The American Academy of Orthopedic Surgeons estimates that 1 in 4 Americans suffers from some form of musculoskeletal impairment, at a total cost to the healthcare system of $850 billion. Bone defects (broken bones, bone voids, osteosarcoma, etc) are currently treated using bone grafts, a $4 billion market with over 1 million annual procedures that is growing at over 12%. However, current bone graft products have a variety of shortcomings, including efficacy, cost, biocompatibility, and availability.
We have developed a biocompatible, synthetic nanocomposite polymer, CitrOSponge, which mimics natural human bone while also addressing the concerns seen with existing products. CitrOSponge’s mechanical properties (such as size, degradation rate, and load-bearing capacity) allow it to be tailored to each patient’s unique needs, while still being manufactured at a more affordable cost than existing products. Our in vivo testing has demonstrated that CitrOSponge is osteocondutive (facilitates new bone formation) and potentially osteoinductive (accelerates the healing process), thus creating a large potential competitive advantage for us. Additionally, its compressibility allows for minimally invasive surgeries.
CitrOSponge provides benefits for patients, physicians, and payors. Patients benefit from a faster healing time, and also do not have to undergo the painful and expensive initial surgery required to harvest autograft (where bone is removed from elsewhere in the patient’s own body) tissue. Our product can be tailored to their unique needs, rather than a “one size fits all” approach often seen with current products. Physicians benefit from a product that offers superior performance to existing products, as they are able to tailor the mechanical properties to best suit each patient, and are also able to benefit from minimally invasive surgeries. Payors benefit from a product that offers superior performance, yet is also more affordable than existing products, thus making reimbursement very likely.
Our belief that we will succeed is based both on discussions with practicing physicians and our own internal research and testing. Physicians exhibited dissatisfaction with existing products and a willingness to try CitrOSponge (following FDA approval), and the criteria they listed for their ideal product fit CitrOSponge well. Our in vivo testing exhibited superiority to existing products, and we plan further large-scale testing to validate these results. Finally, we believe our business model allows us to succeed quickly and at a relatively low cost. Our initial discussions with the FDA have indicated that we can pursue a fast and inexpensive 510(k) filing, allowing us to potentially get to market within 2-3 years. We have also already spoken to several potential strategic partners, which may allow us to accelerate product development, enter into out-licensing agreements, or provide exit opportunities with an acquisition. Our low manufacturing costs allow us to maintain large margins and profitability with even a small market share. The existing market is extremely large yet lacks effective solutions, and we believe that CitrOSponge addresses these needs and will allow us to succeed.
What is this business looking for from KVC?
I learned of KVC from its cofounder David Schonthal, whom I met at a Northwestern Entrepreneurship Week event where we were both panelists, and am extremely interested in working with KVC’s experienced and talented mentors. While our founding team brings together a broad range of experience and is committed to Citrics’ success, we also realize that we lack experience in certain areas (particularly in life sciences-related product development and regulatory matters), and hope to gain from the experience and advice that the KVC mentor community can provide. We are recruiting an advisory board and are interested in any KVC members who would be a good mutual fit, and would also welcome any feedback to further refine our business plan and pitch. Finally, we are currently raising funding to validate our promising initial testing results and meet important milestones, and would welcome the opportunity both to present to KVC and to leverage the KVC network.
A brief biography of A.J. Noronha:
I graduated from the University of Notre Dame with a degree in Finance, and spent several years working as an analyst at a generalist venture capital firm, with my primary duties being initial due diligence on potential investments and strategic work with the management of portfolio companies. This experience gave me a great foundation in analyzing startup companies across a broad range of industries, helped me better understand the challenges facing entrepreneurs, and also greatly piqued my interest in entrepreneurship.
Following my experience at the VC fund, I then attended Northwestern University School of Law. At Northwestern, I co-founded and served as President of the school’s Private Equity and Entrepreneurship club, and was also active with the school’s Small Business Opportunity Center. The latter allowed me to get great experience working with local entrepreneurs on a broad range of legal and strategic issues. I have also worked informally with numerous other startups over the last few years.
At Northwestern, I was a part of the inaugural Medical Innovations course, where I met Dr. Guillermo Ameer. We co-founded Citrics Biomedical following my graduation, and I have served as acting President and Director of Business Development since. I have also remained active in the Northwestern community, including Kellogg’s Entrepreneurship Week this spring and the Northwestern University Venture Challenge, and greatly appreciate the opportunity to work with the KVC community.
Partners already involved in the effort:
Co-founders: myself, Dr. Guillermo Ameer, Dr. Matthew Vaughn; Advisors: Dr. Jason Koh, Dr. Russell Reid, Dr. Salomon Amar; Informal advice and mentoring from Bob Shaw and Dr. Alicia Löffler
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This is exciting technology and I believe it has a lot of potential. I am interested in the advisory board and have regulatory and clinical research experience. I would also be interested in recruiting physicians to perform clinical trials.
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A.J., I believe I may have seen your pitch at the last
NUVC, but I did see Dr. Ameer at the Catalyzing Collaboration event
on 1/13. I could help you in creating a solid value proposition,
expecially for payers, where you need to creat a health-economics
benefit. I look forwrad to hearing from you. Dan -
A.J., I believe I may have seen the Citrics Biomedical
pitch at the NUVC last year. Also, I did see Dr. Ameer at the
Catalyzing Collaboration event today (1/13/11). I can help you
create a compelling value proposition for payers, providers and
investors. A healtheconomic benefit needs to be demonstrated with
your product, which I can help you with as well. I look forward to
hearing from you. Dan -
Ilya Trakhtenberg
November 18th, 2011 on 2:28 amA.J.,
My name is Ilya Trakhtenberg and I am a first year student at Kellogg. I am very interested in the medical applications of nanotechnology and recently learned about the unique and innovative work that you are doing with Citrics. I would love to learn more about it and discuss if there are any opportunities for a current student to get involved.
Thanks and I look forward to hearing from you soon.
Ilya Trakhtenberg
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William Dirkes MD, MBA
January 13th, 2011 on 11:57 am