# OsNovum

Revolutionizing the $25B osteoporosis industry with a novel regenerative solution for weak bones

## Elevator pitch
OsNovum has developed the technology to regenerate bone to maintain skeletal health. Weak bones are a major reason for frailty as we age. OsNovum has the proven technology to regenerate bone but will also open clinics devoted exclusively to skeletal heath and the prevention of frailty as we age.

- Canonical URL: https://wefunder.com/osnovum
- Entity ID: wefunder:company:63072
- Last updated: 2026-06-04T05:02:21Z
- Generated at: 2026-06-04T15:19:06Z

## Quick facts
- Patented bone-regenerating technology ready to disrupt the $25B osteoporosis market.
- FDA-cleared for maxillofacial bone; streamlined path to clearance for full skeletal applications.
- Thousands of successful patients treated with regenerative bone solutions using proven materials.
- Clear exit strategy within 3 years, with potential acquisition by industry leaders.
- Novel alternative to osteoporosis drugs with no systemic side effects—patients demand better.
- Innovative specialty clinics will deliver localized treatment with scalable patient care models.

## Active fundraises
- wefunder:fundraise:98100: 4(a)(6) successful (USD)
- wefunder:fundraise:98101: 4(a)(6) successful (USD)
- wefunder:fundraise:36041: 4(a)(6) successful (USD)

## Story
At OsNovum, we are pioneering a breakthrough solution for osteoporosis and osteopenia—conditions that silently rob millions of their mobility, independence, and quality of life. Our mission is simple but powerful: to transform bone health through innovative regenerative technology and deliver lasting hope for those suffering from these debilitating diseases.Osteoporosis, often called the "silent thief," affects over 200 million people worldwide and causes 8.9 million fractures annually. Current treatments come with severe side effects, leaving patients with limited and often difficult decisions to make. We believe they deserve better.Building on decades of research, our FDA-cleared technology goes beyond treating symptoms—it regenerates poorly mineralized bone, transforming it into dense, healthy vital bone. Our patented molecule works by targeting the patient’s own bone-growing cells (osteoblasts), stimulating natural regeneration without the risks of systemic side effects.Localized Application: Our regenerative material is applied locally to areas of low bone density, ensuring targeted and efficient treatment.Natural Bone Regeneration: The patient’s osteoblasts absorb our patented compound, migrate into surrounding tissue, and rebuild bone with increased mineral density and vitality.A New Standard of Care: Our long-term goal is to establish specialized clinics where patients can access skeletal treatments based on the latest scientific knowledge and advancements in bone health.  The global osteoporosis market is projected to reach $25.3 billion by 2025, presenting a major opportunity for disruptive innovation. OsNovum is uniquely positioned to capture market share by offering a novel, science-based solution to an underserved population. We plan to launch in key U.S. markets and strategically expand to meet international demand.Our maxillofacial technology has already been FDA-cleared and successfully used to regenerate maxillofacial bone in thousands of patients over the past decade. We are now adapting this proven technology for skeletal applications. With regulatory experts and strategic partners on board, we’re on track to submit a De Novo application—an essential milestone on our path to market entry.At OsNovum, our team includes seasoned industry leaders, including a former FDA assistant director and world-class scientists, who bring decades of experience in biotechnology and regulatory compliance. This expertise ensures that every step of our journey—research, development, and market entry—is executed with precision and strategy.We are committed to transforming bone health. Your investment can help accelerate the delivery of this groundbreaking solution to millions of patients in need. Together, we can reshape the future of osteoporosis care.Invest in OsNovum and be part of the next major breakthrough in healthcare innovation. With our proven regenerative technology and a clear path to FDA approval, we’re on the brink of revolutionizing osteoporosis care.Help us create a future where bone loss is no longer a life-altering diagnosis. Join us in turning innovation into impact and redefining the standard of care in bone health.From Dental Success to Skeletal InnovationIn 2016, SteinerBio began adapting its proven regenerative technology—originally FDA-cleared for maxillofacial applications—to treat failing skeletal bone. While this material had successfully restored bone health in thousands of dental patients, applying it to the skeleton required a separate regulatory pathway. Thus, OsNovum was born to pioneer this transition and bring our innovative bone regeneration technology to patients suffering from osteoporosis and other skeletal diseases.Regulatory Journey: Navigating Uncharted TerritoryWe initially pursued a 510(k) application, using SteinerBio’s FDA-cleared regenerative material as predicate technology. However, the FDA’s Skeletal Device division had never encountered a device that actively stimulates bone growth. As a result, they were navigating uncharted regulatory territory and ultimately ruled out the 510(k) option.The core issue: the Skeletal Device division does not recognize maxillofacial materials as predicates for skeletal use. With a PMA submission ruled out due to impracticality, we found the optimal path forward: De Novo submission.Why De Novo?De Novo submissions are designed for unique devices that present moderate risk and have no prior classification history. OsNovum’s technology fits these criteria perfectly. Shortly after receiving our Q-submission response from the FDA, we were approached by a former FDA principal who had worked on our original submissions. Now a consultant, this expert offered to help guide our De Novo application. Contracting their consulting firm was a monumental step in advancing our regulatory process.Next Steps: Securing Clearance and FundingTo succeed with our De Novo application, we need to raise funds to cover critical expenses:$30,000 FDA submission fee for the De Novo requestConsulting fees for experts guiding us through the processAdditional laboratory testing beyond what we've already completed, if required by the FDAWith this team and plan in place, we’re optimistic about achieving clearance without requiring human clinical trials. However, we know that the FDA never grants approval without demanding thorough validation.Forward Momentum: Moving Full Speed AheadRegardless of the challenges or amount raised, OsNovum remains committed to moving forward at full speed. Our mission to revolutionize bone health is too important to slow down. Together, we can create a future where skeletal diseases are treated with precision, innovation, and success.

## FAQ
1. **Hi. I'm very interested but I have some questions if you don't mind: -How much will each application cost? -Will it be covered by insurance? -What are your revenue goals for the next 5 years? This is key for me as it will give me an idea of the company's potential and what kin...**
   - Hello Leonardo All good questions. The cost will of course vary with the location and size of the lesion but we expect the charge approximately $5,000 per hip. Individual vertebrae would be less if multiple vertebrae are treated at once. OsNovum is classified as a bone graft and it will be covered as a bone graft. Virtually any insurance company would be happy to pay $5,000 to prevent a hip fracture. The plane is taxiing so I will complete my response latter. 
2. **Cpñica okay, vacations from back surgery what can I be rewarded from medical malpractice**
   - Cpnica? The vast majority of back surgeries are performed as a result of disk pathology. OsNovum has nothing to do with disk or cartilage pathology.
3. **I hope you can finish your answer before the early bird terms end, I need the revenue goals to make my decision.**
   - Hello Leonardo Please read the following and get back to me. I just recently posted this to our investors. All the best,Financial Projections To: OsNovum Investors Here at OsNovum/SteinerBio we need to deal with facts. When treating a patient, you must put aside any bias or dogma and honestly critique how your patient responds to therapy. You cannot let what you want to happen cloud the reality of what is actually happening. This is ingrained in us and as a result we cannot look at business a...
4. **Thanks for that. I was just hoping for your personal revenue goals, what numbers you are aiming to reach year by year. What's the margin on a $5,000 application? Can You disclose that?**
   - Revenue goals We are wrapping up the FDA submission at this time and will hopefully submit in about 3 months. We could get approval in 6 months to a year and then we go to market. The costs associated with osteoporotic fractures is immense and that is related to our income. Let’s limit our discussion to about vertebral osteoporotic fractures to get a sense of the market and revenue stream. There are approximately 700,000 vertebral compression fractures per year in the US. There are currently ...
5. **Hello Dr. Steiner Iam interested in investing and would like to know what distinguishes OsNovum from other treatments in the market such as Teriparatide(Forteo), Abaloparatide (Tymlos), Romosozumab (Evenity). In other words, what is your competitive advantage? Thanks**
   - Hello SalehThe medications you list are systemic medications. They require continued use and have significant side effects. OsNovum in applied locally to the affected bone via a syringe. It is a one time application to regenerate the health of the bone. Our experience in the jaw indicates the effect is long lasting as we have not seen a decline is density over time. How long the effect will be in the rest of the skeleton is unknown at this time. OsNovum has no known side effects. All the best...

## Team
- Roslynn L Steiner (CEO and President)
- Gregory Steiner (Chief Science Officer)
- Daniel Vargas (VP Marketing of SteinerBio and OsNovum)

## Recent posts
- OsNovum Status (2021-06-02T16:25:29Z)
- New Methods of Diagnosing Who Will Suffer a Bone Fracture (2021-01-30T21:25:46Z)
- Research findings: OsNovum reduces inflammation and stimulates bone growth. (2021-01-25T21:24:02Z)
- Bone Repair vs Bone Regeneration (2021-01-23T20:48:10Z)
- Factors Affecting Osteoporosis (2021-01-19T21:28:01Z)
- OsNovum nearing 150K in funding. (2021-01-16T21:03:11Z)
- Osteoporosis drugs- effectiveness and side effects (2021-01-01T23:03:17Z)
- OsNovum testing progress (2020-12-24T20:20:49Z)
- OsNovum Owners update: FDA testingThe FDA does not have rules to follow when submitting a material for clearance to market a product. The FDA only has guidelines and it is up to the company to convince the FDA that the tests performed on the product are sufficient to determine that product is safe and effective. In addition to no rules, what is accepted will be determined by the attitude of the office who reviews the submission. When you submit to the FDA the officer will reply with a list of... (2020-12-15T00:10:30Z)
- I have just responded to an inquiry about projected revenue for OsNovum. I used percutaneous vertebroplasty as an example of how common collapsed vertebra are and the cost associated with treatment. I used these figures to give an idea of how OsNovum can be used for this problem and how much revenue can be generated. Percutaneous vertebroplasty injects plastic into the vertebrae to support it and stabilize it. The plastic never goes away. The type of material used in percutaneous vertebroplas... (2020-12-08T22:38:22Z)
- Financial ProjectionsTo: OsNovum InvestorsHere at OsNovum/StienerBio we need to deal with facts. When treating a patient, you must put aside any bias or dogma and honestly critique how your patient responds to therapy. You cannot let what you want to happen cloud the reality of what is actually happening. This is ingrained in us and as a result we cannot look at business any differently. For this reason, you did not find a detailed business plan or income projections on the Wefunder fundraisi... (2020-12-06T00:24:15Z)

## Q&A
- Q: Your work is exciting to me. I noticed you raised money 4 years ago to apply for FDA approval. It seemed you were expecting it 6 months later. It is now 4 years later, and not much seems to have occurred in the interim. Was the project put on hold? Your work looks too important to too many people not to make it happen. My concern with investing is the lack of clarity regarding whether this project is of primary importance to you or only one yuo work on when you have time.
  - A: Hello Alan and Leah, Thank you for your interest in OsNovum. We initially applied for FDA clearance, but because our product is entirely novel—with no predicate device—the FDA recommended pursuing a De Novo classification. We’ll be resubmitting our De Novo request this summer. Please let us know if you have any other questions. Best regards, Greg Steiner
- Q: What were the terms for the previous round in 2021 for $209,000? Also what happened to the ownership of those investors who put in that money since the page shows you and Roslynn own 100% of the company? Where can agreement be viewed showing the terms in which you as the owner grant the company rights to the patent, given the patented molecule seems to be 100% critical to the company's business model?
- Q: What is approximately the probability to get an fda permission and on what is it based?
- Q: This is Kevin Hansen. I have been using these products as a dentist for over 10 years. My wife and I had opened an account last November 2020 and thought it was fully funded at that time. it was tied to a personal bank account and w thought the money had been transferred then...to our surprise it was not. We thought the money was held in an acct to be transferred to the WEFUNDER acct when it opened, and wanted to be one of the first in, to take advantage of the early discounted rates and because we believe in these products as well as in the Steiners. At this point we are still very interested in investing our 10K but need to know how to finalize what we started in November. Please respond to this email: kevinandkara@usa.com. Thank you.
- Q: Do you have a LinkedIn profile that can be shared?
  - A: No. Thank you for you interest but I have no social media contacts.
- Q: Just a heads up, looks like there may be an issue with your website. Clicking on 'Newsletter', 'Updates', 'Our Story', etc takes the viewer to a WordPress critical error notification.
  - A: Yes, some technical issue that are being addressed.
- Q: Also in your pitch you mention setting up clinics as the end goal. I think the technology is a very attractive investment opportunity but I am unsure about the idea of opening clinics to specialize in this therapy. Why wouldn’t you just develop, manufacture, market, and distribute to already established healthcare providers and orthopedic specialists? There is a lot of overhead to run clinics and wouldn’t you want to make this product as widely available as possible since it is such a game changer?
  - A: Jeffery I am a health professional and I know how health professionals are slow accept new technology that is outside their experience. The public is begging for an effective and safe therapy for osteoporosis. So, who would you rather work with- hesitant health professionals or eager patients? You cannot revolutionize a profession from the inside. The revolution must come from the outside.
- Q: You mentioned a clear exit in three years - is this acquisition, IPO?
  - A: Craig We are open to anything that benefits the company and the investors. I am confident that we will receive significant interest from other companies if our plans conform with reality but I do not know if their valuation will meet our expectations. Our technology is in direct competition with the largest pharmaceutical companies and if OsNovum challenges their bottom line an acquisition may be feasible and acceptable.
  - A: Hello Craig I apologize for not responding earlier to your inquiry. Yes we fell it will take one year maximum to get the technology to market. We will will have some very large companies that will see us as a threat to their very lucrative drug therapy so an acquisition is very possible early on. If we grow as fast as we think this technology is capable of then an IPO may be a possible route. At this time we are only focused on bringing the technology to market but when that work is completed we will crawl out of the lab and move into maximizing our shareholders investment value. Thank you for the question.
- Q: This is interesting technology. Could you tell me when the relevant patents expire?
  - A: The relevant patent expires in 2024 with an extension
- Q: There was mention of a patent on this technology being owned by the founders, rather than by the company in which you're seeking investment - is there a license granted to OsNovum? Is it exclusive and irrevocable? What are the terms?
  - A: Hello CharlesYes there is a license grafted to OsNovum. The technology is only used by SteinerBio and OsNovum. Other than those two companies the license is exclusive and irrevocable except under one condition. The license is revocable if the founders are forced out under conditions that are not acceptable to the founders. The license is a poison pill against forced actions against the founders. The license is granted to OsNovum at no charge to OsNovum indefinitely. 
- Q: This is really interesting technology however after seeing some of your recent discussions with the FDA causes concern on the challenges before you? Can shed a little light on this? Thanks!
  - A: Kevin I had a friend who is also a significant investor who asked the same question privately and I will copy you my answer to him No FDA clearance no OsNovum. However I must say I am completely confident this will be cleared and here is why. One reason is the exact same material has been cleared for use in the jaws. If it is safe and effective for the jaws how can it not be safe and effective for the rest of the skeleton? It has been in regular use for over 10 years. Whenever there is a problem with a products’ safety or effectiveness an adverse event report is required to be filed with the FDA. We have never had an adverse event report filed. There is nothing is the product that is not already in the body in exact form as in our product. The product is completely resorbed with nothing residual. Under these conditions this has got to be the most guaranteed submission ever. The submission may be bumpy because they always ask for more information that they make you scramble but I am confident in approval. Greg
- Q: Can you discuss the market performance of the product so far for maxillofacial applications? How is market penetration? Any uptake by thought leaders in OMFS? Which predicate are you using for FDA clearance?
  - A: Dear Todd SteinerBio is the newest bone graft material on the market and has the highest growth rate and possibly highest sales numbers depending on the specific product and application. Covid has taken out some established competitors so post covid looks very promising. We have many OMFS customers but no thought leaders because we are not willing to pay lecturers or provide free products. Our main competition is cadaver bone which all OMFS are trained to use but when it becomes known that the main reason for dental implant failure is implants placed in cadaver bone the profession will switch from cadaver bone grafts to science-based bone grafts and we are ready for them. The predicate for OsNovum is Socket Graft K113049. Socket Graft is the only graft material cleared by the FDA that is permitted to claim that is stimulates bone growth. All the best, Dr. Steiner
- Q: Hi. I'm very interested but I have some questions if you don't mind: -How much will each application cost? -Will it be covered by insurance? -What are your revenue goals for the next 5 years? This is key for me as it will give me an idea of the company's potential and what kind of growth you are envisioning for the company. Thanks.
  - A: Hello Leonardo All good questions. The cost will of course vary with the location and size of the lesion but we expect the charge approximately $5,000 per hip. Individual vertebrae would be less if multiple vertebrae are treated at once. OsNovum is classified as a bone graft and it will be covered as a bone graft. Virtually any insurance company would be happy to pay $5,000 to prevent a hip fracture. The plane is taxiing so I will complete my response latter. 
  - A: Leonardo Lee about 23 hours ago Thanks for the detailed explanation. I'm definitely investing but I have some more questions... -Forgive my ignorance in this subject but for a person with weak bones how many localized applications will be required? One per bone? That would be very expensive to treat. -Are you generating income from maxillofacial use since that's already been approved by the FDA? If so, what's the YTD revenue and what's the TAM for this area? -When are you planning to expand internationally? Leonardo You are correct. One treatment per bone. However when you are analyzed for low bone density the exam reveals which bones are at risk of fracture. You need to treat the bones at highest risk. That might be one hip and two vertebrae for example. The treatment for fracture is always going to be more invasive and costly than our prevention by a wide margin. We have been using the material in the jaws and its performance there is why we are bringing it to the skeleton. However, while osteoporosis does reduce the dimensions and mineral density of the jaws it does not result in either tooth loss or implant failure so there is rarely a need for jaw regeneration. The only time our technology is needed for the jaw is when a dentist has failed to treat an extraction socket after tooth removal and poor bone results that is inadequate for implant placement. While some dentists inject our material into all sites where implants are placed to increase implant success this is a minute market compared to the skeleton. One of the biggest advantages of being privately held is no one knows what you are doing and what products of ours are successful. For example, one of SteinerBio's biggest competitors was a publicly traded company. We knew their weaknesses, capitalized on them and now they are bankrupt. So we never provide any financial or propitiatory information. We will be more open with OsNovum because we need to keep our owners informed but we will not provide information that benefits our competitors. OsNovum will go international and we are planning on implementing the process of doing this in parallel with completing FDA clearance.
- Q: Hello Suhail,Thank you for your message and for your continued support. We fully understand that many people have invested their hard-earned money into this venture, and we take that responsibility very seriously.I’m pleased to share that we have now received the results from our last and third GLP animal study, and the data were very encouraging. SteinerBio’s bone grafts showed remarkable performance and compared very favorably against competing products in the study.Based on these results, we are now preparing for the FDA submission process. At this stage, we are seeking additional funding to support the application and move this forward as efficiently as possible.We remain very encouraged by the progress and appreciate your confidence in the team and in the vision behind OsNovum.
- Q: Is there any update? The team sounded so promising and convincing with their ideas. Please understand that so many people here have invested their hard-earned money into the venture.