Transforming Bone Health with Precision Regenerative Solutions
We have periodically updated everyone on our progress. We have had to be patient in sharing our progress because we never want to be sharing what we hope to happen until it actually happens. Here at OsNovum we have been very busy with the financial formalities of running a SEC regulated company. Over recent months, we have been primarily dealing with the financial documents needed to move forward to our second round of funding. For example, we have very skilled legal and accounting advice but that is not enough. When all of our financial records are completed and submitted, then we must have a CPA review our CPA. Yes, we are required to have a review of our reviewer. All of this takes months. The positive side is that every penny is traced and counted twice and after a review of our reviewer there were no questions about our accounting. After spending the last year working with the FDA and the SEC on bureaucratic matters, it will be a joy for us to return to science once funding is in place. The most positive change that happened last year is that we are working with a consulting firm to guide us through the approval process. The ranking officer who was the decision maker for our initial submission has left the FDA and now is working for OsNovum. The consulting firm is called Bruder Consulting & Venture Group.
Joining the OsNovum team is biomedical engineer Laura Rose, PhD, who was serving as Assistant Director within the Office of Orthopedic Devices at the FDA when she oversaw OsNovum’s initial submission. After nearly 8 years at the FDA, she left to join Bruder Consulting, an advisory firm with domain specialization in biologics, medical devices, tissue repair, biomaterials, and regenerative medicine. Upon joining Bruder, Dr. Rose approached OsNovum to help bring our concept to market and accelerate our growth, giving OsNovum powerful new leverage.
Dr. Rose brings to the team a comprehensive understanding of FDA regulations, guidance, and decision-making, as well as a wealth of knowledge about regulation of devices and combination products for tissue engineering and regenerative medicine. Although she has interacted with all corners of FDA, she worked most extensively with their Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research on orthopedic combination products. Prior to joining the FDA, she served as a co-investigator on a cell-therapy Investigational New Drug as a Post-Doctoral Fellow at Johns Hopkins University. Dr. Rose earned her BSc in Biochemistry from the University of British Columbia and her PhD in Biomedical Engineering from the University of Alberta.
Dr. Rose now comes to us by way of Bruder Consulting, which offers diversified expertise in product and market development, clinical and regulatory affairs, and commercialization strategy, with clients in the United States, Europe, Israel, Australia, and Japan. Like Dr. Rose, Bruder’s own founder has ties to the FDA as well. An accomplished authority in the scientific community, Bruder’s CEO, Scott Bruder, MD, PhD, previously served as the industry member of the FDA’s Advisory Committee on Cellular, Tissue and Gene Therapies. He is currently an Adjunct Professor of Orthopaedic Surgery and Biomedical Engineering at Case Western Reserve University.
Dr. Bruder has enjoyed a long and distinguished career in the discovery, development, and commercialization of products to diagnose and treat patients around the world. He founded Bruder Consulting in 2015 after 25 years in the industrial sector, serving as the CSO and CMO for Stryker Corporation, and as the CTO at Becton, Dickinson & Company. Previously, at Johnson & Johnson, his team built a portfolio of musculoskeletal tissue repair products for the DePuy franchise before establishing J&J Regenerative Therapeutics. Dr. Bruder’s inventions, technologies, and teams have launched dozens of products, earning billions of dollars for his employers and patent licensors. He has published more than 125 original articles, book chapters, and abstracts, and lectured extensively around the world. Dr. Bruder received both his MD and PhD (stem cell biology) from Case Western, working in the laboratory of Prof. Arnold Caplan. To have this level of support is remarkable and we are very confident and excited about the path forward.
Assistance in funding is greatly appreciated. Spreading the word to friends and family about the urgent need for advancements in osteoporosis therapy is crucial. We need to let people know and understand that many patients are left with no alternatives for treatment and prevention of osteoporosis. Even when a patient takes the current drugs that are available, they can only take them for 5 years and then must stop. If patients continue to take the drugs for longer than 5 years, they are then subject to bone fracture that is actually caused by the drugs that are intended to prevent bone fractures. New treatment for this disease is greatly needed and OsNovum has a promising solution.
As we prepare to launch our second round of crowdfunding, we want to assure our early investors who purchased shares at $25 and $30 that their investments will remain undiluted. All shares are now valued at $40 per share. This new round will see shares priced at $40, reflecting our company’s improved pre-money valuation of $19.5 million.
Our fundraising efforts so far have proven vital to our continued growth and success. As we reflect on our progress, a colossal effort has already been accomplished and is now behind us, from the preliminary administrative dealings with the FDA to the rigorous testing and studies that make up the backbone of our venture. As we open this new round of funding, we are able to clearly see our goal with a highly leveraged crew at the helm. Our modest target for this round is only $124,000, as we only need to cover the costs of our FDA De Novo submission through the help of our new consultants.
Achieving this will not only ensure a smooth transition into our next phase that will mark the beginning of launching critical operations. With a minor filing, we have the ability to increase funding to $600,000. That would include funds to cover additional testing, obtaining ISO Certification, managing legal and accounting expenses, making capital improvements, acquiring necessary equipment, ramping up manufacturing, and supporting our dedicated team through salaries.
To those who have joined us in our cause, your unwavering support has been instrumental in our journey, and we are deeply grateful for your continued faith in our mission. For that reason, we want to extend the exclusive opportunity to privately invest in our second round directly on Wefunder before our campaign transitions onto the general public platform on Wefunder. We also encourage you to share our mission with others who may be interested in joining us. Your network’s support could be pivotal in helping us reach our goals and expand our impact. Together, we are revolutionizing bone health and bringing hope to millions of patients worldwide.
If you are ready to invest and help take OsNovum technology to the patients who need it, we thank you for being an integral part of our success story and we will strive to keep you informed on all of our progress. To visit our Wefunder page, follow the link below. If you have any questions or need further information, please feel free to reach out.
PROUD MEMBER OF:
Tissue Engineering and Regenerative Medicine International Society (TERMIS)
American Society for Bone and Mineral Research (ASBMR)