Increasing Survivability and Thrivability for Preterm Infants
The inspiration behind Amnion Life, a medical device company occurred 4 years ago during a family trip where we visited a cousin in Europe. They had a beautiful little 3 year old girl who we knew was born very preterm and had a long NICU stay.
This led to complications, including ocular and neurodevelopmental injuries. She needs and will continue to need daily assistance. The overall emotional and financial stress for her parents is immeasurable.
3 weeks later on the same trip, I had a dream that preterm infants should be placed in synthetic amniotic fluid, a controlled bath. The idea, to keep preemies warm and hydrated during their stay in NICU thus avoiding the root cause of many devastating complications seen today.
Per the March of Dimes
- “Premature Birth is the #1 cause of death for babies in the US.”
- The past 25 years saw premature births increase more than 35%.
- Today, one preemie is born every minute.
- The ones who survive often have long-term health problems.
- This creates a lifetime of financial and emotional costs.
NICU Level 3 & 4 Preemies are
- Brain Hemorrage
- Respiratory Distress
- Periventricular Leukomalacia
- Necrotizing Enterocolitis
- Bronchopulmonary Dysplasia
- During pregnancy, Babies live in a comfortable 37c amniotic fluid which provides total temperature regulation and skin protection.
- When the pregnancy is interrupted, Babies are thrown into a very hostile environment one that is not built for development of sensitive organs.
- Subject to hypothermia and dehydration, These babies are subject to all kinds of calamity.
Million Dollar Babies
- Infants, until the 8th month of pregnancy, are designed for a comfortable 37c fluid environment, with no need for temperature regulation.
- The skin is permeable and actually absorbing water from the amniotic fluid.
- When nature’s processes are disrupted the extreme or very preterm infant is born into a cold and hostile” environment.
- They are no longer absorbing fluid from their surroundings, but instead, are losing large amounts.
At these very early stages of development:
- The infant has very little subcutaneous fat and 3x surface-area to volume when compared to full terms.
- This lack of insulation combined with their vessels closeness to the skin causes a large amount of heat loss.
- Their bodies have yet to develop the heating mechanisms that term infants have such as a shivering mechanism, brown fat, or muscular activity that generates heat.
To compensate, they rev up their metabolism and redirect calories needed for growth towards heat generation further delaying the development of their natural heating mechanisms. The combination of Hypothermia and Dehydration is devastating to all preterm infants. The extreme preterm infants can have lengthy NICUs stays of 110 days average and are often referred to as million dollar babies.
The incidence of hypothermia in low and very low birth weight preemies.
- A minimum of 25% among infants <2500 g birth weight
- 56% or greater in infants <750 g within 30 minutes of birth
- An average of 31-78%in infants <1500 g before admission to neonatal intensive care unit. (Bhatt et al. 2007)
To solve this, we have borrowed our ideas from nature.
AmnioBed™, a proprietary device creating
- A controlled bath environment
- The infants head kept safely above the fluid line at all times
- The synthetic fluid is continuously cleaned, monitored, refreshed, and heated
- The osmolality adjusted by medical staff
Thereby recreating the in-womb conditions that allow the infant to survive and thrive.
AmnioBed™ is fluid filled incubator intended to create a warm and safe environment for growth and development of preterm infants.
Five Medical grade water purification filters eliminating heavy metals, contaminants, and microorganisms from the hospital water supply and bringing the water to dialysis grade purification standards.
A medical grade heating system to create on-demand warm water at 98.6F.
Significant safety mechanisms for fluid temperature regulation.
Custom made disposable cartridges filled with concentrated electrolyte and mineral content.
Computer operated dosing pump mixing concentrated electrolyte and mineral solution with purified water.
Capability to adjust synthetic amniotic fluid osmolality from 280mosm/ml to 240 mosm/ml per medical team requirements and infant needs.
Sterile and disposable bath cover and infant harness made of medical grade plastics.
Safety chest and pelvic harness to prevent the infant from submerging into the fluid.
Ergonomically designed infant bed for comfortable positioning of the infant.
Comfortable and natural fluid environment for infant exercising of arms and legs.
Continous filtration of bath fluid through medical grade UV filters.
Fluid clarity sensor to detect stool and automatically flush bath fluid when infant defecates.
Specially designed infant cap with built-in ECG sensors, EEG sensors, Infrared sensor, skin temperature sensor, O2 Saturation sensor and cap opening on the anterior fontanelle for ultrasound probe placement.
Bridge and anchor over the fluid to protect the umbilical catheters from getting submerged.
Audio and Video feed to a smart app on mother's phone for remote visual observation of infant at all times and for remotely speaking to the infant and exposure of the infant to mother's voice.
Amir Fassihi MD Answers: Infant in AmnioBed sits on a donut shaped cushion. The fluid directly below the genitals is constantly monitored for stool content and if stool is detected, the computer system automatically flushes the bath fluid and replaces it with fresh warm synthetic amniotic fluid. The fluid in the bath is also continuously circulated through a UV filter that kills 99% of pathogens on every pass. Infant urine in the bath is not a problem as natural amniotic fluid in mother’s womb is mostly made of fetal urine.
– when the infant is connected to intravenous lines, an umbilical catheter, an endotracheal tube, has a functioning GI tract and is accessed by medical staff and the family?
Amir Fassihi MD Answers: Thank you for our very important question. We’ve spent 3 years on R&D on this element and safety mechanisms in our patent application are what makes our IP unique in this field and why we think we will be the leaders in next generation of synthetic amniotic fluid incubators for preterm infants.
In AmnioBed, the infant is safely and securely harnessed in the bath on angled seat with head and neck above fluid line at all times. The infant wears a head cover/device which partly helps to reduce heat and water loss from head and neck area, but also has important sensors such skin temperature monitoring and O2 saturation monitoring. It also has a fluid sensor on the chin area which can detect fluid if levels rise above the chin so that it can automatically lower fluid level and inform nursing.
We are working on either placing the ECG leads partly on the head/scalp monitoring device or possibly on the bath itself and pick on signal in the bath. Our concern at this time is the noise level on the signal and we will have to do some testing to see where is the best place to capture ECG signal for monitoring. On the central lines, we are developing an umbilical catheter anchoring system to help maintain umbilical catheters isolated from bath fluid at all time. How it works is that in current practice the umbilical cord is cut at 5cm from abdominal wall. We are going to ask cord to be cut at 6-10cm from abdominal wall. The distal 1cm tip of the cord will be anchored device above the fluid line.
The catheter is inserted from the distal tip above the fluid line and anchored in place together with the distal tip of the cord. A plastic splash-proof cover is then being developed to cover the catheter from splashes. As far as peripheral lines, that would be in further development down the line and not necessary in the initial clinical trials and initial infant population if infant has umbilical catheter in place.
But if our device proves to be safe for longer than life of umbilical catheters, our current strategy is to float the extremity and cover with splash-proof cover. We are going to add some new 3D rendered images of the infant in the seat with the infant seat, head scalp monitoring and umbilical catheter.
The fluid in the bath is continuously cleaned, monitored, refreshed, filtered, heated and its osmolality adjusted according to medical needs. If stool particles are detected by our sensors, there is automatic flushing of fluid and replacement with clean warm simulated amniotic fluid. We are going to add some new 3D rendered images of our seat, scalp monitoring device and umbilical catheter anchoring system on our updates on our website this week. Thank you for your very important question and interest.
Amir Fassihi MD Answers: We’ve designed a special seat with cover/harness which the infant sits in and contains the fluid. The infant is seated similar to an infant on a car seat with harness over the pelvis and chest. The harness prevents infant from slipping down into the fluid. We’ve also designed special head gear for infant monitoring devices as O2 and skin tempreture which includes a fluid sensor place on the chin area. The sensor is linked to device computer system and device will automatically lower fluid level if it senses chin being submerged.
The neonate’s in your incubator don’t appear to have any boundaries. As a NICU nurse, this concerns me. Being at the bedside, we see a direct correlation in stable vital signs and lower oxygen needs when our infants are positioned correctly. They are more comfortable, they sleep better, and their weight gain is improved. I even personally feel like it aids in digestion, as I see less reflux and residuals when my infant is calm and contained. We use a z-flow pad and tube to position all our micropreemies; this keeps their position as close to the womb as possible while also providing them a boundary to push and kick against. How will we provide boundaries for an infant surrounded by fluid?
Of course I am also wondering how we will safely secure umbilical lines, PICC lines, peripheral IVs, and PALs, and then also be able to position that limb correctly to provide comfort and security to the baby.
What about kangaroo care? We start kangaroo care on day five of life, even in a 23 weeker who is intubated, if they are stable enough. What will be the ramifications of an infant having to be removed from that environment possibly one or more times daily? Will there be a way to weigh the infant each day without draining the fluid? How will we maintain temperature stability if we are constantly draining and re-filling the fluid?
Amir Fassihi MD Answers: Thank you for your thoughtful and expert questions. These are matters which have preoccupied our research and thought for three years and I am glad you are addressing it as well.
As far as positioning of the infant, we are currently working on an ergonomic comfortable seat with special head rests made for the infants. We are currently trying to do some R&D on adjustable head and neck rest so that a nurse can adjust the head and neck rest similar to a car seat. However, please note that the current design will likely be significantly changed and redone as we progress through usability studies and clinical trials. We are currently projecting a pilot study of 5-10 infants for a maximum of 60 minute bath. We will learn many things from such a trial. However, we have a long way to go with usability testing of the device by nurses (without an infant) followed by potential animal studies before we can do the final design of the seat and neck/headrest. (see photos below on head positioning)
Regarding your question about fetal in-womb push against amniotic sac which aids in bone development, this is also something we’ve taken into consideration. Our challenge in this regard is similar to the current incubator technology. In the current incubators, the infants also don’t have the natural amniotic sac to push against which aids in musculoskeletal development. What we’ve considered is a slightly heavy see-through plastic cover on the infant which can simulate the pressure and comfort of the amniotic sac. But since our initial trials will be in 60 minute or later on on less than 24 hour stays, we are going to tackle that issue when we further design the device for longer AmnioBed stays of >24 hours.
Regarding your concerns about central lines and PICC lines, this is perhaps our most important challenge and something we’ve done significant work on. This is a very important point you have raised. Please refer to Dr Hardy’s questions on our website under FAQ. In addition, photos of how we will attach IV lines via the umbilical cord can be found under the section: Updates From Our Research Facility.
Regarding Kangaroo care, our device will have the same restrictions for removal from the incubator as the current convection incubators. Infants can be removed for kangaroo care and placed back into the incubator at any time if kangaroo care is deemed safe by the nurse and medical staff.
Regarding nursing consultants, that is on our wish list at the moment for the company, but we are limited on funds and still early in the product development. I’ve had the opportunity to discuss our concerns and seek input from NICU nurses unofficially, but with the limited budget we’ve had, we decided that we need expert neonatologists first to make sure all medical needs and concerns are addressed prior to working on the details of the nursing requirements and needs such as positioning and device everyday usability and ease of use.
We look forward to answering any questions you may have. You can submit your questions on our contact us page.
- The caregivers who deal with these life and death situations daily
- Parents who can only stand by and cheer for their hopes and dreams to be realized while in the back of their mind, worrying about the financial implications.
- The public and private insurers who fund health for their insured will stand to save billions.
- For the reduction of time in the NICU that each infant will benefit from
- For the reduction of a lifetime of expenses covering the infant’s complications into childhood and beyond.
- And then there is the preemie who stands a better chance of having a normal life.
Amnion Life is dedicated to drastically improve the care of preterm infants.
Amir Fassihi M.D.
Dr. Fassihi performed his undergraduate work in the field of biology and ecology at UCLA. He was ranked 161 amongst a pool of nearly 35,000 applicants to UCSF School of Medicine for the 1995 incoming class. Upon obtaining his medical degree from UCSF, he spent a year as an intern in general medicine department at VA/West LA Medical Center followed by residency in field of radiology at Keck/USC Medical Center followed by a year of fellowship in Neuroradiology during which time he was the Chief Fellow.
He is a full-time radiologist working as a teleradiologist for Virtual Radiologic and he plans to continue his full-time work as a radiologist during the upstart stage of Amnion Life. Dr. Fassihi intends to initiate operations as the CEO to ensure a smooth operations transition and to build a culture for employees to share in the same dedication and work towards the success of Amnion Life.
Molly’s senior-level leadership and strategic planning expertise encompass pre-commercial regulatory, reimbursement and market entry alignment, strategic market development, market identification, and overall business infrastructure planning for startup, and high-growth companies across multiple industries and a specialty within the medical device industry. She has a strong understanding of healthcare and medical market environments across consumer, hospital, clinical, government, and military segments, and various vertical markets.
BSc Mechanical engineer, with nine years of experience in R&D and production areas, as well as experience in laboratory as a tester and manager.
Experience in system instrumentation and automation top level and detail design, involving activities such as 3D and 2D CAD design, FEA/CFD and prototyping of new and re-engineering or retrofit of existing products, as well as sizing calculations, material selection, producing workshop drawings and technical data sheets. Supervising prototype manufacturing and testing. Application of relevant standards and codes to a product design. Laboratory setup, testing and management according to ISO 17025
Milija has a Master of Science (M.S.) in mechatronics and eight years of experience in electronics, specifically in designing sensors and electronic components. His expertise is in sensor physics, sensor testing with data processing, robotics, microcontrollers and PLC controllers, and SCADA Systems. He has experience working with software packages Matlab, LabView, Autocad, MS office, Protel, Eagle Cad Soft, and others. Milija specifically designs and assists with updating AmnioBed electrical diagrams.
R&D, 3D modeling, technical documentation, productions organization, production, manage suppliers. QC
Bachelor of Engineering (B.Eng.), Mechanical engineering | Mechanical Faculty of Nis, Serbia 2003 – 2010
Productions engineering, rapid prototyping, preparation of technical documentation for production, R&D
CAD Design – Drafting
Mechanical engineer with 30 years of experience in the design of machines, tools and equipment for the production of the civilian sector. 3D/2D CAD SolidWorks as an optimal software for the realization of projects.
Bachelor of Engineering (B.Eng.), projecting and production
Having more than 12 years experience in 2D and 3D artwork, with various different design fields, I know we are the ones who can bring your desings to life. I have always been enthusiastic about design, not only for its use in the world, but for its sense of innovation and sophistication. As an Industrial Designer, my experience, skills, passion, and enthusiasm have lead me to find a team who also meet that criteria. I feel my experience, skills, personality and enthusiasm would make me an ideal choice for your design needs.With extensive experience in 2D and 3D artwork and different design fields,I can make your ideas become reality.I am providing most comprehensive Computer Aided Design services available today and is an offshore solution for CAD contracting services like CAD conversion, CAD drafting, Auto CAD drawing drafting, CAD digitization,SolidWorks 3D modeling Conversion of manual drawings to CAD,High Resolution Animation,Surface Design. Animation, WebDesign, LogoDesign, Illustration etc..
Electrical Engineer For Electronics (M.S.) and 20+ years of experience in many areas of electronics: analog, digital, and RF electronics, embedded systems, medical electronics, artificial neural networks, robotics…
Knowledge and experience in the entire design process, from requirements, schematics, simulations, PCB layout, to build and test a physical prototype. Also have skills in programming micro controllers, FPGAs, PLCs, or desktop applications.
Skilled in: Protel, PSpice, Xilinx-ISE, MATLAB, Delphi, Visual Studio.
Programing languages: C, C++, VHDL, Relay Ladder, Pascal, Java, HTML.
Graduated from the Faculty of Electrical Engineering
– Maintenance of telecommunication systems in telecoms company.
– Work in the company for the production of DDR memory, MP3 player, USB memory. Release in serial production of devices, quality control of products.
– Experience in designing PCB board on the Protel and Altium platform,
– Design of devices based on Microchip and Atmel controller. Creating programs for microcontrollers with 8 bit processor , in the Image Craft environment.
– Design of embedded devices based on 32-bit controller STM 32F407. The application development platform is Keil uVision4.
– Creating applications for the Windows environment in Delphi 7. Applications are intended as HMI for projects where one of the controllers is used.
– 13 years of experience in making applications (ladder diagram and Structured Control Language) for Siemens PLC controllers. Environment is Step7, the Tia portal. Applications have been made for the control and monitoring of pumping plants, drinking water treatment plants, presses, sintering lines, etc ..
– Creating applications for Unitronics PLC controllers in the U90 environment.
– Production of applications for HMI devices manufactured by: Siemes, Wintec and Schneider.
– Creation of SCADA applications in WinCC environment up to 8000 tags.
CAD Design – Drafting
BSc Mechanical engineer with 7 years of experience in the design of tools and equipment for the production of the civilian sector.
3D/2D CAD SolidWorks as an optimal software for the realization of projects.
Graduated Telecommunication engineer with more than 15 years leadership experience in the field of Telecommunication. Quality Systems Consultant and certified auditor for medical devices (ISO 13485), QMS (ISO 9001) with experience in preparation of QMS documentation, Medical Device Management System, Regulatory Requirements, Risk Management, CE marking – Technical file requirements, Software development requirements (IEC 62304), RoHS2 Technical documentation, Clinical Evaluation, Education of employees for quality according to the requirements of ISO 9001, ISO 13485 and ISO 14971.
Licensed Chemical adviser
I worked as engineer of technology in R&D department and as Production manager in plants which manufactured household and industrial chemicals, personal care and cosmetics. Parallelly working for more then 6 years now as chemical adviser for subjects from Serbia and abroad. Possessing national chemical adviser license – REACH EU regulations, related to Registration, Evaluation, Authorization and Restriction of chemicals and biocides in EU. From 2016 I work as independent consultant for chemicals, biocides and cosmetic formulations, as part of ChemEng Pro team(Netherlands), for clients from all over the world from my homeoffice. Through work experience I worked also as responsible person for ISO 9001, 14000, 18000, HACCP and as licensed internal auditor.
Part of my university education was also Medical devices, related regulations and professional practices of it.
I speak English fluently and use it in everyday communication, learned German and Swedish (B1 level) but do not use it.
Michael Drues, Ph.D.
Michael Drues, Ph.D., is a medical technology and regulatory strategy consultant specializing in bringing medical products to market in creative and innovative ways and keeping them on the market once they get there. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.
Danny is a business leader with over 18 years of demonstrated excellence in effective management of global regulatory risk.
Danny has led teams in small, medium, and large companies at site, divisional, and corporate levels. He has hands-on experience with R&D, Clinical Investigation, Manufacturing, and Post-market Surveillance operations. Danny is passionate about application of this experience, and deep knowledge of regulations, for rapid device commercialization.
Danny holds an engineering degree from RMIT University in Melbourne, Australia and an MBA from IE Business School in Madrid, Spain. He is an ASQ Certified Quality Manager, ASQ Certified Biomedical Auditor, and IAPP Certified Information Privacy Professional.
Quality Systems Specialist and Regulatory Affairs Consultant and certified auditor for medical device (ISO 13485), QMS (ISO 9001), Information Security Management Systems (ISO/IEC 27001), Information Technology Service Management (ISO/IEC 20000-1) and Environmental Management Systems (ISO 14001).
Auditing, Medical device, Quality Management Systems, Risk Management, Regulatory Requirements, Technical File for CE Mark, Software Validation, ISMS, ITSM, Process Control, System Improving, Quality Assurance process of production medical devices and laboratory devices in accordance to ISO 9001, ISO 13485, FDA QSR 21 CFR Part 820, ISO 14971, MDD (93/42/EEC) and Regulation (EU) 2017/745.
Risk Management, Risk Analysis and Hazard Identification Consultant
Pharmaceutical and Medical Device Consultant having more than 15 years of experience in end to end implementation of:
– Quality Management System Implementation (ISO 9001: 2015, ISO 13485, ICH Q7 & Q9, USFDA, 21CFR part 210, 211, 820, EU GMP) in pharma, bio-pharma and medical device facilities.
Dragan Cibrev, M.D.
Dragan is currently a neurology resident, and he maintains active interest in the field of early age neurodevelopment.
Having a background in clinical epidemiology, he is eager to address issues regarding translation of novel findings to the clinical practice. His main tools are : IBM SPSS, R studio, Endnote, Microsoft Office.
Mohamed is an International Procurement and Supply Chain Specialist Consultant with more than 17 years of experience in that field both in North America and Europe. With a focus on technology, consumer products, and industrial systems, Mohamed’s expertise covers several industries such as Oil & Gas, Healthcare, Aircraft, and Energy. As a procurement expert, he helps clients reduce their spending on third-party goods and services across both direct and indirect categories. Also, he has worked with clients on large scale cost reduction programs as well as functional organization transformations.
Residing in Portland, Oregon – USA. Mr. Reed holds two degrees – Associates of Science & Associates of Culinary Arts. With approximately 20 years working in the hospitality industry – Mr. Reed provides a depth of knowledge in providing excellent service. Mr Reed has demonstrated initiative, leadership, interpersonal skills, teamwork & goal achievement through educational accomplishments, work experience & volunteer work.
Mr Reed will be providing assistance in a wide range of executive duties for Dr. Fassihi and the staff of Amnion Life LLC.
Michael Narvey M.D.
Mohamed Hamed M.D.
Dr. Hamed completed 5 years of postgraduate education and training in Pediatrics and Neonatology and received an MD, PhD from Nagoya City University, Nagoya, Japan in 2006 after which he accomplished a 3 year Pediatric Surgery and Transplantation fellowship in Fujita Health University, Aichi, Japan in 2010.
Hamed returned to the department of Pediatrics and Neonatology in the Nagoya City University as a lecturer from 2010 to 2013 during which he also worked with the Cure2Children foundation, an international medicinal collaboration with professionals and institutions in developing countries committed to the cure of children with severe hematological diseases, for two years.
From 2013 Hamed joined the Neonatology division of Saitama Medical University as an Assistant Professor of Neonatology. He has special interest in resuscitation and respiratory support of preterm infants.
Joe Kaur M.D.
Dr. Prabhjot Kaur Chohan is commonly known as Joe Kaur. She did her MD with post graduation in Physiology from India and graduation in Psychology from United States. She is currently working as a medical writer, editor, peer reviewer and clinical research assistant in Toronto, Canada.
She has elaborated her competence in clinical research and regulatory writing through her training as a Clinical Research Associate (CRA) and work experience as a research and clinical trials assistant in clinical research related to Bioequivalence/Bioavailability studies and Phase I-IV clinical trials involving different therapeutic areas and medical devices. She got certified with Association of Clinical Research Professionals (ACRP), United States as ACRP Certified Professional and is affiliated as a member with ACRP, Society of Clinical Research Associates (SOCRA) and American Medical Writers Association (AMWA). In addition, the medical and clinical research experience in United States and India developed her insight into research methodologies in the field of clinical trials, Physiology and Psychology, which also boosted her writing and critical thinking skills.
Before focusing on clinical performance analysis, Nathan worked in wide-ranging roles for various medical device companies, with particularly extensive experience in regulatory affairs. He brings a regulatory mindset to each project, and is well-versed in how MEDDEV 2.7/1 r4 and the MDR affect clinical evaluation strategies. As a consultant, he has experience collaborating with individual innovators, startups, and established medical device manufacturers. Nathan has personally authored over 25 CERs and helped numerous companies develop clinical evaluation processes, working closely with internal cross-functional teams and external regulatory entities to ensure deliverables meet the needs of all stakeholders.
He holds a BS in Biomedical Engineering from Bucknell University.
With nearly 7,000 neonatology doctors, nurses and NICU professionals in their membership, 99NICU.org provides Amnion Life an unparalleled access and advice to help us build an international team of medical experts who can oversee the company’s design and development of medical devices for preterm infants and help design and draft the very important clinical trials for our devices.
Shaban is a senior medical student and scientific committee member at Student Research Unit, serving as a research trainer and program coordinator. He has a research experience of five years and has been involved in different types of research projects. Shaban is quite familiar with research databases. He can easily formulate search strategies to search and screen for relevant research articles as well as data extraction and literature review. He is also experienced with referencing and referencing software.
Wilson Sonsini Goodrich & Rosati is the premier legal advisor to technology, life sciences, and growth enterprises worldwide, as well as the venture firms, private equity firms, and investment banks that finance them. We represent companies from entrepreneurial start-ups to multibillion-dollar global corporations at every stage of development. The firm’s attorneys collaborate across a comprehensive range of practice areas and industry groups to help the management, boards of directors, shareholders, and in-house counsel of our clients address their most pressing challenges and pursue their most promising opportunities.
The firm is nationally recognized for providing high-quality services to address the legal solutions required by its enterprise and financial institution clients. Our services include corporate law and governance, public and private offerings of equity and debt securities, mergers and acquisitions, securities class action litigation, intellectual property litigation, antitrust counseling and litigation, joint ventures and strategic alliances, technology licensing and other intellectual property transactions, tax, and employee benefits and employment law, among other areas.
With long-standing roots in Silicon Valley and 15 offices in technology, business, and regulatory hubs worldwide, Wilson Sonsini Goodrich & Rosati has a national presence with a global reach. Over the past five decades, we have developed a wide-ranging international practice, with particular strength in North America, Asia, and Europe.
J.D., University of California, Hastings College of the Law, 2015
Cum Laude; Recipient, CALI and Witkin Award for Highest Grade in Investment Management; Inductee, Pro Bono Society; Executive Managing Editor, Science & Technology Law Journal
B.A., Philosophy, UCLA, 2011
With Highest Honors, College Honors Program; Cum Laude; Departmental Honors in Philosophy
State Bar of California
Jennifer Knapp represents public and private life sciences and technology companies, as well as venture capital and other institutional investors. She focuses on the representation of companies throughout their entire life cycle from formation to exit, and in all manner of strategic and complex transactions, including corporate formation and structuring, venture capital financings, corporate governance, spin-ins and spin-outs, mergers and acquisitions, public offerings, public company disclosure requirements, and SEC compliance matters. She also has significant experience advising investors with respect to venture capital financings and other strategic investments and transactions.
J.D., University of California, Hastings College of the Law, 2001
Magna Cum Laude
B.A., Sociology, University of California, Santa Barbara, 1997
ASSOCIATIONS AND MEMBERSHIPS:
Member, Board of Advisors, Palo Alto Humane Society
Member, Board of Advisors, Food Empowerment Project
Wilson Sonsini Goodrich & Rosati Pro Bono Service Award, 2010-2011
Co-author, “Preparing for an Initial Public Offering” chapter in Advising High-Technology Companies, Practicing Law Institute, 2006
State Bar of California
Zach Jun Hyuk Hong J.D.
Zack specializes in intellectual property law, with an emphasis on U.S. and foreign patent prosecution and patent portfolio management in the chemical, medical device, healthcare IT, and software fields.
Cornell Law School (J.D. 2011)
The Johns Hopkins University (B.S. Chemical & Biomolecular Engineering 2008)
Thomas Yee J.D.
Thomas Y. Yee, a partner in Knobbe and Martens Orange County office, focuses on optimizing the commercial value of the intellectual property of our clients. Leveraging his diverse business experiences, Mr. Yee counsels clients on strategic actions for patent portfolio development, intellectual property transactions and licensing, and trademark portfolio procurement.
Bryan Wahl M.D.
Bryan W. Wahl is a partner in Knobbe and Martens Orange County office. He focuses on intellectual property protection, infringement studies, financings, and strategic transactions especially with respect to medical devices, biotechnology, and pharmaceuticals, and has counseled clients from the pre-Series A stage through exit. Dr. Wahl has represented clients in a variety of technical fields including aesthetic, bariatric, cardiovascular, gynecologic, imaging, neurologic, orthopedic, and pulmonary devices.
Partner at Wright Ford Young & Co.
Hani Sharestan started his career in public accounting in 1993 with a large national firm, before joining Wright Ford Young & Co. in 2006. He obtained his master in business taxation (MST) degree from the University of Southern California and his undergraduate degree from California State University, Fullerton.
Master graduate in Financial Management and Management of Financial Risk
Faculty of Organizational Sciences – year 2012
– Over 5 years of work experience in accounting and financial reporting working in meat production and trade company. Also I’ve been working in bookkeeping company for 2 years and external associate for audit company from Belgrade.
Beyond the dream
US Patent No. 15,342,988 and US Patent No 10,166,161 – Intellectual Property (IP) is represented by Knobbe and Martens law firm who specializes in Intellectual Property strategy, both defensive patent aggregation (DPA) and offensive patent aggregation (OPA). Currently pending in Europe
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By Nick Tippmann, March 12, 2019 , in Case Study and Electronic Quality Management System (eQMS) and QMS Softwareand Medical Device Product
The majority of medical device companies operate on an emphasis of high quality outcomes and scalability. Early investment decisions are daunting for game-changing startups, like Amnion Life. It is important for startups to lay the foundation for success that minimizes risk and unnecessary complexity that can limit their path to market – and it all starts with a strong quality management system.
When investing in an electronic quality management system (eQMS), it is essential for medical device companies to identify a solution that they are confident will improve their processes and allow them to scale effectively. A spreadsheet or paper-based system may sound like a quick or cheap solution, but sacrificing quality in your quality system will only come back to bite you down the road.
The team at Amnion Life was committed to setting themselves up for success from the beginning. We spoke with CEO and founder, Amir Fassihi, M.D. and their Lead Engineer, Milos Radovanovic to better understand how Greenlight Guru helped them lay their foundation for success. As it turns out, the answer was quite simple… read more
Legal Risk Assesment: See Risk Assesment section at end.
- August 19, 2019
- February 27, 2019
- February 13, 2019
- December 2, 2018
- February 20, 2019
The Market U.S. Only
Over $43 Billion is spent annually in the United States on costs associated with premature births.
This includes hospital costs, physician support, and other expenses.
- The US ranks 6th in the number of premature births when compared to other countries.
- The Centers for Disease Control and Prevention (CDC) estimated US premature births in 2016 at 388,130 per year.
- India ranks first among all counties with more than 3.5 Million premature births per year. Globally there are an estimated 15 Million premature births per year.
1/3 of those born are very or extreme preterm and ideally suited for AmnioBed.
The U.S. Market
648 NICU Facilities
19,600 Total Beds
AmnioBed Market Segment (U.S. Only)
Our target market is Level lll and Level lV NICUs
By bed count
309 Level lll and lV NICUs
Beds replaced every 7 – 10 yrs.
@ 8.5 yr avg replacement, =
984 beds replaced each and every yr.
By preterm birth count
Total preterm births 368,129
Very premature < 34 weeks 108,775
Very low birth weight > 34 weeks 870
Total to Benefit from AmnioBed = 109,645
Avg. NICU stay =47 days
Typical Cost of stay = $8K per day
Data from 2016
1472 Beds by 8.5 yr avg replacement = 173 beds per year.
Rest of World: 2100 Beds = 247 Beds per year
Total “go to market” replacement opportunities per year = 420 beds
Who are we competing against?
Who and what is the Competition
These top four manufactures control 70% of the market. All the others combined control 30%.
Existing infant incubator Technologies, as used by our competitors was originally developed in the 19th century. Essentially, they are mattresses with a warming mechanism.
They are insufficient at replacing the optimal environment of a mother’s womb.
That’s right, our competitors can be looked to for a friendly acquisition when the time is right. Additionally, there is a very active market by the medical device sector to acquire new groundbreaking technology.
Current research indicates a price of $80,000 each to be sold in pairs as one needs to be operable at all times.
Sale of Consumables
AmnioBed, by design, has an ongoing revenue model that gives us the advantage of staying in touch with our clients on a regular basis.
Each unit must be maintained daily with associated accessories as listed.
For each new unit activated, the overall revenue model is enhanced for the next 7 to 10 years.
- 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.
- 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.
- 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.
- We rely on third parties to conduct our preclinical studies and clinical 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.
- 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 respond effectively to changing consumer preferences and demand.
- 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.
- We may not be able to enforce our intellectual property rights throughout the world.
- 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.
- 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.
- Legislative or regulatory reform of the healthcare system in our target markets may affect our operations and profitability.
- Healthcare laws and regulations may affect the pricing of our medical device products and may affect our 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.