# OsNovum Status | OsNovum

- Canonical URL: https://wefunder.com/feed/145483
- Entity ID: wefunder:feed_item:145483
- Published at: 2021-06-02 16:25:29 UTC
- Updated at: 2025-07-09 03:20:19 UTC

## Author
Gregory Steiner

## Subject
OsNovum

## Content
Hello OsNovum Owners,Our team at OsNovum has been quite busy. &nbsp;We have closed funding, raising a total sum of $225,000. Wefunder will collect a small percentage of the total fee for helping us with the crowd funding project but ultimately, OsNovum will receive over $200,000 with the primary purpose of completing the FDA application and product clearance to market in the US. All proposed tests are now underway. Six tests are currently at NAMSA and are due to complete in approximately 2 months. We have initiated the last portion of the animal histopathology study at the vivarium located at SteinerBio facility. As we have discussed previously, we may not need to submit this portion of the study to the FDA if they accept our reasoning that the last portion will not provide any more information. If they require the information, then we will have it in process so as not to delay the submission. For the last portion of the histopathological submission, we brought together the “A” team. Over a recent weekend we grafted 12 rabbits with OsNovum bone graft products. The team is led by veterinarian Dr. Siegfried Coady who has extensive clinical experience plus a rare certification for laboratory animal research methodology. The surgeon and study director are Dr. Steiner assisted by Roslynn Steiner who is also the GLP and USDA compliance officer. In all actuality, the study has been designed, developed, and executed by Roslynn.&nbsp;The complexity and extensive documentation for the study cannot be adequately related in this communication. The entirety of this work was performed by Roslynn resulting in the FDA approval of our research design and documentation. The team was rounded out by veterinary technologist Melissa Schalles. Melissa brings years of experience having been an instructor at the veterinary collage for 17 years and having been entrusted for the care of such prominent animals such as Traveler, the USC mascot. You might think the USC mascot is the Trojan rider, but Traveler the horse is the mascot. Melissa provided sedation and medication for the surgical phase of the research including post-operative antibiotic and pain control. The rabbits are now resting well and are continually monitored according to FDA GLP and USDA regulations. In addition to our surgical team in the background is, Katie Misko who is our quality assurance unit who cannot participate in the study but evaluates every step of the study to make sure it meets FDA GLP and USDA requirements.&nbsp;&nbsp;The team relaxing after two days of hard work. Dr. Cody with a very relaxed patient. &nbsp;Now that the organization of the tests is complete for FDA submission, the team will move on to completing the development of packaging and methodology of application of the material.&nbsp;For this we will bring our ideas to orthopedic surgeons to help us understand what methods of packaging and application their profession is accustomed to using. On the regulatory and investment front, we have signed engagement letters with new legal and accounting firms to help guide OsNovum through the very strict regulatory requirements to have the level of compliance we have achieved with the FDA and USDA. The new accounting firm is Layton, Layton & Tobler LLP located in Las Vegas. We will soon be producing regular accounting reports for your viewing. For legal advice, we have acquired the services of the law firm Thompson Hine LLP with offices across the United States. What brought us to this firm is attorney Lindsay Karas Stencel. Lindsay has spent her entire career working with startup companies. Her expertise is not just legal, but she has extensive funding contacts that will be invaluable as OsNovum moves from FDA clearance to the marketplace. At this time we feel OsNovum is on pace to meet its goals and we welcome your comments and communication. All the best, Greg and Roslynn Steiner &nbsp;