businesses worldwide, resulting in an economic slowdown. Global stock markets have also experienced great volatility and a significant weakening. Governments and central banks have responded with monetary and fiscal interventions to stabilize economic conditions.
The Company has taken measures to comply with travel bans, quarantine and social distancing
guidelines. As such, the Company's research facility in Pozega, Serbia has limited its operations to comply with the guidelines and requirements for the duration of the pandemic. In addition, the Company canceled two private events in California which were intended to raise capital for the Company. This compliance is expected to add delays in the development of our products. The overall economic slowdown is also anticipated to add additional risks and difficulties in raising money in future rounds due to the volatile financial situation risen from the pandemic.
The Company has determined that these events are non-adjusting subsequent events. Accordingly, the financial position and results of operations as of and for the year ended December 31, 2019 have not been adjusted to reflect their impact. The duration and impact of the COVID-19 pandemic, as well as the effectiveness of government and central bank responses, remains unclear at this time. It is not possible to reliably estimate the duration and severity of these consequences, as well as their impact on the financial position and results of the Company for future periods.
Note: this disclosure is based on management’s assumption that there is no significant doubt about the entity’s ability to continue as a going concern.
There is no expected revenue over the next six months. The Company's expenses are expected to be further limited to less than $10,000 per month. As a result of the pandemic, the Company took steps to cancel two private fundraising events in California intended to raise capital. The Company intends to reschedule those events once restrictions are lifted in order to raise additional capital. We expect it will take between $2.5M - $5M in total financing for us to reach break even. We hope to begin generating revenues in 2022.
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.
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.
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.
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.
Competitors successfully challenging Company's patent and other intellectual properties and entering the market with similar devices.
Clinical Trials for the device do not meet Superiority classification requirements compared to previous devices currently on the market.
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 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.
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.
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.
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 may be exposed to claims and may not be able to obtain or maintain adequate product liability insurance.
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.
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 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.
System failures may disrupt our business operations and delay our product development programs and commercialization activities.
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.
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.
The commercial success of our medical device products depends on the availability and sufficiency of third-party payor coverage and reimbursement.
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 build our marketing and sales capabilities or enter into agreements with third parties to market and sell our medical device products.
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.
Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.
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.
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.
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.
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 commercial success depends largely on our ability to protect our intellectual property.
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 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.
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.
We may be subject to claims from third parties that our products infringe their intellectual property rights.
Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
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.
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.
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
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