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FDA Status Review PDF is listed below, please click to download for your viewing.
FDA STATUS REVIEW
The FDA Report PDF document is listed below, please click it to download for your viewing.
Premarket Notification – Status Review – 01.21.22
Despite the continuing effects of the pandemic, there has been progress in regards to our FDA application for approval.
Yes, there was a promise of a quarterly report update. In regards to this, the individual who does the updates is in the middle of fight against the pandemic. He is a first responder, and has volunteered his time to provide the updates on his own time. With this said, despite the delay in reporting, the work has continued, and is progressing.
The first is that the FDA assigned a new reviewer for our application. This reviewer requested additional test results, which requires more patients being tested. We are still in need of approximately 300 more patients to fulfill this request. This is an ongoing process and information regarding the progress will be forthcoming. As you know, the patients we test must be MRSA positive, to assure the that tests we are conducting on them show the reliability and accuracy of our test as well.
Completing this portion of the testing will satisfy the FDA’s requirement of equivalency for our 510K Pre-Market Notification.
In regards to the manufacturing of the testing supplies, the new clear tube we designed is working very well, with excellent clarity. We have a manufacturer, but due to the supply chain shortages currently plaguing all areas of manufacturing and distribution, we do not have a price per unit at this time.
As to when the device can go before the FDA for final review, this is solely dependent on the completion of the tests, which in turn requires patients who test positive for MRSA. We all hoped to go to market by this time, but the reality is that the pandemic has created a delay in all non-covid related applications.
As any news comes available, updates will be posted.
April 16, 2021,
To Our Valued Angel Investors,
2020 was a year like no other. When we started out, we were looking forward to a great year of accomplishment in the development of our AptaSure™ MRSA product. As you are aware, the COVID-19 pandemic has had an unprecedented effect on global health and our global economy. As a startup founder, we know you’re concerned on many fronts: concerned for the health of your families, and to the success of the company that you’ve worked so hard to contribute to.
We share your concerns deeply. We were well on track to achieving all the short-term targets we had set out in our strategy, and luckily maintained a portion of our committed project efforts despite the pandemic. As you may understand, the pandemic had placed a substantial burden on healthcare systems, as well as regulatory agencies. In fact, most of our work with the Food & Drug Administration (FDA) was delayed due to the FDA’s commitment to work with companies focused on the development of devices, vaccines, and products, related to COVID-19.
From March, 2020, through the end of December, 2020, each and every vendor in the medical device space had only one focus, this being a full-force, all hands-on-deck movement in the creation of COVID-19 testing devices. Every single lateral flow test strip manufacturer was only taking on new projects that related to COVID-1. Furthermore, all product suppliers of raw materials also jumped into the same band wagon, making their priority – pandemic centric.
The global pandemic also allowed for us to establish many new contacts within the medical device industry, as well as within the FDA. We collaborated with a company from Sweden, who was one of the first to offer a COVID-19 Rapid Antibody test. The company needed a way into the American Market, and they had been in the process of working for Emergency Use Authorization with the FDA. We offered to place the product on our website, which would in turn be a form of “free advertising “for Invenio Medical, Inc., all while gaining more attention from FDA. As you may understand, gaining credibility with the FDA is critical, especially when trying to promote other technologies.
For the next 3 months, we couldn’t even obtain a single nasal swab, as each manufacturer was producing swabs only to supply backorders for COVID-19 testing. Even the raw materials for lateral-flow-test-strips, including nitrocellulose paper, as well as the buffer/lysing agent was practically impossible to purchase unless the request was made by a large manufacturer. Buffer solutions were being created primarily for laboratory testing equipment, predominantly for PCR testing platforms, and limited to any other company that was not focused on COVID-19 only.
Nonetheless, with the obstacles encountered by the pandemic, we did actually accomplish other milestones that were of significant importance, as well as vital in the satisfaction process for our FDA documentation. Below is a list of some of our accomplishments from 2020.
Lateral-flow-test strip tube/holder Our initial concerns involved the optical clarity of the AptaSure™ tube. As a reminder, we would need to ensure that the tube would allow for an accurate visual read of the test and control lines on the test strip.
Due to the initial opaque plastic tubing material, we had concern over missed-reads, or false negatives due to the end-user not being able to clearly visualize the line. This concern made us deliberate on whether or not we would need to create a “reader” device, which would allow for us to eliminate this risk of improper reading. However, with numerous variations of plastic injection formulations, we reached a success in having achieved an optically clear tube made. This was a very big success, one which could have been very costly should this not have worked in our favor.
We were able to concentrate our efforts on additional required testing requirements as defined by the FDA. This included the additional need to conduct “interference testing.” In other words, challenging our test by subjecting it to various competing strains of viruses, bacteria, as well as chemical substances. This testing alone has taken 5 continuous months of sample preparation, dilution, and confirmatory PCR testing. We are very fortunate to report that we had no interference with our MRSA test, when subjected to various interfering substances and pathogens.
Because the standards are so rigorous, we are still testing patients to complete the requirements as set forth by the FDA. This requires that only patients who have already tested positive for MRSA by laboratory means are used for the testing of our process. This insures that the results we receive are accurate and reliable. The roadblock we have run into is that the pool of actual patients is very small because of the pandemic. In addition, we have to be cautious in the use of our resources to keep costs down and avoid waste, as we currently have a limited stock of test products.
When the testing is complete, we will submit our 510(k) documentation to the FDA for approval. A 510(k) is a submission made to FDA prior to marketing a device, to demonstrate that the device to be sold is safe and effective, and equal to a legally marketed device.
This vital study information is provided herein:
Invenio-Medical-2020 Test Results (PDF)
We have also worked on tested various control solutions. These positive and negative controls are required to be provided with the test kit. This would allow for the end-user to validate that the particular device is working properly. We have also been validating the controls in the context of our analytical and clinical studies (External control materials are considered particularly important when good manufacturing practice (GMP) requirements are waived and reagent stability studies are limited).
No Loss for 2020. $7,277.36 income from commissions earned on passive internet sales of COVID-19 Rapid Antibody test.
Please see attached detailed reports for more information.
As our society unites to overcome the coronavirus outbreak, we hope this unity will serve as a promising model – a model for how we can come together to build a safer and more sustainable world for generations.
We, the undersigned, have a responsibility as partners, investors and mentors to stand by your side and support you during hard times. We’re not going anywhere.
Victor R. Lange, PhD, JD President/CEO, Invenio Medical, Inc.
2020 Invenio Medical Profits & Losses (PDF)
2020 Invenio Medical Balance Sheet (PDF)
Invenio Medical 2020 Test Results (Downloadable Document)
Invenio Medical, Inc.’s vision is to research, design and develop, groundbreaking medical technologies/devices, increasing provider efficiency, while providing thehighest level of patient safety.
Invenio Medical, Inc. recognizes the challenges of modern healthcare. Our research and development team consists of experts from around the world. We are fortunate to have retained leading pioneers in research and development, who have developed numerous groundbreaking technologies within the healthcare sector. Most of these devices had been developed for use in hospitals, clinics, nursing homes, as well as physician office settings.
Invenio Medical, Inc. has entered into agreements with several highly regarded research laboratories, to develop and optimize our AptaSure™ product line. First, the University of California – Irvine, Medical College, Department of Microbiology and Genomics, has agreed to assist in the development and rapid-prototyping of our AptaSure™ MRSA product. This particular laboratory is led by Dr. Yongsheng Shi, PhD a highly skilled professor, and researcher, who has committed the time and resources available to bring our prototype to a reality in a relatively rapid time frame. The majority of his work is conducted via National Institute of Health (NIH) grants. His personal interest in our project, of aiding humankind with our AptaSure™ devices, has provided Invenio Medical, Inc. with an incredible opportunity for to partner with such a remarkable industry expert. Dr. Shi is acknowledged and credentialed by The American Cancer Society for his research and work. We are honored to have Dr. Shi as part of our remarkable research and development team, providing his knowledge, clinical skills and expertise, along with his Doctoral student lab assistants, helping us reach our ultimate goal, of providing state of the art, low cost, rapid diagnostics to patients worldwide.
Dr. Robert Bohannon, PhD. is another valuable member of our Research and Development team. Dr. Bohannon is President of Catalloid Products, Inc., On Site Testing Labs, Inc., as well as Chief Scientific Officer for EKF Life Sciences and Diagnostic Company. Bob obtained his PhD from Baylor College of Medicine in Molecular Virology. He holds degrees from the University of Colorado in Molecular Biology and a degree in Organic Chemistry from The University of California at Berkley. Dr. Bohannon helped develop lateral flow, EIA and molecular tests for various diagnostic companies worldwide. He developed a novel POC oral cancer screening test as well as avian flu, HPV, Strep A/B and drugs of abuse. He oversaw development of lateral flow tests for anthrax, ricin, botulism toxin and agents for First Responders. He has been called a first rate scientist with a flair for developing cutting edge technologies to solve practical problems by his fellow researchers. He calls himself an innovator, visionary and creative guru. We call him the PREMIER scientist in the field. He is an out-of-the-box thinker, a true genius in every regard. We are honored to have such an amazing scientist as Dr. Robert Bohannon, PhD, working with us on our project.
As you can see, Invenio Medical, Inc. will go above and beyond, to partner with outstanding research and development scientists, ultimately ensuring that the investment you have made in our company, has the greatest potential for success in the healthcare marketplace. We thank you for your investment, and we will strive daily to ensure that your investments reach maximum potential in the shortest timeframe possible.
Many of you have either called, sent text messages, or emailed me, regarding our website and investor page. You have most likely also obtained the generic password, and noticed the updated information on the status of our company. This page is the current information for your review and consideration.
We at Invenio Medical Inc. want to thank you, our Investors, very much. There are MANY individuals who unfortunately did NOT have the opportunity to purchase stock in Phase 1, and there were also many of you who did purchase initial stock, and came back, wanting to purchase more. Hold those thoughts and capital. In the interest of keeping the valuation of stock from being damaged, and the subsequent need for additional Phase 2 funding to be secure, you will soon have the opportunity to become an investor in this exciting company.
Phase 1 Financing stock sale has successfully come to a conclusion (penny stock). We are happy to report we have reached our funding goals as stated in the business plan. We thank all investors who participated. There WILL be a Phase 2 sometime in 2018. The sale of shares WILL be at a higher cost to investors (undetermined), but still a tremendous potential for those who wish to participate.
As mentioned previously both prototype and optimization of AptaSure™ devices are concurrently in development. We will report the status of this process after the New Year. We are encouraged that to date, there have been no unresolved issues identified, and the process is on track and going smoothly.
Our CEO, Dr. Lange, and CFO Kevin Ohler, have engaged in final negotiations with our aptamer provider to secure licensing and provide Invenio Medical, Inc. the protection for our AptaSure™ devices from competition. We hope to have this completed soon after the New Year as well.
Dr. Lange has reached out to the USPTO to understand the timing of our application for patent protection. He was told the number of patents applied for has increased nearly 5 fold and the process is ongoing, and will be completed, but a time line is just not available at this time.
Once again, we are honored to have you as part of our investor team. After all, you will be part of the evolution of a groundbreaking medical device that will revolutionize the way by which Infectious Diseases are screened for and identified.
On behalf of Invenio Medical, Inc. , we wish you and your families a very Happy & Healthy Holiday Season!
Jay Haischer, MHA, RPA-RT, VA-BC
Chief Operations Officer
951-956-3561 – Mobile
951-845-5075 – Home Office / Fax
877-688-8829 – Corporate Office
www.invenio-medical.com – Web
The following information has been provided to us by both of our research scientists who are developing our AptaSure MRSA device.
Dr. Yongsheng Shi, PhD, MD: UCI – College of Medicine, Department of Molecular Biology and Genomics
Invenio Medical, Inc. is in the process of developing a new lateral flow strip assay (LFSA) utilizing aptamers functionalized with gold nanoparticles (AuNP). This new LFSA biosensor utilizes a cognate aptamer duo binding to pbp2a, a target protein, at 2 different binding sites, exhibiting a sensitive and highly selective response. Our studies have shown successful development of a single yet effective LFSA for pbp2a detection without any special laborious instrumentations. This system will be particularly useful as a screening tool for rapid, on-site detection of any targets with a pair of aptamers generated.
Immobilize the various AuNP biosensors into plastic – injection molded holders for allowance to incorporate design into products that will be supplied to Dr. Bohannon for further optimization of the system that he is currently testing. Our designers are currently obtaining various siliconized plastics for infusion into plastic injection.
23/01/2018 – News
Dr. Robert Bohannon, PhD: Catalloid Products, Inc.
We have come a long way in a short time. We look towards our future, knowing that we have the very best scientists working with us to bring a state of the art medical device to the forefront of rapid infectious disease diagnostics. We strive to fulfill our desire of becoming THE “tool” that healthcare providers will insist upon for enhancing patient safety to the highest levels possible.
The Invenio Medical Team
Invenio Medical, Inc. Continues to make amazing progress in Research & Development of our AptaSureTM MRSA device. Over the past 3 months, we have conducted thousands of tests on our product, including the use of live MRSA bacteria, with outstanding results. We are seeing improved sensitivity and specificity, resulting in a significant reduction of false positives/negatives over current state of the art technology. We have also seen that our product will have an increased shelf life beyond 1 year, approaching 2 years. Our research team continues to develop the optimal recipe of aptamer, monoclonal antibody, utilizing the best detergents and buffers. Every day, we near the final process of our product R&D, along with upcoming discussions with manufacturing entities. We are still on track for product delivery to the market-place sometime in the 3rd quarter of 2018. We appreciate your faith in our research team and officers as we continue to develop a medical device which has been described by one of our research scientists as a “REVOLUTIONARY” product.
The Invenio-Medical, Inc. Team
Invenio Medical Inc. is in the final stages of research and development of the AptaSure MRSATM test kit. The Standard Operating Procedures (SOPs), and technology transfers, are being prepared by our Research & Development (R&D) team. We have recently commenced interviewing Manufacturers for production of the product. Once we have completed these interviews, with the ultimate selection of a desired Manufacturer, we will build our first product batch for a LIVE test phase at several, highly regarded, University Medical Centers throughout the country. We anticipate the test phase to rapidly demonstrate what we have learned at the bench. This includes high sensitivity, high specificity, and rapid identification of MRSA, which will provide significantly higher quality of care to patients, and reduction in attributable hospital costs. We look forward to hearing from the feedback that these elite hospitals will provide us. Once these milestones are accomplished, we will begin marketing, and selling the AptaSure MRSATM to hospitals, from coast to coast. We anticipate a healthy return. Again, we thank you for your trust as we move into these final R&D stages. It is not often that simple investors are able to partake in a “revolutionary” product such as AptaSure MRSATM. We will only continue to move forward with great strides, thereby increasing the valuation of our company.
Invenio Medical, Inc. Board of Directors
“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair …”
So begins Dickens’ “A Tale of Two Cities,” and what a great articulation it is of the transformative time we live in. We’re in an era of great inspiration and possibility, but with this opportunity comes the need for tremendous thoughtfulness and responsibility as medical technology is deeply and irrevocably interwoven into the foundation of our healthcare evolution.
Invenio Medical, Inc. has been holding true to delivering a revolutionary Point-of-Care medical device for the rapid identification of Methicillin Resistant Staphylococcus Aureus (MRSA). Insofar, our progress has been remarkable, exceeding normal timeframes in Research & Development, as well as forward momentum with negotiations with manufacturing entities.
In short, as of June 6th, 2018, our research and development team has successfully tested thousands of samples, each cultured from human biological specimens. Each individual test undergoes a complex process, which involves culturing the specimen, followed by isolating the target organism (MRSA). The specimen is then lysed (killed), in which the MRSA isolate is exposed to a chemical wash, thereby releasing the target proteins. These proteins are then identified in our technology via visual identification, as in a traditional overt-the-counter pregnancy test device. We are in discussions with various companies to have both disposable and stationary readers for increased sensitivity and ease-of-use (CLIA waived).
In order to maintain the highest level of sensitivity, and profitability, our aim is to get at least two bids for making the strips. The collection device has been developed, and the potential readers are in the works. Our Research & Development Scientists have already completed our SOP’s and we will then pass this on the manufacturing vendor to replicate what we did (side by side comparison), ultimately creating microlots, and running those against what we both created using samples and controls.
The microlot is then subject to stability testing, clinical testing, etc. and can be used to sample in the field for customer feedback. At that point, the vendor usually makes three production lots, tests them, sets up a validation plan and compares it against an approved predicate device. This component will complete the validation phase, and finally we will have a product ready for sale.
In order to prevent any issues with production, the above validation phase is extremely important. We are very pleased to say that we have exceeded our expectations with timelines on this project. Thanks to a highly sophisticated group of scientists, along with countless hours dedicated by our founders, we are making progress with this revolutionary medical technology.
We look forward to providing you an update in the upcoming weeks.
Victor R. Lange, JD, PhD CEO, Invenio Medical, Inc.
Invenio Medical, Inc. is pleased to announce the completion of the optimization testing of the AptaSure™ MRSA device. The SOP’s (“recipes”) have been written and delivered to our Corporate Officers. A functioning prototype is being developed and tested as we speak, with Tech Transfer to occur once a manufacturer has been selected. We have interviewed 5 different manufacturers, with final selection for domestic production within a few weeks. These manufacturers will include distribution agreements for our product.
We are also negotiating with several large financial organizations for additional financing via our remaining stock. This will facilitate full-time operations for Corporate Officers and Regional Distributors, to facilitate distribution of product to hospitals across the country. We intend to provide kits to several highly regarded, major University Medical Centers nationwide to conduct live testing of our device on their patients prior to release to the marketplace. We anticipate production, and marketing to being in the upcoming months, along with sales to begin shortly thereafter. Fasten your seat belts. Here we go!
Invenio Medical, Inc. – Board of Directors
Dear Invenio Investor,
The past few months have been a very busy time for Invenio Medical Inc. Founders.
As you may be aware, we have had a great deal of success in optimizing our lateral flow technology, along with securing our own proprietary aptamer formulation. We were even able to accomplish optimization several months ahead of schedule.
Our next phase of our Research & Development, included Stress/Stability Testing, focusing on “Version 3” of our lateral flow strip design, in order to finalize the strip. We literally tested thousands of clinical specimens obtained from a hospital laboratory, making several mini/pilot lots, establishing a “gold standard” of what the assay should perform as. This followed by finalization of SOPs, as well as working on Tech Transfer documentation.
However, as with all projects, hurdles are encountered, which require us to regroup our strategies in order to move forward in accordance to pre-established projected timelines. As such, we had experienced difficulty in receiving timely bids for prototype (tube development), as well as commercialization quotations.
Invenio Medical Inc. has held in-person meetings with 2 separate potential manufacturers, both of which took over 2 months to provide simple estimates for manufacturing. Despite added pressure placed on the manufacturers to provide us with said information, we continued moving forward to interview additional potential manufacturers. We have been able locate a third potential manufacturer, who will benefit us on many levels.
First and foremost, this last manufacturer is also located in California, and they have been very receptive of our needs, as well as understanding precisely what we are trying to accomplish. Furthermore, this manufacturer has already started documentation exchange with our Chief Scientist, and reagent samples and strips are being designed into our collection tubes as I write this update letter.
We have all been very frustrated with this delayed forward momentum, however, without the initial hurdle, we would not have found the last manufacturer mentioned, who has proven to be very promising.
Invenio Medical Inc. looks forward to providing you with additional updates in the upcoming month, with much more promising timelines and projections. We truly appreciate your patience during this phase of our revolutionary product development.
Victor R. Lange, PhD, JD, MSPH
Invenio Medical, Inc.